ISO 17665的本部分规定了医疗器械湿热灭菌过程的开发、验证和常规控制要求。注:尽管ISO 17665本部分的范围仅限于医疗器械，但它规定了可能适用于其他医疗保健产品的要求并提供了指导。ISO 17665本部分涵盖的湿热灭菌过程包括但不限于:a）饱和蒸汽通风系统；b） 饱和蒸汽主动排风系统；c） 空气-蒸汽混合物；d） 喷水；e） 浸水。

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.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.