当前位置： 首页 > 标准详情页

NF 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：Association Francaise de Normalisation

获取原文如何获取原文？问客服获取原文，即可享受本标准状态变更提醒服务！

专家解读视频

基本信息

标准编号： NF EN ISO 11737-2:2010

发布时间：2010/1/1 0:00:00

标准类别：Standard

出版单位：Association Francaise de Normalisation

标准页数：31

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.

标准备注

Indice de classement: S98-118-2. Supersedes NFS 98 118. (03/2004) PR NF EN ISO 11737-2 February 2008. (02/2008)

本标准替代的旧标准

NF EN ISO 11737-2:2000

等同采用的国际标准

UNE EN ISO 11737-2:2010 - Identical

NEN EN ISO 11737-2:2009 - Identical

NBN EN ISO 11737-2:2010 - 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 11737-2:2000 - Identical