ANSI/AAMI/ISO 14937-2000 医疗保健产品灭菌.医用设备用消毒剂的特性及消毒方法的开发、确认和常规控制的一般要求

标准号：ANSI/AAMI/ISO 14937-2000
中文标准名称：医疗保健产品灭菌.医用设备用消毒剂的特性及消毒方法的开发、确认和常规控制的一般要求
英文标准名称：Sterilization of Health Care Products - General Requirements for Characteristics of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process
标准类型：C30
发布日期：2000/6/7 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 10993-1;ISO 10993-17;ISO 11138-1;ISO 11140-1
适用范围：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.