GOST ISO 10993-11-2011 医疗器械.医疗器械的生物学评价.第11部分.系统毒性试验
Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST ISO 10993-5-2011 医疗器械.医疗器械的生物学评价.第5部分.体外细胞毒性试验
Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-6-2011 医疗器械.医疗器械的生物学评价.第6部分.植入后局部反应试验
Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
YY/T 0127.12-2008 牙科学.口腔医疗器械生物学评价.第2单元：试验方法.微核试验
YY/T 0127的本部分规定了口腔医疗器械遗传毒性——骨髓细胞微核试验方法和技术要求。 本部分适用于检测口腔医疗器械及其组分或其浸提液可能的致突变作用
Dentistry.Biological evaluation of medical devices used in dentistry Part 2:Test method.Micronucleus test
GOST ISO 10993-1-2011 医疗器械.医疗器械的生物学评价.第1部分.评价与测试
Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GB/T 16886.20-2015 医疗器械生物学评价 第20部分:医疗器械免疫毒理学试验原则和方法
GB/T 16886的本部分给出了医疗器械潜在免疫毒性方面的免疫毒理学综述。本部分还给出了用于检验不同类型医疗器械免疫毒性的方法指南。 本部分是根据过去几十年间由不同免疫毒理学专家组撰写的几种出版物给出的，免疫毒理学作为毒理学范畴内的一个独立分支在发展。 附录A中描述了关于免疫毒性的当前认知状态
Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices
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
GOST R ISO 10993-11-1999 医疗器械.医疗器械的生物学评价.第11部分:系统毒性测试
Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
BS EN ISO 10993-5:1999 医疗器械的生物评定.实验室细胞毒性试验
This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured
Biological evaluation of medical devices - Tests for in vitro cytotoxicity
KS P ISO 10993-20-2009(2019 医疗器械生物学评价第20部分:医疗器械免疫毒理学试验原理和方法
Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
GOST ISO 10993-10-2011 医疗器械.医疗器械的生物学评价.第10部分.刺激与持续型过敏症试验
Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
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 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
YY/T 1532-2017 医疗器械生物学评价纳米材料溶血试验
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
GOST ISO 10993-11-2011 医疗器械.医疗器械的生物学评价.第11部分.系统毒性试验
Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST ISO 10993-5-2011 医疗器械.医疗器械的生物学评价.第5部分.体外细胞毒性试验
Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-6-2011 医疗器械.医疗器械的生物学评价.第6部分.植入后局部反应试验
Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
YY/T 0127.12-2008 牙科学.口腔医疗器械生物学评价.第2单元：试验方法.微核试验
YY/T 0127的本部分规定了口腔医疗器械遗传毒性——骨髓细胞微核试验方法和技术要求。 本部分适用于检测口腔医疗器械及其组分或其浸提液可能的致突变作用
Dentistry.Biological evaluation of medical devices used in dentistry Part 2:Test method.Micronucleus test
GOST ISO 10993-1-2011 医疗器械.医疗器械的生物学评价.第1部分.评价与测试
Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GB/T 16886.20-2015 医疗器械生物学评价 第20部分:医疗器械免疫毒理学试验原则和方法
GB/T 16886的本部分给出了医疗器械潜在免疫毒性方面的免疫毒理学综述。本部分还给出了用于检验不同类型医疗器械免疫毒性的方法指南。 本部分是根据过去几十年间由不同免疫毒理学专家组撰写的几种出版物给出的，免疫毒理学作为毒理学范畴内的一个独立分支在发展。 附录A中描述了关于免疫毒性的当前认知状态
Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices
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
GOST R ISO 10993-11-1999 医疗器械.医疗器械的生物学评价.第11部分:系统毒性测试
Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
BS EN ISO 10993-5:1999 医疗器械的生物评定.实验室细胞毒性试验
This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured
Biological evaluation of medical devices - Tests for in vitro cytotoxicity
GOST ISO 10993-10-2011 医疗器械.医疗器械的生物学评价.第10部分.刺激与持续型过敏症试验
Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
KS P ISO 10993-20-2009(2019 医疗器械生物学评价第20部分:医疗器械免疫毒理学试验原理和方法
Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
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
YY/T 1532-2017 医疗器械生物学评价纳米材料溶血试验
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
编辑：北检院编辑部
