医疗器械（化学）检测

GB/T 16886.18-2022 医疗器械生物学评价 第18部分：风险管理过程中医疗器械材料的化学表征

Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process

KS P ISO 10993-18:2021 医疗器械的生物学评价.第18部分:风险管理过程中医疗器械材料的化学特性

Biological evaluation of medical devices —Part 18: Chemical characterization of medical device materials within a risk management process

BS EN 13727:2003 化学消毒剂和防腐剂.医疗器械用化学消毒剂杀菌活性评价的定量悬浮试验.试验方法和要求(第2阶段/第1步)

This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant products that form

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (Phase 2/Step 1)

NF T72-600:2013 化学消毒剂和抗菌剂.医疗器械用化学消毒剂的杀菌活性评价用定量悬浮试验.试验方法和要求(第2阶段,第1步)

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)

BS EN 13624:2013 化学消毒剂与防腐剂.医疗器械用化学消毒剂杀真菌能力评价用定量悬浮液试验.试验方法和要求(第2阶段第1步)

Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area. Test method and requirements (phase 2, step 1)

BS EN 13624:2021 化学消毒剂与防腐剂.医疗器械用化学消毒剂杀真菌能力评价用定量悬浮液试验.试验方法和要求(第2阶段第1步)

This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant products

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)

BS EN 13624:2003 化学消毒剂与防腐剂.医疗器械用化学消毒剂杀真菌能力评价用定量悬浮液试验.试验方法和要求(第2阶段第1步)

This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant products

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)

EN 13727:2003 化学消毒剂和防腐剂.医疗器械用化学消毒剂的杀菌作用评价用定量悬浮试验的试验方法和要求(第2阶段第1步骤)

Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area Test method and requirements (phase 2, step 1)

EN 13624:2003 化学消毒剂与防腐剂.医疗器械用化学消毒剂杀真菌能力评价用定量悬浮液试验的试验方法和要求(第2阶段第1步骤)

This European Standard specifies a test method andThe minimum requirements for fungicidal or yeasticidalactivity of chemical disinfectant products

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)

EN 13624:2013 化学消毒剂与防腐剂.医疗器械用化学消毒剂杀真菌能力评价用定量悬浮液试验的试验方法和要求(第2阶段第1步骤)

This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)

GOST R 52770-2016 医疗器械. 安全要求. 卫生化学和毒理学试验方法

Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests

DIN EN 13727:2012 化学消毒剂和防腐剂.医疗器械用化学消毒剂的杀菌作用评价用定量悬浮试验.试验方法和要求(第2阶段第1步).德文版本EN 13727-2012

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1); German version EN 13727:2012

YY 0970-2023 医疗保健产品灭菌 一次性使用动物源性医疗器械的液体化学灭菌剂 医疗器械灭菌过程的特征、开发、确认和常规控制的要求

本文件规定了对全部或部分来源于动物材料的一次性使用医疗器械进行灭菌的液体化学灭菌剂的特征，以及灭菌开发、确认、过程控制和监控的要求。本文件适用于液体化学灭菌过程中细菌和真菌污染的风险控制，与其它微生物相关的风险可使用其他方法进行评估。本文件不适用于：人体来源的材料；病毒和传染性海绵状脑病（TSE）灭

YY/T 0734.5-2020 清洗消毒器 第5部分：对不耐高温的非介入式医疗器械进行化学消毒的清洗消毒器 要求和试验

DIN EN 13727:2014 化学消毒剂和防腐剂.医疗器械用化学消毒剂的杀菌作用评价用定量悬浮试验.试验方法和要求(第2阶段第1步).德文版本EN 13727-2012+A1-2013

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1); German version EN 13727:2012+A1:2013

GB/T 16886.18-2022 医疗器械生物学评价 第18部分：风险管理过程中医疗器械材料的化学表征

Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process

KS P ISO 10993-18:2021 医疗器械的生物学评价.第18部分:风险管理过程中医疗器械材料的化学特性

Biological evaluation of medical devices —Part 18: Chemical characterization of medical device materials within a risk management process

BS EN 13727:2003 化学消毒剂和防腐剂.医疗器械用化学消毒剂杀菌活性评价的定量悬浮试验.试验方法和要求(第2阶段/第1步)

This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant products that form

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (Phase 2/Step 1)

NF T72-600:2013 化学消毒剂和抗菌剂.医疗器械用化学消毒剂的杀菌活性评价用定量悬浮试验.试验方法和要求(第2阶段,第1步)

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)

BS EN 13624:2013 化学消毒剂与防腐剂.医疗器械用化学消毒剂杀真菌能力评价用定量悬浮液试验.试验方法和要求(第2阶段第1步)

Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area. Test method and requirements (phase 2, step 1)

BS EN 13624:2021 化学消毒剂与防腐剂.医疗器械用化学消毒剂杀真菌能力评价用定量悬浮液试验.试验方法和要求(第2阶段第1步)

This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant products

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)

BS EN 13624:2003 化学消毒剂与防腐剂.医疗器械用化学消毒剂杀真菌能力评价用定量悬浮液试验.试验方法和要求(第2阶段第1步)

This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant products

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)

EN 13727:2003 化学消毒剂和防腐剂.医疗器械用化学消毒剂的杀菌作用评价用定量悬浮试验的试验方法和要求(第2阶段第1步骤)

Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area Test method and requirements (phase 2, step 1)

EN 13624:2003 化学消毒剂与防腐剂.医疗器械用化学消毒剂杀真菌能力评价用定量悬浮液试验的试验方法和要求(第2阶段第1步骤)

This European Standard specifies a test method andThe minimum requirements for fungicidal or yeasticidalactivity of chemical disinfectant products

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)

EN 13624:2013 化学消毒剂与防腐剂.医疗器械用化学消毒剂杀真菌能力评价用定量悬浮液试验的试验方法和要求(第2阶段第1步骤)

This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)

GOST R 52770-2016 医疗器械. 安全要求. 卫生化学和毒理学试验方法

Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests

DIN EN 13727:2012 化学消毒剂和防腐剂.医疗器械用化学消毒剂的杀菌作用评价用定量悬浮试验.试验方法和要求(第2阶段第1步).德文版本EN 13727-2012

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1); German version EN 13727:2012

YY 0970-2023 医疗保健产品灭菌 一次性使用动物源性医疗器械的液体化学灭菌剂 医疗器械灭菌过程的特征、开发、确认和常规控制的要求

本文件规定了对全部或部分来源于动物材料的一次性使用医疗器械进行灭菌的液体化学灭菌剂的特征，以及灭菌开发、确认、过程控制和监控的要求。本文件适用于液体化学灭菌过程中细菌和真菌污染的风险控制，与其它微生物相关的风险可使用其他方法进行评估。本文件不适用于：人体来源的材料；病毒和传染性海绵状脑病（TSE）灭

YY/T 0734.5-2020 清洗消毒器 第5部分：对不耐高温的非介入式医疗器械进行化学消毒的清洗消毒器 要求和试验

DIN EN 13727:2014 化学消毒剂和防腐剂.医疗器械用化学消毒剂的杀菌作用评价用定量悬浮试验.试验方法和要求(第2阶段第1步).德文版本EN 13727-2012+A1-2013

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1); German version EN 13727:2012+A1:2013