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SN EN ISO 11737-2:2010現(xiàn)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:Swiss Standards

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基本信息
標(biāo)準(zhǔn)編號(hào): SN EN ISO 11737-2:2010
發(fā)布時(shí)間:2010/4/1 0:00:00
標(biāo)準(zhǔn)類別:Standard
出版單位:Swiss Standards
標(biāo)準(zhǔn)頁數(shù):0
標(biāo)準(zhǔn)簡(jiǎn)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.

本標(biāo)準(zhǔn)替代的舊標(biāo)準(zhǔn)

SN EN ISO 11737-2:2000

等同采用的國際標(biāo)準(zhǔn)

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

UNI EN ISO 11737-2:2010 - Identical

NS EN ISO 11737-2:2009 - Identical

NBN EN ISO 11737-2:2010 - Identical

NF EN ISO 11737-2:2010 - Identical

BS EN ISO 11737-2:2009 - Identical

NEN EN ISO 11737-2:2009 - Identical

I.S. EN ISO 11737-2:2009 - Identical

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

ONORM EN ISO 11737-2:2010 - Identical

UNE EN ISO 11737-2:2010 - Identical