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99/562423 DC : DRAFT APR 99

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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
Superseded date

15-03-2001

Published date

23-11-2012

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Superseded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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