GOST ISO 10993-17-2011 医疗器械.医疗器械的生物学评价.第17部分.可滤取物质允许限度的建立
Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances
ANSI/AAMI/ISO 11737-1:2006 医疗器械消毒.微生物法.第1部分:产品微生物群落数测定
Specifies requirements and provides guidance for the enumeration and characterization of the population of viable microorganisms on or in a medical
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
AS ISO 10993.17:2004 医疗器械的生物学评价．浸出物允许极限的确定
Specifies a method for the determination of allowable limits for substances leachable from medical devices. It describes a systematic process through
Biological evaluation of medical devices - Establishment of allowable limits for leachable substances
GOST ISO 11737-1-2012 医疗器械灭菌.微生物法.第1部分.产品上微生物数量的估计
Sterilization of medical devices. Microbiological methods. Part 1. Estimation of population of microorganisms on products
GOST R ISO 11737-1-2000 医疗器械灭菌.微生物法.第1部分:产品上微生物数量的估计
Sterilization of medical devices. Microbiological methods. Part 1. Estimation of population of microorganisms on products
GOST ISO 10993-13-2011 医疗器械.医疗器械的生物学评价.第13部分.聚合物医疗器械降解产物的识别与量化
Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
KS P ISO 10993-17-2017 医疗器械的生物学评估 - 第17部分:建立可浸出物质的允许限度
Biological evaluation of medical devices — Part 17：Establishment of allowable limits for leachable substances
BS EN ISO 10993-17:2002 医疗器械的生物评定.可浸出物质容许限值的确定
ISO 10993-17:2002 specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving
Biological evaluation of medical devices - Establishment of allowable limits for leachable substances
KS P ISO 11737-1:2012 医疗器械的消毒.微生物法.第1部分:产品的微生物群数的判断
이 표준은 의료 용구, 구성 성분, 원재료, 포장에 대한 미생물 오염 정도를 평가하는 데
Sterilization of medical devices－Microbiological methods－Part 1：Determination of population of microorganisms on products
KS P ISO 11737-1:2018 医疗器械灭菌 - 微生物方法 - 第1部分:产品中微生物群体的测定
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
KS P ISO 11737-1-2018 医疗器械灭菌 - 微生物方法 - 第1部分:产品中微生物群体的测定
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
GB/T 19973.1-2015 医疗器械的灭菌 微生物学方法 第1部分:产品上微生物总数的测定
GB/T 19973的本部分规定了医疗器械、部件、原材料、包装上(或内)的存活微生物总数的计数和鉴定的要求，并提供了指南。 本部分没有规定对病毒性污染或原虫性污染计数和鉴定的要求。 本部分没有规定对生产医疗器械的环境中微生物监测的要求
Sterilization of medical devices.Microbiological methods.Part 1:Determination of a population of microorganisms on products
GOST ISO 10993-13-2016 医疗器械. 医疗器械的生物学评价. 第13部分. 高分子医疗器械降解产物的定性与定量
Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
EN ISO 11737-1:2018 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
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
NF S98-118-1:2006 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
Sterilization of medical devices - Microbiological methods - Part 1 : determination of a population of microorganisms on products.
GOST ISO 10993-17-2011 医疗器械.医疗器械的生物学评价.第17部分.可滤取物质允许限度的建立
Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances
ANSI/AAMI/ISO 11737-1:2006 医疗器械消毒.微生物法.第1部分:产品微生物群落数测定
Specifies requirements and provides guidance for the enumeration and characterization of the population of viable microorganisms on or in a medical
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
AS ISO 10993.17:2004 医疗器械的生物学评价．浸出物允许极限的确定
Specifies a method for the determination of allowable limits for substances leachable from medical devices. It describes a systematic process through
Biological evaluation of medical devices - Establishment of allowable limits for leachable substances
GOST ISO 11737-1-2012 医疗器械灭菌.微生物法.第1部分.产品上微生物数量的估计
Sterilization of medical devices. Microbiological methods. Part 1. Estimation of population of microorganisms on products
GOST R ISO 11737-1-2000 医疗器械灭菌.微生物法.第1部分:产品上微生物数量的估计
Sterilization of medical devices. Microbiological methods. Part 1. Estimation of population of microorganisms on products
GOST ISO 10993-13-2011 医疗器械.医疗器械的生物学评价.第13部分.聚合物医疗器械降解产物的识别与量化
Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
KS P ISO 10993-17-2017 医疗器械的生物学评估 - 第17部分:建立可浸出物质的允许限度
Biological evaluation of medical devices — Part 17：Establishment of allowable limits for leachable substances
BS EN ISO 10993-17:2002 医疗器械的生物评定.可浸出物质容许限值的确定
ISO 10993-17:2002 specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving
Biological evaluation of medical devices - Establishment of allowable limits for leachable substances
KS P ISO 11737-1:2012 医疗器械的消毒.微生物法.第1部分:产品的微生物群数的判断
이 표준은 의료 용구, 구성 성분, 원재료, 포장에 대한 미생물 오염 정도를 평가하는 데
Sterilization of medical devices－Microbiological methods－Part 1：Determination of population of microorganisms on products
KS P ISO 11737-1:2018 医疗器械灭菌 - 微生物方法 - 第1部分:产品中微生物群体的测定
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
KS P ISO 11737-1-2018 医疗器械灭菌 - 微生物方法 - 第1部分:产品中微生物群体的测定
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
GB/T 19973.1-2015 医疗器械的灭菌 微生物学方法 第1部分:产品上微生物总数的测定
GB/T 19973的本部分规定了医疗器械、部件、原材料、包装上(或内)的存活微生物总数的计数和鉴定的要求，并提供了指南。 本部分没有规定对病毒性污染或原虫性污染计数和鉴定的要求。 本部分没有规定对生产医疗器械的环境中微生物监测的要求
Sterilization of medical devices.Microbiological methods.Part 1:Determination of a population of microorganisms on products
GOST ISO 10993-13-2016 医疗器械. 医疗器械的生物学评价. 第13部分. 高分子医疗器械降解产物的定性与定量
Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
EN ISO 11737-1:2018 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
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
NF S98-118-1:2006 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
Sterilization of medical devices - Microbiological methods - Part 1 : determination of a population of microorganisms on products.
编辑：北检院编辑部
