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 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 0127.5-2014

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 0127.13-2018

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 10993-7-2016

Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 7. Остаточное содержание этиленоксида после стерилизации
医疗设备 医疗器械生物学评价 环氧乙烷灭菌残留物

2016-10-25

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

KS P ISO 10993-7

의료기기의 생물학적 평가－제7부：에틸렌 옥사이드 멸균 잔류물
医疗器械生物学评价第7部分:环氧乙烷灭菌残留物

2017-12-29

现行

GB/T 16886.7-2015

医疗器械生物学评价　第7部分：环氧乙烷灭菌残留量
Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

2015-12-10

现行

KS P ISO 10993-7

의료기기의 생물학적 평가 — 제7부: 에틸렌 옥사이드 멸균 잔류물
医疗器械的生物学评价第7部分:环氧乙烷灭菌残留物

2022-12-28

现行

ISO 10993-7-2008

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
医疗器械的生物学评价第7部分:环氧乙烷灭菌残留物

2008-10-13

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

UNE-EN ISO 10993-7-2009

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
医疗器械的生物学评价.第7部分:环氧乙烷灭菌残留物（ISO 10993-7-2008）

2009-06-03

现行

UNE-EN ISO 10993-7-1996

BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 7: ETHYLENE OXIDE STERILIZATIONN RESIDUALS. (ISO 10993-7:1995).
医疗器械的生物学评价 第7部分:环氧乙烷灭菌残留物 （ISO 10993-7-1995）

1996-05-23

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

AAMI/ISO 10993-7-2008/(R)2012

Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, includes Errata (2010)
医疗器械的生物学评价.第7部分:环氧乙烷灭菌残留物 包括勘误表（2010）

2007-12-10

现行

ISO 10993-7-2008/Amd 1-2019

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
新生儿和婴儿允许限值的适用性

2019-12-09