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AAMI TIR16 Ed. 1 (2000)被替代

Process Development And Performance Qualification For Ethylene Oxide Sterilization - Microbiological Aspects

出版:Association for Advancement of Medical Instrumentation

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基本信息
标准编号: AAMI TIR16 Ed. 1 (2000)
发布时间:2000/3/13 0:00:00
标准类别:Standard
出版单位:Association for Advancement of Medical Instrumentation
标准页数:28
标准简介

Gives additional guidance to augment ANSI/AAMI/ISO 11135:1994, Medical devices - Validation and routine control of ethylene oxide sterilization (AAMI 1994) for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.

标准备注

Formerly it was AAMI ST27 (It is an updated material from ANSI/AAMI ST27:1988 (05/2001)

本标准替代的旧标准

AAMI ST27:1988

替代本标准的新标准

AAMI TIR16:2009 (R2013)

等同采用的国际标准

ISO 11135:1994 - Identical