标准编号：ISO 22441:2022
中文名称：保健产品的灭菌 低温汽化过氧化氢 医疗器械灭菌过程的开发、验证和常规控
英文名称：Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
发布日期：2022-08
标准范围
1.1.1 This document provides requirements for the development, validation and routine monitoring and control of a low temperature sterilization process for medical devices using vaporized hydrogen peroxide (VH2O2) as the sterilizing agent.
1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, organizations performing process validation of VH2O2 sterilization, and organizations responsible for sterilizing medical devices.
NOTE VH2O2 sterilizers can be used in both health care and industrial facilities, and this document acknowledges the similarities and differences between the two applications.
立即下载标准文件