ISO 17665-1:2006 保健产品的杀菌消毒 在湿空气中加热 第1部分：对开发、确认医疗设备的灭菌流程及对其实施常规控制的要求

标准编号：ISO 17665-1:2006

中文名称：保健产品的杀菌消毒 在湿空气中加热 第1部分：对开发、确认医疗设备的灭菌流程及对其实施常规控制的要求

英文名称：Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

发布日期：2006-08

标准范围

1.1 Inclusions 1.1.1 This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.NOTE Although the scope of this part of ISO 17665 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products.1.1.2 Moist heat sterilization processes covered by this part of ISO 17665 include but are not limited to:a) saturated steam venting systems;b) saturated steam active air removal systems;c) air steam mixtures;d)water spray;e)water immersion. NOTESee also Annex E.1.2 Exclusions1.2.1 This part of ISO 17665 does not specify requirements for development, validation, and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3.1.2.2 This part of ISO 17665 does not apply to those sterilization processes that are based on a combination of moist heat with other biocidal agents (e.g. formaldehyde) as the sterilizing agent.1.2.3 This part of ISO 17665 does not detail a specified requirement for designating a medical device as "sterile."NOTE Attention is drawn to national or regional requirements for designating medical devices as "sterile." See, for example, EN 556-1 or ANSI/AAMI ST67.

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