標準號：ANSI/AAMI/ISO 14937-2000
中文標準名稱：醫療保健產品滅菌.醫用設備用消毒劑的特性及消毒方法的開發、確認和常規控制的一般要求
英文標準名稱：Sterilization of Health Care Products - General Requirements for Characteristics of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process
標準類型：C30
發布日期：2000/6/7 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 10993-1;ISO 10993-17;ISO 11138-1;ISO 11140-1
適用范圍：Specifies general requirements for the characterization of a sterilizing agent, and for the development, validation and routine control of a sterilization process for medical devices. Although the scope of this standard is limited to medical devices, the principles described may be applied to other health care products. This standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of products to be sterilized and the organization with responsibility for sterilizing the product. This standard does not supersede or modify the published standards for particular sterilization processes.