现行

YY/T 0268-2008

牙科学　口腔医疗器械生物学评价　第1单元：评价与试验
Dentistry—Biological evaluation of medical devices used in dentistry—Part 1:Evaluation and test

2008-04-25

现行

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
Dentistry—Biological evaluation of medical devices used in dentistry Part 2:Test method—Micronucleus test

2008-04-25

现行

YY/T 0127.3-2014

口腔医疗器械生物学评价　第3部分：根管内应用试验
Biological evaluation of medical devices used in dentistry—Part 3:Endodontic usage test

2014-06-17

现行

YY/T 0127.11-2014

口腔医疗器械生物学评价　第11部分：盖髓试验
Biological evaluation of medical devices used in dentistry—Part 11:Pulp capping test

2014-06-17

现行

YY/T 0127.5-2014

口腔医疗器械生物学评价　第5部分：吸入毒性试验
Biological evaluation of medical devices used in dentistry—Part 5:Inhalation toxicity test

2014-06-17

现行

ISO 10993-17-2023

Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
医疗器械生物学评价第17部分:医疗器械成分的毒理学风险评估

2023-09-13

现行

YY/T 0127.7-2017

口腔医疗器械生物学评价　第7部分：牙髓牙本质应用试验
Biological evaluation of medical devices used in dentistry—Part 7:Pulp and dentine usage test

2017-03-28

现行

YY/T 0127.13-2018

口腔医疗器械生物学评价　第13部分：口腔黏膜刺激试验
Biological evaluation of medical devices used in dentistry—Part 13:Oral mucous irritation test

2018-04-11

现行

YY/T 0127.18-2016

口腔医疗器械生物学评价　第18部分：牙本质屏障细胞毒性试验
Biological evaluation of medical devices used in dentistry－Part 18:Dentine barrier cytotoxicity test

2016-01-26

现行

GOST ISO 10993-17-2011

Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 17. Установление пороговых значений для вымываемых веществ
医疗设备 医疗器械生物学评价 第17部分建立可浸出物质的允许限度

2011-11-29

现行

YY/T 0127.14-2009

口腔医疗器械生物学评价　第2单元：试验方法　急性经口全身毒性试验
Biological evaluation of medical devices used in dentistry—Part 2:Test method—Acute oral toxicity test

2009-06-16

现行

YY/T 0127.15-2018

口腔医疗器械生物学评价　第15部分：亚急性和亚慢性全身毒性试验：经口途径
Biological evaluation of medical devices used in dentistry—Part 15:Subacute and subchronic systemic toxicity test:oral route

2018-04-11

现行

GB/T 16886.17-2005

医疗器械生物学评价　第17部分：可沥滤物允许限量的建立
Biological evaluation of medical devices—Part 17:Establishment of allowable limits for leachable substances

2005-11-04

现行

KS P ISO 10993-17

의료 기기의 생물학적 평가－제17부： 용출 물질에 대한 허용 기준의 설정
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

2017-12-29

现行

KS P ISO 10993-17(2022 Confirm)

의료 기기의 생물학적 평가－제17부： 용출 물질에 대한 허용 기준의 설정
医疗器械的生物评价.第17部分:可浸出物质允许限值的确定

2017-12-29

现行

AAMI/ISO 10993-17-2002/(R)2012

Biological evaluation of medical devices - Part 17: Methods for the establishment of allowable limits for leachable substances
医疗器械的生物学评价.第17部分:可浸出物质允许限值的确定方法

2008-12-03

现行

UNE-EN ISO 10993-17-2009

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
医疗器械的生物评定第17部分:可浸出物质允许限值的确定

2009-09-09

现行

YY/T 0127.10-2009

口腔医疗器械生物学评价　第2单元：试验方法　鼠伤寒沙门氏杆菌回复突变试验(Ames试验)
Biological evaluation of medical devices used in dentistry—Part 2:Test method—Salmonella typhimurium reverse mutation assay(Ames mutagenicity test)

2009-06-16

现行

DIN EN ISO 10993-17-DRAFT

Draft Document - Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/DIS 10993-17:2021); German and English version prEN ISO 10993-17:2021
文件草案医疗器械的生物学评价第17部分:医疗器械成分的毒理学风险评估；德文和英文版本prEN ISO 10993-17:2021

2021-12-01