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

ISO 17665-1:20 06规定了医疗器械湿热灭菌工艺的开发、验证和常规控制的要求。ISO 17665-1:20 06涵盖的湿热灭菌工艺包括但不限于:饱和蒸汽通风系统；饱和蒸汽主动除气系统；空气蒸汽混合物；喷水；水浸。

ISO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.Moist heat sterilization processes covered by ISO 17665-1:2006 include but are not limited to:

• saturated steam venting systems;
• saturated steam active air removal systems;
• air steam mixtures;
• water spray;
• water immersion.

标准预览图