当前位置： 首页 > 标准详情页

ISO 11135:2014现行

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

出版：International Organization for Standardization

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： ISO 11135:2014

发布时间：2014/7/7 0:00:00

标准类别：Standard

出版单位：International Organization for Standardization

标准页数：78

标准简介

This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

本标准替代的旧标准

ISO 11135-1:2007

ISO/TS 11135-2:2008

ISO/FDIS 11135

ISO/DIS 11135 : 60.00 (2014)

ISO 11135 : 1994

ISO TS 11135-2 : 2008

ISO 11135-1 : 2007

等同采用的国际标准

NBN EN ISO 11135 : 2014 - Identical

UNE EN ISO 11135 : 2015 - Identical

AAMI ISO 11135 : 2014 - Identical