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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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
Available format(s)

Hardcopy , PDF

Superseded date

17-10-2019

Language(s)

English

Published date

03-01-2016

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Superseded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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