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ISO 14937:2000被替代

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

出版：International Organization for Standardization

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基本信息

标准编号： ISO 14937:2000

发布时间：2000/12/21 0:00:00

标准类别：Standard

出版单位：International Organization for Standardization

标准页数：35

标准简介

This International Standard specifies general requirements for the characterization of a sterilizing agent, and for the development, validation and routine control of a sterilization process for medical devices.This International Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.This International Standard does not apply to processes that rely solely on physical removal of microorganisms (for example, filtration).This International Standard does not describe detailed test procedures for assessing microbial inactivation.This International Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organization with responsibility for sterilizing the medical device.This International Standard does not supersede or modify published International Standards for particular sterilization processes.NOTE 1 Although the scope of this International Standard is limited to medical devices, the principles described may also beapplied to other health care products.NOTE 2 Sterilization processes validated and controlled in accordance with the requirements of this International Standard should not be assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

替代本标准的新标准

ISO 14937:2009

等同采用的国际标准

Amd 13353 (Corr to BS EN ISO 14937:2001) - Identical

GB/T 19974-2005 - Identical

SN EN ISO 14937:2001 - Identical

BS EN ISO 14937:2001 - Identical

DIN EN ISO 14937 (2001-05) - Identical

ONORM EN ISO 14937:2005 - Identical

NBN EN ISO 14937:2001 - Identical

NF EN ISO 14937:2001 - Identical

UNI EN ISO 14937:2002 - Identical