Standard

NS-EN ISO 11737-2:2000

Jun 2000 Withdrawn

Note: This standard has a new edition: NS-EN ISO 11737-2:2020

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Abstract

1.1 This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices which have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be performed when validating a sterilization process. 1.2 This part of ISO 11737 is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process; b) performance of a pharmacopoeial test for sterility; or NOTE 1 The performance of a) or b) above is not a requirement of ISO 11134, 11135 or 11137. c) culturing of biological indicators, including inoculated products. NOTE 2 Methods of culturing biological indicators are described in ISO 11138.

Document information

Standard from SN
Published: 13 June 2000
Withdrawn: 1 February 2010
Edition: 1
Version: 1
Document type: NAT
ISBN:

ICS 07.100.10
ICS 11.080
ICS 11.080.01
National Committee CEN/TC 204

Product Relations

Replaced by: NS-EN ISO 11737-2:2009

Product life cycle

Current product

Withdrawn

NS-EN ISO 11737-2:2000
Replaced by

Withdrawn

NS-EN ISO 11737-2:2009

NS-EN ISO 11737-2:2000

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NS-EN ISO 11737-2:2020

NS-EN ISO 11737-2:2009