
Sterilization Of Medical Devices - Microbiological Methods - Part 2: Tests Of Sterility Performed In The Validation Of A Sterilization Process
出版:Association Francaise de Normalisation

专家解读视频
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.
Indice de classement: S98-118-2PR. Supersedes NFS 98 118. (03/2004) PR NF EN ISO 11737-2 February 2008. (02/2008)
SS EN ISO 11737-2 Ed. 1 (2000) - Identical
UNE EN ISO 11737-2:2000 - Identical
UNI EN ISO 11737-2:2001 - Identical
NBN EN ISO 11737-2 Ed. 1 (2000) - Identical
ONORM EN ISO 11737-2:2000 - Identical
NEN EN ISO 11737-2:2009 - Identical
SN EN ISO 11737-2:2000 - Identical
BS EN ISO 11737-2:2000 - Identical
DIN EN ISO 11737-2 (2000-04) - Identical
I.S. EN ISO 11737-2:2000 - Identical
NS EN ISO 11737-2 Ed. 1 (2000) - Identical
ISO 11737-2:1998 - Identical
NEN EN ISO 11737-2:2000 - Identical