標準號：ANSI/AAMI/ISO 17665-1-2005
中文標準名稱：醫療保健產品.濕熱.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 - Moist heat - Requirements for development, validation and routine control of a sterilization process for medical devices
標準類型：C46
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：C46
國際標準分類號：11.080.01
適用范圍：Specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. Moist heat sterilization processes covered by this standard include saturated steam venting processes, saturated steam active air removal processes, air steam mixture processes, water spray processes, and water immersion processes.