99/562423 DC : DRAFT APR 99
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS:ENISO 14937 - STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL CRITERIA FOR CHARACTERIZATION OF A STERILIZING AGENT AND DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS
03-15-2001
11-23-2012
1 Scope
2 Normative references
3 Definitions
4 Quality System
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
Draft BS: EN ISO 14937
| Committee |
CH/67
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO 13488:1996 | Quality systems — Medical devices — Particular requirements for the application of ISO 9002 |
| 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 11140-1:2014 | Sterilization of health care products Chemical indicators Part 1: General requirements |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
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