ISO 20857:2010 医疗保健产品灭菌 干热 医疗器械灭菌工艺的设定、确认和常规控制的要求

标准编号：ISO 20857:2010

中文名称：医疗保健产品灭菌 干热 医疗器械灭菌工艺的设定、确认和常规控制的要求

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

发布日期：2010-08

标准范围

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.

标准预览图