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美国医疗器械促进协会 -[AAMI]
Association for Advancement of Medical Instrumentation
国家:
美国[US]
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标准编号
标准名称
发布部门
发布日期
状态
AAMI STBK15-1:2015
Sterilization - Part 1: Sterilization In Health Care Facilities
Associatio..
2015-05-01
现行
AAMI ST91:2015
Flexible And Semi-Rigid Endoscope Processing In Health Care Facilities
Associatio..
2015-04-10
现行
AAMI ESM4:2015
Electrical Safety Manual
Associatio..
2015-04-10
现行
AAMI QSC:3RD EDITION
The Quality System Compendium: Cgmp Requirements And Industry Practice
Associatio..
2015-04-08
现行
AAMI IEC TIR 80001-2-5:2014
Application Of Risk Management For It-Networks Incorporating Medical Devices - Part 2-5: Application Guidance - Guidance On Distributed Alarm Systems
Associatio..
2015-03-02
现行
AAMI IEC 62366-1:2015
Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices
Associatio..
2015-02-23
现行
AAMI EQ89:2015
Guidance For The Use Of Medical Equipment Maintenance Strategies And Procedures
Associatio..
2015-02-12
现行
AAMI ISO 11140-1:2014
Sterilization Of Health Care Products - Chemical Indicators - Part 1: General Requirements
Associatio..
2015-01-22
现行
AAMI TIR55:2014 (R2017)
Human Factors Engineering For Processing Medical Devices
Associatio..
2015-01-22
现行
AAMI ISO TIR 37137:2014
Cardiovascular Biological Evaluation Of Medical Devices - Guidance For Absorbable Implants
Associatio..
2015-01-22
现行
AAMI TIR63:2014 (R2017)
Management Of Loaned Critical And Semi-Critical Medical Devices That Require Sterilization Or High-Level Disinfection
Associatio..
2015-01-22
现行
AAMI TIR60:2014
Common Mode Rejection In Ecg Monitoring
Associatio..
2014-12-11
现行
AAMI TIR61:2014
Generating Reports For Human Factors Design Validation Results For External Cardiac Defibrillators
Associatio..
2014-12-11
现行
AAMI ST79:2010 (R2014)
Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities
Associatio..
2014-11-19
被替代
AAMI ISO TIR 17665-3:2014 (R2016)
Sterilization Of Health Care Products - Moist Heat - Guidance On The Designation Of A Medical Product To A Product Family And Processing Category For Steam Sterilization
Associatio..
2014-11-18
现行
AAMI ST15883-1:2009
Washer-disinfectors - Part 1: General Requirements, Terms And Definitions And Tests
Associatio..
2014-11-18
现行
AAMI TIR51:2014 (R2017)
Human Factors Engineering - Guidance For Contextual Inquiry
Associatio..
2014-11-18
现行
AAMI ISO 10993-16:2010 (R2014)
Biological Evaluation Of Medical Devices - Part 16: Toxicokinetic Study Design For Degradation Products And Leachables
Associatio..
2014-11-05
废止
AAMI ISO 10993-6:2007 (R2014)
Biological Evaluation Of Medical Devices - Part 6: Tests For Local Effects After Implantation
Associatio..
2014-11-05
被替代
AAMI ISO 10993-10:2010 (R2014)
Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
Associatio..
2014-11-05
现行
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