AAMI ISO 11137-1 : 2006 : INC : AMD 1 : 2013 : R201000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Hardcopy , PDF
02-09-2021
English
01-01-2010
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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 201000
|
| 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Superseded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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