ANSI/AAMI/ISO 11137-1-2006 保健产品的灭菌.辐射.第1部分:医疗装置消毒的开发、确认和程序控制的要求

标准号：ANSI/AAMI/ISO 11137-1-2006
中文标准名称：保健产品的灭菌.辐射.第1部分:医疗装置消毒的开发、确认和程序控制的要求
英文标准名称：Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
标准类型：C30
发布日期：2005/12/23 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C30
国际标准分类号：11.080.01
引用标准：ISO 10012-1;ISO 11137-2-2006;ISO 11737-1;ISO 11737-2;ISO 13485-2003
适用范围：Specifies requirements for validation, process control and routine monitoring in the radiation sterilization for health care products. It applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or x-ray generator.