DIN EN ISO 17665-1-2006 保健产品的灭菌.辐射.第1部分:医疗器件消毒过程的制定、确认和常规控制的要求(ISO 17665-1:2006)

标准号：DIN EN ISO 17665-1-2006
中文标准名称：保健产品的灭菌.辐射.第1部分:医疗器件消毒过程的制定、确认和常规控制的要求(ISO 17665-1:2006)
英文标准名称：Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); English version of DIN EN ISO 17665-1:2006-11
标准类型：C30
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C30
国际标准分类号：11.080.01
引用标准：ISO 11138-1;ISO 11138-3;ISO 10012;ISO 11140-1;ISO 11140-3
适用范围：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. NOTE See also Annex E.