I.S. EN ISO 11137-1:2015/A2:2019
Current
The latest, up-to-date edition.
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137- 1:2006/Amd 2:2018)
Hardcopy , PDF
English
08-12-2019
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.
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
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
0
|
| ProductNote |
THIS STANDARD ALSO REFERS-EN 556-1 The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 11137-1:2015 | Identical |
| ISO 11137-1:2006 | Identical |
| ISO 10993-1:2003 | Biological evaluation of medical devices — Part 1: Evaluation and testing |
| ISO 9000:2005 | Quality management systems — Fundamentals and vocabulary |
| 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 14001:2015 | Environmental management systems — Requirements with guidance for use |
| ISO 11607-1:2019 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling |
| ISO 11607-2:2019 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 9001:2000 | Quality management systems — Requirements |
| 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 |
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