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NBN EN ISO 11737-2:2010现行

Sterilization Of Medical Devices - Microbiological Methods - Part 2: Tests Of Sterility Performed In The Definition, Validation And Maintenance Of A Sterilization Process

出版：Belgian Standards

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基本信息

标准编号： NBN EN ISO 11737-2:2010

发布时间：2010/1/1 0:00:00

标准类别：Standard

出版单位：Belgian Standards

标准页数：18

标准简介

Establishes the general requirements for tests on medical devices that 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 carried out when validating a sterilization process. Does not apply to sterility testing for routine release of product that has been subjected to a sterilization process, nor to performance of a pharmacopoeial sterility test.

本标准替代的旧标准

NBN EN ISO 11737-2 Ed. 1 (2000)

等同采用的国际标准

ONORM EN ISO 11737-2:2010 - Identical

SN EN ISO 11737-2:2000 - Identical

ONORM EN ISO 11737-2:2000 - Identical

UNE EN ISO 11737-2:2000 - Identical

SS EN ISO 11737-2 Ed. 1 (2000) - Identical

SN EN ISO 11737-2:2010 - Identical

SS EN ISO 11737-2 Ed. 2 (2009) - Identical

UNE EN ISO 11737-2:2010 - Identical

DIN EN ISO 11737-2 (2010-04) - Identical