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

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 0127.18-2016

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 10993-13-2016

Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 13. Идентификация и количественное определение продуктов деструкции полимерных медицинских изделий
医疗设备 医疗器械生物学评价 第13部分从聚合物医疗器械中鉴定和定量降解产物

2016-10-25

现行

GB/T 16886.13-2017

医疗器械生物学评价　第13部分：聚合物医疗器械降解产物的定性与定量
Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

2017-12-29

现行

KS P ISO 10993-13(2023 Confirm)

의료기기의 생물학적 평가 — 제13부: 고분자성 의료기기에서 나온 분해 산물의 확인 및 정량화
医疗器械生物学评价第13部分:聚合物医疗器械降解产物的鉴定和定量

2018-08-22

现行

KS P ISO 10993-13

의료기기의 생물학적 평가 — 제13부: 고분자성 의료기기에서 나온 분해 산물의 확인 및 정량화
医疗器械的生物学评估 - 第13部分:聚合物医疗器械降解产品的鉴定和定量

2018-08-22

现行

ISO 10993-13-2010

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
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鉴定和定量

2010-06-04

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

UNE-EN ISO 10993-13-2010

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
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和量化（ISO 10993-13-2010）

2010-11-17

现行

AAMI/ISO 10993-13-2010/(R)2019

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric devices
医疗器械的生物学评价.第13部分:聚合物器械降解产物的识别和量化

2010-10-08

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