【EP3561683A1】SETTINGIDENTIFICATIONINFORMATIONINACO

PERFORANCE QUALIFICATION PROTOCOL性能确认方案EO Processing Category PQ in1#sterilization chamberEO处理组在1#灭菌柜内的性能确认File Number文件编号Version版本号Description描述011st VersionValidation Team 验证团队Name/Position姓名/职位Signature签名Date日期Written By 起草者Reviewer 审核者Reviewer 审核者Approver 批准者目录1.验证目标Validation Objective (3)2.范围Scope (3)3.职责Responsibilities (9)4.验证策略Validation Strategy (9)5.接受标准Acceptance Criteria (11)6.偏差处理Deviations Handling (13)7.参考References (13)8.程序Procedure (14)9.附录Appendices (22)1.验证目标Validation Objective1.1.此次性能确认的目的是证实及用文件记录在现有的1#灭菌柜内采用的现有已验证的灭菌循环参数，通过实施灭菌微生物杀灭性研究（MPQ）及物理性研究（PPQ），能够实现现有EO处理组的无菌保证水平10-6。

此方案的设计持续符合ISO11135:2014-医疗产品灭菌-环氧乙烷-医疗器械灭菌过程的发展，验证及常规控制的要求。

The purpose of this Performance Qualification(PQ)is to demonstrate and document the attainment of a minimum Sterility Assurance Level of10-6for the sterilization of exiting EO Processing Category in existing1#EO Sterilization Chamber through the execution of sterilization microbiological lethality studies(MPQ)and physical performance studies(PPQ), using existing validated sterilization cycle parameters.This PQ protocol is designed to be consistent with ISO11135:2014Sterilization of health care products-Ethylene oxide-Requirements for development,validation and routine control of a sterilization process for medical devices.1.2.正常全周期循环完成后，通过EO/ECH残留的测试结果，确认达到残留放行标准的现有自然解析的时间是否足够。

Safety Data SheetRevision Date 2022-12-26Revision Number 91. IdentificationProduct identifier Product NameTALON Superflow Metal Affinity ResinOther means of identification Product Code635670 UN number or ID number UN3082SynonymsNo information availableRecommended use of the chemical and restrictions on use Identified uses No information available Restrictions on useNo information availableDetails of the supplier of the safety data sheetEmergency telephone number Emergency telephoneIn case of emergency, call PERS (Professional Emergency Resource Services) 1-800-633-8253 (US) or 801-629-0667 (international).2. Hazard(s) identificationProduct Classification Data Acute toxicity - Oral Category 2 CarcinogenicityCategory 1AHazards not otherwise classified (HNOC) Not applicable Label elements Supplier USA:Takara Bio USA, Inc. 2560 Orchard Parkway San Jose, CA 95131, USAPhone: 800.662.2566/888.251.6618 Web: DangerHazard statements Fatal if swallowed May cause cancerAppearance Pink slurry Physical state Paste / Gel Liquid Odor Alcohol Precautionary Statements - PreventionObtain special instructions before useDo not handle until all safety precautions have been read and understoodWear protective gloves/protective clothing/eye protection/face protectionWash face, hands and any exposed skin thoroughly after handlingDo not eat, drink or smoke when using this productPrecautionary Statements - ResponseIF exposed or concerned: Get medical advice/attentionSpecific treatment (see supplemental first aid instructions on this label)IF SWALLOWED: Immediately call a POISON CENTER or doctorRinse mouthPrecautionary Statements - StorageStore locked upPrecautionary Statements - DisposalDispose of contents/container to an approved waste disposal plantUnknown acute toxicity50.941 % of the mixture consists of ingredient(s) of unknown acute oral toxicityOther informationHarmful to aquatic life with long lasting effects. Harmful to aquatic life.3. Composition/information on ingredientsSubstanceNot applicable.MixtureChemical name CAS No Weight-% Trade secret Ethanol 64-17-5 10 - 20 *4. First-aid measuresDescription of first aid measuresGeneral advice Immediate medical attention is required. Show this safety data sheet to the doctor inattendance. IF exposed or concerned: Get medical advice/attention.Inhalation Remove to fresh air.Eye contact Rinse thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids.Consult a physician.Skin contact Wash skin with soap and water.Ingestion Get immediate medical advice/attention. Do NOT induce vomiting. Clean mouth with waterand drink afterwards plenty of water. Never give anything by mouth to an unconsciousperson.Most important symptoms and effects, both acute and delayedSymptoms No information available.Indication of any immediate medical attention and special treatment neededNote to physicians Treat symptomatically.5. Fire-fighting measuresSuitable Extinguishing Media Use extinguishing measures that are appropriate to local circumstances and thesurrounding environment.Large Fire CAUTION: Use of water spray when fighting fire may be inefficient.Unsuitable extinguishing media Do not scatter spilled material with high pressure water streams.Specific hazards arising from thechemicalNo information available.Explosion DataSensitivity to mechanical impact None.Sensitivity to static discharge None.Special protective equipment for fire-fighters Firefighters should wear self-contained breathing apparatus and full firefighting turnout gear. Use personal protection equipment.6. Accidental release measuresPersonal precautions, protective equipment and emergency proceduresPersonal precautions Ensure adequate ventilation.Other information Refer to protective measures listed in Sections 7 and 8.Methods and material for containment and cleaning upMethods for containment Prevent further leakage or spillage if safe to do so.Methods for cleaning up Pick up and transfer to properly labeled containers.7. Handling and storagePrecautions for safe handlingAdvice on safe handling Handle in accordance with good industrial hygiene and safety practice. Avoid contact withskin, eyes or clothing.Conditions for safe storage, including any incompatibilitiesStorage Conditions Store locked up. Keep containers tightly closed in a dry, cool and well-ventilated place.Keep out of the reach of children.8. Exposure controls/personal protectionControl parametersExposure LimitsChemical name ACGIH TLV OSHA PEL NIOSHEthanol 64-17-5 STEL: 1000 ppm TWA: 1000 ppmTWA: 1900 mg/m3(vacated) TWA: 1000 ppm(vacated) TWA: 1900 mg/m3IDLH: 3300 ppmTWA: 1000 ppmTWA: 1900 mg/m3Appropriate engineering controlsEngineering controls ShowersEyewash stationsVentilation systems.Individual protection measures, such as personal protective equipmentEye/face protection No special protective equipment required.Hand protection Wear suitable gloves.Skin and body protection Wear suitable protective clothing.Respiratory protection No protective equipment is needed under normal use conditions. If exposure limits areexceeded or irritation is experienced, ventilation and evacuation may be required. General hygiene considerations Do not eat, drink or smoke when using this product. Wash hands before breaks andimmediately after handling the product.9. Physical and chemical propertiesInformation on basic physical and chemical propertiesPhysical state Paste / Gel LiquidAppearance Pink slurryColor No information availableOdor AlcoholOdor Threshold No information availableProperty Values Remarks • MethodpH No data available None knownMelting point / freezing point No data available None knownBoiling point/boiling range (°C) No data available None knownFlash point No data available Open cupEvaporation Rate No data available None knownFlammability (solid, gas) No data available None knownFlammability Limit in Air None knownUpper flammability limit: No data availableLower flammability limit: No data availableVapor pressure No data available None knownVapor density No data available None knownRelative density No data available None knownWater solubility No data available None knownSolubility in other solvents No data available None knownPartition coefficient No data available None knownAutoignition temperature 363 °C / 685.4 °F None knownDecomposition temperature None knownKinematic viscosity No data available None knownDynamic Viscosity No data available None knownOther informationExplosive properties No information availableOxidizing properties No information availableSoftening point No information availableMolecular weight No information availableVOC content No information availableLiquid Density No information availableBulk Density No information available10. Stability and reactivityReactivity No information available.Chemical stability Stable under normal conditions.Possibility of hazardous reactions None under normal processing.Conditions to Avoid None known based on information supplied.Incompatible materials None known based on information supplied.Hazardous decomposition products None known based on information supplied.11. Toxicological informationInformation on likely routes of exposureProduct InformationInhalation Specific test data for the substance or mixture is not available.Eye contact Specific test data for the substance or mixture is not available.Skin contact Specific test data for the substance or mixture is not available.Ingestion Specific test data for the substance or mixture is not available. Fatal if swallowed. (based oncomponents).Symptoms related to the physical, chemical and toxicological characteristicsSymptoms No information available.Acute toxicityNumerical measures of toxicityThe following values are calculated based on chapter 3.1 of the GHS documentATEmix (oral) 9.81 mg/kgATEmix (inhalation-dust/mist) 573.50 mg/lUnknown acute toxicity50.941 % of the mixture consists of ingredient(s) of unknown acute oral toxicityComponent InformationChemical name Oral LD50 Dermal LD50 Inhalation LC50 Ethanol = 7060 mg/kg ( Rat ) - = 116.9 mg/L ( Rat ) 4 h64-17-5 = 133.8 mg/L ( Rat ) 4 hDelayed and immediate effects as well as chronic effects from short and long-term exposureSkin corrosion/irritation No information available.Serious eye damage/eye irritation No information available.Respiratory or skin sensitization No information available.Germ cell mutagenicity No information available.Carcinogenicity Contains a known or suspected carcinogen. Classification based on data available foringredients. May cause cancer.The table below indicates whether each agency has listed any ingredient as a carcinogen.Chemical name ACGIH IARC NTP OSHA Ethanol64-17-5A3 Group 1 Known XLegendACGIH (American Conference of Governmental Industrial Hygienists)A3 - Animal CarcinogenIARC (International Agency for Research on Cancer)Group 1 - Carcinogenic to HumansNTP (National Toxicology Program)Known - Known CarcinogenOSHA (Occupational Safety and Health Administration of the US Department of Labor)X - PresentReproductive toxicity No information available.STOT - single exposure No information available.STOT - repeated exposure No information available.Target organ effects Liver, Respiratory system, Eyes, Skin, Central nervous system, Blood, Reproductivesystem.Aspiration hazard No information available.Other adverse effects No information available.Interactive effects No information available.12. Ecological informationEcotoxicity Harmful to aquatic life with long lasting effects.Chemical name Algae/aquatic plants Fish Toxicity tomicroorganismsCrustaceaEthanol 64-17-5 - LC50: 12.0 - 16.0mL/L(96h, Oncorhynchus- LC50: 9268 - 14221mg/L(48h, Daphnia magna)mykiss)LC50: >100mg/L (96h, Pimephales promelas) LC50: 13400 - 15100mg/L (96h, Pimephalespromelas) EC50: =2mg/L (48h, Daphnia magna)Persistence and degradability No information available.Bioaccumulation There is no data for this product.Component InformationChemical name Partition coefficientEthanol64-17-5-0.35Other adverse effects No information available.13. Disposal considerationsWaste treatment methodsWaste from residues/unused products Dispose of in accordance with local regulations. Dispose of waste in accordance with environmental legislation.Contaminated packaging Do not reuse empty containers.California Hazardous Waste Status This product contains one or more substances that are listed with the State of California asa hazardous waste.14. Transport informationDOTUN number or ID number UN3082Proper shipping name Environmentally hazardous substance, liquid, n.o.s.Transport hazard class(es) 9Packing group IIISpecial Provisions 8, 146, 173, 335, 441, IB3, T4, TP1, TP29DOT Marine Pollutant NPDescription UN3082, Environmentally hazardous substance, liquid, n.o.s., 9, IIIEmergency Response GuideNumber171TDGUN number or ID number UN3082UN proper shipping name Environmentally hazardous substance, liquid, n.o.s.Transport hazard class(es) 9Packing group IIISpecial Provisions 16, 99Description UN3082, Environmentally hazardous substance, liquid, n.o.s. (Ethanol), 9, IIIMEXUN number or ID number UN3082UN proper shipping name Environmentally hazardous substance, liquid, n.o.s.Transport hazard class(es) 9Packing group IIITechnical Name EthanolDescription UN3082, Environmentally hazardous substance, liquid, n.o.s. (Ethanol), 9, IIISpecial Provisions 274, 331, 335ICAO (air)UN number or ID number UN3082UN proper shipping name Environmentally hazardous substance, liquid, n.o.s.Transport hazard class(es) 9Packing group IIIDescription UN3082, Environmentally hazardous substance, liquid, n.o.s. (Ethanol), 9, III Special Provisions A97, A158, A197, A215IATAUN number or ID number UN3082UN proper shipping name Environmentally hazardous substance, liquid, n.o.s.Transport hazard class(es) 9Packing group IIITechnical Name EthanolDescription UN3082, Environmentally hazardous substance, liquid, n.o.s. (Ethanol), 9, III Special Provisions A97, A158, A197ERG Code 9LUN number or ID number UN3082UN proper shipping name Environmentally hazardous substance, liquid, n.o.s.Transport hazard class(es) 9Packing group IIIEmS-No F-A, S-FSpecial Provisions 274, 335, 969Marine pollutant PDescription UN3082, Environmentally hazardous substance, liquid, n.o.s., 9, III, Marine Pollutant RIDUN number or ID number UN3082UN proper shipping name Environmentally hazardous substance, liquid, n.o.s.Transport hazard class(es) 9Packing group IIIClassification code M6Special Provisions 274, 335, 375, 601Description UN3082, Environmentally hazardous substance, liquid, n.o.s. (Ethanol), 9, IIIADRUN number or ID number UN3082UN proper shipping name Environmentally hazardous substance, liquid, n.o.s.Transport hazard class(es) 9Packing group IIIClassification code M6Tunnel restriction code (-)Special Provisions 274, 335, 601, 375Description UN3082, Environmentally hazardous substance, liquid, n.o.s. (Ethanol), 9, III, (-) ADNNotes Could not find a Marine Pollutant Name.UN number or ID number UN3082UN proper shipping name Environmentally hazardous substance, liquid, n.o.s.Transport hazard class(es) 9Packing group IIIClassification code M6Special Provisions 274, 335, 375, 601Description UN3082, Environmentally hazardous substance, liquid, n.o.s. (Ethanol, Cobalt), 9, III Equipment Requirements PP15. Regulatory informationInternational InventoriesTSCA -.*Contact supplier for details. One or more substances in this product are either not listed on the US TSCA inventory, listed on the confidential US TSCA inventory or are otherwise exempted from inventory listing requirementsDSL/NDSL -.EINECS/ELINCS -.ENCS -.IECSC -.KECL -.PICCS -.AICS -.Legend:TSCA - United States Toxic Substances Control Act Section 8(b) InventoryDSL/NDSL - Canadian Domestic Substances List/Non-Domestic Substances ListEINECS/ELINCS - European Inventory of Existing Chemical Substances/European List of Notified Chemical SubstancesENCS - Japan Existing and New Chemical SubstancesIECSC - China Inventory of Existing Chemical SubstancesKECL - Korean Existing and Evaluated Chemical SubstancesPICCS - Philippines Inventory of Chemicals and Chemical SubstancesAICS - Australian Inventory of Chemical SubstancesUS Federal RegulationsSARA 313Section 313 of Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA). This product does not contain any chemicals which are subject to the reporting requirements of the Act and Title 40 of the Code of Federal Regulations, Part 372. SARA 311/312 Hazard CategoriesShould this product meet EPCRA 311/312 Tier reporting criteria at 40 CFR 370, refer to Section 2 of this SDS for appropriate classifications.CWA (Clean Water Act)This product does not contain any substances regulated as pollutants pursuant to the Clean Water Act (40 CFR 122.21 and 40 CFR 122.42).CERCLAThis material, as supplied, does not contain any substances regulated as hazardous substances under the Comprehensive Environmental Response Compensation and Liability Act (CERCLA) (40 CFR 302) or the Superfund Amendments and Reauthorization Act (SARA) (40 CFR 355). There may be specific reporting requirements at the local, regional, or state level pertaining to releases of this material.US State RegulationsCalifornia Proposition 65This product contains the following Proposition 65 chemicals:.Chemical name California Proposition 65Ethanol - 64-17-5 CarcinogenDevelopmentalCobalt - 7440-48-4 CarcinogenU.S. State Right-to-Know RegulationsChemical name New Jersey Massachusetts Pennsylvania EthanolX X X 64-17-5X X X Cobalt7440-48-4U.S. EPA Label InformationEPA Pesticide Registration Number Not applicable16. Other informationNFPA Health hazards 3 Flammability 1 Instability 0 Special hazards - HMIS Health hazards * 3 Flammability 1 Physical hazards 0 Personal protection X Chronic Hazard Star Legend * = Chronic Health HazardKey or legend to abbreviations and acronyms used in the safety data sheetLegend Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTIONTWA Time weighted average STEL Short term exposure limitCeiling Maximum limit value * Skin designationKey literature references and sources for data used to compile the SDSAgency for Toxic Substances and Disease Registry (ATSDR)U.S. Environmental Protection Agency ChemView DatabaseEuropean Food Safety Authority (EFSA)EPA (Environmental Protection Agency)Acute Exposure Guideline Level(s) (AEGL(s))U.S. Environmental Protection Agency Federal Insecticide, Fungicide, and Rodenticide ActU.S. Environmental Protection Agency High Production Volume ChemicalsFood Research JournalHazardous Substance DatabaseInternational Uniform Chemical Information Database (IUCLID)Japan GHS ClassificationAustralia National Industrial Chemicals Notification and Assessment Scheme (NICNAS)NIOSH (National Institute for Occupational Safety and Health)National Library of Medicine's ChemID Plus (NLM CIP)National Library of Medicine’s PubMed database (NLM PUBMED)National Toxicology Program (NTP)New Zealand's Chemical Classification and Information Database (CCID)Organization for Economic Co-operation and Development Environment, Health, and Safety PublicationsOrganization for Economic Co-operation and Development High Production Volume Chemicals ProgramOrganization for Economic Co-operation and Development Screening Information Data SetWorld Health OrganizationRevision Date 2022-12-26Revision Note No information available.DisclaimerThe information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any process, unless specified in the text.End of Safety Data Sheet。

SAFETY DATA SHEET1. IdentificationMERCON ULV AUTOMATIC TRANSMISSION FLUIDProduct identifierOther means of identification196825FIR No.Automatic Transmission FluidRecommended useNone known.Recommended restrictionsManufacturer/Importer/Supplier/Distributor informationFord Motor CompanyCompany NameAttention: SDS Information, P.O. Box 1899AddressDearborn, Michigan 48121USA1-800-392-3673Telephone1-800-448-2063 (USA and Canada)SDS InformationEmergency telephonenumbersPoison Control Center: USA and Canada: 1-800-959-3673INFOTRAC (Transportation): USA and Canada 1-800-535-50532. Hazard(s) identificationNot classified.Physical hazardsAspiration hazardCategory 1Health hazardsNot classified.Environmental hazardsNot classified.OSHA defined hazardsLabel elementsSignal word DangerHazard statement May be fatal if swallowed and enters airways.Precautionary statementPrevention Observe good industrial hygiene practices.Response If swallowed: Immediately call a poison center/doctor. Do NOT induce vomiting. Take offcontaminated clothing and wash it before reuse.Storage Store locked up.Disposal Dispose of contents/container in accordance with local/regional/national/international regulations. Hazard(s) not otherwiseNone known.classified (HNOC)Supplemental information None.3. Composition/information on ingredientsMixturesCAS number% Chemical name Common name and synonyms89 - 90Distillates (petroleum), hydrotreated64742-55-8light paraffinicSpecific chemical identity and/or exact percentage (concentration) of composition has been withheld as a trade secret.4. First-aid measuresMove to fresh air. Call a physician if symptoms develop or persist.Inhalation Wash off with soap and water. Get medical attention if irritation develops and persists.Skin contact Rinse with water. Get medical attention if irritation develops and persists.Eye contact Call a physician or poison control center immediately. Rinse mouth. Do not induce vomiting. If vomiting occurs, keep head low so that stomach content doesn't get into the lungs.IngestionAspiration may cause pulmonary edema and pneumonitis.Most importantsymptoms/effects, acute and delayedProvide general supportive measures and treat symptomatically. Keep victim under observation.Symptoms may be delayed.Indication of immediatemedical attention and special treatment needed Ensure that medical personnel are aware of the material(s) involved, and take precautions to protect themselves.General information5. Fire-fighting measuresWater fog. Foam. Dry chemical powder. Carbon dioxide (CO2).Suitable extinguishing media Do not use water jet as an extinguisher, as this will spread the fire.Unsuitable extinguishing mediaDuring fire, gases hazardous to health may be formed. Upon decomposition, this product emits carbon monoxide, carbon dioxide and/or low molecular weight hydrocarbons.Specific hazards arising from the chemicalSelf-contained breathing apparatus and full protective clothing must be worn in case of fire.Special protective equipment and precautions for firefighters Move containers from fire area if you can do so without risk.Fire fightingequipment/instructions Use standard firefighting procedures and consider the hazards of other involved materials.Specific methods No unusual fire or explosion hazards noted.General fire hazards6. Accidental release measuresAvoid contact with eyes, skin, and clothing. Avoid inhalation of vapors and spray mists. Ensure adequate ventilation. Keep people away from and upwind of spill/leak. Keep unnecessarypersonnel away. Local authorities should be advised if significant spillages cannot be contained.Wear appropriate protective equipment and clothing during clean-up. For personal protection, see section 8 of the SDS.Personal precautions,protective equipment and emergency proceduresThe product is immiscible with water and will spread on the water surface.Large Spills: Stop the flow of material, if this is without risk. Dike the spilled material, where this is possible. Absorb in vermiculite, dry sand or earth and place into containers. Following product recovery, flush area with water.Small Spills: Wipe up with absorbent material (e.g. cloth, fleece). Clean surface thoroughly to remove residual contamination.Never return spills to original containers for re-use. For waste disposal, see section 13 of the SDS.Methods and materials for containment and cleaning upAvoid discharge into drains, water courses or onto the ground.Environmental precautions7. Handling and storageAvoid contact with eyes, skin, and clothing. Avoid breathing mist or vapor. Avoid prolongedexposure. Provide adequate ventilation. Observe good industrial hygiene practices. Wash hands thoroughly after handling. Wear appropriate personal protective equipment. For personal protection, see Section 8 of the SDS.Precautions for safe handlingStore locked up. Store in tightly closed container. Store away from incompatible materials (see Section 10 of the SDS).Conditions for safe storage,including any incompatibilities8. Exposure controls/personal protectionOccupational exposure limitsThe following constituents are the only constituents of the product which have a PEL, TLV or other recommended exposure limit.At this time, the other constituents have no known exposure limits.US. OSHA Table Z-1 Limits for Air Contaminants (29 CFR 1910.1000)Form Value Components Type PEL5 mg/m3Mist.Distillates (petroleum),hydrotreated light paraffinic (CAS 64742-55-8)US. ACGIH Threshold Limit Values FormValue ComponentsType TWA5 mg/m3Inhalable fraction.Distillates (petroleum),hydrotreated light paraffinic (CAS 64742-55-8)US. NIOSH: Pocket Guide to Chemical Hazards Form Value Components Type STEL10 mg/m3Mist.Distillates (petroleum),hydrotreated light paraffinic (CAS 64742-55-8)TWA 5 mg/m3Mist.No biological exposure limits noted for the ingredient(s).Biological limit values Use adequate ventilation to control airborne concentrations below the exposure limits/guidelines. If user operations generate a vapor, dust and/or mist, use process enclosure, appropriate local exhaust ventilation, or other engineering controls to control airborne levels below the recommended exposure limits/guidelines.Appropriate engineering controlsIndividual protection measures, such as personal protective equipmentWear safety glasses with side shields (or goggles).Eye/face protectionSkin protectionSuitable chemical protective gloves should be worn when the potential exists for skin exposure.The choice of an appropriate glove does not only depend on its material but also on other quality features and is different from one producer to the other. Nitrile gloves are recommended.Hand protectionWear appropriate chemical resistant clothing if applicable.OtherIf engineering controls do not maintain airborne concentrations to a level which is adequate to protect worker health, an approved respirator must be worn. Respirator selection, use and maintenance should be in accordance with the requirements of OSHA Respiratory Protection Standard 29 CFR 1910.134 and/or Canadian Standard CSA Z94.4.Respiratory protectionWear appropriate thermal protective clothing, when necessary.Thermal hazards Always observe good personal hygiene measures, such as washing after handling the material and before eating, drinking, and/or smoking. Routinely wash work clothing and protective equipment to remove contaminants.General hygiene considerations9. Physical and chemical propertiesAppearanceLiquid.Physical state Liquid.Form Red.Color PETROLEUM OdorOdor threshold Not available.pHNot available.Melting point/freezing point Not available.Initial boiling point and boiling range Not available.Flash point > 314.6 °F (> 157.0 °C) Pensky-Martens Closed Cup Evaporation rate Not available.Not applicable.Flammability (solid, gas)Upper/lower flammability or explosive limits Explosive limit - lower (%)Not available.Explosive limit - upper (%)Not available.Vapor pressure< 1 mm HgVapor density > 1 (Air=1)Relative density0.83 - 0.85 (Water=1)Relative density temperature 60.08 °F (15.6 °C)Solubility(ies)Solubility (water)Negligible Partition coefficient (n-octanol/water)Not available.Auto-ignition temperature Not available.Decomposition temperature Not available.Viscosity19 - 20 cSt Viscosity temperature104 °F (40 °C)10. Stability and reactivityThe product is stable and non-reactive under normal conditions of use, storage and transport.Reactivity Material is stable under normal conditions.Chemical stability No dangerous reaction known under conditions of normal use.Possibility of hazardous reactionsContact with incompatible materials.Conditions to avoid Strong oxidizing agents.Incompatible materials Upon decomposition, this product emits carbon monoxide, carbon dioxide and/or low molecular weight hydrocarbons.Hazardous decomposition products11. Toxicological informationInformation on likely routes of exposureInhalationBased on available data, the classification criteria are not met. Prolonged inhalation may be harmful.Skin contact Based on available data, the classification criteria are not met.Eye contact Based on available data, the classification criteria are not met.IngestionDroplets of the product aspirated into the lungs through ingestion or vomiting may cause a serious chemical pneumonia.Symptoms related to the physical, chemical andtoxicological characteristics Aspiration may cause pulmonary edema and pneumonitis.Information on toxicological effectsAcute toxicityMay be fatal if swallowed and enters airways.Prolonged skin contact may cause temporary irritation.Skin corrosion/irritation Direct contact with eyes may cause temporary irritation.Serious eye damage/eye irritationRespiratory or skin sensitizationRespiratory sensitizationNot a respiratory sensitizer.This product is not expected to cause skin sensitization.Skin sensitization No data available to indicate product or any components present at greater than 0.1% are mutagenic or genotoxic.Germ cell mutagenicity CarcinogenicityNot classifiable as to carcinogenicity to humans.IARC Monographs. Overall Evaluation of CarcinogenicityNot listed.OSHA Specifically Regulated Substances (29 CFR 1910.1001-1053)Not listed.This product is not expected to cause reproductive or developmental effects.Reproductive toxicitySpecific target organ toxicity -single exposureNot classified.Specific target organ toxicity -repeated exposureNot classified.Aspiration hazard May be fatal if swallowed and enters airways.Chronic effectsProlonged inhalation may be harmful.12. Ecological informationThe product is not classified as environmentally hazardous. However, this does not exclude the possibility that large or frequent spills can have a harmful or damaging effect on the environment.EcotoxicityNo data is available on the degradability of any ingredients in the mixture. Persistence and degradabilityBioaccumulative potential No data available.Mobility in soil Other adverse effectsNo other adverse environmental effects (e.g. ozone depletion, photochemical ozone creationpotential, endocrine disruption, global warming potential) are expected from this component.13. Disposal considerationsCollect and reclaim or dispose in sealed containers at licensed waste disposal site. Dispose of contents/container in accordance with local/regional/national/international regulations. Don't pollute. Conserve resources. Return used oil to collection centers.Disposal instructionsDispose in accordance with all applicable regulations.Local disposal regulations The waste code should be assigned in discussion between the user, the producer and the waste disposal company.Hazardous waste code Dispose of in accordance with local regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a safe manner (see:Disposal instructions).Waste from residues / unused productsSince emptied containers may retain product residue, follow label warnings even after container is emptied. Empty containers should be taken to an approved waste handling site for recycling or disposal.Contaminated packaging14. Transport informationDOTNot regulated as dangerous goods.IATANot regulated as dangerous goods.IMDGNot regulated as dangerous goods.Not established.Transport in bulk according toAnnex II of MARPOL 73/78 and the IBC Code15. Regulatory informationThis product is a "Hazardous Chemical" as defined by the OSHA Hazard Communication Standard, 29 CFR 1910.1200.US federal regulationsToxic Substances Control Act (TSCA)TSCA Section 12(b) Export Notification (40 CFR 707, Subpt. D)Not regulated.CERCLA Hazardous Substance List (40 CFR 302.4)Not listed.SARA 304 Emergency release notificationNot regulated.OSHA Specifically Regulated Substances (29 CFR 1910.1001-1053)Not listed.SARA 302 Extremely hazardous substanceSuperfund Amendments and Reauthorization Act of 1986 (SARA)Not listed.YesSARA 311/312 Hazardous chemicalAspiration hazardClassified hazard categoriesSARA 313 (TRI reporting)Not regulated.Other federal regulationsClean Air Act (CAA) Section 112 Hazardous Air Pollutants (HAPs) ListNot regulated.Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR 68.130)Not regulated.Not regulated.Safe Drinking Water Act(SDWA)International InventoriesAll components are listed or are exempt from listing on the Toxic Substances Control Act Inventory.16. Other information, including date of preparation or last revision08-20-2021Issue date Version 01Health: 0Flammability: 1Physical hazard: 0HMIS® ratingsHealth: 0Flammability: 1Instability: 0NFPA ratingsThis document was prepared by FCSD-Toxicology, Ford Motor Company, Diagnostic Service Center II, 1800 Fairlane Drive, Allen Park, MI 48101, USA, based in part on information provided by the manufacturer. The information on this data sheet represents our current data and is accurate to the best of our knowledge as to the proper handling of this product under normal conditions and in accordance with the application specified on the packaging and/or technical guidance literature. Any other use of the product which involves using the product in combination with any other product or any other process is the responsibility of the user. To the extent that there are any differences between this product’s Safety Data Sheet (SDS) and the consumer packaged product labels, the SDS should be followed.Preparation Information and DisclaimerXT-12-QULV, XT-12-QULV1Part number(s)。

体外诊断试剂IVD欧盟EN13612性能评估部分中英3 General requirements for the performance evaluation3.1 Responsibilities and resourcesThe manufacturer takes the responsibility for the initiation and/or the conduct of a performance evaluation study. He shall define the responsibility and the interrelation of all personnel who manageand conduct the performance evaluation of IVD MDs,particularly for personnel who need theorganisational freedom and authority toa) assess the validity of test results and data already available;b) specify performance claims which shall be further examined or confirmed;c) specify and document the evaluation plan and the test procedures;d) prepare the evaluation report.The manufacturer shall appoint a co-ordinator with overall responsibility of the performance evaluationstudy. The co-ordinator shall himself assure that adequate resources are available. The investigatorshall ensure that the evaluation plan is followed at his location and that the study is appropriatelyreviewed from an ethical point of view.3.2 DocumentationThe documentation of the performance evaluation study shall contain the files relating to clauses 3 to7 of this standard and shall be part of the technical documentation of the IVD MD.3.3 Final assessment and reviewThe co-ordinator shall assess and document which performance claims are met, state whether claimsare not met and give recommendations for corrective actions, where necessary.The responsible management of the manufacturer shall make sure that the results of the performanceevaluation study and the recommendations for corrective actions are carefully considered and properlydocumented before issuing a declaration of conformity.4 Organisation of a performance evaluation study4.1 PreconditionsBefore starting a performance evaluation study it shall be ensured by the co-ordinator thata) the performance claims of the IVD MD which are the subject of the study are specified;b) the IVD MD has been manufactured under controlled production processes and conditions;c) the IVD MD to be evaluated meets the quality control release specifications;d) a sufficient number of samples of the IVD MD can be provided during the entire period of theperformance evaluation study;e) all legal requirements for performance evaluation studies are met;f) the investigator(s) is (are) adequately skilled andtrained to conduct the study and the necessaryresources are available.4.2 Evaluation planThe evaluation plan shall state the purpose on scientific, technical or medical grounds, the scope ofthe evaluation, the structure and organization of the study and the number of devices concerned.Defining the objective of the study, the co-ordinator shall have assessed which performance claimsare already verified by data or scientific literature.The evaluation plan shall be designed to minimise the requirements for invasive sampling. In the caseof IVD MDs for self-testing it shall be ensured that the evaluation plan is appropriate and acceptable tousers and the information provided shall be clear and easily understood.The evaluation plan shall specifya) that the investigator(s) is (are) adequately skilled and trained to use the IVD MD;b) the list of laboratories or other institutions taking part in the performance evaluation study; for selftesting,the location and number of lay persons involved;c) the time-table;d) the necessary minimum number of probands from whom specimens are collected by invasiveprocedures in order to adequately assess the performance of the IVD MD;e) instructions for use including a description of the conditions of use;f) the performance claims (e.g. analytical sensitivity, diagnostic sensitivity, analytical specificity,diagnostic specificity, accuracy, repeatability, reproducibility) to be validated;g) the format of performance study records.4.3 Sites and resourcesIn general, the performance study procedure(s) shall be carried out under conditions reflecting therelevant intended conditions of use.The co-ordinator shall take the responsibility for the proper conduct of the performance evaluationstudy at all sites. All investigators shall be named.The co-ordinator shall ensure adequate competence and skill at all sites involved and that thenecessary resources are available.Where lay persons are involved in a performance evaluation study of an IVD MD for self-testing, thelocation of the study and the number of persons shall be given. The co-ordinator shall specify thecriteria for the selection of a representative panel. Especially for studies involving lay persons it shall be ensured that these persons do not receiveadditional information on the use of the IVD MD apart from that which is provided with the IVD MDwhen it is placed on the market because the comprehension of the manufacturer's instructions for useis one of the important aspects of the study. lt shall also be ensured that the untrained person(s) donot receive any additional information or help, e. g. from a tutor, other than the training specified andprovided by the manufacturer in the instructions for use.4.4 Basic design informationThe co-ordinator shall provide the investigator(s) with sufficient information in order to understand thefunction and application of the IVD MD and, where necessary, the investigator shall make himselffamiliar with the IVD MD and its application. The information provided shall include a statement thatthe device in question conforms with the requirements of the Directive 98/79/EC apart from those to beevaluated.4.5 Experimental designThe experimental procedures to validate each performance claim subject to the performanceevaluation study shall be documented in the evaluation plan. Special consideration in performance evaluation studies of reagents/kits shall be given, whereapplicable, to the following:–specification of type (e.g. serum, plasma, urine) and properties (e.g. concentration range, ageand sex of the proband population) of specimens appropriate to the intended use;– probands to be enrolled;– suitability, stability and volume of specimens and specimen exclusion criteria;–blind procedures, where necessary;– reagent stability;–inclusion of common interfering factors, caused by specimen condition or thepathological/physiological status of the specimen donor or treatment;–conditions for use which can be reasonably anticipated; special attention shall be paid to theconditions of use by lay persons;–selection of an appropriate reference measurement procedure and reference material ofhigher order, where available;–determination of the status of specimens (for qualitative tests with a nominal or ordinal scale);–calibration procedures, including traceability, where appropriate;– appropriate means of control;– limitations of the test;– criteria for re-examination and data exclusion;–availability of additional information concerning the specimen or donor if follow-up ofunexpected results is required;– appropriate measures to reduce risk of infection to the user.Where the study is intended to validate the performance claims of an instrument special considerationshall be given additionally to the following:– maintenance and cleaning;– carry-over effects;– software validation.NOTE For the investigation of the technical aspects of instruments,other standards can be relevant.4.6 Performance study recordsThe performance study records shall– refer to the experimental procedures in the evaluation plan;– be unequivocally identifiable;– contain or refer to all results and related relevant data;– be part of the technical documentation of the IVD MD.The protection of all confidential data shall be ensured.4.7 Observations and unexpected outcomesSpecial attention shall be paid to observations andunexpected outcomes, e. g. drop outs, outliers,instability of sample or reagent signal etc., non-reproducibility, non-correlation of results to thereference or to the diagnostic pattern, defects or breakdowns, software errors, or error signals.Any deviation from the defined procedures shall be recorded.In the case of IVD MDs for self-testing,the investigator or tutor shall duly note any difficulty or question a user may have and any deviationfrom the mode of application of the IVD MD as described by the manufacturer.Any such observation shall be properly recorded. The co-ordinator shall, together with the investigator,trace the cause whenever possible. The result shall be recorded and shall be part of the evaluationreport.Where the validity of the examinations already performed may be questionable because of anidentified source of error the tests shall be repeated after exclusion of that cause.Where a misuse or misinterpretation of the instructions for use has been the cause and where anunexpected risk inherent to the product design or the mode of application has been identified this shallbe clearly stated.The proposals of the investigator(s) and the co-ordinator for any improvement of the IVD MD and/or itsapplication shall be recorded.4.8 Evaluation reportThe co-ordinator shall establish an evaluation report. It shallcontain a description of the study, ananalysis of the results together with a conclusion on the performance claims investigated.The report shall also discuss any unexpected outcomes which have occurred. It shall identify thecause whenever possible and give recommendations for corrective actions to be taken, wherenecessary.If several studies have been conducted for one IVD MD, a single summarizing report may beestablished.5 Modifications during the performance evaluation studyWhere the manufacturing process has been changed it shall be checked whether the performanceclaims of the IVD MD still conform to those which had been set initially. Otherwise the validity of theexaminations already performed shall be questioned and the evaluation plan shall be revisedaccordingly.Where design changes are introduced, the evaluation plan shall be revised.6 Re-evaluationIn case of changes to the design or manufacturing process of the IVD MD, the performance evaluationstudy shall be repeated as far as necessary, to ensure that the intended use and the performanceclaims of the IVD MD placed on the market are adequately evaluated.This re-evaluation may refer to documented results of a preceding evaluation insofar as these are considered valid andtransferable after critical review.7 Protection and safety of probandsThe removal, collection and use of tissues, cells and substances of human origin is governed, inrelation to ethics, by the principles laid down in the Convention of the Council of Europe for theprotection of human rights and dignity of the human being with regard to the application of biology andmedicine and by any national regulations on this matter.In any case, the results obtained from a specimen by means of the IVD MD under evaluation shall notbe used for other purposes than for performance evaluation, unless ethical reasons, fully supported bya responsible medical professional, suggest the contrary. In such a case the medical professionalassumes complete responsibility.3 性能评估的一般要求3.1 责任和谋略生产商负责性能评估研究的开始和/或引导。

Eaton 197166Eaton Moeller® series EMS2 DOL starter, 24 V DC, 1,5 - 7 (AC-53a), 9 (AC-51) A, Screw terminals, Controlled stop, PTB 19 ATEX 3000General specificationsEaton Moeller® series EMS2 DOL starter197166EMS2-DOS-Z-9-24VDC4015080896074114.5 mm 99 mm 22.5 mm 0.287 kgIEC/EN 60947-4-2 IEC 61508 EN ISO 13849 UL508UL File No.: E338590UL Category Control No.: NLDX, NLDX7 PTB 19 ATEX 3000 UL 60947-4-1CSA-C22.2 No. 60947-4-1-14 CE marking UL listedCertified by UL for use in Canada UL report applies to both US and CanadaProduct NameCatalog Number Model CodeEANProduct Length/Depth Product Height Product Width Product Weight Certifications9 AIs the panel builder's responsibility. The specifications for the switchgear must be observed.3 kW500 V AC42 - 550 V0 A0 VMeets the product standard's requirements.Is the panel builder's responsibility. The specifications for the switchgear must be observed.Rail mounting possibleTop-hat rail fixing (according to IEC/EN 60715, 35 mm)Does not apply, since the entire switchgear needs to be evaluated.3 kW0 kW0 kWMeets the product standard's requirements.24 V EMS 2 Electronic motor starters - brochureEMS 2 Electronic motor starters - flyerSwitching and protecting motors - catalogDA-DC-00004126.pdfeaton-contactors-ems2-reversing-starter-characteristic-curve-002.eps eaton-contactors-ems2-reversing-starter-characteristic-curve.eps eaton-contactors-ems2-reversing-starter-characteristic-curve-004.epsDA-DC-00004947.pdfDA-DC-00004948.pdfeaton-contactors-ems2-reversing-starter-dimensions-002.eps eaton-contactors-ems2-reversing-starter-3d-drawing-002.epsDA-CE-ETN.EMS2-DOS-Z-9-24VDCIL034089ZUEaton's electronic motor starter EMS2eaton-electronic-motor-starter-ems2-manual-mn034003en-us.pdfDA-CD-ems2_dos_ros_z_24_230vDA-CS-ems2_dos_ros_z_24_230vRated operational current for specified heat dissipation (In) 10.11 Short-circuit ratingRated operational power at AC-3, 380/400 V, 50 Hz Rated operational voltageRated conditional short-circuit current, type 1, 480 Y/277 V Rated control supply voltage (Us) at AC, 50 Hz - min10.4 Clearances and creepage distances10.12 Electromagnetic compatibilityMounting method10.2.5 LiftingRated operational power at AC-53A, 380/400 V, 50 Hz Rated power at 575 V, 60 Hz, 3-phaseRated power at 460 V, 60 Hz, 3-phase10.2.3.1 Verification of thermal stability of enclosures Rated control supply voltage (Us) at DC - minAmbient storage temperature - min BrochuresCatalogsCertification reports Characteristic curveDeclarations of conformity DrawingseCAD modelInstallation instructions Installation videos Manuals and user guides mCAD model40 °CNumber of pilot lightsRated control supply voltage (Us) at AC, 50 Hz - max0 V10.8 Connections for external conductorsIs the panel builder's responsibility.Coordination class (IEC 60947-4-3)Class 1Terminal capacity (AWG)26 - 14, Control circuit cables24 - 14, Main cablesRated conditional short-circuit current, type 1, 600 Y/347 V0 AAmbient operating temperature - max70 °CRated operational power at AC-3, 220/230 V, 50 Hz1.5 kWConnection to SmartWire-DTNoNumber of command positionsStatic heat dissipation, non-current-dependent Pvs2 WElectrical connection type of main circuitScrew connectionElectrical connection type for auxiliary- and control-current circuit Screw connectionPower consumption (sealing) at DC12 WRated control supply voltage (Us) at DC - max24 VHeat dissipation detailsIf necessary, Allow for derating10.9.3 Impulse withstand voltageIs the panel builder's responsibility.Rated control supply voltage19.2 - 30 V DCAmbient operating temperature - min-25 °C10.6 Incorporation of switching devices and componentsDoes not apply, since the entire switchgear needs to be evaluated.10.5 Protection against electric shockDoes not apply, since the entire switchgear needs to be evaluated.Mounting positionVerticalMotor feeder at bottomRated operational current (Ie) at AC-15, 220 V, 230 V, 240 V2 ASafety parameter (EN ISO 13849-1)PL e, Performance level (safe switch off)3 (safe switch off), Category60 (safe switch off) / 70 (motor protection) years; MTTFDClassCLASS 10 A10.13 Mechanical functionThe device meets the requirements, provided the information in the instruction leaflet (IL) is observed.10.2.6 Mechanical impactDoes not apply, since the entire switchgear needs to be evaluated.10.9.4 Testing of enclosures made of insulating materialIs the panel builder's responsibility.10.3 Degree of protection of assembliesDoes not apply, since the entire switchgear needs to be evaluated.Heat dissipation per pole, current-dependent Pvid0 WActuating voltage24 V DCVoltage typeDCProduct categoryElectronic motor starterRadio interference classClass A (EN 61000-6-3, emitted interference, radiated)EN 55011Residual ripple≤ 5 % (input voltage)Terminal capacity0.2 - 2.5 mm², Main cables0.14 - 2.5 mm², Control circuit cables0.2 - 2.5 mm², Main cables, Push-in terminalsRated control voltage (Uc)24 V (Actuating circuit ON, L, R)Equipment heat dissipation, current-dependent Pvid12 WHeat dissipation capacity Pdiss0 WRated operational current (Ie)9 ANumber of auxiliary contacts (normally closed contacts)1Rated conditional short-circuit current (Iq), type 2, 380 V, 400 V, 415 V0 APower consumption12 W10.2.3.2 Verification of resistance of insulating materials to normal heatMeets the product standard's requirements.10.2.3.3 Resist. of insul. mat. to abnormal heat/fire by internal elect. effectsMeets the product standard's requirements.Rated control supply current Is40 mASwitching level-3 - 9.6 V DC, Switching level "Low", Actuating circuit (ON, L, R) 19.2 - 30 V DC, Switching level "High", Actuating circuit (ON, L, R)< 5 V DC, Switching level "confirm Off", Actuating circuit (ON, L, R)10.9.2 Power-frequency electric strengthIs the panel builder's responsibility.Degree of protectionIP20NEMA OtherAmbient storage temperature - max80 °CRated control supply voltage (Us) at AC, 60 Hz - min0 V10.7 Internal electrical circuits and connectionsIs the panel builder's responsibility.Safety parameter (IEC 62061)99 %, SFF99 % (safe switch off) / 98 % (motor protection), DCSIL 3 (Safe switch off) / SIL 2 (Motor protection)Opening delay [ms]: 200 (safe switch off) / Class 10A (motor protection)PFHd [FIT]: 2.3 (Safe switch off)Λsd [FIT]: 0Λsu [FIT]: 1072 (Safe switch off) / 969 (Motor protection)Λdu [FIT]: 2.3 (Safe switch off) / 11 (Motor protection)Λdd [FIT]: 580 (Safe switch off) / 601 (Motor protection)ConnectionScrew terminals10.10 Temperature riseThe panel builder is responsible for the temperature rise calculation. Eaton will provide heat dissipation data for the devices.FunctionsTemperature compensated overload protectionMotor protectionControlled stopDOL startingRated actuating current (Ic)5 mAExplosion safety category for dustATEX dust-ex-protection, II (2) D [Ex t] [Ex p]ATEX dust-ex-protection, II (2) G [Ex e] [Ex d] [Ex px]Eaton Corporation plc Eaton House30 Pembroke Road Dublin 4, Ireland © 2023 Eaton. All Rights Reserved. Eaton is a registered trademark.All other trademarks areproperty of their respectiveowners./socialmedia0 A DOL starter (complete device)Meets the product standard's requirements.Meets the product standard's requirements.Meets the product standard's requirements.0 V7 A Direct starter19 A7 A12 ARated conditional short-circuit current (Iq), type 2, 230 V Type10.2.2 Corrosion resistance10.2.4 Resistance to ultra-violet (UV) radiation 10.2.7 InscriptionsRated control supply voltage (Us) at AC, 60 Hz - max Rated operational current (Ie) at AC-3, 380 V, 400 V, 415 V Model Number of auxiliary contacts (normally open contacts)Rated operational current (Ie) at AC-51Rated operational current (Ie) at AC-53A - max Number of contacts (change-over contacts)Rated operational current (Ie) at DC-13, 24 V。

Accuracy. Confidence.QA S OFTWARESpecifications subject to change without notice. Modus Medical Devices Inc is not responsible for errors or omissions. ©2013 Modus Medical Devices Inc. PDS100-3060, 06/13KEY FEATURES± Compatible with LINACS from multiple vendors ± Automated image analysis, trending and reporting of 3D CBCT and kV-MV projection images ± Analysis runs unattended in the background ± Configure baseline values and set thresholds ± Specify the tolerance level for each test ± Review and approve test results± Save reports in PDF format or export results to Excel ± Control multiple user access and security levels± Email test results to a pre-determined list of recipients ±Unlimited QUASAR™ Penta-Guide Client installationsThe QUASAR™ Penta-Guide QA Software is a time-saving applicationdesigned to simplify, enhance and automate the image analysis, trending and reporting of 3D CBCT and kV-MV projection images.The software is available in two versions, QUASAR™ Penta-Guide Enterprise and QUASAR™ Penta-Guide Lite. The Enterprise edition utilizes a central SQL database to enable administrators to manage LINAC configurations, define user-roles, security access levels and adjust outgoing mail server settings to automatically send test results to physicist to view, approve, analyze and monitor trends. The central server runs unattended in the background andautomatically analyzes QUASAR™ Penta-Guide Phantom images based on the DICOM tag configuration. Test results are retained in the central SQL database for long-term storage and trend analysis.The QUASAR™ Penta-Guide Lite edition is a free feature-limited version of the original application (SQL database is not available for storage and retrieval of data). Modus is pleased to include QUASAR™ Penta-Guide Lite as a FREE Download with all QUASAR™ Penta-Guide Phantom orders.Above : Screen shot, Daily kV-MV Isocenter QA trending chartDaily kV-MV ProjectedImage Analysis QA SoftwarePenta-GuideAbove : The QUASAR™ Penta-Guide Phantom, used for commissioning and regularly scheduled QA. The Phantom requires little or no extra time to complete daily testing of IGRT systems during equipment warm-up procedures.Accuracy. Confidence.Modus Medical Devices Inc. 1570 North Routledge Park, | London, Ontario | Canada N6H 5L6IGRT testing can be completed during equipment warm-upQA P HANTOMSORDERING INFORMATION100-3060 QUASAR ™ Penta-Guide Enterprise: ± 1-Network License for 1 LINAC ± 1-Year of Annual (Software) Updates ± 4 hours of (Software) Installation Support 500-5009 Additional QUASAR ™ Penta-Guide Enterprise ± 1-Network License for 1 LINAC500-5012 QUASAR ™ Penta-Guide Enterprise Support ± Annual Service AgreementsOPTIONAL ACCESSORIES100-1009 QUASAR ™ Penta-Guide Phantom CONTACT INFORMATIONToll Free: (866) 862-9682 (North America)Phone: +1 (519) 438-2409Fax: +1 (519) 643-0127***************** QUASAR ™ in Radiation TherapyThe Quality Assurance System for Advanced Radiotherapy (QUASAR ™) supports the testing of a wide variety of dosimetric and nondosimetric functions of planning systems, CT simulators and delivery systems.QUASAR ™ is a valuable part of any quality assurance program. From respiratory motion and MLC beam geometry to daily on-board imaging QA, QUASAR ™ phantoms and software are ready to be incorporated into your QA protocols for regularly scheduled testing. They are also effective for commissioning new systems and upgrades, and testing repairs.Designed by and for medical physicists, QUASAR ™ quality assurance tools provide you with confidence that every patient is getting the best possible treatment.MINIMUM TECHNICAL REQUIREMENTS± Standard desktop or laptop PC with Windows 7, Vista, or XP ± 1 GB RAM± .NET framework 4.0 for client and server ± SQL Server (version 2008) for dataIMAGE ANALYSISThe QUASAR™ Penta-Guide Enterprise edition offers enhanced trending and reporting features based on the following parameters:± Central Sphere Location ± MV Isocenter Location ± Isocenter and Scale Error ± Phantom Rotation ± Contrast to Noise Ratio ± Pitch, Roll and Yaw±CT# for Air and Acrylic。

EC Type-Examination CertificateReg.-No.: 01/205/5632.01/23Product testedSafety-Related Programmable Logic ControllerCertificate holderRockwell Automation, Inc.1201 South Second Street Milwaukee, WI 53204USAType designationCompact GuardLogix 5380 SIL 2 Controller Familyas listed in the current "Compact GuardLogix 5380 SIL 2 Controller Family Revision List"Codes and standardsEN ISO 13849-1:2015IEC 61508 Parts 1-7:2010IEC 61326-3-1:2017EN 61131-2:2007 (clause 6.1 - 6.3, 8)IEC 61131-2:2017 (clauses 5.2.1, 5.3, 7)Intended applicationThe Compact GuardLogix 5380 Family SIL 2 Controllers comply with the requirements of SIL 2 / SC 3 (IEC 61508) and PL d / Cat. 3 (EN ISO 13849-1) and can be used in safety-related applications, where the safe state is the de-energized state, up to PL d / Cat. 3 acc. to EN ISO 13849-1 and SIL 2 acc. to IEC 61508.The product was also reviewed in reference to the requirements of EN IEC 62061:2021,IEC 61511-1:2016+ Corr.1:2016 + AMD1:2017, NFPA 72:2022, NFPA 79:2021, NFPA 85:2023, NFPA 86:2023, NFPA 87:2021, ANSI B11.19:2019, ANSI/RIA R15.06:2012,EN 54-2:1997 + AC:1999 + A1:2006, EN 50156-1:2015, EN 746-1:1997 + A1:2009,EN 746-2:2010, EN 298:2012 and EN 60204-1:2018 applicable during a type examination and can be used in application as such.Specific requirementsThe instructions of the associated Safety Reference Manual and User Manuals shall be considered.It is confirmed, that the product under test complies with the requirements for machines defined in Annex I of the EC Directive 2006/42/EC.Valid until 2028-04-04The issue of this certificate is based upon an examination, whose results are documented in Report No. 968/FSP 1488.15/23 dated 2023-03-30.This certificate is valid only for products which are identical with the product tested.Notified Body for Machinery, NB 0035Dipl.-Ing. Jelena StenzelKöln, 2023-04-0410/222 12. 12 E A 4 ® T ÜV , T U E V a n d T U V a r e r e g i s t e r e d t r a d e m a r k s . U t i l i s a t i o n a n d a p p l i c a t i o n r e q u i r e s p r i o r a p p r o v a l.T ÜV R h e i n l a n d I n d u s t r i e S e r v i c e G m b H , A m G r a u e n S t e i n , 51105 K öl n / G e r m a n y T e l.: +49 221 806-2434, F a x : +49 221 806-1354, E -M a i l : i n d u s t r i e -s e r v i c e @d e .t u v .c o mRockwell Automation, Inc.TÜV Rheinland Industrie Service GmbHAutomation Control & Information Group Automation / Functional Safety & Cyber Security1201 South Second Street Am Grauen SteinMilwaukee, WI 53204 United States of America 51105 Köln GermanyPage 1 of 3Rockwell Automation maintains an internet Knowledge Base which contains different types of information regarding the released products and their versions. This information can include safety related and important information which is not available within this revision list. Therefore, additionally to this revision list safety relevant information within the Knowledge Base has to be considered prior to use of relevant product or firmware. (For further information please see “note 1” at the end of this list)SIL 2 – certified – componentsCatalog Number Description / SystemSeries: Firmware RevisionReport-No.Certification Status 5069-L306ERMS2 Safety Controller A/B 31.011 31.012 31.015 32.011 32.012 32.016 - 32.013 33.011 31.013 33.012 33.015 34.011 35.011 968/FSP 1488.00/18 968/FSP 1488.01/18 968/FSP 1488.14/23 968/FSP 1488.02/18 968/FSP 1488.03/19 968/FSP 1488.12/22 968/FSP 1488.04/19 968/FSP 1488.05/20 968/FSP 1488.06/20 968/FSP 1488.07/21 968/FSP 1488.08/21 968/FSP 1488.12/22 968/FSP 1488.09/22 968/FSP 1488.13/23Valid 5069-L306ERS2 Safety Controller A/B Valid 5069-L310ERMS2 Safety Controller A/B Valid 5069-L310ERS2 Safety ControllerA/B Valid 5069-L310ERS2K Safety Controller (Coated Version) B Valid 5069-L310ERMS2K Safety Controller (Coated Version) B Valid 5069-L320ERMS2 Safety Controller A/B Valid 5069-L320ERS2 Safety ControllerA/B Valid 5069-L320ERS2K Safety Controller (Coated Version) A/B Valid 5069-L320ERMS2K Safety Controller (Coated Version) A/B Valid 5069-L330ERMS2 Safety Controller A/B Valid 5069-L330ERS2 Safety ControllerA/B Valid 5069-L330ERS2K Safety Controller (Coated Version) A/B Valid 5069-L330ERMS2K Safety Controller (Coated Version) A/B Valid 5069-L340ERMS2 Safety Controller A/B Valid 5069-L340ERS2 Safety Controller A/B Valid 5069-L350ERMS2 Safety Controller A/B Valid 5069-L350ERS2 Safety ControllerA/B Valid 5069-L350ERS2K Safety Controller (Coated Version) A/B Valid 5069-L350ERMS2K Safety Controller (Coated Version) A/B Valid 5069-L380ERMS2 Safety Controller A/B Valid 5069-L380ERS2Safety ControllerA/BValidRockwell Automation, Inc.TÜV Rheinland Industrie Service GmbHAutomation Control & Information Group Automation / Functional Safety & Cyber Security1201 South Second Street Am Grauen SteinMilwaukee, WI 53204 United States of America 51105 Köln GermanyPage 2 of 3Catalog Number Description / SystemSeries: Firmware Revision Report-No. Certification Status5069-L3100ERMS2Safety ControllerA/B31.011 31.012 31.015 32.011 32.012 32.016 - 32.013 33.011 31.013 33.012 33.015 34.011 35.011968/FSP 1488.00/18 968/FSP 1488.01/18 968/FSP 1488.14/23 968/FSP 1488.02/18 968/FSP 1488.03/19 968/FSP 1488.12/22 968/FSP 1488.04/19 968/FSP 1488.05/20 968/FSP 1488.06/20 968/FSP 1488.07/21 968/FSP 1488.08/21 968/FSP 1488.12/22 968/FSP 1488.09/22 968/FSP 1488.13/23Valid5069-L3100ERS2 Safety Controller A/B ValidThe user is obliged to fully verify the correct execution of every safety function within an application before commissioning of a machine.The Release Notes for all and any revision of the listed controllers above are available from the Rockwell Automation website: /Pages/Home.aspxSafety relevant user documentation for Compact GuardLogix:Catalog Number Description / SystemRevisionReport-No. Certification Status 1756-RM012F-EN-P Safety Reference Manual (November 2022)F 968/FSP 1488.13/23 Valid5069-IN014E-EN-P Compact GuardLogix 5380 SIL 2 Controllers Installation Instructions (January 2022)E 968/FSP 1488.10/22 Valid 5069-UM001J-EN-PCompactLogix 5380 and Compact GuardLogix 5380 Controllers User Manual (November 2022)J968/FSP 1488.13/23ValidNotes:Rockwell Automation, Inc.TÜV Rheinland Industrie Service GmbHAutomation Control & Information Group Automation / Functional Safety & Cyber Security1201 South Second Street Am Grauen SteinMilwaukee, WI 53204 United States of America 51105 Köln GermanyPage 3 of 31 To access information from the Knowledge Base for products listed on this Revision List please create an account at the Rockwell Automation Support Center websitehttps:// (click ‘Log In’, in the top right corner and provide required information). Rockwell Automation recommends that customers who have put into service products listed in this Revision List also sign up for Automatic Email Notifications for those products as described on the https:///app/answers/detail/a_id/63302. After signing up, weekly emails about products related notifications will be received and email notifications will be sent when new Product Safety Advisories (PSA) or Product Notices (PN) are issued for the product catalog numbers that customers subscribe for.The content of this revision list has been agreed between manufacturer and certification body.Document-RevisionDate Version Changes Author 2018-04-19 1.0 Initial releasekg/962, hei/962 2018-12-07 1.1 Assessment of 31.012 based on 968/FSP 1488.01/18 Rud/962 2018-12-14 1.2 Assessment of 32.011 based on 968/FSP 1488.02/18 Rud/962 2019-07-22 1.3 Assessment of 32.012 based on 968/FSP 1488.03/19 Rud/962 2019-12-20 1.4 Assessment of HW series B based on 968/FSP 1488.04/19 Rud/962 2020-02-14 1.5 Assessment of 32.013 based on report 968/FSP 1488.05/20Rud/962 2020-09-25 1.6 Assessment of 33.011, added 5069-L310ERMS2K and 5069-L310ERS2K based on report 968/FSP 1488.06/20 Rud/962 2021-02-18 1.7 Assessment of 31.013 based on 968/FSP 1488.07/21; Rockwell logo updated. Rud/962 2021-07-27 1.8 Assessment of 33.012 based on 968/FSP 1488.08/21. Rud/962 2022-04-07 1.9 Assessment of 34.011 based on 968/FSP 1488.09/22.Rud/962 2022-04-20 2.0 Updated Installation Instructions 5069-IN014E-EN-P to revision “E” based on 968/FSP 1488.10/22. Rud/962 2022-06-22 2.1 Update related to UKCA certificationRd/A-FS 2022-12-05 2.2 Assessment of firmware versions V32.016 on V33.015 based on 968/FSP 1488.12/22. Rud/962 2023-01-17 2.3 Assessment of firmware versions V35.011 based on 968/FSP 1488.13/23. Rud/962 2023-03-10 2.4 Assessment of 31.015, based on 968/FSP 1488.14/23. Rud/962 2023-03-302.5Renewal of the certificate, based on 968/FSP 1488.15/23.Rud/962。

二氧化钛海运鉴定报告一、鉴定机构简介本鉴定报告由XXX国际货运代理有限公司出具，我司具备相关的国际运输和鉴定经验，可以提供准确可靠的鉴定服务。

本机构已经获得国家相关部门的认证，具备出具正式鉴定报告的资质。

二、申请方信息申请方名称：XXX公司地址：XXXXXXXXX联系人：XXX电话：XXX-XXXX-XXXX三、鉴定物品信息物品名称：二氧化钛数量：XXX吨包装方式：袋装外观形态：固体粉末产地：中国生产日期：XXXX年XX月质量保证文件：提供产品检验合格证明和产品安全数据表。

四、运输方式和路线运输方式：海运起运港：中国XX港目的港：美国XX港运输路线：经南海、马六甲海峡、印度洋、大西洋、直抵目的港。

五、鉴定结论根据申请方提供的资料和现场查验，该批二氧化钛符合国际海运危险品法规的要求，不属于危险品，可以正常进行海运。

同时，该批二氧化钛的包装符合国际标准，能够承受海上运输的颠簸和振动。

在运输过程中，不会对船只和货物造成危害。

六、使用限制和安全注意事项虽然该批二氧化钛不属于危险品，但在运输和使用过程中仍需注意以下几点：1. 避免与易燃、易爆物品混装；2. 避免与食品、药品等易受污染物品接触；3. 防止包装破损和泄漏，如果发生泄漏，需及时处理。

4. 请按照当地法律法规要求，合规操作。

在海关查验时主动提交所有必要文件，如果未能提供或提供错误文件，可能会导致海关延迟或拒绝放行货物。

尽可能了解货物的目的地的海关规定，以防止因未预见到的限制而导致海关延误或其他问题。

本鉴定报告并不包括针对特定的保险方案的核准或许可，如果有任何关于保险问题的询问，应在货物启运前与保险公司联系。

我们保证遵循适用的国家和国际法规以及行业标准，但我们不对除显而易见错误外的报告内容承担任何责任。

如果此报告是用于第三方（例如保险、货物接收或发运等），我们建议您在做出任何决定之前直接与有资质的专家或相关机构进行核实。

本报告不作为任何合同或协议的一部分。

Order FormWXT530 Series09.03.2017DOC232212AJing Lin Vaisala WXT Weather TransmitterWXT530 SeriesWXT53123456789101112Price 1VersionWXT536Parameters: W, R, P, T, U6WXT535Parameters: R, P, T, U5WXT534Parameters: P, T, U4WXT533Parameters: W, R3WXT532Parameters: W2WXT531Parameters: R12Communication InterfaceSDI-12 v 1.3, 1200 baud, 7, E, 1ARS-232, Std. ASCII auto, 19200 baud, 8, N, 1BRS-485, Std. ASCII polled, 19200 baud, 8, N, 1CRS-485, Std. ASCII polled, 9600 baud, 8, N, 1DRS-422, Std. ASCII auto, 19200 baud, 8, N, 1ERS-422, NMEA 0183 v3.0, 4800 baud, 8, N, 1GUSB/RS-232, 1.4 m USB / M12 cable, ASCII auto, 19200,8,N,1 HUSB/RS-485, 1.4 m USB / M12 cable, ASCII polled, 19200,8,N,1 JmA output 4-20 mA KmA output 0-20 mA LRS-485, NMEA 0183 v3.0, 4800 baud, 8, N, 1R3Analog InterfacesNone1Analog Outputs 2x 0..20mA for WS and WD2Analog Outputs 2x 4..20mA for WS and WD3Analog Inputs: Temp. SR. 10uV/W/m^2, Level (0..5V), TB. (0.2mm)44Data ConnectorNo Connector (bushing and grounding accessories included)A8-pin M12 male connector (bushing and grounding accessories included)BNo Connector (No bushing and No grounding accessories)C5HeatingNone1Heating26User ProfileStandard A7CableNo Cable1Shielded 2 meters long cable, 8-pin M12 connector in one end2Shielded 10 meters long cable, 8-pin M12 connector in one end3Shielded 10 meters long cable, 8-pin M12 connector in both ends4Shielded 40 meters long cable, 12 wires, open ends on both cable ends58Installation AccessoriesNone AMounting Kit BBird Spike CMounting Kit and Bird Spike D9Supporting SoftwareNone1Configuration tool for windows + USB service cable210ManualNone AEnglish Manual BJapanese Manual DRussian Manual G11PackingStandard Packing112Calibration CertificateNone AFactory Test Reports BAccredited Wind Calibration (MEASNET)CTOTALQTYTOTAL VALUE Selections in bold are included in the prices of the basic versions.Selections in italic are available at an extra price.Example of order code with typical settings:WXT536A1A1A1A1A1AACCESSORIES & SPARE PARTS220614Vaisala Configuration Tool, USB Service cable SP220782Cable USB RS-232/485, 1.4m USB / M12 SP222287Cable 2m Shielded 8-pin M12 SP222288Cable 10m Shielded 8-pin M12 SP215952Cable 10m Shielded 8-pin M12, connectors on both ends SP 217020Cable 40m Shielded 12-pin, open end wires SP222109Bushing & Grounding Accessory Kit212792Mounting KitWMSFIX60Mounting Accessory between Mounting kit and 60mm tube 212793Bird KitWSP150Vaisala Surge Protector, no connectorsWSP152Vaisala Surge Protector with connectors for 220782 and 215952 229104Nokeval Converter229110Nokeval Programming Kit218817SP WXT Radiation Shield Set SPWXTPTUSP WXT PTU-Module SP224171WXT Bottom Connector Kit SP214273Analog input connector SP, IP67, 8P,M12,ShieldedWXT530BOTTOMDIGISP WXT530 Bottom Assy with Digital Board SPWXT530BOTTOMANAINSP WXT530 Bottom Assy with Analog Input Board SPWXT530BOTTOMMAOUTSP WXT530 Bottom Assy with mA Output Board SPTM-PT1000Module Temperature Sensor Assembly TM-PT1000。

海关工业品与原材料检测技术中心更改危险特性分类鉴别检测项目专用情况说明式样一、项目名称：更改危险特性分类鉴别检测项目专用情况说明二、项目背景：为了确保工业品和原材料的安全性和合规性，海关工业品与原材料检测技术中心进行了更改危险特性分类鉴别检测项目。

该项目旨在准确鉴别工业品和原材料的危险特性分类，并进行必要的分类调整，以确保进出口货物的安全和合规性。

三、项目目标：通过更改危险特性分类鉴别检测项目，实现以下目标：1.准确鉴别工业品和原材料的危险特性分类；2.提供必要的分类调整建议；3.确保进出口货物的安全和合规性。

四、项目内容：更改危险特性分类鉴别检测项目包括以下内容：1.根据相关法规和标准，对工业品和原材料的危险特性进行鉴别；2.确定工业品和原材料的危险特性分类；3.对存在分类不准确或有误的工业品和原材料提供分类调整建议；五、项目步骤：1.收集相关法规和标准：收集国内外工业品和原材料危险特性分类的相关法规和标准，包括但不限于国内法律法规、国际协议和标准；2.查阅科学文献：通过查阅国内外科学文献，了解工业品和原材料的危险特性分类方法和技术；3.实施实验室测试：根据收集到的相关法规和标准，对工业品和原材料进行实验室测试，鉴别其危险特性；4.分析危险特性：对实验室测试结果进行分析，确定工业品和原材料的危险特性分类；5.提供分类调整建议：对于存在分类不准确或有误的工业品和原材料，提供相应的分类调整建议；六、项目具体要求：1.高质量的实验室测试：实验室测试需遵循相关法规和标准，确保测试结果准确可靠；2.细致的分析和评估：对实验室测试结果进行细致的分析和评估，确保准确鉴别工业品和原材料的危险特性分类；3.及时提供分类调整建议：对于存在分类不准确或有误的工业品和原材料，及时提供分类调整建议，并给出具体操作方法；5.保护商业秘密和客户信息：严格保护客户的商业秘密和相关信息，确保客户的权益。

七、项目预期结果：通过更改危险特性分类鉴别检测项目1.准确鉴别工业品和原材料的危险特性分类；2.提供准确的分类调整建议，确保工业品和原材料的分类符合相关法规和标准；3.提高进出口货物的安全性和合规性。