AAMI/ISO 13485:2016
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
Available format(s)
Hardcopy , PDF
Superseded date
10-17-2019
Superseded by
Language(s)
English
Published date
01-03-2016
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
WG 01
|
| DevelopmentNote |
Supersedes AAMI ISO 13488 (06/2004)
|
| DocumentType |
Standard
|
| Pages |
50
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 13485:2016 | Identical |
| AAMI TIR14 : 2016 | CONTRACT STERILIZATION USING ETHYLENE OXIDE |
| AAMI TIR35 : 2016 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - PRODUCT ADOPTION AND ALTERNATIVE SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS |
| AAMI TIR59:2017 | INTEGRATING HUMAN FACTORS INTO DESIGN CONTROLS |
| AAMI HE75 : 2009(R2013) | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
| AAMI TIR39:2009 | GUIDANCE ON SELECTING A MICROBIAL CHALLENGE AND INOCULATION SITES FOR STERILIZATION VALIDATION OF MEDICAL DEVICES |
| AAMI TIR39:2009(R2017) | GUIDANCE ON SELECTING A MICROBIAL CHALLENGE AND INOCULATION SITES FOR STERILIZATION VALIDATION OF MEDICAL DEVICES |
| AAMI TIR26 : 2000 | VENTRICULAR ASSIST AND HEART REPLACEMENT SYSTEMS |
| AAMI HE74 : 2001 | HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES |
| 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 |
| AAMI HE74 : 2001 : R2009 | HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES |
| AAMI ST67 : 2011 | STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE' |
| ANSI/AAMI ST8:2013(R2018) | HOSPITAL STEAM STERILIZERS |
| ANSI/AAMI ST90:2017 | PROCESSING OF HEALTH CARE PRODUCTS - QUALITY MANAGEMENT SYSTEMS FOR PROCESSING IN HEALTH CARE FACILITIES |
| ANSI/AAMI EQ89:2015 | GUIDANCE FOR THE USE OF MEDICAL EQUIPMENT MAINTENANCE STRATEGIES AND PROCEDURES |
| AAMI HE75 : 2009 | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
| AAMI TIR56:2013(R2020) | GUIDANCE FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN ETHYLENE OXIDE STERILIZATION PROCESS UTILIZING FLEXIBLE BAG SYSTEMS FOR THE STERILIZATION OF MEDICAL DEVICES |
| AAMI TIR56 : 2013 | GUIDANCE FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN ETHYLENE OXIDE STERILIZATION PROCESS UTILIZING FLEXIBLE BAG SYSTEMS FOR THE STERILIZATION OF MEDICAL DEVICES |
| AAMI ST67 : 2011 : R2017 | STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE' |
| AAMI TIR49 : 2013 | DESIGN OF TRAINING AND INSTRUCTIONAL MATERIALS FOR MEDICAL DEVICES USED IN NON-CLINICAL ENVIRONMENTS |
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