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AAMI ISO 11137-1:2006

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Available format(s)

Hardcopy , PDF

Superseded date

13-07-2019

Language(s)

English

Published date

01-01-2010

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO
11137-1:2006
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (informative) - Guidance
Bibliography

Describes requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

Committee
WG 02
DevelopmentNote
Supersedes AAMI ISO 11137 and AAMI TIR27. (03/2006) Supersedes AAMI ISO TIR 15843. (09/2009)
DocumentType
Standard
Pages
54
ProductNote
Reconfirmed 2006
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 11137-1:2006 Identical

ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ANSI N43.10 : 2001(R2010) SAFE DESIGN AND USE OF PANORAMIC, WET SOURCE STORAGE GAMMA IRRADIATORS (CATEGORY 4) AND DRY SOURCE STORAGE GAMMA IRRADIATORS (CATEGORY 2)
ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
AAMI TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 14001:2015 Environmental management systems — Requirements with guidance for use
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 9001:2015 Quality management systems — Requirements
ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
ISO 14040:2006 Environmental management Life cycle assessment Principles and framework
ISO 10012-1:1992 Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment

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