標(biāo)準(zhǔn)號(hào)：BS EN ISO 11737-1-2006
中文標(biāo)準(zhǔn)名稱：醫(yī)學(xué)器材的消毒.微生物學(xué)方法.產(chǎn)品上微生物種群的測(cè)定
英文標(biāo)準(zhǔn)名稱：Sterilization of medical devices - Microbiological methods - Determination of a population of microorganisms on products
標(biāo)準(zhǔn)類型：C05
發(fā)布日期：2006/4/28 12:00:00
實(shí)施日期：2006/4/28 12:00:00
中國(guó)標(biāo)準(zhǔn)分類號(hào)：C05
國(guó)際標(biāo)準(zhǔn)分類號(hào)：07.100.10;11.080.01
引用標(biāo)準(zhǔn)：ISO 10012;ISO 13485-2003;ISO/IEC 17025-2005
適用范圍：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.