DIN EN ISO 11737-1-2009 医疗设备的消毒.微生物法.第1部分:产品上微生物群落的测定(ISO 11737-1-2006)(包括勘误表AC-2009).英文版本DIN EN ISO

标准号：DIN EN ISO 11737-1-2009
中文标准名称：医疗设备的消毒.微生物法.第1部分:产品上微生物群落的测定(ISO 11737-1-2006)(包括勘误表AC-2009).英文版本DIN EN ISO 11737-1-2009-09
英文标准名称：Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) (includes Corrigendum AC:2009); English version of DIN EN ISO 11737-1:2009-09
标准类型：C05
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：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 microbial characterization 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 and detection of the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.This part of ISO 11737 does not specify requirements for the microbiological monitoring of the environment inwhich medical devices are manufactured.