I.S. EN ISO 11137-1:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013)
Hardcopy , PDF
English
01-01-2015
17-12-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
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
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 90/385/EEC
on active implantable medical devices
Annex ZB (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC on medical devices
Annex ZC (informative) - Relationship between this
European Standard and the Essential Requirements of
EU Directive 98/79/EC on in vitro diagnostic
medical devices
Describes requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
| DevelopmentNote |
Supersedes I.S. EN 552. (07/2006)
|
| DocumentType |
Standard
|
| Pages |
65
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NBN EN ISO 11137-1 : 2015 | Identical |
| EN ISO 11137-1:2015 | Identical |
| NS EN ISO 11137-1 : 2015 | Identical |
| NEN EN ISO 11137-1 : 2015 | Identical |
| BS EN ISO 11137-1:2015 | Identical |
| DIN EN ISO 11137-1:2015-11 | Identical |
| ISO 11137-1:2006 | Identical |
| NF EN ISO 11137-1 : 2016 | Identical |
| UNE-EN ISO 11137-1:2015 | 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 |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology — Basic and general concepts and associated terms (VIM) |
| 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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