ISO 11737-1-2006 医疗器械灭菌.微生物学方法.第1部分:产品上微生物群落的测定

标准号：ISO 11737-1-2006
中文标准名称：医疗器械灭菌.微生物学方法.第1部分:产品上微生物群落的测定
英文标准名称：Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
标准类型：C30
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：C30
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.This part of ISO 11737 does not specify requirements for the enumeration or identification of viral or protozoancontaminants.This part of ISO 11737 does not specify requirements for the microbiological monitoring of the environment inwhich medical devices are manufactured.