BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Sterilization of health care products. Radiation Requirements for development, validation and routine control of a sterilization process for medical devices
Hardcopy , PDF
English
31-07-2015
30-12-2019
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.
| Committee |
CH/198
|
| DevelopmentNote |
Supersedes 04/30048301 DC. (08/2006) Together with BS EN ISO 11137-2 and BS EN ISO 11137-3, it supersedes BS EN 552. (06/2007)
|
| DocumentType |
Standard
|
| Pages |
54
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator. ISO 11137-1:2006 does not: specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease; detail specified requirements for designating a medical device as sterile; specify a quality management system for the control of all stages of production of medical devices; specify requirements for occupational safety associated with the design and operation of irradiation facilities; specify requirements for the sterilization of used or reprocessed devices.
| Standards | Relationship |
| NEN EN ISO 11137-1 : 2015 | Identical |
| NBN EN ISO 11137-1 : 2015 | Identical |
| 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 |
| NS EN ISO 11137-1 : 2015 | Identical |
| I.S. EN ISO 11137-1:2015 | Identical |
| UNE-EN ISO 11137-1:2015 | Identical |
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