ISO 11135-1:2007 保健产品的消毒 环氧乙烷 第1部分：医疗设备消毒工艺的开发、确认和常规控制要求

标准编号：ISO 11135-1:2007

中文名称：保健产品的消毒 环氧乙烷 第1部分：医疗设备消毒工艺的开发、确认和常规控制要求

英文名称：Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

发布日期：2007-05

标准范围

ISO 11135-1:2007规定了医疗器械环氧乙烷灭菌过程的开发、验证和常规控制要求。根据ISO 11135-1:2007的要求验证和控制的灭菌过程在灭活海绵状脑病（如羊瘙痒病、牛海绵状脑病和克雅氏病）病原体方面并不有效。对于可能被这些制剂污染的材料的处理，特定国家已经提出了具体的建议。

ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.Sterilization processes validated and controlled in accordance with the requirements of ISO 11135-1:2007 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

标准预览图