DIN EN ISO 14937-2010 保健产品灭菌.医疗器械用消毒剂的特性和消毒方法的研发,验证及常规控制的一般要求 (ISO 14937-2009); 德文版本 EN ISO 14937-20

标准号：DIN EN ISO 14937-2010
中文标准名称：保健产品灭菌.医疗器械用消毒剂的特性和消毒方法的研发,验证及常规控制的一般要求 (ISO 14937-2009); 德文版本 EN ISO 14937-2009
英文标准名称：Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009
标准类型：C04
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C04
国际标准分类号：11.080.01
引用标准：ISO 10012;ISO 10993-1;ISO 10993-17;ISO 11138-1-2006;ISO 11140-1;ISO 11737-1;ISO 11737-2;ISO 13485-2003;IEC 61010-2-040
适用范围：This Standard specifies general requirements for the characterization of a sterilizing agent, and for the development, validation, and routine monitoring and control of a sterilization process for medical devices.Note Although the scope of this International Standard is limited to medical devices, the requirements specified herein can also be applied to sterilization processes for other health care products.This Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.