BS EN ISO 11737-1-2006 医学器材的消毒.微生物学方法.产品上微生物种群的测定

标准号：BS EN ISO 11737-1-2006
中文标准名称：医学器材的消毒.微生物学方法.产品上微生物种群的测定
英文标准名称：Sterilization of medical devices - Microbiological methods - Determination of a population of microorganisms on products
标准类型：C05
发布日期：2006/4/28 12:00:00
实施日期：2006/4/28 12:00:00
中国标准分类号：C05
国际标准分类号：07.100.10;11.080.01
引用标准：ISO 10012;ISO 13485-2003;ISO/IEC 17025-2005
适用范围：This part of ISO 11737 specifies requirements and provides guidance for the enumeration and microbialcharacterization of the population of viable microorganisms on or in a medical device, component, rawmaterial or package.NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of the bioburden data.This part of ISO 11737 does not specify requirements for the enumeration or identification of viral or protozoancontaminants.NOTE 2 Furthermore, the requirements specified in this part of ISO 11737 are not intended to address the removal anddetection of the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathyand Creutzfeldt-Jakob disease.This part of ISO 11737 does not specify requirements for the microbiological monitoring of the environment inwhich medical devices are manufactured.