AIAA-51218-591

国外标准目录美国国家标准ANSI EIA 541-1988 静电放电敏感产品包装材料标准ANSI ESD STM 3.1-1991 静电放电敏感产品防护－离子化静电消除器ANSI ESD S20.20-1999 保护电气和电子器件，组件及设备静电放电控制大纲美国联邦标准FED STD 101 Method 4046.1 材料的静电性能FED STD 101 Method 4046.1 防静电包装材料静电性能的试验方法美国军用标准MIL STD 1686B（1992）电子和电子元件、组件与设备（电起爆装置除外）的静电电防护控制大纲MIL HDBK 263A（1991）电子和电子元件、组件与设备（电起爆装置除外）的静电放电控制手册MIL HDBK 773 静电防护包装手册MIL B 81705C（1989）柔性可热封防静电阻隔材料规范MIL P 81997B（1983）柔性可再封防静电透明缓冲袋规范MIL P 82646A（1985）柔性可热封导电塑料薄膜规范MIL P 82647A（1986）柔性可热封导电塑料袋规范MIL W 87893（30）（1987）静电放电控制工作台规范美国标准协会BS5958-1988 防静电危害操作法规BS2050-1978 柔性高聚物的导电和抗静电产品的电阻美国电气过载（EOS）/静电放电（ESD）协会标准EOS/ESD-S1-1987 静电放电敏感产品防护用标准：人员接地腕带ESD DS-2.1-1995 静电放电敏感产品防护用标准（草案）：服装ANSI/EOS/ESD-S3.1-1991 静电放电敏感产品防护用标准：电离器ESD DS-4.1-1995 静电放电敏感产品防护用标准（草案）：工作面EOS/ESD-S4.1-1990 静电放电敏感产品防护用标准：工作面电阻的表征EOS/ESD-S5.1-1993 静电放电敏感产品防护用标准：元器件级，人体模型EOS/ESD-S5.2-1994 静电放电敏感产品防护用标准：元器件级，机械模型ANSI/EOS/ESD-S6.1-1991 静电放电敏感产品防护用标准：接地推荐做法ESD-S7.1-1994 静电放电敏感产品防护用标准：地板材料电阻的表征EOS/ESD-S8.1-1993 静电放电敏感产品防护用标准：静电放电警示符号ESD-S9.1-1995 静电放电敏感产品防护用标准：鞋子的电阻表征EOS/ESD-S11.11-1993 静电放电敏感产品防护用标准：静电耗散平面材料的表面电阻测ESD-S11.31-1994 评价静电放电屏蔽材料性能用标准：包装袋ESD ADV1.0-1994 静电放电术语指导资料：词汇ESD ADV3.2-1995 静电放电敏感产品指导资料：空气电离器的选择和验收ESD ADV53.1-1995 静电放电敏感产品指导资料：ESD防护工作台ESD ADV11.2-1995 静电放电敏感产品指导资料：摩擦电荷积聚试验美国材料与试验协会标准ASTM D 4865-88 石油燃料系统静电生产和消除导则ASTM D 4308-1988 液体烃类电导率精密测定法ASTM D 2624-86 含静电剂的喷气燃料电导率测定法ASTM D 991 橡胶制品特征性——电气导体和抗静电产品的体积电阻率ASTM D 257-92 绝缘材料的直流电阻或电导的标准试验方法ASTM D 4470-1997 静电起电的标准试验方法ASTM F 150-1998 导电及静电耗散型弹性地板电阻的测试方法美国电子工业协会标准RS-471（1980）静电敏感器件的标记和符号EIA-541（1988）静电放电敏感产品包装材料标准美国电气电子工程师协会标准IEEE std 1100-1992 敏感电子设备接电源和接地推荐操作指南IEEE std 81-1983 接地系统的地表电位、接地电阻和大地电阻率测量指南IEEE std C62.47-1992 静电放电指南，静电放电环境表征美国防火协会标准NFPA77（1998）静电推荐操作指南美国石油学会APIRP2003-1985 防静电危害操作规定IEC15D/55/CD（1995）《静电学第2部分：测量方法第1节：借助于直接测量静电荷耗散率测试绝缘和静电耗散材料及其表面的方法》15D/51/CD（1995）《静电学第2部分：测量方法第2节：起电性测量》15D/50/CD（1995）《静电学第2部分：测量方法第3节：测定控制静电用固体材料电阻率的试验方法》101/16/NP（1996）《静电防护鞋性能试验方法》15D（sec）39（1994）《静电现象原理指南》15D/47/CD（1995）《电子器件防护规范——总的要求》15D/48/CD（1995）《电子器件防护规范——用户指南》15D/52/NP（1995）《静电学第3部分：静电效应的模拟方法第1节：元器件试验人体模型》15D/53/NP（1995）《静电学第3部分：静电效应的模拟方法第2节：元器件试验机械模型》15D/54/NP（1995）《静电学第3部分：静电效应的模拟方法第3节：元器件试验带电器件模型》101/26/FDIS（1997）《对IEC1340-4-1的第1次补充：起电性的测量》IEC1340-4-1（1995）《静电学第4部分：供作专门用途的标准试验方法第1节：地板覆盖层和装配地板的静电性能》IEC/TC47（sec）1330（1993）《静电敏感器件的防护》IEC1000-4-2（1995）《电子设备静电放电抗扰度试验方法》IEC747-1（1993）《半导体器件分立器件第1部分：总则第九章：静电敏感器件》IEC93（1980）《固体电工绝缘材料体积电阻率和表面电阻率的试验方法》IEC61340-5-1-1998 《静电电子器件的静电防护通用要求》欧洲标准DIN EN 100015 T1-1992 对静电危害的电子元件的保护DIN VDE 0100T610-1994 额定电压至1000V的强电设备的安装检测DIN EN 1081-1998 弹性地面饰材电阻的确定DIN EN 1815-1998 弹性地面饰材和地毯：静电行为的评价DIN 51953 地面涂（垫）层静电放电能力测试DIN 53482 非金属材料表面电阻测量DIN VDE 0100 保护措施，防危害人体电流保护DIN 54345 T1-1992 纺织品的检测：静电行为－电阻值的测定DIN 54345 T2-1992 纺织品的检测：静电行为－在地毯上行走时人员起电电压的确定DIN 54345 T3-1985 纺织品的检测：静电行为－地毯起电电压的仪器确定DIN 54345 T6-1992 纺织品的检测：静电行为－电阻值的测定DIN 51953 有机地面锦材的检测DIN 53276 地面胶粘剂的检测：胶粘剂涂膜导电性能的检测EN 1801-1998 导电及静电耗散型弹性地板电阻的测试方法BS 2050-1978 柔性高聚物材料制作的导电和抗静电产品的电阻BS 5958-1980 静电控制实务规范：第一部分：通用因素其它标准JIS L1094-1997 织物和编织物带电性能试验方法ISO 2882-1980 硫化橡胶－医院用抗静电和导电产品－电阻极限值ISO 2883-1980 硫化橡胶－工业用抗静电和导电产品－电阻极限值ISO 2878-1987 硫化橡胶－抗静电和导电产品－电阻值的确定VDI 2083-4-1996 洁净室技术：表面洁净度。

A INDEXA IndexB ScopeC ObjectD ReviewE Related DocumentsF Standard Requirements for Production MaterialsG General RequirementsH Sample RequirementsI Classification System / Use of Specification on DrawingJ Specific RequirementsZ Change HistoryAppendix 1 Recommended Peel StrengthsB SCOPEThis standard defines conditions of supply and performance requirements for self adhesive tape systems used to adhere, but not limited to, badges, decals and side mouldings to all areas of the vehicle.The location of self-adhesive components is extremely undesirable where fuel contamination is likely, e.g. in and below fuel filler neck apertures.C OBJECTTo define the test methods and acceptance criteria for self-adhesive tape systems.D REVIEWThis document is to be reviewed at least every three years from the date of the last review or update.E RELATED DOCUMENTSSAE J 948 TPJLR.52.155SAE J 2412 TPJLR.52.351SAE J 2527 TPJLR.52.352ASTM D1000 TPJLR.52.353ISO 3795 TPJLR.52.154STJLR.51.5226 TPJLR.52.209TPJLR.52.055 ASTM B117This document is approved for use by both Jaguar Cars and Land Rover.Prepared by: Dave RaffertyMaterials Engineering Authorised by: Andrew HaggieManager, Materials EngineeringF STANDARD REQUIREMENTS FOR PRODUCTION MATERIALSMaterial suppliers and part producers must conform to the company's 'Standard Requirements for Production Materials' (STJLR.51.5226). All conditions apply except that the conditioning period for test assemblies shall be 48 hours, instead of the period of 24 hours detailed in section F3 of STJLR.51.5226. For example, when bonding to a painted panel, 7 days would be required to allow the paint finish to air cure (or 24 hours for stoved finishes) before applying the adhesive tape. A further 48 hours would then be required to allow the adhesive bond to stabilize prior to testing.G GENERAL REQUIREMENTS1 ManufactureThe method of manufacture must be capable of close control and be reproducible.2PerformanceWhen used for the specified application, components must be capable of withstanding, without detrimental effect, all environmental conditions that may be encountered during service.3 Dimensions and tolerancesThe dimensions and tolerances of the component shall be as specified on the relevant engineering drawing.4Component weightWhere applicable, the component weight shall be specified on the relevant engineering drawing.The weight tolerance shall be ± 2 % unless otherwise stated.5 Materials and FinishMaterials, colours, painting, metallising and surface finish shall be as stated on the engineering drawing and an acceptable match to the agreed master sample.6 Release LinerThe release liner shall be readily and completely removable from the component, without removal of adhesive or other deleterious effects. The release liner shall contain no migratory release agents that may affect the adhesive bond.7 Defects, Corrosion and StainingThe materials shall be free from defects and shall not cause corrosion, staining or any other detrimental effects on contacting materials or surrounding areas.8 StorageComponents shall be capable of meeting the requirements of this standard. Additionally, they shall perform satisfactorily in service after 3 years storage in a clean dry area in temperatures ranging from 5 °C ± 2 °C to 30 °C ± 2 °C and away from direct sunlight and solvent vapours. Excessive pressure may cause adhesive creep, therefore the method of storage shall be agreed between the supplier, purchasing and stores.9IdentificationAll deliveries shall be identified with the manufacturer's reference and batch number and any Jaguar or Land Rover part number.10Application ConditionsImmediately prior to bonding of production components, the receiving surface shall be wiped clean using a 50 % isopropanol/water mix, applied and removed with a soft, lint-free cloth. Any special application conditions (e.g. application pressure and surface pre-treatments) from the tape supplier shall also be followed and these conditions must be detailed in a work instruction, available at the point of use.H SAMPLE REQUIREMENTS1 Adhesive Systems/TapesSample rolls of product ≥ 0.5 m2 in area, with a minimum width of 10 mm are required for adhesive tests as outlined in Table 6. Suppliers shall be responsible for providing full system information and ensuring the samples submitted are fully production representative.2 Self Adhesive ComponentsThe quantity of self-adhesive components required for test purposes shall be recommended by JLR Materials Engineering. Suppliers shall be responsible for providing full system information and ensuring the samples are fully production representative.3 Test Panels3.1 Wherever possible these shall be taken from the finished, production intent component. Thesurface condition, e.g. clean, bare metal, oiled, protected etc, shall represent that to which the tape/self-adhesive component is to be applied. Test panel dimensions shall be 50 mm minimum width, an appropriate length for the peel tests and greater than those of the specimen when used for the performance tests.3.2 If it is not possible to make use of a component, test panels shall be prepared and finished asspecified on the engineering drawing for the component. The surface condition shall represent that of the component to which the adhesive system is to be applied in the production process.3.3 Paint finish surfaces shall be conditioned as in section F for the following minimum periods.Seven days for air dried/low bake (≤ 90 °C) finishes and 24 Hours for stoved/high bake (> 90 °C) finishes.3.4 Panels shall be cleaned with a 50% isopropanol/water mix, applied and removed with asoft, lint-free cloth.3.5 Where any other treatment is applied, e.g. temporary protective, the prepared panel shall beconditioned as in section F for 24 hours. This shall be additional to any previous paint conditioning.4 Test SpecimensFor the 90° peel test, specimens shall be 10 mm ± 0.5 mm wide strips wherever possible. Where this is not possible the specimen width shall be measured, reported and results calculated and reported as for N/10 mm width.5 Test AssembliesThe test specimen shall be bonded to the test panel in accordance with the specified production technique, the supplier's recommendation or in agreement with Jaguar and Land Rover Materials Engineering. The assembly shall be conditioned in accordance with section F for 48 hours, unless otherwise stated by tape supplier.I CLASSIFICATION SYSTEM/USE OF SPECIFICATION ON DRAWING1 Components shall be specified by reference to this standard followed by suffices defining theapplication and special requirements as shown below. The first suffix shall indicate the location on the vehicle and the relevant heat/environmental test temperature, classed as the ‘in-service' temperature.Table 1. LocationSuffix LocationA Engine CompartmentB InteriorC Exterior – DecorativeD Exterior – Hidden (including under body)2 For each application the ‘in-service’ temperature shall be defined by TPJLR.52.353 and thetemperature shall be specified by means of a final suffix to the standard reference.3S = Gasket/Sandwich applicationsAn additional control suffix 'S' is added to the first suffix (from Table 1) for gasket/sandwich applications. In such cases a nominal adhesive strength (in accordance with ASTM D1000) of 4 N/10 mm is required to hold the part in place before subsequent assembly, when the part is mechanically or physically held e.g. foam sealing gaskets, trim pads which are stitched etc.Component tests from Table 5 do not apply in this case, as the adhesive is redundant once the assembly is complete.4 The second suffix shall indicate the receiving surface to which a tape/component assembly isapplied.Table 2. Vehicle surfaceSuffix Surface1 Sheet metal/rigid plastics finished with the vehicle body colour production paintprocess.2 Ferrous and non-ferrous machined surfaces3 Cast iron (as cast)4 Sand cast non-ferrous metals5 Die cast non-ferrous metals6 Painted or unpainted rigid plastics, other than those finished with the vehiclebody colour production paint process.7 Supported or unsupported flexible plastic sheet8 Glass, toughened or laminated as appropriate9 Decorative chromium plating10 Any other surface as supplied on the engineering drawing.5 The third suffix shall indicate the component surface to which the tape is applied.Table 3. Component surfaceSuffix Component Surface1 Sheet metal/rigid plastics finished with the production paint process.2 Ferrous and non-ferrous machined surfaces3 Cast iron (as cast)4 Sand cast non-ferrous metals5 Die cast non-ferrous metals6 Rigid Plastics, type as appropriate to the application7 Supported or unsupported flexible plastic sheet8 Glass, toughened or laminated as appropriate9 Decorative chromium plating10 Any other surface as supplied on the engineering drawing.11 No surface (single-sided tape etc).6 These application surfaces are to be finished in accordance with the specified production process.Suppliers must ascertain surface condition prior to submitting samples.7 The fourth suffix shall be numerical and shall indicate the environmental temperature of thecomponent, as specified in TPJLR.52.353, appendix A.8 Additional suffices8.1 U = UV ExposureA suffix 'U'shall be used to signify that the tape or component is exposed to sunlight inservice. The 'U' shall be used in conjunction with a number (1, 2, 3, 4) in order to signify the level of UV exposure.Table 4. UV ExposurePart Location Exposure SuffixLower Mouldings, Seat Tracks, ScuffMild exposure 110 KJ/m2U1 Mouldings, Overhead Console, GrabHandlesFloor Console, Door Trim, Pillars (Lower),Below the beltline 220 KJ/m2U2 Seat ValanceAbove the beltline 440 KJ/m2U3 Instrument Panel, Centre Console, DoorTrim (Top Roll), Pillars (upper), DoorGarnishExterior Components 1250 KJ/m2U48.2 FR = FlammabilityAn additional suffix'FR' shall be used to signify compliance with the ISO 3795flammability test.8.3 Y =Abrasion ResistanceAn additional suffix'Y' shall be used to where the component should meet abrasionrequirements.8.4 The suffix 'Z' shall be used if any additional requirements and/or deviations from thisspecification are desired. These shall be recorded in full on the relevant engineering drawing. 9Example of the use of Classification System9.1 STJLR 51.5181 A.2.6.120Denotes an application in the engine compartment where a plastic component is adhered to a machined metallic surface and expected to operate at temperatures up to 120 °C.9.2 STJLR 51.5181 C.1.11.90.U4.Y.Z1This denotes a decal applied to the outer vehicle body panel (painted) requiring environmental testing to 90 °C and UV, abrasion resistance and indicating an addition or deviation to thespec.9.3 STJLR 51.5181 BS.6.11.95.FRThis denotes a sandwiched foam gasket adhered (on one side only) to a rigid plasticsubstrate in the vehicle interior. The part requires flammability resistance.J SPECIFIC REQUIREMENTS1 Assemblies employing self-adhesive tape systems shall meet the specific requirements detailed inTable 5. These requirements are additional to those of the applicable component specification as advised by JLR Materials Engineering,2 Table 6, Appendix 1 details recommended requirements for adhesive peel strengths that arenecessary in order to meet the performance requirements in Table 5. This specification does not require the reporting of peel strengths. The supplier shall ensure that peel strength values are at a sufficient level to meet the performance requirements detailed in Table 5.Jaguar Cars & Land Rover - Engineering Standards Title: Self Adhesive Tape Systems Standard: STJLR.51.5181 Issue: 4Date: 26 November 2009 Page 7 of 9TABLE 5:- SPECIFIC REQUIREMENTS FOR SELF ADHESIVE COMPONENTSComponent Tests Class A B C D Accelerated Environmental Ageing(Visually assess bond integrity after 1st cold cycle)TPJLR.52.353 NDE NDE NDE NDEResistance to Direct UV (Visible applications only) Interior = 110, 220, 440 KJ/m2SAE J 2412VA GS4(Min)Resistance to Direct UV (Visible applications only) Exterior = 1250 KJ/m2 SAE J 2527VA GS4(Min)Flammability (where specified by an ‘FR’ suffix).ISO 3795 80mm/min(Max) 80mm/min (Max)Heat Ageing for 500 hours TPJLR.52.352 NDE NDE NDE NDE Abrasion Resistance (Decals Only)CS10 Wheels 250 g Load 100 Cycles. SAE J948NRC NRC NRC NRC Migration Staining TPJLR.52.209 NS NSCold Slam (closure applications and adjacent parts only)TPJLR.52.055NLAExposure to Factory fill Engine Oil(Apply fluid to edge of tape/substrate interface)TPJLR.52.154NDEExposure to Diesel Fuel (parts adjacent to fuel filler only)(Apply fluid to edge of tape/substrate interface)TPJLR.52.154NDE NDE Exposure to Ref Fuel C + 15 % Methanol(Parts adjacent to fuel filler only)(Apply fluid to edge of tape/substrate interface)TPJLR.52.154NDE NDEExposure to windscreen washer fluid (both 50 % & 100 %isopropanol). *Apply fluid directly to edge of tape/substrateinterface, do not use polythene washers.TPJLR.52.155*NDE NDEHumidity exposure, 72 hours for interior components (B) and 168hours for engine bay and exterior components (A, C and D).TPJLR.52.351NDE NDE NDE NDEKey – See overleafPrinted copies are uncontrolled Official Record Series 25.01, © Jaguar Cars and © Land RoverJaguar Cars & Land Rover - Engineering StandardsTitle: Self Adhesive Tape SystemsStandard: STJLR.51.5181 Issue: 4Date: 26 November 2009 Page 8 of 9NRC - No removal of markings or colours to background. NLA - No loss of adhesion.VA GS - Visual assessment against Grey Scales. NS -No staining or migration staining.NDE - No detrimental effects e.g. colour change greater than GS4, gloss change, loss of adhesion, swelling, crazing or distortion.Z CHANGE HISTORYIssue DateDescription of Change 1 06 Mar 2006 Replaces Land Rover std .06Replaces Jaguar stds JMS.20.11.01, JMS.20.11.02, JMS.20.11.03 & JMS.20.11.042 03 Jul 2007 Peel strength requirements revised using data gathered from validated and proventape systems. Peels now "for indication only".3 09 Mar 2009 Humidity durations aligned with trim and plastics specs.Peel strengths moved to Appendix 1. Interior weatherometer durations revised426 Nov 2009 FLTMs replaced with TPJLRs.Jaguar Cars & Land Rover - Engineering Standards Title: Self Adhesive Tape Systems Standard: STJLR.51.5181 Issue: 4Date: 26 November 2009 Page 9 of 9APPENDIX 1Recommended peel strengths for adhesive selection. Component tests in Table 5 shall be used for validation. TABLE 6: ADHESIVE TEST SCHEDULE90° Peel in accordance with ASTM D1000, except test panels (48.2 of ASTM D1000) shall conform to section H3 of this specification. This test to be conducted after conditioning methods below. Tape sample width 10 mm.Class AEnginebayBInteriorCExterior,decorativeDExterior,hiddenSSandwich/gasketConditioningTest Method (N/10 mm sample width)As conditioned N/A 6 6 6 6 4 7 Day Heat Age @ ‘In-service temperature TPJLR.52.352 6 6 6 672 hours interior (B) and 168 hrs engine bay andexterior (A, C and D) humidity exposure TPJLR.52.3516 6 6 6Tested after reconditioning at 23 °C ± 2 °C and 50 % ± 5 % RH for 2 hours after removal from the test environmentPrinted copies are uncontrolled Official Record Series 25.01, © Jaguar Cars and © Land Rover。

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IEEE T ANTENN PROPAG IEEE T ADV PACKAGING IEEE T INTELL TRANSP SENSOR ACTUAT A-PHYS IEEE T COMPUT IEEE MICROW WIREL CO MICROELECTRON ENG IEEE T DEVICE MAT RE IEEE MICROW MAG IEEE J OCEANIC ENG IEEE T PARALL DISTR J MICROLITH MICROFAB IEEE T BROADCAST OPT FIBER TECHNOL IEEE CIRCUITS DEVICE IEEE T CONTR SYST T IEEE T COMMUN SOLDER SURF MT TECH IEEE T WIREL COMMUN IMAGE VISION COMPUT ETRI J SOLID STATE ELECTRON IEEE T CIRCUITS-I IEEE SENS J SIGNAL PROCESS-IMAGE INT J ROBUST NONLIN IEEE T VEH TECHNOL ELECTRON LETT MAT SCI SEMICON PROC IEEE T POWER ELECTR J MATER SCI-MATER EL DISPLAYS IEEE T SPEECH AUDI P NETWORK-COMP NEURAL INT J IMAG SYST TECH IEEE-ASME T MECH EXPERT SYST APPL IEEE T MAGN IEE P-CONTR THEOR AP IEEE T CIRCUITS-II IEEE T POWER SYST DIGIT SIGNAL PROCESS IEEE ANTENN PROPAG M

Association for the Advancement of Medical Instrumentation协会中文名称：AAMI；美国医疗器械促进协会1 AAMI 7198-1998 (R 2004) CARDIOVASCULAR IMPLANTS - TUBUAL VASCULAR PROSTHESES-FDA RECOGNIZED2 AAMI 10993-1-2003 Biological evaluation of medical devices - Part 1: Evaluation and testing-FDA RECOGNIZED3 AAMI 10993-2-2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements4 AAMI 10993-3-2003 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity5 AAMI 10993-4-2002 Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood-Incorporates Amendment 1: 20066 AAMI 10993-5-1999 BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 5: TEST FOR IN VITRO CYTOTOXICITY-FDA RECOGNIZED7 AAMI 10993-6-1995 (R 2001) BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION-FDA RECOGNIZED8 AAMI 10993-7-1995 (R 2001) Biological Evaluation of Medical Devices, Part 7: Ethylene Oxide Sterilization Residuals-Only FDA RECOGNIZED if used in conjunction to AAMI TIR19: 1988; Replaces AAMI ST29: 1988 and AAMI ST30: 1989 [Use: AAMI TIR19 AMD 1]9 AAMI 10993-9-1999 (R 2005) Biological evaluation of medical devices - Part 9: for identification and quantification of potential degradation products10 AAMI 10993-11-2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity11 AAMI 10993-12-2002 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials-FDA RECOGNIZED12 AAMI 10993-13-1999 (R 2004) Biological evaluation of medical devices, Part 13: Identification and quantification of degradation products from polymeric devices.13 AAMI 10993-14-2001 (R 2006) BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCT FROM CERAMICS14 AAMI 10993-15-2000 (R 2006) Biological evaluation of medical devices?Part 15: Identification and quantification of degradation products from metals and alloys15 AAMI 10993-16-1997 (R 2003) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES FROM MEDICAL DEVICES16 AAMI 10993-17-2002 BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES17 AAMI 11135 ERTA-2005 Medical devices ?Validation and routine control of ethylene oxide sterilization-Erratum issued: 20 January 1995 (print copy only) and Erratum issued: 6 April 2005 (PDF copy only)18 AAMI 11135-1994 Medical devices - Validation and routine control of ethylene oxide sterilization-FDA RECGOGNIZED; esignations: AAMI OPEO, AAMI ST27, and AAMI TIR1 [Refer to: AAMI TIR14, AAMI TIR15, AAMI TIR16, AAMI TIR20, AAMI TIR28]19 AAMI 11137-1-2006 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices-Also replaces AAMI ST31, AAMI ST32, AAMI TIR520 AAMI 11137-3-2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects-Also replaces AAMI ST31, AAMI ST32, AAMI TIR521 AAMI 11138-1-2006 Sterilization of health care products - Biological indicators - Part 1: General requirements [Refer to: AAMI 18472] 22 AAMI 11138-2-2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes [Refer to: AAMI 18472]23 AAMI 11138-3-2006 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes [Refer to: AAMI 18472]24 AAMI 11138-4-2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes [Refer to: AAMI 18472]25 AAMI 11138-5-2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and aldehyde sterilization processes [Refer to: AAMI 18472]26 AAMI 11607-2-2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for ing, sealing and assembly processes27 AAMI 11737-2-1998 Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Per ed in the Validation of a Sterilization Process-FDA RECOGNIZED28 AAMI 13485-2003 Medical devices - Quality management systems - Requirements for regulatory purposes29 AAMI 14155-1-2003 Clinical investigation of medical devices for human subjects - Part 1: General requirements30 AAMI 14155-2-2003 Clinical investigation of medical devices for human subjects?Part 2: Clinical investigation plans31 AAMI 14160-1998 Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin - Validation and Routine Control of Sterilization by Liquid Chemical Sterilants-FDA RECOGNIZED32 AAMI 14161-2000 Sterilization of health care products?Biological indicators?Guidance for the selection, use, and interpretation of results-FDA RECOGNIZED33 AAMI 14937-2000 Sterilization of health care products?General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices-FDA RECOGNIZED34 AAMI 15223-2000 Medical Devices - Symbols to be used with medical device labels, labeling and in ation to be supplied.-FDA RECOGNIZED; Includes Amendment 1: 11/5/2001 and Amendment 2: 4/23/200435 AAMI 15225-2000 (R 2006) NOMENCLATURE - SPECIFICATION FOA A NOMENCLATURE SYSTEM FOR MEDICAL DEVICES FOR THE PURPOSE OF REGULATORY DATA EXCHANGE-Includes Amendment 1: 200436 AAMI 15674-2001 Cardiovascular implants and artificial organs —Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags37 AAMI 15675-2001 Cardiovascular implants and artificial organs?Cardiopulmonary bypass systems?Arterial blood line filters38 AAMI 15882-2003 Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results-FDA RECOGNIZED39 AAMI 17665-1-2006 Sterilization of health care products - Moist heat - Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices- er Designation: AAMI ST2540 AAMI 25539-1 AMD 1-2005 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses, Amendment 1: Test methods 41 AAMI 25539-1-2003 Cardiovascular implants?Endovascular devices?Part 1: Endovascular prostheses42 AAMI 60601-2-21-2000 Medical electrical equipment, Part 2: Particular requirements for the safety of infant radiant warmers-FDA RECOGNIZED; er Designation: AAMI II52; Incorporates Amendment 1: 2000 43 AAMI 62304-2006 Medical device software - Software life cycle processes [Refer to: AAMI TIR32]44 AAMI BE78-2002 BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 10: TEST FOR IRRITATION AND DELAYED TYPE HYPERSENSITIVITY-In place of AAMI 10993-10; FDA RECOGNIZED45 AAMI BE83-2006 Biological evaluation of medical devices - Part 18: Chemical characterization of materials46 AAMI BF7-1989 (R 2002) Blood Transfusion Micro-Filters-FDA RECOGNIZED47 AAMI BF64-2002 LEUKOCYTE REDUCTION FILTERS48 AAMI 7199-1996 (R 2002) Cardiovascular implants and artificial organs - Blood-ga* **changers (oxygenators)49 AAMI BP22-1994 (R 2006) Blood Pressure Transducers-FDA RECOGNIZED; Incorporates Errata: 08/05/200450 AAMI 5840-2005 Cardiovascular implants - Cardiac valve prostheses-FDA RECOGNIZED51 AAMI DF80-2003 Medical electrical equipment, Part 2: Particular requirements for the safety of cardiac defibrillators [including automated external defibrillators]-Also repalces AAMI TIR252 AAMI EC11-1991 (R 2001) Diagnostic electrocardiographicdevices-FDA RECOGNIZED53 AAMI EC12-2000 (R 2005) Disposable ECG Electrodes-FDA RECOGNIZED54 AAMI EC13 ERTA-2002 Cardiac Monitors, Heart Rate Meters and Alarms55 AAMI EC13-2002 Cardiac Monitors, Heart Rate Meters and Alarms56 AAMI EC38-1998 Ambulatory Electrocardiographs-FDA RECOGNIZED57 AAMI EC53 ERTA-2001 ECG cables and leadwires-Includes Erratum issued: 31 May 199858 AAMI EC53-1995 (R 2001) ECG cables and leadwires59 AAMI EC57-1998 (R 2003) Testing and reporting per ance results of cardiac rhythm and ST segment measurement algorithms-Includes Errata: 4/14/2004; Revision of ECAR: 1987; FDA-Recognized60 AAMI EC71-2001 Standard Communications Protocol - Computer Assisted Electrocardiography-Proposed equivalency to IEC60601-2-53/Ed.1: Harmonized61 AAMI EQ56-1999 (R 2004) Recommended practices for a medical equipment management program62 AAMI ES60601-1-2005 Medical electrical equipment, Part 1: General requirements for basic safety and essential per ance63 AAMI HE48-1993 Human Factors Engineering Guidelines and Preferred Practices for the Design of Medical Devices64 AAMI HE74-2001 Human Factors Design Process for MedicalDevices-FDA RECOGNIZED65 AAMI HFMD-1996 An Introduction to Human Factors in Medical Devices66 AAMI ID26 ERTA-2006 Medical electrical equipment, Part 2: Particular requirements for the safety of infusion pumps and controllers 67 AAMI ID54-1996 (R 2005) Enteral Feeding Set Adapters and Connectors-FDA RECOGNIZED68 AAMI NS4-1986 (R 2002) Transcutaneous Electrical Nerve Stimulators69 AAMI NS14-1995 (R 2002) Implantable spinal cord stimulators70 AAMI NS15-1995 (R 2002) Implantable peripheral nerve stimulators71 AAMI NS28-1988 (R 2006) Intracranial Pressure Monitoring Devices-FDA RECOGNIZED; Incorporates Errata: 06/200172 AAMI PAC49-1993 (R 2000) Pacemaker Emergency Intervention System73 AAMI PB70-2003 LIQUID BARRIER PER ANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CAREFACILITIES-FDA RECOGNIZED74 AAMI PC69-2000 ACTIVE IMPLANTABLE MEDICAL DEVICES ELECTROMAGNETIC COMPATIBILITY EMC TEST PROTOCOLS FOR IMPLANTABLE CARDIAC PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS75 AAMI RD5-2003 Hemodialysis Systems76 AAMI RD16 AMD 1-2002 (R 2005) Hemodialyzers-FDA RECOGNIZED77 AAMI RD16-1996 (R 2005) Hemodialyzers [Refer to: IEC 60601-2-16]78 AAMI RD17-1994 (R 2005) Hemodialyzer Blood Tubing-Includes Amendment 1: 200279 AAMI RD47-2002 Reuse of Hemodialyzers-Incorporates Amendment 1: 7/2003 and Errata: 07/200380 AAMI RD52-2004 Dialysate for hemodialysis81 AAMI RD62-2006 WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS APPLICATIONS82 AAMI SP10-2006 Manual, electronic, or automated sphygmomanometers-FDA REGOGNIZED; Incorporates Amendment 1: 2003; Amendment 2: 200683 AAMI ST8-2001 Hospital Steam Sterilizers-FDA RECOGNIZED84 AAMI ST24-1999 (R 2005) Automatic, General-Purpose Ethylene Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended for Use in Health Care Facilities-FDA RECONIZED85 AAMI ST40-2004 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities-FDA RECOGNIZED86 AAMI ST41-1999 (R 2005) Ethylene Oxide Sterilization in Health Care Facilities: Safety and Effectiveness-FDA RECOGNIZED87 AAMI ST50-2004 Dry Heat (Heated Air) Sterilizers-FDA RECOGNIZED88 AAMI ST55-2003 Table-Top Steam Sterilizers-FDA RECOGNIZED89 AAMI ST63-2002 Sterilization of health care products—Requirements for the development, validation, and routine control of an industrial sterilization process for medical devices—Dry heat-FDA RECOGNIZED90 AAMI ST65-2000 PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES91 AAMI ST66-1999 STERILIZATION OF HEALTHCARE PRODUCTS - CHEMICAL INDICATORS - PART 2 : CLASS 2 INDICATORS FOR AIR REMOVAL TEST SHEETS AND PACKS-FDA RECOGNIZED [Refer to: AAMI 18472]92 AAMI ST67-2003 Sterilization of health care products—Requirements for products labeled “STERILE?FDA RECOGNIZED93 AAMI ST77-2006 Containment devices for reusable medical device sterilization94 AAMI ST81-2004 Sterilization of medical devices - In ation to be provided by the manufacturer for the processing of resterilizable medical devices-FDA RECOGNIZED95 AAMI TIR4-1989 Apnea Monitoring by Means of Thoracic ImpedancePneumography96 AAMI TIR11-2005 Selection and use of protective apparel and surgical drapes in health care facilities97 AAMI TIR12-2004 Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers-2nd Edition98 AAMI TIR13-1997 Principles of Industrial Moist HeatSterilization-(Updated material from ANSI/AAMI ST25:1987 )99 AAMI TIR14-1997 Contract Sterilization for EthyleneOxide-Updated material from AAMI ST27; Cited by FDA as "relevant guidance" for ANSI/AAMI/ISO 11135: 1994; Includes Amendment 1: 2004 [Refer to: AAMI 11135 ERTA]100 AAMI TIR15-1997 Ethylene Oxide Sterilization Equipment, Process Considerations and Pertinent Calculations-Updated material from AAMI ST27; Cited by FDA as "relevant guidance" for ANSI/AAMI/ISO 11135: 1994 [Refer to: AAMI 11135 ERTA]101 AAMI TIR16-2000 PROCESS DEVELOPMENT AND PER ANCE QUALIFICATION FOR ETHYLENE OXIDE STERILIZATION - MICROBIOLOGICAL ASPECTS-Updated material from AAMI ST27; Cited by FDA as "relevant guidance" forANSI/AAMI/ISO 11135: 1994 [Refer to: AAMI 11135 ERTA]102 AAMI TIR17-1997 Radiation Sterilization MaterialQualification-Cited by FDA as "relevant guidance" for ANSI/AAMI/ISO 11137: 1994; Replaces AAMI ST32 [Refer to: AAMI 11137]103 AAMI TIR18-1997 Guidance on Electromagnetic Compatibility of Medical Devices for Clinical/Biomedical Engineers - Part 1: Radiated Radio-Frequency Electromagnetic Energy [Replaced by: IEC 61326-2-6] 104 AAMI TIR19 AMD 1-1999 Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical deices—Part 7: Ethylene oxide sterilization residuals Amendment105 AAMI TIR19-1998 Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals-Replaces AAMI ST29 and AAMI ST30; Cited as relevant guidance to FDA-recognized standard ANSI/AAMI/ISO 10993-7 [Refer to: AAMI 10993-7]106 AAMI TIR20-2001 PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION-Cited by FDA as "relevant guidance" for ANSI/AAMI/ISO 11135: 1994 [Refer to: AAMI 11135 ERTA]107 AAMI TIR21-1998 Systems Used to Forecast Remaining Pacemaker Battery Service Life108 AAMI TIR22-1998 Guidance for ANSI/AAMI/ISO 11607, Packaging for Terminally Sterilized Medical Devices-AMD 1: 2001109 AAMI TIR23-1999 Signal Averaging110 AAMI TIR24-1999 Acquisition and use of physiologic wave databases for testing of medical devices111 AAMI TIR26-2000 Ventricular assist and heart replacement systems 112 AAMI TIR28-2001 PRODUCT ADOPTION AND PROCESS EQUIVALENCY FOR ETHYLENE OXIDE STERILIZATION [Refer to: ISO 11135, AAMI 11135 ERTA] 113 AAMI TIR29-2002 GUIDE FOR PROCESS CONTROL IN RADIATION STERILIZATION-Cited by FDA as "relevant guidance" for ANSI/AAMI/ISO 11137: 1994 [Refer to: AAMI 11137]114 AAMI TIR30-2003 A Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices 115 AAMI TIR31-2003 PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARD FACILITIES116 AAMI TIR32-2004 Medical device software risk management [Refer to: AAMI 14971, AAMI 62304]117 AAMI TIR35-2006 Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits- er designation: AAMI ST31, AAMI ST32, and AAMI TIR5118 AAMI TIR10993-19-2006 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials119 AAMI TIR10993-20-2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices120 AAMI TIR11139-2006 Sterilization of health careproducts ?Vocabulary121 AAMI TIR14969-2004 Medical devices—Quality management systems?Guidance on the application of ISO 13485:2003122 AAMI TIR15844-1998 Sterlization of Health Care Products - Radiation Sterlization - Selection of a Sterilization Dose for a Single Production Batch-Edition 1123 AAMI TIR16142-2005 Guidance on the selection of standards in support of recognized essential principles of safety and per ance of medical devices-2006 printing124 AAMI TIR19218-2006 Medical devices - Coding structure for adverse event type and cause125 AAMI TIR60878-2003 Graphical symbols for electrical equipment in medical practice126 AAMI TIR62296-2003 Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements [Refer to: IEC 60601-1]127 AAMI TIR62348-2006 Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended。