标准号：ISO 14937-2000
实施状态：作废
中文名称：医疗保健产品灭菌 消毒剂的特性及医疗装置消毒的开发、确认和程序控制的一般要求
英文名称：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
发布日期：2000-12
被替代标准：ISO 14937-2009
代替标准：ISO/FDIS 14937-2000
采用标准：DIN EN ISO 14937-2001,IDT;ANSI/AAMI/ISO 14937-2000,IDT;BS EN ISO 14937-2001,IDT;EN ISO 14937-2000,IDT;EN ISO 14937/AC-2003,IDT;EN ISO 14937/AC-2005,IDT;NF S98-115-2001,IDT;CAN/CSA-ISO 14937-01-2001,IDT;SN EN ISO 14937-2001,IDT;SN EN ISO 14937/AC-2004,IDT;SN EN ISO 14937/AC-2005,IDT;OENORM EN ISO 14937-2001,IDT;OENORM EN ISO 14937-2004,IDT;OENORM EN ISO 14937-2005,IDT;UNE-EN ISO 14937-2001,IDT;GOST R ISO 9919-2007,MOD
起草单位：ISO/TC 198
标准简介：1 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.
2 This International Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.
3 This International Standard does not apply to processes that rely solely on physical removal of microorganisms (for example, filtration).
4 This International Standard does not describe detailed test procedures for assessing microbial inactivation.
5 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.
6 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 be applied 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.
文件格式：PDF
文件大小：1.74MB
文件页数：45
（以上信息更新时间为：2019-11-23）
ISO 14937-2000 医疗保健产品灭菌 消毒剂的特性及医疗装置消毒的开发、确认和程序控制的一般要求.pdf
(1.74 MB)
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