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 0127.11-2014

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

YY/T 0127.4-2023

口腔医疗器械生物学评价　第4部分：骨植入试验
Biological evaluation of medical devices used in dentistry—Part 4:Bone implant test

2023-11-22

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

KS P ISO 10993-18(2019 Confirm)

의료기기의 생물학적 평가－제18부：재료의 화학적 특성화
医疗器械生物学评价第18部分:材料的化学特性

2009-12-29

现行

AAMI BE83-2006/(R)2011

Biological evaluation of medical devices - Part 18: Chemical characterization of materials
医疗器械的生物学评价.第18部分:材料的化学特性

2006-03-21

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

UNE-EN ISO 10993-18-2009

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
医疗器械的生物学评价.第18部分:材料的化学特性（ISO 10993-18-2005）

2009-09-09

现行

YY/T 0127.19-2023

口腔医疗器械生物学评价　第19部分：亚急性和亚慢性全身毒性试验：植入途径
Biological evaluation of medical devices used in dentistry—Part 19:Subacute and subchronic systemic toxicity test:implant route

2023-11-22

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 16886.18-2022

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

2022-12-30

现行

KS P ISO 10993-18

의료기기의 생물학적 평가 —제18부: 위험 관리 과정에서의 의료기기 원자재의 화학적 특성화
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

2021-12-28

现行

ISO 10993-18-2020

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

2020-01-13

现行

YY/T 0127.17-2014

口腔医疗器械生物学评价　第17部分：小鼠淋巴瘤细胞(TK)基因突变试验
Biological evaluation of medical devices used in dentistry—Part 17:Mouse lymphoma cells(TK)gene mutation test

2014-06-17

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

ISO 10993-18-2020/Amd 1-2022

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process — Amendment 1: Determination of the uncertainty factor
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.修改件1:不确定因素的测定

2022-05-11