標準號：ANSI/AAMI/ISO 11137-1-2006
中文標準名稱：保健產品的滅菌.輻射.第1部分:醫療裝置消毒的開發、確認和程序控制的要求
英文標準名稱：Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
標準類型：C30
發布日期：2005/12/23 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C30
國際標準分類號：11.080.01
引用標準：ISO 10012-1;ISO 11137-2-2006;ISO 11737-1;ISO 11737-2;ISO 13485-2003
適用范圍：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.