Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
保健品灭菌——干热;医疗器械灭菌过程的开发、验证和常规控制要求
发布日期:
2010-08-17
ISO 20857:2010规定了医疗器械干热灭菌过程的开发、验证和常规控制要求。
尽管ISO 20857:2010主要针对干热灭菌,但它也规定了与使用干热的脱热原过程相关的要求并提供了指南。
ISO 20857:2010 specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices.
Although ISO 20857:2010 primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.