shell_products_2010 GTC

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CONTENTSPART ONEIn respect of FOB deliveries 3 Section 1. – Delivery 3 Section 2. – Measurement and sampling, independent inspection and certification 3 Section 3. – Risk and Property 3 Section 4. – Laydays 3 Section 5. – Nomination of Vessels, etc. 4 Section 6. – Arrival of Vessel, loading, Berth etc. 6 Section 7. – Time allowed, delays and demurrage 7PART TWOIn respect of CFR, CIF and DES deliveries 10 Section 8. – Delivery 10 Section 9. – Measurement and sampling, independent inspection and certification 10 Section 10. – Risk and Property 12 Section 11. – Laydays and Indicative Discharge Dates 12 Section 12. – Insurance 12 Section 13. – Charter party conditions 14 Section 14. – Nomination of Vessels, etc. 15 Section 15. – Arrival of Vessel, Berth, discharge, etc. 17 Section 16. – Time allowed, delays and demurrage 18PART THREEIn respect of Barge (FOB, CFR, CIF) deliveries 21 Section 17. – Applicability 21 Section 18. – Nominations in respect of FOB deliveries 21 Section 19. – Nominations in respect of CFR and CIF deliveries 21 Section 20. – Laytime 22 Section 21. – Demurrage 22PART FOURIn respect of Ex Tank, Into Tank, In Situ (stock transfer) and Free Into Pipeline (“FIP”) deliveries 23 Section 22. – Nominations 23 Section 23. – Measurement and sampling; independent inspection 23 Section 24. – Risk and Property 24Page 1PART FIVEIn respect of deliveries in bulk to/by Road Tanker/Rail Tank Cars FCA, CPT, CIP, DDU, DDP or DAF 25 Section 25. – Nominations 25 Section 26. – Risk and Property 25 Section 27. – Acceptance of road or rail tank cars 25 Section 28. – Insurance 25 Section 29. – Other terms and conditions applicable to delivery by rail tank car 26PART SIXApplicable to each of Parts One, Two, Three, Four and Five 27 Section 30. – Definitions, etc. 27 Section 31. – Quality and Claims in respect of quality/quantity 30 Section 32. – Health, Safety and Environment 30 Section 33. – Destination 32 Section 34. – VAT, GST, MOT and other taxes, duties etc. 32 Section 35. – Payment 35 Section 36. – New and changed regulations, etc. 40 Section 37. – Force majeure, etc. 40 Section 38. – Limitation of liabilities 41 Section 39. – Termination or suspension, etc. 42 Section 40. – Limitation on assignment 42 Section 41. – Notices 42 Section 42. – Trade controls and boycotts 43 Section 43. – Facilitation Payments and Anti-Corruption 43 Section 44. – Referee, High Court, Arbitration and Small Claims 44 Section 45. – Miscellaneous 45 Section 46. – Applicable law 46PART SEVENSchedules 47 Schedule A – Seller’s Indemnity format 47 Schedule B – Letter of Credit format 49 Schedule C – Standby Letter of Credit format 51 Schedule D – Supplement in respect of EU documentation, etc. 52 Schedule E – Requirements in respect of Vessels at the Loading Terminal or Discharge Port and,where applicable, during the voyage 55 Schedule F – Shell Casualty Procedure 59 Schedule G – Supplement in respect of LPG 60 Schedule H – Supplement in respect of CFR and CIF deliveries with Shell Group companies where the Loading Terminal is located in the U.S.A or U.S. Territories 61PART ONEIn respect of FOB deliveriesSection 1.– DeliveryThe Product shall be delivered by the Seller to the Buyer, in bulk FOB at the Loading Terminal on to Vessel(s) provided or procured by the Buyer.Section 2.– Measurement and sampling, independent inspection and certification2.1Measurement and samplingThe quantity and quality of the Product delivered under the Agreement shall be determined by measurement, sampling and testing in accordance with the standard practice at the Loading Terminal at the time of shipment. Notwithstanding the provisions of Section 2.2, the certificates of quantity and quality (or such other equivalent documents as may be issued at the Loading Terminal) for the Product comprising the shipment issued in accordance with such standard practice shall, except in cases of manifest error or fraud, be conclusive and binding on both parties for invoicing purposes but without prejudice to the rights of either party to make any claim pursuant to Section 31.2.2Independent inspection2.2.1Either party may appoint a mutually acceptable independent inspector at the LoadingTerminal, subject to any necessary prior agreement of the Loading Terminal operator havingbeen obtained. Such appointment shall be notified in writing to the other party. Unlessotherwise provided for in the Special Provisions, all charges in respect thereof shall be sharedequally between the parties and the inspector's report shall be made available to both parties.2.2.2In addition to the independent inspector appointed pursuant to Section 2.2.1 or should the partiesfail to mutually agree upon an independent inspector, either party may, at its own expense,appoint a representative at the Loading Terminal, subject to any necessary prior agreement of theLoading Terminal operator.2.3Place of CertificationShould it not be customary practice at the Loading Terminal at the time of shipment for measurement and sampling pursuant to Section 2.1 to take place at the Vessel’s manifold immediately prior to loading, or should the parties agree otherwise, then it is a condition of the Agreement that the Seller shall be obliged to provide the same quantity and quality of the Product at the Vessel’s permanent hose connection as set out in the certificates of quantity and quality so issued.Section 3.– Risk and Property3.1Notwithstanding any right of the Seller to retain the documents referred to in Section 35 until payment,the risk and property in the Product delivered under the Agreement shall pass to the Buyer as the Product passes the Vessel's permanent hose connection at the Loading Terminal.3.2Any loss of or damage to the Product during loading, if caused by the Vessel or its officers or crew,shall be for the account of the Buyer. Any claim made by the Seller’s supplier(s) against the Seller in respect of damage to any facilities at the Loading Terminal (or in the event the facilities are operated by the Seller any claim by the Seller or by an Affiliate of the Seller) caused by the Buyer’s Vessel shall be borne by the Buyer.Section 4.– Laydays4.1The Laydays shall be the day or range of days (issued in accordance with standard practice at theLoading Terminal) in which:4.1.1the Buyer’s nominated Vessel must tender a valid NOR at the Loading Terminal pursuant toSection 6.1; and4.1.2the Seller shall have a sufficient quantity of the Product deliverable under the Agreementavailable at the Loading Terminal so as to enable loading to commence and continue on anuninterrupted basis pursuant to Section 6.2.4.2The Laydays shall be either:4.2.1as specified in the Special Provisions; or4.2.2established in accordance with the procedure(s) specified in the Special Provisions; or4.2.3where such Laydays cannot be ascertained by reference to Sections 4.2.1 or 4.2.2, asnotified by the Seller to the Buyer by not later than either:(a)the date 12 days prior to the first day of the Laydays so notified; or(b)the 20th day of the month preceding the first month in which the Laydays fall, whicheveris the later.4.3The Laydays established in accordance with Sections 4.2.2 or 4.2.3 shall, unless otherwisespecifically agreed between the parties, fall entirely within any delivery period specified in the Special Provisions.Section 5.– Nomination of Vessels, etc.5.1Full and part cargo lotsUnless otherwise provided in the Special Provisions, delivery hereunder shall be given and taken in one full cargo lot or a part cargo lot at the Buyer's option but subject always to the prior agreement of the Loading Terminal operator.5.2Nomination of Vessel5.2.1Each Vessel shall be nominated in writing by the Buyer to the Seller. Such nomination shallspecify:(a)the name of the Vessel, date built, summer deadweight, length and flag;(b)the grade and approximate quantity to be loaded;(c)the ETA of the Vessel;(d)the destination(s) of the Vessel;(e)such other information as may be required by the Loading Terminal operator from time totime;(f)full written instructions regarding the particulars and destination of the bills of lading andsuch other customary Loading Terminal documentation which may be required by theBuyer;(g)details of any cargo on board or to be laden on board if loading a part cargo; and(h)confirmation that the Vessel complies with the requirements of Schedule E hereto.5.2.2The nomination shall not be effective unless it is received by the Seller not later than 5 daysprior to the first day of the Laydays. Notwithstanding the foregoing, if the nomination isreceived by the Seller after such 5th day and is accepted by the Seller, it shall be effective butthe Buyer shall be liable for all costs resulting from any delays in loading the Product under theAgreement that are due directly to the failure by the Buyer to nominate in a timely manner andany such delays shall not count as time allowed to the Seller for loading or if the Vessel is ondemurrage, as demurrage. In the event that the Agreement is entered into 5 days or less priorto the first day of the Laydays then the nomination must be received, by the Seller, no less than2 days prior to the first day of the Laydays.5.3Substitution of VesselsIn respect of any nominated Vessel, the Buyer may, or if necessary to perform its obligations under the Agreement must, substitute therefor another Vessel provided always that:5.3.1the size of the substitute Vessel and the quantity to be loaded shall not, without the priorwritten consent of the Seller, differ materially from the size of the Vessel previously named andthe quantity specified in the nomination;5.3.2the Laydays which would have applied in respect of the Vessel originally nominated shallapply to the substitute Vessel; and5.3.3the Buyer shall give to the Seller notice in writing of the name and the destination(s) of thesubstitute Vessel as soon as practicably possible but in any event not later than the ETA of thesubstitute Vessel or the ETA of the Vessel originally nominated, whichever is the earlier.5.4ETAThe Buyer or its representative shall notify the Seller or its representative of any change(s) in the ETA notified pursuant to Sections 5.2 or 5.3, but the Laydays shall be revised only with the Seller's specific written agreement. The giving or withholding of such agreement shall be at the absolute discretion of the Seller.5.5Rejection of nominations and Vessels5.5.1The Seller shall give notice accepting or rejecting any Vessel nominated by the Buyer within 1Business Day of receipt of the Buyer’s nomination.5.5.2Notwithstanding anything to the contrary express or implied elsewhere herein, the Seller shall havethe right:(a)to reject any nomination made by the Buyer pursuant to Sections 5.2 or 5.3 on anyreasonable ground; and/or(b)to refuse, on any reasonable ground, to accept for loading any Vessel named pursuantto Sections 5.2 or 5.3; and/or(c)to reject the Vessel in question, notwithstanding any prior acceptance of such Vessel(whether named in the Special Provisions or nominated or substituted pursuant to Sections5.2 or 5.3), on any reasonable ground if such Vessel is involved in any incident or morerecent information regarding such Vessel becomes available to the Seller which indicatesthat the information relied upon by the Seller in previously accepting the Vessel wasmaterially incorrect or incomplete; and/or(d)without derogating from any other reasonable grounds that may be available to theSeller it shall be a reasonable ground for the Seller to reject or refuse a Vessel pursuantto this Section if the Vessel, either at the time of nomination or subsequently at any timeup to the time of commencement of loading, is not approved by any internal ship vettingsystem operated by the Seller or alternatively is determined by such internal ship vettingsystem to be unacceptable under the Seller’s ship vetting policy.5.6Regulations at the Loading Terminal5.6.1All restrictions at the Loading Terminal with respect to maximum draft, length, deadweight,displacement, age, flag and the like, the procedures relevant to health, safety and Vesseloperations and all applicable governmental, local and port authority regulations and anyother applicable requirements of whatever nature in force at the Loading Terminal shall applyto the Buyer's Vessel (including without limitation the requirements set out in Schedule E).Notwithstanding Section 5.6.2, the Buyer shall be deemed to be fully familiar with suchLoading Terminal requirements and shall nominate a Vessel that can comply with suchrequirements at all times.5.6.2The Seller shall provide all information regarding restrictions at the Loading Terminal and suchother Loading Terminal requirements that are readily available to it, upon the Buyer’s writtenrequest.5.6.3Notwithstanding anything to the contrary express or implied in this Section 5 or in Sections 6and 7, if any Vessel nominated by the Buyer does not comply with the foregoing provisions orany of them, the Seller or the Seller's supplier may refuse to berth or load the Vessel inquestion.5.7Changes in proceduresThis Section 5 shall be subject to modification, by written notice from the Seller to the Buyer, to take account of changes in the nomination and/or other procedures applicable from time to time at the Loading Terminal.5.8LiabilityThe Seller shall not be liable for the consequences of rejection or delay (including but not limited to demurrage) of the Vessel or other restriction suffered in respect of the Vessel by virtue of the application of any regulations or other requirements of this Section 5 and/or of Schedule E, and the Buyer shall be liable for any costs or damages incurred by the Seller arising out of any such rejection of, delay to or restriction of the Vessel.Section 6.– Arrival of Vessel, loading, Berth etc.6.1Arrival of Vessel6.1.1The Buyer shall arrange for its Vessel to report its ETA to the Loading Terminal, with a copy tothe Seller, at least 72, 48 and 24 hours prior to its arrival and otherwise in accordance withthe standard reporting procedure applicable from time to time at the Loading Terminal inquestion. If the Buyer’s Vessel fails, for any reason, to give at least 24 hours’ prior notice ofarrival at the Loading Terminal, the time allowed to the Seller for loading pursuant to Section7.1 shall be extended by a period equal to the delay in giving such 24 hours’ notice, but inany case not exceeding an additional 24 hours.6.1.2By no later than 2400 hours (local time) on the last day of the Laydays the Vessel must have:(a)arrived at the Loading Terminal in question (or the usual waiting place), and be in allrespects ready to commence loading the Product deliverable hereunder; and(b)tendered a valid NOR.6.1.3Once a valid NOR has been tendered pursuant to Section 6.1.2, the Buyer shall be obligedto receive delivery of the Product in accordance with Section 6.2.2.6.2Loading6.2.1Unless otherwise agreed in writing by the Seller, the Seller shall not be under any obligationto commence loading hereunder prior to 0600 hours (local time) on the first day of theLaydays.6.2.2After receipt of the NOR pursuant to Section 6.1.2, the Seller, having regard to therequirements of the Loading Terminal, Loading Terminal procedures and the time when theVessel has complied with the provisions of Section 6.1, shall commence loading as soon asreasonably practicable, even if this means that loading is effected or completed outside theLaydays or outside any other period specified in the Special Provisions.6.3Berth6.3.1Subject to compliance by the Buyer’s nominated Vessel with all other requirements of theLoading Terminal at the time in question, the Seller shall provide or cause to be provided freeof charge to the Buyer (subject to the provisions of Section 34) a Berth to be indicated by theSeller or its representative that the Vessel can safely reach and leave and where it can lie andload always safely afloat.6.3.2The Seller shall at all material times and at no expense to the Buyer provide and maintain orcause to be provided and maintained, in good working order, all necessary flexible hoses,connections, pipelines, tankage facilities necessary for the loading of the Buyer’s Vessel.6.3.3The Seller shall not be deemed to warrant the safety of any channel, fairway or otherwaterway used in approaching or departing from the Berth designated by the Seller. TheSeller shall not be liable for any loss, damage, injury or delay to the Buyer’s Vessel resultingfrom the use of such waterways; or any damage to the Buyer’s Vessel caused by other usersof the waterway.6.3.4Notwithstanding Section 6.3.1 above, if the Berth in question requires the Buyer’s Vessel tobe loaded from a floating storage facility, lighter or other Vessel by means of ship-to-shiptransfer, such Berth shall be subject to the Buyer’s ship or Loading Terminal vetting proceduresand the Buyer may, on any reasonable ground and without liability, refuse the use of suchfacility for the purpose of loading its nominated Vessel. Any ship-to-ship or lighteringoperations shall be carried out in accordance with the procedures set out in the ICS/OCIMFShip-to-Ship transfer guides.6.4Vacation of BerthThe Buyer's Vessel shall vacate the Berth as soon as loading hoses have been disconnected, provided that such Vessel’s departure is not delayed awaiting production of Loading Terminal documents unless such documents can be delivered to the Vessel at a suitable anchorage or where early departure procedure (“EDP”) is applied. If the Vessel fails to vacate the Berth due to a cause within the control of the Vessel and/or the Buyer, any loss or damage suffered by the Seller, or its supplier, resulting from such failure shall be paid by the Buyer to the Seller. For the avoidance of doubt, it is agreed that for the purposes of this Section any technical failure or breakdown on the part of the Vessel shall be a cause within the control of the Vessel and the Buyer.The Buyer’s liability in such event shall be limited to no more than the excess Berth utilisation charge actually incurred by the Seller pursuant to Section 6.5 and/or any demurrage suffered by the next Vessel scheduled to load that had been delayed as a direct result of such failure and such demurrage having actually been incurred by the Seller. The Buyer’s liability for such demurrage shall be limited to no more than the excess time taken by the Buyer’s vessel to vacate the Berth.6.5Berth utilisationNotwithstanding the provisions of Section 7, if at the Loading Terminal the Seller's supplier or any other agency (whether or not an Affiliate of the Seller) imposes on the Seller, in respect of the Buyer's Vessel, an excess Berth utilisation charge in accordance with the Loading Terminal regulations or a contractually agreed or otherwise established scale for any hours of Berth utilisation in excess of a specified period of hours (as such scale may be advised by the Seller to the Buyer from time to time), but does not impose such charge directly on the Buyer's Vessel itself, such charge shall be for the Buyer's account, except where such excess Berth utilisation is caused by the Loading Terminal, the Seller or the Seller’s supplier.6.6Shifting and Lightering6.6.1The Seller shall have the right to shift the Vessel from one Berth to another. All costs, includingbut not limited to damages for delay, shall be for the Seller's account if such shifting is for theSeller's purposes and otherwise shall be for the Buyer's account.6.6.2The Seller shall have the option to load the Vessel from lighters subject always to the Buyer’srights under Section 6.3.4, when the cost of such lighterage (together with any additionalexpense reasonably incurred by the Vessel in respect thereof) shall be for the Seller’s account.The Seller shall be obliged to notify the place of lightering to the Vessel when NOR istendered. The place of lightering so notified shall be deemed the Berth for the purposes ofSections 6 and 7 and all references therein to the Berth shall be construed accordingly. Section 7.– Time allowed, delays and demurrage7.1Time allowedThe time allowed to the Seller for the loading of the quantity of the Product deliverable hereunder to each Vessel shall be:7.1.1in the case of Vessels of 15,000 tons summer deadweight or less, 24 running hours; or7.1.2in all other cases, 36 running hours;all days and holidays included unless loading on the day or holiday in question is prohibited by law or regulation at the Loading Terminal.7.2Running hours7.2.1Except as otherwise provided in the Special Provisions or in this Section 7.2, provided alwaysthat the Buyer has complied with Section 6.1, running hours shall commence Berth or no Bertheither:(a) 6 hours after a valid NOR is tendered to the Seller or its representative by the master ofthe Vessel (or the master’s representative) after its arrival at the Loading Terminal, or(b)if the Vessel moved directly to the Berth, when the Vessel is securely moored at the Berth,whichever is the earlier.7.2.2If NOR is given for the Vessel before the first day of the Laydays, running hours shallcommence at 0600 hours (local time) on the first day of the Laydays or on commencement ofloading, whichever is the earlier. If NOR is given for the Vessel after the last day of theLaydays and is accepted for loading by the Seller in its sole and absolute discretion, then,without prejudice to any of the Seller’s other rights, running hours shall commence only oncommencement of loading.7.2.3Time shall cease to run upon final disconnection of loading hoses after completion of loading ofthe cargo. However, time shall recommence 2 hours after disconnection of hoses if the Vessel isdelayed in its departure due to the Seller’s or the Seller’s supplier’s purposes and shall continue untilthe termination of such delay.7.2.4Any delay arising out of or in connection with any of the following situations shall not becounted or included in calculating the time taken by the Seller to load the shipment or the timein respect of which the Seller is liable for demurrage (whether or not the Vessel is already ondemurrage):(a)awaiting tide, tugs, pilot, daylight, ice, moderation of weather or sea state prior toberthing;(b)awaiting immigration, customs or pratique;(c)on an inward passage until the Vessel is securely moored at the Berth;(d)preparing for and handling or shifting of ballast, bilges, slops or other substances orbunkering unless concurrent with cargo operations;(e)restrictions imposed by the owner, charterer or master of the Vessel;(f)any breakdown of the Vessel's equipment or failure to comply with the requirements ofthe Loading Terminal with respect to equipment aboard;(g)cleaning and inspection of the Vessel's cargo tanks;(h)time spent complying with any of the regulations and other requirements referred to inSection 5;(i)any other delay attributable to the Vessel, the Buyer or agents of the Buyer; or(j)any onboard strike, lockout, stoppage or restraint of labour by members of the crew.7.3DelaysIn the event of any delay of any kind or from any cause whatsoever whether in connection with the scheduling of the Vessel's turn to load (including any change in such scheduling), provision of a Berth for the Vessel, berthing or loading of the Vessel or otherwise howsoever without limitation, and provided always that the Vessel is eventually loaded pursuant to Section 6.2.2, any rights of the Buyer against the Seller, however the same may arise and whether or not arising under the Agreement, shall be limited in all circumstances whatsoever to a claim for the payment of demurrage, and the Buyer shall not be entitled to complain directly or indirectly of any delay except for the purpose of founding a claim to such demurrage.7.4Demurrage7.4.1If the shipment is not loaded within the time allowed in accordance with Section 7.1, the timeso allowed shall be extended by the excess time but (subject always to Section 5.2.2 and6.1.1) the Seller shall pay to the Buyer demurrage, in the same currency as is prescribed forpayment for the Product delivered under the Agreement, in respect of the excess time at theappropriate rate per day (or pro rata for part of a day) as hereinafter specified. The Seller'sliability for demurrage shall be absolute and not be subject to the provisions of Section 37, butin the event of delay directly attributable to fire or explosion or the breakdown or failure ofequipment, plant or machinery at the Loading Terminal (not resulting from want of due diligenceby the Seller), act of war, civil commotion, or arrest or restraint of princes, rulers or peoples, therate of demurrage shall be reduced by one half for the period of such delay.7.4.2The appropriate rate of demurrage shall be either:(a)the rate, if any, specified in the Special Provisions; or(b)the applicable single voyage charterparty rate; or(c)where there is no single voyage charterparty rate or, in the Seller’s sole opinion thesingle voyage charterparty rate is not representative of the market rate, the market ratecurrent on the date running hours commence as aforesaid for a Vessel of the size andtype used for a single voyage charter from the Loading Terminal to the Discharge Port. Ifthe parties fail to agree within 30 days upon such rate, then at the request of eitherparty, such rate shall be determined by The London Tanker Brokers Panel Ltd. (or itssuccessors in title), whose decision thereon shall be final and binding and whose costsshall be paid for by the applicant;7.4.3Any demurrage claim must be notified to the Seller in writing within 45 days of the date ofdisconnection of loading hoses, with full supporting documentation (including, but notexclusively, the time computation, NOR, Vessel’s port log, statement of facts and, whereapplicable, evidence of the charterparty rate), together with any other documentation that theSeller may reasonably require. Any such documentation not then available shall be providedto the Seller within 180 days of the disconnection of loading hoses. If the Buyer fails to givesuch notice or provide such documentation within the above respective time limits, then theBuyer’s claim shall be deemed to have been waived and any liability of the Seller fordemurrage shall be extinguished.7.4.4Notwithstanding the provisions of this Section 7 or the charterparty (where the SpecialProvisions specify that laytime and demurrage shall be determined in accordance with thecharterparty terms and conditions), the Buyer shall not be entitled to recover demurrage fromthe Seller except to the extent that the Seller is able to recover and does recover suchdemurrage from the Seller’s supplier and the Seller shall not be obliged to pay any amounts inexcess thereof.7.4.5The Seller may only rely on Section 7.4.4 if, and to the extent that:(a)the Seller’s acquisition terms with Seller’s supplier include laytime and demurrageprovisions so as to allow the recovery of demurrage on terms that are no worse than theLoading Terminal's usual terms; and(b)the Seller has exercised reasonable endeavours to recover from the Seller’s supplier anydemurrage for which the Buyer has presented a claim.7.5Part cargo lotsIf the delivery hereunder is co-loaded with the Product being delivered to the Buyer by another supplier at the same Berth, the Seller shall only be liable for that proportion of the demurrage equal to the ratio of the volume delivered by the Seller to the total volume loaded onto the Vessel at that Berth.。

PanelView Plus 7 Performance终端产品目录说明书

Technical DataPanelView Plus 7 Performance TerminalsCatalog Numbers 2711P-T7C22D9P , 2711P-T7C22D9P-B, 2711P-T7C22A9P , 2711P-T7C22A9P-B, 2711P-B7C22D9P , 2711P-B7C22D9P-B, 2711P-B7C22A9P, 2711P-B7C22A9P-B, 2711P-T9W22D9P , 2711P-T9W22D9-B, 2711P-T9W22A9P , 2711P-T9W22A9P-B, 2711P-T10C22D9P , 2711P-T10C22D9P-B, 2711P-T10C22A9P, 2711P-T10C22A9P-B, 2711P-B10C22D9P , 2711P-B10C22D9P-B, 2711P-B10C22A9P , 2711P-B10C22A9-B, 2711P-T12W22D9P , 2711P-T12W22D9P-B, 2711P-T12W22A9P , 2711P-T12W22A9P-B, 2711P-T15C22D9P , 2711P-T15C22D9P-B, 2711P-T15C22A9P , 2711P-T15C22A9P-B, 2711P-B15C22D9P , 2711P-B15C22D9P-B, 2711P-B15C22A9P , 2711P-B15C22A9P-B, 2711P-T19C22D9P , 2711P-T19C22D9P-B, 2711P-T19C22A9P , 2711P-T19C22A9P-BSummary of ChangesThe PanelView™ Plus 7 Performance terminals are operator interface devices. They monitor and control devices that are attached to ControlLogix® and CompactLogix™ 5370controllers on an EtherNet/IP network. Animated graphic and text displays provide operators a view into the operating state of a machine or process. Operators interact with the control system by using touch screen or keypad input.TopicPage Environmental Specifications 2Certifications 3Technical Specifications 4Product Dimensions 7Accessories 8HMI Software 9Additional Resources10TopicPage Updated system memory to 512 MB RAM and 512 MB storage.Updated user memory to 80 MB, approx, nonvolatile storage for applications.4, 5, 62Rockwell Automation Publication 2711P-TD009C-EN-P - July 2016PanelView Plus 7 Performance TerminalsFeatures include the following:•FactoryTalk® View Machine Edition software, version 8.1, provides a familiar environment for creating HMI applications•Windows CE operating system with desktop access for configuration and third-party applications •Connection to ControlLogix or CompactLogix 5370 controllers•Ethernet communication that can support Device Level Ring (DLR), linear, or star network topologies•W eb browser, Microsoft file viewers, text editor, PDF viewer, remote desktop connection, and media player on the terminal desktopEnvironmental SpecificationsThis table lists environmental specifications for the PanelView Plus 7 Performance terminals.AttributeValueTemperature, operating (1)(1)The 19-inch terminals (2711P-T19C22D9P , 2711P-T19C22D9P-B, 2711P-T19C22A9P , and 2711P-T19C22A9P-B) are rated up to 50 °C (122 °F) operating temperature.0…55 °C (32…131 °F)Temperature, nonoperating-25…+70 °C (-13…+158 °F)Heat dissipation (2)(2)Typical BTU measurements were taken at 25 °C (77 °F).7-in. DC (touch, and touch with keypad), 51 BTU (typical)7-in. AC (touch, and touch with keypad), 53 BTU (typical)9-in. DC, 55 BTU (typical)9-in. AC, 58 BTU (typical)10-in. DC (touch, and touch with keypad), 51 BTU (typical)10-in. AC (touch, and touch with keypad), 56 BTU (typical)12-in. DC, 60 BTU (typical)12-in. AC, 67 BTU (typical)15-in. DC (touch, and touch with keypad), 61 BTU (typical)15-in. AC (touch, and touch with keypad), 68 BTU (typical)19-in. DC, 114 BTU (typical)19-in. AC, 119 BTU (typical)Altitude, operating 2000MRelative humidity 5…95% without condensation Vibration 0.012 pk-pk, 10…57 Hz 2 g peak at 57…500 Hz (3)(3)The 15-inch and 19-inch terminals (2711P-T15C22D9P , 2711P-T15C22D9P-B, 2711P-T15C22A9P , 2711P-T15C22A9P-B, 2711P-B15C22D9P , 2711P-B15C22D9P-B,2711P-B15C22A9P , 2711P-B15C22A9P-B, 2711P-T19C22D9P , 2711P-T19C22D9P-B, 2711P-T19C22A9P , 2711P-T19C22A9P-B) are rated to: 0.006 in. pk-pk, 10...57 Hz, 1 g peak at 57...640 Hz.Shock, operating 15 g at 11 ms Shock, nonoperating 30 g at 11 msEnclosure ratingsNEMA and UL Type 12, 13, 4X, also rated IP66 as Classified by ULRockwell Automation Publication 2711P-TD009C-EN-P - July 20163PanelView Plus 7 Performance TerminalsCertificationsThis table lists certifications for the PanelView Plus 7 Performance terminals.Certification (1)(1)When marked. See the Product Certification link at /global/certification/overview.page for Declarations of Conformity, Certificates, and othercertification details.ValuecULuscULus Listed Industrial Control Equipment for use in Hazardous Locations (E10314) per standards ANSI / ISA 12.12.01 and CSA C22.2 No. 213. rated:•Class I, Div 2, Groups A, B, C, DEnclosure type ratings per UL50 and CSA C22.2 No. 94.2-07. Enclosure ingress protection classified by UL per IEC 60529.CE (EMC)European Union 2004/108/EC EMC Directive, compliant with:•EN 61000-6-2; Industrial Immunity •EN 61000-6-4; Industrial Emissions •EN 61131-2; Programmable ControllersCE (LVD)European Union 2006/95/EC Low Voltage Directive, compliant with:•EN 61131-2; Programmable Controllers RCM Australian Radiocommunications Act, compliant with:•AS/NZS CISPR 11; Industrial Emissions RoHS China RoHS, Turkey RoHS, European RoHS KCC Certificate of complianceEtherNet/IPODVA conformance tested to EtherNet/IP specifications4Rockwell Automation Publication 2711P-TD009C-EN-P - July 2016PanelView Plus 7 Performance TerminalsTechnical SpecificationsThe tables in this section provide technical specifications for the PanelView Plus 7 Performance terminals.PanelView Plus 7 Performance 7-in and 9-in TerminalsAttribute 7-in. Touch2711P--T7C22D9P , 2711P--T7C22D9P-B (1)2711P-T7C22A9P , 2711P-T7C22A9P-B (1)Catalog numbers with a -B extension denote terminals that exclude the Allen-Bradley brand marking. Customers can put their own brand labels on these terminals.7-in. Touch with Keypad2711P-B7C22D9P , 2711P-B7C22D9P-B (1)2711P-B7C22A9P , 2711P-B7C22A9P-B 9-in. Touch2711P-T9W22D9P, 2711P-T9W22D9P-B (1)2711P-T9W22A9P , 2711P-T9W22A9P-BOperator input Touch Touch with keypadTouchDisplay type TFT Color Display size, diagonal 6.5-in.9-in. widescreen Viewing area (W x H)132 x 99 mm (5.2 x 3.9 in.)196 x 118 mm (7.7 x 4.6 in.)Display resolution 640 x 480 VGA, 18-bit color graphics 800 x 480 WVGA, 18-bit color graphics Aspect ratio 4:3 5:3Brightness, typical 300 cd/m 2 (Nits)Backlight lifeWhite light-emitting diode, solid-stateLife: 50,000 h min at 40 °C (104 °F) to half-brightness, backlight is not replaceable Touch screenAnalog resistiveActuation rating: 1 million presses Operating force: 100 grams Battery (real-time clock backup)Accuracy: +/-2 minutes per month.Battery life: 4 years min at 25 °C (77 °F)Replacement: CR2032 lithium coin cellMemory:•System •User •512 MB RAM and 512 MB storage•80 MB, approx, nonvolatile storage for applicationsSecure Digital (SD) card slot One SD card slot for external storage; supports cat. no. 1784-SD x cardsUSB ports:•Host •Device •Two USB high-speed 2.0 host ports (type A) support removable flash drives for external storage •One high-speed 2.0 device port (type B) that will be functional in a future releaseOperating system Windows CE with Extended Features and MS Office Viewers (includes FTP , VNC client server, ActiveX controls, PDF reader, third-party device support)Ethernet ports Two 10/100Base-T, Auto MDI/MDI-X Ethernet ports that support Device Level Ring (DLR), linear, or star network topologies Software FactoryTalk View Studio for Machine Edition, FactoryTalk ViewPoint, version 2.6 or laterElectrical Input voltage 24V DC nom (18…30V DC)100…240V AC 24V DC nom (18…30V DC)100…240V AC 24V DC nom (18…30V DC)100…240V AC Power consumption 50 W max(2.1 A at 24V DC)105VA 50 W max(2.1 A at 24V DC)105VA 50 W max(2.1 A at 24V DC)105VA Power supply Supports (SELV) and (PELV) 24V DC supplies (2)(2)DC-powered terminals support safety extra low voltage (SELV) and protective extra low voltage (PELV) 24V DC power supplies such as cat. nos. 1606-XLP95E, 1606-XLP100E, 2711P-RSACDIN.—Supports (SELV) and (PELV) 24V DC supplies (2)—Supports (SELV) and (PELV) 24V DC supplies (2)—Mechanical Weight, approx 1.2 kg (2.65 lb) 1.47 kg (3.25 lb) 1.58 kg (3.48 lb)Dimensions, approx (H x W x D)170 x 212 x 69.6 mm 6.69 x 8.35 x 2.74 in.179 x 285 x 69.6 mm 7.05 x 11.22 x 2.74 in.190 x 280 x 69.6 mm 7.48 x 11.02 x 2.74 in.Cutout dimensions, approx (H x W)142 x 184 mm 5.59 x 7.24 in.142 x 237 mm 5.59 x 9.33 in.162 x 252 mm 6.38 x 9.92 in.Rockwell Automation Publication 2711P-TD009C-EN-P - July 20165PanelView Plus 7 Performance TerminalsPanelView Plus 7 Performance 10-in and 12-in TerminalsAttribute 10-in. Touch2711P-T10C22D9P, 2711P-T10C22D9P-B (1)2711P-T10C22A9P , 2711P-T10C22A9P-B (1)Catalog numbers with a -B extension denote terminals that exclude the Allen-Bradley brand marking. Customers can put their own brand labels on these terminals.10-in. Touch with Keypad2711P-B10C22D9P , 2711P-B10C22D9P-B (1)2711P-B10C22A9P , 2711P-B10C22A9P-B 12-in. Touch2711P-T12W22D9P , 2711P-T12W22D9P-B (1)2711P-T12W22A9P , 2711P-T12W22A9P-B Operator input Touch Touch with keypadTouchDisplay type TFT Color Display size, diagonal 10.4-in.12.1-in.Viewing area (W x H)211 x 158 mm (8.3 x 6.2 in.)261 x 163 mm (10.3 x 6.4 in.)Display resolution 800 x 600 SVGA, 18-bit color graphics 1280 x 800 WXGA, 18-bit color graphics Aspect ratio 4:316:10Brightness, typical 300 cd/m 2 (Nits)Backlight lifeWhite light-emitting diode, solid-stateLife: 50,000 h min at 40 °C (104 °F) to half-brightness, backlight is not replaceable Touch screenAnalog resistiveActuation rating: 1 million presses Operating force: 100 grams Battery (real-time clock backup)Accuracy: +/-2 minutes per month.Battery life: 4 years min at 25 °C (77 °F)Replacement: CR2032 lithium coin cellMemory:•System •User •512 MB RAM and 512 MB storage•80 MB, approx, nonvolatile storage for applicationsSecure Digital (SD) card slot One SD card slot for external storage; supports cat. no. 1784-SD x cardsUSB ports:•Host •Device •Two USB high-speed 2.0 host ports (type A) support removable flash drives for external storage •One high-speed 2.0 device port (type B) that will be functional in a future releaseOperating system Windows CE with Extended Features and MS Office Viewers (includes FTP , VNC client server, ActiveX controls, PDF reader, third-party device support)Ethernet ports Two 10/100Base-T, Auto MDI/MDI-X Ethernet ports that support Device Level Ring (DLR), linear, or star network topologies Software FactoryTalk View Studio for Machine Edition, FactoryTalk ViewPoint, version 2.6 or laterElectrical Input voltage 24V DC nom (18…30V DC)100…240V AC 24V DC nom (18…30V DC)100…240V AC 24V DC nom (18…30V DC)100…240V AC Power consumption 50 W max(2.1 A at 24V DC)105VA 50 W max(2.1 A at 24V DC)105VA 50 W max(2.1 A at 24V DC)105VA Power supply Supports (SELV) and (PELV) 24V DC supplies (2)(2)DC-powered terminals support safety extra low voltage (SELV) and protective extra low voltage (PELV) 24V DC power supplies such as cat. nos. 1606-XLP95E, 1606-XLP100E, 2711P-RSACDIN.—Supports (SELV) and (PELV) 24V DC supplies (2)—Supports (SELV) and (PELV) 24V DC supplies (2)—Mechanical Weight, approx 2.28 kg (5.03 lb) 2.58 kg (5.69 lb) 2.54 kg (5.60 lb)Dimensions, approx (H x W x D)252 x 297 x 69.6 mm 9.92 x 11.69 x 2.74 in.252 x 385 x 69.6 mm 9.92 x 15.16 x 2.74 in.240 x 340 x 69.6 mm 9.69 x 13.39 x 2.74 in.Cutout dimensions, approx (H x W)224 x 269 mm 8.82 x 10.59 in.224 x 335 mm 8.82 x 13.19 in.218 x 312 mm 8.58 x 12.28 in.6Rockwell Automation Publication 2711P-TD009C-EN-P - July 2016PanelView Plus 7 Performance TerminalsPanelView Plus 7 Performance 15-in and 19-in TerminalsAttribute 15-in. Touch2711P-T15C22D9P , 2711P-T15C22D9P-B (1)2711P-T15C22A9P , 2711P-T15C22A9P-B (1)Catalog numbers with a -B extension denote terminals that exclude the Allen-Bradley brand marking. Customers can put their own brand labels on these terminals.15-in. Touch with Keypad2711P-B15C22D9P, 2711P-B15C22D9P-B (1)2711P-B15C22A9P , 2711P-B15C22A9P-B 19-in. Touch2711P-T19C22D9P , 2711P-T19C22D9P-B (1)2711P-T19C22A9P, 2711P-T19C22A9P-B Operator input Touch Touch with keypadTouchDisplay type TFT Color Display size, diagonal 15-in.19-in.Viewing area (W x H)304 x 228 mm (12.0 x 9.0 in.)376 x 301 mm (14.8 x 11.9 in.)Display resolution 1024 x 768 XGA, 18-bit color graphics 1280 x 1024 SXGA, 18-bit color graphics Aspect ratio 4:35:4Brightness, typical 300 cd/m 2 (Nits)Backlight lifeWhite light-emitting diode, solid-stateLife: 50,000 h min at 40 °C (104 °F) to half-brightness, backlight is not replaceable Touch screenAnalog resistiveActuation rating: 1 million presses Operating force: 100 grams Battery (real-time clock backup)Accuracy: +/-2 minutes per month.Battery life: 4 years min at 25 °C (77 °F)Replacement: CR2032 lithium coin cellMemory:•System •User •512 MB RAM and 512 MB storage•80 MB, approx, nonvolatile storage for applicationsSecure Digital (SD) card slot One SD card slot for external storage; supports cat. no. 1784-SD x cardsUSB ports:•Host •Device •Two USB high-speed 2.0 host ports (type A) support removable flash drives for external storage •One high-speed 2.0 device port (type B) that will be functional in a future releaseOperating system Windows CE with Extended Features and MS Office Viewers (includes FTP , VNC client server, ActiveX controls, PDF reader, third-party device support)Ethernet ports Two 10/100Base-T, Auto MDI/MDI-X Ethernet ports that support Device Level Ring (DLR), linear, or star network topologies Software FactoryTalk View Studio for Machine Edition, FactoryTalk ViewPoint, version 2.6 or laterElectrical Input voltage, DC 24V DC nom (18…30V DC)100…240V AC 24V DC nom (18…30V DC)100…240V AC 24V DC nom (18…30V DC)100…240V AC Power consumption, DC 50 W max(2.1 A at 24V DC)105VA 50 W max(2.1 A at 24V DC)105VA 50 W max(2.1 A at 24V DC)105VA Power supply Supports (SELV) and (PELV) 24V DC supplies (2)(2)DC-powered terminals support safety extra low voltage (SELV) and protective extra low voltage (PELV) 24V DC power supplies such as cat. nos. 1606-XLP95E, 1606-XLP100E, 2711P-RSACDIN.—Supports (SELV) and (PELV) 24V DC supplies (2)—Supports (SELV) and (PELV) 24V DC supplies (2)—Mechanical Weight, approx 3.69 kg (8.14 lb) 4.14 kg (9.13 lb) 5.62 kg (12.40 lb)Dimensions, approx (H x W x D)318 x 381 x 69.6 mm 12.52 x 15.00 x 2.74 in 329 x 484 x 69.6 mm 12.95 x 19.06 x 2.74 in 411 x 485 x 69.6 mm 16.18 x 19.09 x 2.74 in Cutout dimensions, approx (H x W)290 x 353 mm 11.42 x 13.90 in290 x 418 mm 11.42 x 16.46 in383 x 457 mm 15.08 x 17.99 inRockwell Automation Publication 2711P-TD009C-EN-P - July 20167PanelView Plus 7 Performance TerminalsProduct DimensionsThe table provides product dimensions. The 10.4-inch touch and combination keypad with touch devices are shown for illustrative purposes. All other terminal sizes look similar.PanelView Plus 7 Performance Dimensions - 10.4-in. ModelProduct Dimensions - PanelView Plus 7 Performance TerminalsTerminal Size Input Type Height (a)mm (in.)Width (b)mm (in.)Overall Depth (c)mm (in.)Mounted Depth (d)mm (in.)6.5-in.Key/touch 179 (7.05)285 (11.22)69.6 (2.74)63.6 (2.50)Touch 170 (6.69)212 (8.35)9-in.Touch 190 (7.48)280 (11.02)10.4-in.Key/touch 252 (9.92)385 (15.16)Touch 252 (9.92)297 (11.69)12.1-in.Touch 246 (9.69)340 (13.39)15-in.Key/touch 329 (12.95)484 (19.06)Touch 318 (12.52)381 (15.00)19-in.Touch411 (16.18)485 (19.09)TIPWhen mounted in a panel, the front of the bezel extends less than 6.36 mm (0.25 in.) from the front of the panel.b8Rockwell Automation Publication 2711P-TD009C-EN-P - July 2016PanelView Plus 7 Performance TerminalsAccessoriesThe tables in this section list accessories for the PanelView Plus 7 Performance terminals.Protective OverlaysPower Supplies and Power Terminal BlocksMounting HardwareSecure Digital (SD) CardsBattery ReplacementCat. No.(1)(1)Three overlays are shipped with each catalog number.Display Size Operator Input Touch Key and Touch2711P-RGT7SP 6.5-in.•2711P-RGB7P •2711P-RGT9SP 9-in. (wide)•2711P-RGT10SP 10.4-in.•2711P-RGB10P •2711P-RGT12SP 12.1-in. (wide)•2711P-RGT15SP 15-in.•2711P-RGB15P •2711P-RGT19P19-in.•Cat. No.DescriptionQuantity1606-XLP95E DIN rail power supply, 24…28V DC output voltage, 95 W 11606-XLP100E DIN rail power supply, 24…28V DC output voltage, 100 W 12711P-RSACDIN DIN rail power supply, AC-to-DC, 85…265V AC, 47…63 Hz 12711P-RTBAP 3-pin AC power terminal block 102711P-RTBDSP3-pin DC power terminal block10Cat. No.Description Quantity 2711P-RMCP (1)(1)Catalog number 2711P-RMCP mounting levers are used with PanelView Plus 7 Performance terminals. Do not use gray mounting levers; they are notcompatible with PanelView Plus 7 Performance terminals.Mounting levers (black)16Cat. No.Description 1784-SD1 1 GB SD card 1784-SD2 2 GB SD card2711C-RCSDUSB to SD adapter for SD cardCat. No.DescriptionQuantity2711P-RY2032Lithium coin cell battery, CR2032 equivalent1Rockwell Automation Publication 2711P-TD009C-EN-P - July 20169PanelView Plus 7 Performance TerminalsHMI SoftwareAll PanelView Plus 7 terminals are configured with FactoryTalk View Studio software and have an integrated runtime system called FactoryTalk View Machine Edition Station.Machine Edition Station runs projects that are developed with FactoryTalk View Studio software and is included on all PanelView Plus 7 terminals.Two versions of FactoryTalk View Studio software support application development for PanelView Plus 7 terminals.Y ou can import PanelView Standard/PanelBuilder® 32 and PanelView applications into FactoryTalk View Studiosoftware as Machine Edition applications by using the Machine Edition Import Wizard. The Import Wizard steps you through a few options such as scaling to a new screen resolution size, and then converts objects, text, tags, and communication configurations to ones that are available in Machine Edition.FactoryTalk ViewPoint software, an add-on to FactoryTalk View Studio software, allows plant managers, production supervisors, system integrators, and other key stakeholders to view and control real-time plant floor operations remotely from a web browser. FactoryTalk ViewPoint enabled displays are fully scalable and animated in the browser. The remote user can also view displays that are not the active display of the terminal.Each PanelView Plus 7 terminal contains one license that supports one client connection to the terminal. No additional software is required.For a complete list of available HMI software, visit /rockwellsoftware .Cat. No.(1)(1)To order localized versions of the software, replace EN in the catalog number with DE for German, FR for French, JP for Japanese, or ZH for Chinese.Description9701-VWSTMENEFactoryTalk View Studio for Machine Edition software - Configuration software for developing and testingmachine-level human machine interface (HMI) applications. Includes RSLinx® Enterprise and KEPServer Enterprise software.9701-VWSTENEFactoryTalk View Studio software - Configuration software for developing and testing machine-level and supervisory-level human machine interface (HMI) applications.10Rockwell Automation Publication 2711P-TD009C-EN-P - July 2016PanelView Plus 7 Performance TerminalsAdditional ResourcesThese documents contain more information about related products from Rockwell Automation.Y ou can view or download publications at /global/literature-library/overview.page . T o order paper copies of technical documentation, contact your local Allen-Bradley distributor or Rockwell Automation sales representative.ResourceDescriptionPanelView Plus 7 Performance Terminals User Manual, publication 2711P-UM008 Provides instructions on how to install, configure, and operate the PanelView Plus 7 Performance terminals.Industrial Automation Wiring and Grounding Guidelines, publication 1770-4.1 Provides general guidelines on how to install a Rockwell Automation industrial system.Product Certifications website, /global/certification/overview.pageProvides declarations of conformity, certificates, and other certification details.PanelView Plus 7 Performance Terminals Notes:Rockwell Automation Publication 2711P-TD009C-EN-P - July 201611Allen-Bradley, CompactLogix, ControlLogix, FactoryTalk, PanelBuilder, PanelView, LISTEN. THINK. SOLVE, Rockwell Automation, Rockwell Software, and RSLinx are trademarks of Rockwell Automation, Inc.Trademarks not belonging to Rockwell Automation are property of their respective companies.Publication 2711P-TD009C-EN-P - July 2016Supersedes Publication 2711P-TD009B-EN-P - May 2016Copyright © 2016 Rockwell Automation, Inc. All rights reserved. Printed in the U.S.A.Rockwell Automation SupportUse the following resources to access support information.Documentation FeedbackY our comments will help us serve your documentation needs better. If you have any suggestions on how to improve this document, complete the How Are W e Doing? form at /idc/groups/literature/documents/du/ra-du002_-en-e.pdf .Technical Support CenterKnowledgebase Articles, How-to Videos, FAQs, Chat, User Forums, and Product Notification /knowledgebase Local Technical Support Phone NumbersLocate the phone number for your /global/support/get-support-now.page Direct Dial CodesFind the Direct Dial Code for your product. Use the code to route your call directly to a technical support /global/support/direct-dial.page Literature LibraryInstallation Instructions, Manuals, Brochures, and Technical /literature Product Compatibility and Download Center(PCDC)Get help determining how products interact, check features and capabilities, and find associated /global/support/pcdc.pageRockwell Otomasyon Ticaret A.Ş., Kar Plaza İş Merkezi E Blok Kat:6 34752 İçerenköy, İstanbul, T el: +90 (216) 5698400Rockwell Automation maintains current product environmental information on its website at /rockwellautomation/about-us/sustainability-ethics/product-environmental-compliance.page .。

MBRB20100CT中文资料

0.74 18.79
0.065 1.651 0.420 10.66 0.07 1.78 0.14 3.56
inches mm
0.330 8.38
D2PAK POWER DISSIPATION
The power dissipation of the D2PAK is a function of the drain pad size. This can vary from the minimum pad size for soldering to a pad size given for maximum power dissipation. Power dissipation for a surface mount device is determined by TJ(max), the maximum rated junction temperature of the die, RθJA, the thermal resistance from the device junction to ambient; and the operating temperature, TA. Using the values provided on the data sheet for the D2PAK package, PD can be calculated as follows: PD = TJ(max) – TA RθJA The 50°C/W for the D2PAK package assumes the use of the recommended footprint on a glass epoxy printed circuit board to achieve a power dissipation of 2.5 watts. There are other alternatives to achieving higher power dissipation from the D2PAK package. One is to increase the area of the drain pad. By increasing the area of the drain pad, the power dissipation can be increased. Although one can almost double the power dissipation with this method, one will be giving up area on the printed circuit board which can defeat the purpose of using surface mount technology. Another alternative would be to use a ceramic substrate or an aluminum core board such as Thermal Clad™. Using a board material such as Thermal Clad, an aluminum core board, the power dissipation can be doubled using the same footprint.

ETP910C001(GE文件集成)

1.ETP #910C001 ETP Title ELECTRONICS RELIABILITYETP Type: ReliabilityRevision # 0Revision Date 12/08/03 Revision Author J Holmes, Lucas Mallory (See section 13 for revision history)Superseded Doc # (if applicable) SI700000SI700002SI700003Applicable Product Line(s): All and/or (enter other here)Platform:Subsystem: ElectronicsComponent: Board assemblies and componentsKeywords: Reliability LifeElectronics ALT85/85 Temperature CyclingHumidity Cyclic TemperatureEvaluation HALTFlatness VibrationalWarpage EmbrittlementDesign MarginIonic ChromeotographyStatic RoseCoupon TinWhisker PrintedCircuit AcceleratedHighly ChamberContents1 INTRODUCTION (3)2 ACCELERATED LIFE TESTING (4)3 HIGHLY ACCELERATED LIFE TESTING (16)4 TIN WHISKER (31)5 CIRCUIT BOARD ASSEMBLY FLATNESS (37)6 CIRCUIT BOARD EMBRITTLEMENT (42)7 HIGHLY ACCELERATED STRESS AUDIT (46)8 DESIGN MARGIN EVALUATION (51)9 CYCLIC RELIABILITY (56)10 IONIC CHROMETOGRAPHY (61)11 STATIC ROSE TESTING (66)12 COUPON SAMPLING (69)13 THERMAL CYCLE RELIABILITY AUDIT TESTING (74)1 IntroductionAccelerated life testing consists of various tests that accelerate different failure modes. For example, thevibration testing may accelerate solder joint failures that can be a result of poor workmanship. GECIP uses a family of different tests that exercise various failure modes that can occur in electronics assemblies. The table below shows a summary of the failure modes exercised by the different tests in this document.This document contains test procedures that are used to evaluate the reliability and quality of electronicassemblies. Each test procedure accomplishes a different task. In some cases, two or more test procedures will test for the same failure mode or modes.The following table outlines common electronics design and qualification scenarios, as well as the tests that are appropriate for that intent.Reliability audit tests defined in the table above are the maximum amount of testing that could be done. Each program will specify which of the above tests are to be used in their quality audit plan. All products built with lead free solder should use the thermal cycle reliability audit test as a production audit with an initial baseline run done during the initial product launch.* It is recommended that the tin whisker test be done on a vendor by vendor basis, rather than a program by program basis.** In addition to the tests defined in this document, there are other product specific tests that may be required in the product specification. Some of those tests may include rack life, slat, salt spray, acid fog, HCC (under the bag), etc.2 Accelerated Life Testing2.1 ETP ObjectivePurpose: Introduction to Cyclic Temperature, Power & Humidity Evaluation ( ALT )The process elements to successfully implement and perform Cyclic Temperature,Humidity & Power cycle testing are defined in this section. This section of the ETP willdescribe the methodology, requirements and procedure for Accelerated Life Testing (ALT).For certain projects, an electromigration test may be required (as opposed to the completeALT test). When this test is required, the ALT procedure should be followed with a testduration of 2 weeks. Upon completion of the two week test a full microscopic exam of theunits under test should be done. This examination should focus on any evidence ofdendritic growth.Limitations: Any failures found during this testing should be fully investigated until root cause is found.There are components that can not operate without failure in high temperatures. Thesetypes of failures will no longer follow the Arrhenius equation. They will in fact be specialcause failures for which no acceleration can be calculated.2.2 Key Parameters & Requirement InputsThe test variables, which impact product performance, can either be classified as Key Noise Parameters or Key Control Parameters as described below. They may be set as test inputs, recorded for analysis or both as specified for this ETP in the following charts.Key Noise Parameters - A key noise parameter (KNP) is any product usage or interaction variablewhich cannot be controlled by design (i.e. voltage, ambient temperature, water quality, etc.). Note thatfor the purposes of this test, the parameter may be controlled (i.e. specified as an input below) in orderto understand the impact of the KNP upon product performance.Key Control Parameters- A key control parameter (KCP) is any product usage or interaction variablewhich can be controlled by design (dimensions, operating range, material, etc.).2.3 Test Equipment and Supplies2.4 Expected Test Duration(Based on average conditions; may vary significantly depending upon lab load)Set-up: 1 DayTest Procedures: Several weeks. The Lab shall inspect the UUTs each day for the durationof the test. Duration is dependent on the usage profile of the product & theacceleration factor.Post-test/Cleanup: 1 DayDocumentation: 0.5 DayTotal Expected Test Duration: Several Weeks, Dependent on Usage Profile & acceleration factor.2.5 Test SamplesSample SizeSample size shall be selected to support a 90% C.I. of being 90% reliable. If appropriate, alternative confidence intervals and reliability targets may be chosen. The sample size calculation shall be reviewed with the SCE as part of the test plan review. The reliability sample size, assuming an exponential distribution, can be calculated using:n = (L / (T * Af)) * (ln (1-CI)) / (ln (R))L: Specified product life in HoursT: Total number of hours on testAf: Acceleration factor (See the acceleration factor calculator)CI: Confidence intervalR: Reliabilitye.g., to get 90% CI, 90% R Where T * Af = L the required sample size is 22.Qualification/Preconditioning/SetupCompletion of Reliability 10 Step ProcessPrior to starting any accelerated life testing a completion of the first 8 steps in the 10 step process is required.These steps are necessary in order to understand what types of environments and the lifetime usage conditions are for the system being tested. The 10 step process is located at the Reliability Home page/TechnetRedirect.html?redirectTo=/upload/18174/doc _267672.htmTemperatures used in testing should incorporate temperatures that will be seen in real life applications . ( e.g., 105 C. for cooktop applications . )Assemblies shall be tested for twice life or 20 years of life, which ever of the 2 choices is less. Additionally, alternative test requirements may be accepted with prior review and approval of the electronics chief engineer.Request for testingA request for testing must be submitted prior to testing the boards. This should be submitted as soon as therequirement for testing is determined. The method of submitting a test request varies by site. Typical testrequest information may include:- Engineer(s) in charge of electrical design.- Complete item name and/or designation.- Date boards will be available.- Requested completion dates and reasons for that date (i.e. E-Review) for prioritizing purposes.Required for Test- Calculations of sample size> Use the Reliability website (available from technet) or Alta program- Hard copy of Acceleration calculation to be attached to the front of the chamber.> /eng/dept/electronics2/reliability.htm- Electrical interface box:- Complete schematic of circuit board and test box.- Load(s) required for operation.- Functional Test Procedure.- Mechanical Fixture.- Information sheet with the description of the test , start time, stop time and who to contact in case ofemergency . This will also be posted on the front of the test chamber.2.6 Test ProcedureThe electrical control system is used to verify the operation of the components that make up the units being tested. All systems that have microprocessor controls should be programmed with test software that allows for accelerated operation of all the function within the system . Dumb systems should incorporate a method toexercise these functions on a periodic basis to ensure that lifetime usage is met.Design- The electrical control system should be designed to power the units under test with a separate control and fuse for each board. The control system shall power each board in a repeating cycle of 180 minutes on and 20minutes off. This cycle shall repeat for the duration of the test.- Loads should simulate ( if possible ) to real life loads.- All wiring inside the chamber must be rated for 125 degree C operation. Wiring outside of the chamber can be standard hook-up wire rated for the application used. The minimum length for the cable going into the chamber is ten feet (four feet inside the chamber and 6 feet outside). If this length presents a problem to the functioning of units, coordinate with Reliability engineering to determine a solution.Construction & MaterialsThe basic control system should be constructed to be to be intrinsically safe to the operator. All connections and terminals with hazardous voltages will be enclosed or covered. The test setup, wiring and device under test shall be in compliance with electrical safety rules.The functional test should use optical, audible, or other means to feedback system status in order for theoperator to determine whether that function of the system has failed. The goal of the functional test is to achieve 100% test coverage, or as much coverage as is possible, of the sample under test.A monitoring system ( optimal ) should be in place in order to capture any functional failures that might occurduring the testing process. Continuous data capture should be incorporated when possible. If not, then at aminimum, daily inspection shall be performed in order to determine whether a failure of the system has occurred.Mechanical FixtureThe mechanical fixture is used to hold the units being tested in the chamber. The fixture is designed not to mimic the real-life mounting of the product but rather maximize airflow.Design Considerations- The fixture should be made to be strong and safe but yet have the least amount of mass as possible in order to minimize the thermal loading inside the chamber.- Vertical mounting of UUTs is preferred.- The fixtures at no time should be allowed to come in contact with high potential voltages. The use of insulators and plastic tie wraps should be used in order to assure that wiring won’t move.- Proper airflow must be allowed to evenly heat and cool the units.- Room must be allowed for electrical connections and cables around the units.- If UUT must be handled or checked during test, make sure that the temperature in the chamber is allowed to stabilize at a safe level and that all power to the circuits are disconnected.MaterialThe material used ( plastic cases, LED displays ) must be able to withstand the temperature range that isprogrammed into the chamber . If temperatures exceed the rated limits of the plastic part, then the temperature must be lowered and the acceleration factor re-calculated.Product requirementsQualityAll units shall be constructed to standard quality levels as determined by the test type. Pre-production andproduction units shall go through the complete production cycle. Units shall be verified operational beforesubmission to testing.WarningsChamberDuring testing, the chamber and assemblies contained inside the chambers can reach temperatures that can cause severe burns if allowed to come in contact with the human body, also if the door is open prior to cool down, steam can rapidly escape from the chamber causing burns to the face. Before entering the chamber allow the chamber to cool to room temperature for at least ½ hour.Units under testAlways disconnect the power to any electrical test boxes prior to connecting and disconnecting units in thechamber. Take all precautions to avoid a shock hazard.System verification and startupProfilesProfile 1 :Segment SegmentTime(min) CycleTime(min)CycleTime(Hrs)Temp(degC)RH (%)1 30 30 0.50 85 402 15 45 0.75 85 853 570 615 10.25 85 854 15 630 10.50 85 405 30 660 11.00 30 406 60 720 12.00 30 40Note: The power cycles are 180 minutes on and 20 minutes off for a 200 minute cycle. Profile 2:Segment SegmentTime(min) Cycle Time(min)CycleTime(Hrs)Temp (degC) RH (%)1 70 70 1.17 105 402 30 100 1.67 105 403 10 110 1.83 85 854 180 290 4.83 85 855 10 300 5.00 85 406 60 360 6.00 0 40Note: The power cycles are 180 minutes on and 20 minutes off for a 200 minute cycle. Profile 3:Segment SegmentTime(min) CycleTime(min)CycleTime(Hrs)Temp(degC)RH (%)1 30 30 0.50 85 402 15 45 0.75 85 853 570 615 10.25 85 854 15 630 10.50 85 405 30 660 11.00 0 206 60 720 12.00 0 20Note: The power cycles are 180 minutes on and 20 minutes off for a 200 minute cycle.Selecting a ProfileProgram ProfileRange 2Refrigeration (inside) 3Refrigeration (outside) 1Dishwasher 1Washer / Dryer 1Microwave 1Lighting 1Profiles are used to assure that lifetime temperatures are fully simulated in the life testing of the assembly. If the profiles listed don’t cover the range of life temperatures then an alternate profile must be created with the approval of the Electronic Reliability Expert or the Chief Engineer.When using the acceleration calculator, you must use the profile that matches the appliance and application being tested. These acceleration calculations with profiles can be located on./eng/dept/electronics2/reliability.htmOnce the correct profile has been chosen then these temperatures, humidities and times must be programmed into the appropriate test chamber. The test assemblies can be power and verified functional. At this point the test may be started.Monitoring for FailuresThe test assemblies shall be checked continuously (if possible with computer assistance) or at a minimum should be checked once a day for a failure of the system. Once a failure has occurred, the board number and the time to failure should be logged into a spreadsheet or Reliasoft program for later calculation of the total reliability of the assemblies. When the temperature reaches a minimum, the failed assembly may be pulled out and replaced with a new assembly.A note must be made as to the start time of the new assembly. The new assembly will only accumulate the actual hours that it has been tested, not the hours before the failure.The failed board should under go root cause analysis and must be logged into FRACAS so as to keep a running record of the history of failures.ResultsResult Evaluation:Once the required time for testing life has been achieved the data should be tabulated using Weilbull ++ , Alta Pro or other reliability software in order to determine the 1, 10 and 20 year reliabilityMigration:All boards shall be both visual and microscopically evaluated for signs of electromigration. If migration has occurred, the Engineer in charge shall capture pictures for further investigation work.Evaluation of parts:The parts located on the board shall be free from distortion, corrosion, or burnt discoloration to the PCB.2.7 ResultsNote - All test results to include:∙Equipment used to generate data∙Calibration (accuracy) of test equipment∙Resolution of test∙Measurement error (variability, σe) of test2.8 Results Interpretation(Includes any pertinent guidelines, limitations or insights needed for interpreting results)2.9 Failure Modes Exercised/Acceleration Factors/Field Failure CorrelationThis test accellerates the life of an electronic control. The acceleration factor is taken at the system level as an average acceleration of the types of parts and assemblies being tested. The test duration (described below) is based on an acceleration factor calculated from the modified Arrhenius equation.The equation is modified to include the humidity effects as described by Hallberg-peck. According to Henry Livingston's paper, the equation is defined as:Af = ( [RHt / RHu] ^ p ) * exp [ (Ea/K) * (1/Tu - 1/Tt)]Where: Af - Acceleration factor, RH - test and usage humidity, Ea - Activation Energy, K - Boltzman's constant and T - test and usage temperatures.For GECP electronics typical numbers are p=2.66 and Ea = 0.7 eV.2.10 Nomenclature/VocabularyALT (Accelerated Life Test) – provide timely information about the life distribution of materials andproducts. Information from tests at high levels of stress is extrapolated, through a physically reasonable statistical model, to obtain estimates of life at lower, normal levels of stress.Cycle Time – The period of time that the temperature and/or Humidity takes to execute once through the program and return to the initial settings. ( e.g., 2 cycles per day )Test period – The time it takes to run a given number of test cycles that equates to an equivalent amount of real time years .UNIT - Electrical or mechanical part, subassembly, or the productProduct life – The time at which a product is deemed to not function per its specification.Activation Energy– ( State of activation ) energy (eV) to surmount the barrier of activationfrom the beginning of a starting system to its final reaction.Acceleration Factor – Magnification factor of the life of a system ( standard conditions ) and testing conditions ( accelerated conditions ) , respectively.SCE - Senior Consulting Engineer2.11 Background(Related theory, methods and standards used to develop test procedure)2.12 Reference(Technical studies, standards, articles, etc., which are related to this ETP)2.13 Revision History(Includes reasoning for release of current revision, with date and name of person releasing revision)2.14 Power Cycle ExampleOne of the requirements for this test is that the power be cycled to the controls on test. There are several ways to do this. One cost effective method to power the UUTs using a power box containing a repeat cycle timer relay with two independently adjustable T1 and T2 settings. A logic diagram of the appropriate connections and an example parts list is included here for reference.3 Highly Accelerated Life Testing3.1 ETP ObjectivePurpose: (Overview of parameter(s) to be measured as well as scope of conclusions test is expected to facilitate)The process elements to successfully implement and perform HALT are defined in thissection of the document. This ETP will describe the methodology, requirements andprocedure for HALT testing.HALT should be used as part of the design process to rapidly expose design weaknessesby: combining a wide range of temperature (-100ºC to + 170ºC), rapid rate of temperaturechange (60ºC/min), multi-axis vibration (6 degrees of freedom, 2Hz-10KHz, up to 60Grms)and power cycling, and other product specific extremes.During HALT the boards are over-stressed to very quickly induce failures and expose theweak points. The goal of a HALT test is to quickly break the product and learn from thefailure modes. A HALT test is considered successful when: failures are induced, failuremodes are understood, corrective action taken and limits defined and pushed out as far aspossible.During HALT testing the products are stressed far beyond its specification as well as farbeyond what the product will encounter in the field. HALT is then used to precipitate anddetect failures or weakness in the design. As failures are identified and eliminated, designand process margins are extended to affect optimized field reliability and use-life. Limitations: (Any qualifications that apply to this test procedure or its results)HALT testing is not the same as Design Verification Testing. HALT testing quickly findsfailure modes that would not be discovered in Design Verification Testing. But, it is notintended to replace Design Verification Testing.3.2 Key Parameters & Requirement InputsThe test variables which impact product performance can either be classified as Key Noise Parameters or Key Control Parameters as described below. They may be set as test inputs, recorded for analysis or both as specified for this ETP in the following charts.Key Noise Parameters - A key noise parameter (KNP) is any product usage or interaction variablewhich cannot be controlled by design (i.e. voltage, ambient temperature, water quality, etc.). Note thatfor the purposes of this test, the parameter may be controlled (i.e. specified as an input below) in orderto understand the impact of the KNP upon product performance.Key Control Parameters- A key control parameter (KCP) is any product usage or interaction variablewhich can be controlled by design (dimensions, operating range, material, etc.).3.3 Test Equipment and SuppliesThe following equipment list is a typical list available at the Louisville Center. Appropriate substitutions may be made depending on the design center. The equipment list should be included in the results.3.4 Expected Test Duration(Based on average conditions; may vary significantly depending upon lab load)Set-up: 1HRTest Procedures: 48HRPost-test/Cleanup: 4HRDocumentation: 1HRTotal Expected Test Duration: 54HR3.5 Test SamplesSample Size (Number of samples and/or rationale for sample size selection)Quantity - Purpose3 - Hot Step3 - Cold Step3 - Vibration3 - Thermal Cycle3 - Combination Cycle3 - Spares-------------------------------------------18 - Total SamplesQualification/Preconditioning/Setup (Any test sample preparation, stabilization, preconditioning or certification required before testing)Test Request:A request for testing must be submitted prior to testing the boards. This should be submitted as soon as therequirement for testing is determined. The method of submitting a test request varies by site. The following items are typical in a lab request:- Engineer(s) in charge of electrical design.- Complete item name and/or designation.- Date boards will be available.- Requested completion date and reason for that date (i.e. E-Review) for prioritizing purposes.- Determine will supply the electrical interface box.- Account number for test fixtures and dock number for time charges.Test Prep:Prework should be done ahead of the testing schedule. Prework requires the following items.- Physical sample of the circuit board.- Pre-test inspection procedures and criteria. Written approval required for deviations.- If electrical interface box to be built by HALT engineering:> Complete schematic of circuit board and test box.> Load(s) required for operation.> Additional time will be required for in laboratory fabrication.- Functional Test Procedure.Functional Test Requirements:The electrical control system is used to verify the operation of the components that make up the units being tested. This is not a verification of the software programs of any microprocessors, but only that they and all other components function. The verification sequence should take less than five minutes.The electrical control system should be designed to power the units under test with a separate control and fuse for each board. Additionally, the system should have the ability to cycle the power to the unit under test while it is being tested.All wiring inside the chamber must be rated for 200 Degrees C operation. Wiring outside of the chamber can be standard hook-up wire rated for the application used. The minimum length for the cable going into the chamber is ten feet (four feet inside the chamber and 6 feet outside). If this length presents a problem to the functioning of units, coordinate with HALT engineering to determine a solution.The basic control system should be constructed to be to be intrinsically safe to the operator. All connections and terminals with hazardous voltages will be enclosed or covered. The test setup, wiring and device under test shall be in compliance with electrical safety rules.The functional test of should be of adequacy to determine the performance of the sample and the occurrence of multiple types of failure modes. The test must as a minimum exercise the major functions of the product with a feedback measurement of performance of these functions. The goal of the functional test is to achieve 100% test coverage, or as complete test coverage as is possible, of the sample under test.At each level of applied stress, functional testing is performed on the boards to evaluate the operation.Whenever possible product specific stresses should be performed during each step stress to enhance additional failure precipitation and detection. These stresses may include power cycling, line voltage margining, and line frequency margining, DC power supply margining, on-board oscillator margining, output loading, and any others that are applicable.Mechanical Fixture:The mechanical fixture is used to hold the units being tested in the chamber. The fixture is designed not to mimic the real-life mounting of the product but rather maximize the transmission of energy into the product, maximize airflow as well as improve the transmission of low frequency energy.Design Considerations:Three units should be mounted in the chamber for each step of the test.Units must be mounted to ensure maximum vibration energy transfer. Typically the units will be mounted to a Family plate constructed of Magnesium-Aluminum or Aluminum.The Family plate should be mounted in the center of the vibration platform to minimize the variation in vibration energy transmitted to each UUT. A 6-sigma experiment verified a minimum 2x reduction in variation between a center mount and an edge mount.Proper airflow must be allowed to evenly heat and cool the units. Airflow is can also maximized using the flexible air ducts.Room must be allowed for electrical connections and cables around the units.If UUT must be handled during test (buttons, pot, etc.), make sure all units will be in reach of glove port.For uniformity between UUT positions, mount fixture as close to the center as possible.Material:The material used must be able to withstand the temperature range in the chamber (-100 to +200 degrees C).The material must be rigid enough to transfer the vibration to the units under test without attenuating the energy.The recommended material is magnesium or aluminum alloys.Product Requirements:All units shall be constructed to standard quality levels as determined by the test type. Pre-production andproduction units shall go through the complete production cycle. Units shall be verified operational beforesubmission to testing.3.6 Test Procedure(Detailed, step-by-step directions for running test including photos/diagrams as appropriate) Warnings:Liquid NitrogenLiquid nitrogen is a colorless, odorless, extremely cold liquid and gas under pressure. It can cause rapidsuffocation when concentrations are sufficient to reduce oxygen levels below 19.5%. Contact with liquid or cold vapors can cause severe frostbite.In case of a leak, open door, evacuate area and turn off valve at tank. Contact security and other persons as required.DO NOT TOUCH LIQUID OR ANY UNINSULATED PIPING WITH LIQUID NITROGEN IN IT.Ref: GE MSDS 4889Chamber:。

iso8536-42010医用输液器具-重力输液式一次性使用输液器

Reference number ISO 8536-4:2010(E)© ISO 2010INTERNATIONAL STANDARD ISO 8536-4Fifth edition 2010-10-01Infusion equipment for medical use — Part 4:Infusion sets for single use, gravity feedMatériel de perfusion à usage médical —Partie 4: Appareils de perfusion non réutilisables, à alimentation par gravitéISO 8536-4:2010(E)PDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area.Adobe is a trademark of Adobe Systems Incorporated.Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.COPYRIGHT PROTECTED DOCUMENT© ISO 2010All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright officeCase postale 56 • CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyright@ Web Published in Switzerlandii © ISO 2010 – All rights reservedISO 8536-4:2010(E)Contents PageForeword (iv)1Scope (1)2Normative references (1)3General requirements (1)4Designation (4)4.1Infusion set (4)4.2Air-inlet device (4)5Materials (4)6Physical requirements (5)6.1Particulate contamination (5)6.2Leakage (5)6.3Tensile strength (5)6.4Closure-piercing device (5)6.5Air-inlet device (5)6.6Tubing (6)6.7Fluid filter (6)6.8Drip chamber and drip tube (6)6.9Flow regulator (6)6.10Flow rate of infusion fluid (6)6.11Injection site (6)6.12Male conical fitting (6)6.13Protective caps (6)7Chemical requirements (7)7.1Reducing (oxidizable) matter (7)7.2Metal ions (7)7.3Titration acidity or alkalinity (7)7.4Residue on evaporation (7)7.5UV absorption of extract solution (7)8Biological requirements (7)8.1General (7)8.2Sterility (7)8.3Pyrogenicity (7)8.4Haemolysis (7)8.5Toxicity (8)9Labelling (8)9.1Unit container (8)9.2Shelf or multi-unit container (8)10Packaging (9)Annex A (normative) Physical tests (10)Annex B (normative) Chemical tests (14)Annex C (normative) Biological tests (16)Bibliography (17)© ISO 2010 – All rights reserved iiiISO 8536-4:2010(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 8536-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use.This fifth edition cancels and replaces the fourth edition (ISO 8536-4:2007), of which it constitutes a minor revision. In detail, 7.1 was more clarified in alignment with B.2, and A.2.2 was changed in order to go back with the leakage test pressure to 20 kPa and to restrict the leakage test for (40 ± 1) °C.ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use:⎯Part 1: Infusion glass bottles⎯Part 2: Closures for infusion bottles⎯Part 3: Aluminium caps for infusion bottles⎯Part 4: Infusion sets for single use, gravity feed⎯Part 5: Burette infusion sets for single use, gravity feed⎯Part 6: Freeze drying closures for infusion bottles⎯Part 7: Caps made of aluminium-plastics combinations for infusion bottles⎯Part 8: Infusion equipment for use with pressure infusion apparatus⎯Part 9: Fluid lines for use with pressure infusion equipment⎯Part 10: Accessories for fluid lines for use with pressure infusion equipment⎯Part 11: Infusion filters for use with pressure infusion equipment⎯Part 12: Check valvesiv © ISO 2010 – All rights reservedINTERNATIONAL STANDARD ISO 8536-4:2010(E)Infusion equipment for medical use —Part 4:Infusion sets for single use, gravity feed1 ScopeThis part of ISO 8536 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.Secondary aims of this part of ISO 8536 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirementsISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittingsISO 3696, Water for analytical laboratory use — Specification and test methodsISO 7864, Sterile hypodermic needles for single useISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness1) ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements2)3 General requirements3.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given in Figures 1, 2 and 3. These figures illustrate examples of the configuration of infusion sets and air-inlet devices; other configurations may be used provided they lead to the same results. Infusion sets as illustrated in Figure 2 should only be used for collapsible plastic containers. Infusion sets as illustrated in Figure 2 used1) Under preparation. (Revision of ISO 14644-1:1999)2) To be published. (Revision of ISO 15223-1:2007)© ISO 2010 – All rights reserved1ISO 8536-4:2010(E)with separate air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated in Figure 1, shall be used for rigid containers.3.2 The infusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until the set is used. The air-inlet device shall be provided with a protective cap over the closure-piercing device or needle.Key1 protective cap of closure-piercing device 7 fluid filter2 closure-piercing device 8 tubing3 air inlet with air filter and closure 9 flow regulator4 fluid channel 10 injection site5 drip tube 11 male conical fitting6 drip chamber 12 protective cap of male conical fittinga Closure of the air inlet is optional.b The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has anominal pore size of 15 µm.c The injection site is optional.Figure 1 — Example of a vented infusion set2 © ISO 2010 – All rights reservedISO 8536-4:2010(E)Key1 protective cap of closure-piercing device 7 tubing2 closure-piercing device 8 flow regulator3 fluid channel 9 injection site4 drip tube 10 male conical fitting5 drip chamber 11 protective cap of the male conical fitting6 fluid filtera The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has anominal pore size of 15 µm.b The injection site is optional.Figure 2 — Example of a non-vented infusion set© ISO 2010 – All rights reserved3ISO 8536-4:2010(E)Key1 protective cap 4 clamp2 closure-piercing device or needle 5 air-inlet with air filter3 tubinga Other designs are acceptable if the same safety aspects are ensured.Figure 3 — Example of an air-inlet device4 Designation4.1 Infusion setInfusion sets complying with the requirements specified in this part of ISO 8536 shall be designated by the descriptor words, followed by a reference to this part of ISO 8536, followed by the letters IS, followed by the letter G:Infusion set ISO 8536-4 - IS - G4.2 Air-inlet deviceAir-inlet devices complying with the requirements specified in this part of ISO 8536 shall be designated by the descriptor words, followed by a reference to this part of ISO 8536, followed by the letters IS, followed by the letters AD:Air-inlet device ISO 8536-4 - IS - AD5 MaterialsThe materials from which the infusion set and its components are manufactured (as described in Clause 3) shall comply with the requirements specified in Clause 6. Where components of the infusion set come into contact with solutions, the materials shall also comply with the requirements specified in Clauses 7 and 8.4 © ISO 2010 – All rights reservedISO 8536-4:2010(E)6 Physical requirements6.1 Particulate contaminationThe infusion sets shall be manufactured under conditions that minimize particulate contamination. All parts shall be smooth and clean at the fluid pathway surfaces. When tested as specified in A.1, the number of particles shall not exceed the contamination index limit.6.2 LeakageThe infusion set, when tested in accordance with A.2, shall show no signs of air leakage.6.3 Tensile strengthWhen tested as specified in A.3, the infusion set, excluding protective caps, shall withstand a static tensile force of not less than 15 N for 15 s.6.4 Closure-piercing deviceThe dimensions of the closure-piercing device shall conform to the dimensions shown in Figure 4.NOTE The dimension of 15 mm in Figure 4 is a reference measurement. The cross-section of the piercing device at this site is a circle.The closure-piercing device shall be capable of piercing and penetrating the closure of a fluid container without pre-piercing. No coring should occur during this procedure.Dimensions in millimetresFigure 4 — Dimensions of the closure-piercing device6.5 Air-inlet deviceThe air-inlet device shall conform to 3.2 and 8.2.The air-inlet device shall be provided with an air filter to prevent the ingress of microorganisms into the container into which the device is to be inserted.The air-inlet device shall be separate from, or integral with, the closure-piercing device.When the air-inlet device is inserted into a rigid infusion container, the air admitted into the container shall not become entrained in the liquid outflow.The air filter shall be fitted such that all air entering the rigid container passes through it, and such that the flow of fluid is not reduced by more than 20 % of that from a freely ventilated container when tested in accordance with A.4.© ISO 2010 – All rights reserved5ISO 8536-4:2010(E)6.6 TubingThe tubing, made of flexible material, shall be transparent or sufficiently translucent that the interface of air and water during the passage of air bubbles can be observed with normal or corrected vision.The tubing from the distal end to the drip chamber shall be not less than 1 500 mm in length, including the injection site, when provided, and the male conical fitting.6.7 Fluid filterThe infusion set shall be provided with a fluid filter.When tested in accordance with A.5, the retention of latex particles on the filter shall be not less than 80 %. 6.8 Drip chamber and drip tubeThe drip chamber shall permit continuous observation of the fall of drops. The liquid shall enter the drip chamber through a tube that projects into the chamber. There shall be a distance of not less than 40 mm between the end of the drip tube and the outlet of the chamber, or a distance of not less than 20 mm between the drip tube and the fluid filter. The wall of the drip chamber shall not be closer than 5 mm to the end of the drip tube. The drip tube shall be such that 20 drops of distilled water or 60 drops of distilled water at (23 ± 2) °C at a flow rate of (50 ± 10) drops/min deliver a volume of (1 ± 0,1) ml or a mass of (1 ± 0,1) g. The drip chamber should permit and facilitate the priming procedure.6.9 Flow regulatorThe flow regulator shall adjust the flow of the infusion solution between zero and the maximum. The flow regulator should be capable of continuous use throughout an infusion without the tubing being damaged. There should be no deleterious reaction between the flow regulator and the tubing when they are stored in such a way that there is contact.6.10 Flow rate of infusion fluidThe infusion set shall deliver not less than 1 000 ml of a sodium chloride solution [mass concentration ρ(NaCl) = 9 g/l] in 10 min under a static head of 1 m.6.11 Injection siteWhen provided, the self-sealing injection site shall reseal when tested in accordance with A.6, and there shall be no leakage of more than one falling drop of water. The injection site should be located near the male conical fitting.6.12 Male conical fittingThe distal end of the tubing shall terminate in a male conical fitting in accordance with ISO 594-1 or ISO 594-2. Luer lock fittings in accordance with ISO 594-2 should preferably be used.6.13 Protective capsThe protective caps at the end of the infusion set shall maintain the sterility of the closure-piercing device, the male conical fitting and the interior of the infusion set. Protective caps should be secure but easily removable.6 © ISO 2010 – All rights reserved7 Chemical requirements7.1 Reducing (oxidizable) matterWhen tested in accordance with B.2, the difference of volume of Na2S2O3 solution [c(Na2S2O3) = 0,005 mol/l] for the extract solution S1 and of volume of Na2S2O3 solution for blank solution S0 shall not exceed 2,0 ml. 7.2 Metal ionsThe extract shall not contain in total more than 1 µg/ml of barium, chromium, copper, lead and tin, and not more than 0,1 µg/ml of cadmium, when determined by atomic absorption spectroscopy (AAS) or an equivalent method.When tested in accordance with B.3, the intensity of the colour produced in the test solution shall not exceed that of the standard matching solution with a mass concentration ρ(Pb2+) = 1 µg/ml.7.3 Titration acidity or alkalinityWhen tested in accordance with B.4, not more than 1 ml of either standard volumetric solution shall be required for the indicator to change to the colour grey.7.4 Residue on evaporationWhen tested in accordance with B.5, the total amount of dry residue shall not exceed 5 mg.7.5 UV absorption of extract solutionWhen tested in accordance with B.6, the extract solution S1 shall not show absorption greater than 0,1.8 Biological requirements8.1 GeneralThe infusion set shall be assessed for biological compatibility according to the guidelines given in C.2.8.2 SterilityThe infusion set or the air-inlet device, or both, in its unit container shall have been subjected to a validated sterilization process (see ISO 11135, ISO 11137 and ISO 17665).8.3 PyrogenicityThe infusion set and/or the air-inlet device shall be assessed for freedom from pyrogens by using a suitable test, and the results shall indicate that the infusion set is free from pyrogens. Guidance on testing for pyrogenicity is given in C.1.8.4 HaemolysisThe infusion set shall be assessed for freedom from haemolytic constituents and the result shall indicate that the infusion set is free from haemolytic reactions. Guidance on testing for haemolytic constituents is given in ISO 10993-4.© ISO 2010 – All rights reserved78.5 ToxicityMaterials shall be assessed for toxicity by carrying out suitable tests, and the results of the tests shall indicate freedom from toxicity. Guidance on testing for toxicity is given in ISO 10993-1.9 Labelling9.1 Unit containerThe unit container shall be labelled with at least the following information:a) a textual description of the contents, including the words “Gravity feed only”;b) indication that the infusion set is sterile, using the graphical symbol as given in ISO 15223-1;c) indication that the infusion set is free from pyrogens, or that the infusion set is free from bacterialendotoxins;d) indication that the infusion set is for single use only, or equivalent wording, or using the graphical symbolin accordance with ISO 15223-1;e) instructions for use, including warnings, e.g. about detached protective caps;NOTE Instructions for use can also take the form of an insert.f) the lot (batch) designation, prefixed by the word LOT, or using the graphical symbol in accordance withISO 15223-1;g) year and month of expiry, accompanied by appropriate wording or the graphical symbol in accordancewith ISO 15223-1;h) the manufacturer's or supplier's name and address, or both;i) a statement that 20 drops of distilled water or 60 drops of distilled water delivered by the drip tube areequivalent to a volume of (1 ± 0,1) ml or a mass of (1 ± 0,1) g;j) the nominal dimensions of the intravenous needle, if included.9.2 Shelf or multi-unit containerThe shelf or multi-unit container, when used, shall be labelled with at least the following information:a) a textual description of the contents, including the words “Gravity feed only”;b) the number of infusion sets;c) indication that the infusion sets are sterile, using the graphical symbol as given in ISO 15223-1;d) the lot (batch) designation, prefixed by the word LOT, or using the graphical symbol in accordance withISO 15223-1;e) year and month of expiry, accompanied by appropriate wording or the graphical symbol in accordancewith ISO 15223-1;f) the manufacturer's and/or supplier's name and address;g) the recommended storage conditions, if any.10 Packaging10.1 The infusion set and/or the air-inlet device shall be individually packed so that they remain sterile during storage. The unit container shall be sealed in a tamper-evident manner.10.2 The infusion sets and/or the air-inlet devices shall be packed and sterilized in such a way that there are no flattened portions or kinks when they are ready for use.© ISO 2010 – All rights reserved9Annex A(normative)Physical testsA.1 Test for particulate contaminationA.1.1 PrincipleThe particles are rinsed from the inner fluid pathway surfaces of the infusion set, collected on a membrane filter and microscopically counted.A.1.2 Reagents and materialsA.1.2.1 Distilled water,filtered through a membrane of pore size 0,2 µm.A.1.2.2 Non-powdered gloves.A.1.2.3 Vacuum filter, single membrane filter of pore size 0,45 µm.A.1.3 ProcedureThe filter unit, filter and all other equipment shall be thoroughly cleaned before the test using distilled water (A.1.2.1).Flush through 10 ready-to-use infusion appliances, under laminar flow conditions (clean-air work station class N5 in accordance with ISO 14644-1), with 500 ml of distilled water (A.1.2.1). The total volume is subsequently vacuum filtered (A.1.2.3). Place the particles on the membrane screen filter under a microscope at ×50 magnification using diagonally incident illumination, and measure and count in accordance with the size categories given in Table A.1.A.1.4 Determination of resultsA.1.4.1 GeneralAn appropriate number of single infusion sets (minimum of 10) are tested. The number of particles per10 infusion sets tested in each of the three size categories is the assay result.A.1.4.2 Particle countsThe values obtained from a blank control sample shall be recorded in a test report and taken into account when calculating the contamination index limit.The blank control sample is the number and size of particles obtained from 10 equivalent 500 ml water samples classified in accordance with the three size categories set out in Table A.1, using the same test equipment but not passed through the appliances under test.The number of particles in the blank, N b, shall not exceed the value of 9. Otherwise, the test apparatus shall be disassembled, re-cleaned, and the background test performed again. Values of the blank determination shall be noted in the test report.Table A.1 — Evaluation of contamination by particlesSize categoryParticle parameters1 2 3 Particle size in µm 25 to 50 51 to 100 over 100Number of particles in 10 infusion appliances n a1n a2n a3Number of particles in the blank control sample n b1n b2n b3Evaluation coefficient 0,1 0,2 5The contamination index limit is calculated as follows.For each of the three size categories, multiply the number of particles in 10 infusion appliances by the evaluation coefficients, and add the results in order to obtain the number of particles in the infusion appliances(test pieces), N a. Then, for each of the size categories, multiply the number of particles in the blank control sample by the evaluation coefficients and add the results to obtain the number of particles in the blank sample,N b.Subtract N b from N a to obtain the contamination index limit.Number of particles in the infusion appliances (test pieces):N a=n a1× 0,1 +n a2× 0,2 +n a3× 5Number of particles in the blank sample:N b=n b1× 0,1 +n b2× 0,2 +n b3× 5Contamination index limit:N=N a−N b u 90A.2 Test for leakageA.2.1 At the beginning of the test, condition the whole system at the test temperature.A.2.2 Immerse the infusion set, with one end blocked, in water at (40 ±1) °C and apply an internal air pressure of 20 kPa for 15 s. Examine the infusion set for air leakage.A.2.3 Fill the infusion set with degassed, distilled water, connect it with its openings sealed to a vacuumdevice and subject it to an internal excess pressure of −20 kPa at (40 ± 1) °C for 15 s. Atmospheric pressureshall be the reference pressure. Excess pressure, in accordance with ISO 80000-4, can assume positive or negative values. Ascertain whether air enters the infusion set.A.3 Test for tensile strengthExpose the infusion set to be tested to a static tensile force of 15 N applied along the longitudinal axis for 15 s. Inspect whether the infusion set withstands the test force applied.© ISO 2010 – All rights reserved11A.4 Determination of flow rate when using an air-inlet deviceA.4.1 Fill an infusion container with distilled water at (23 ± 2) °C and insert its closure. Insert the air-inlet device through the closure into the container and then insert the infusion set with the flow regulator set, such that no liquid flows. Arrange the container to give the equivalent of a pressure of 1 m head of water throughout the test. Open the flow regulator of the infusion set to maximum and measure the rate of flow of water from the set. Repeat the procedure with the filter removed from the air-inlet device.A.4.2 For air-inlet devices integral with the closure-piercing device of the infusion set, follow the procedure given in A.4.1 but omit the insertion of the separate air-inlet device.A.5 Test for efficiency of the fluid filterA.5.1 Preparation of the test fluidAs a test liquid, use an aqueous suspension of latex particles with a diameter of (20 ± 1) µm and a concentration of approximately 1 000 particles per 100 ml.A.5.2 ProcedureAssemble the fluid filter and position it so that it is equivalent to that of actual use in a suitable test apparatus in accordance with Figure A.1. Cut the tubing of the infusion set approximately 100 mm below the fluid filter. Flush the fluid filter with 5 ml of the test fluid from the storage bottle and discard the filtrate. Pass 100 ml of the test fluid through the fluid filter and collect the effluent under vacuum after passing it through a black gridded membrane filter with a pore size of 5 µm to 8 µm and 47 mm diameter. Mount the membrane with any retained latex particles on a suitable microscope slide or holder and count the latex particles in a minimum of 50 % of the grid squares under a magnification of ×50 to ×100. Disregard any particles which are obviously non-latex.Carry out the test in duplicate.Repeat the test if the required limit value of 80 % retention rate is not met.All procedures involved in this test should be conducted in a clean environment, if possible under laminar flow.A.5.3 Expression of results The retention rate of the filter, expressed as a percentage, is given by101100n n ⎛⎞−×⎜⎟⎝⎠ (A.1)wheren 1 is the number of particles retained on the filter;n 0 is the number of particles in the test fluid used.Dimensions in millimetresKey1 storage bottle 5 piercing device2 transfer tube 6 fluid filter3 flow regulator 7 membrane filter4 connecting pieceFigure A.1 — Apparatus for testing the efficiency of the fluid filterA.6 Test of the injection sitePlace the injection site in a horizontal, stress-free position. Fill the infusion set with water in such a manner that no air bubbles are trapped and apply a pressure of 50 kPa above the atmospheric air pressure. Perforate the injection site at the foreseen area using a hypodermic needle with an outside diameter of 0,8 mm and which conforms to ISO 7864. Keep the needle in position for 15 s. Remove the needle and immediately dry the perforated site. Over a period of 1 min, observe whether there is any leakage from the injection site. In the case of an alternative injection site design, the test should be performed by injection into the site in accordance with the instructions provided by the manufacturer.© ISO 2010 – All rights reserved13。

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