Standard Code | Standard Title | Standard Class | Order |
---|---|---|---|
YY/T 0127.19—2023 |
Biological evaluation of oral medical devices Part 19: Subacute and subchronic systemic toxicity testing: Route of implantation {译} 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 |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.4—2023 |
Biological evaluation of oral medical devices Part 4: Bone implant test {译} 口腔医疗器械生物学评价 第4部分:骨植入试验 |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 1912-2023 |
Biological evaluation and testing of medical devices for soft tissue regeneration {译} 用于软组织再生医疗器械的生物学评价与试验 |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.16-2009 |
Biological Evaluation of Dental Medical Devices Unit 2: Test Methods Chromosomal Aberration Test of Mammalian Cells in Vitro {译} 口腔医疗器械生物学评价 第2单元:试验方法 哺乳动物细胞体外染色体畸变试验 |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.4-2009 |
Biological Evaluation of Dental Medical Devices Unit 2: Test Methods Bone Implant Test {译} 口腔医疗器械生物学评价 第2单元: 试验方法 骨埋植试验 |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.9-2009 |
Biological Evaluation of Dental Medical Devices Unit 2: Test Methods Cytotoxicity Test: Agar Diffusion Method and Membrane Diffusion Method {译} 口腔医疗器械生物学评价 第2单元:试验方法 细胞毒性试验:琼脂扩散法及滤膜扩散法 |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 1897-2023 |
Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test {译} 纳米医疗器械生物学评价 遗传毒性试验 体外哺乳动物细胞微核试验 |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 1295—2015 |
Biological Evaluation of Medical Devices Nanomaterials: Bacterial Endotoxin Test {译} 医疗器械生物学评价 纳米材料:细菌内毒素试验 |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 0993—2015 |
Biological Evaluation of Medical Devices Nanomaterials: In Vitro Cytotoxicity Tests (MTT Test and LDH Test) {译} 医疗器械生物学评价 纳米材料:体外细胞毒性试验(MTT试验和LDH试验) |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 1863-2023 |
Biological evaluation of nanomedical devices Release and characterization of nanosilver particles and silver ions from nanosilver-containing dressings {译} 纳米医疗器械生物学评价 含纳米银敷料中纳米银颗粒和银离子的释放与表征方法 |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 1815-2022 |
Biological Evaluation of Medical Devices Application of Toxicological Thresholds of Concern (TTC) to Assess the Biocompatibility of Medical Device Components {译} 医疗器械生物学评价 应用毒理学关注阈值(TTC)评定医疗器械组分的生物相容性 |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 1775.1-2021 |
Biological Evaluation of Absorbable Medical Devices Part 1: Guidelines for Absorbable Implants {译} 可吸收医疗器械生物学评价 第1部分:可吸收植入物指南 |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 0616.1-2016 |
(Disposable medical gloves - Part 1: Requirements and test biological evaluation) 一次性使用医用手套 第1部分:生物学评价要求与试验 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.18-2016 |
(Oral Biological evaluation of medical devices - Part 18: dentin barrier Cytotoxicity test) 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 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0993-2015 |
Biological evaluation of medical devices. Nanomaterial: In vitro cytotoxicity tests (MTT assay and LDH assay) 医疗器械生物学评价 纳米材料:体外细胞毒性试验(mtt试验和ldh试验 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 1295-2015 |
Biological evaluation of medical devices. Nanomaterial: Endotoxin test 医疗器械生物学评价 纳米材料:细菌内毒素试验 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.5-2014 |
Biological evaluation of medical devices used in dentistry. Part 5: Inhalation toxicity test 口腔医疗器械生物学评价 第5部分:吸入毒性试验 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.3-2014 |
Biological evaluation of medical devices used in dentistry-Part 3: Endodontic usage test 口腔医疗器械生物学评价 第3部分:根管内应用试验 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.17-2014 |
Biological evaluation of medical devices used in dentistry. Part 17: Mouse lymphoma cells (TK) gene mutation test 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 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.11-2014 |
Biological evaluation of medical devices used in dentistry. Part 11: Pulp capping test 口腔医疗器械生物学评价 第11部分:盖髓试验 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.17-2014 |
Biological Evaluation of Oral Medical Devices Part 17: Murine Lymphoma Cell (TK) Gene Mutation Test{译} {译} 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 |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.11-2014 |
Biological Evaluation of Oral Medical Devices Part 11: Pulp Capping Test{译} {译} 口腔医疗器械生物学评价 第11部分:盖髓试验 |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.5-2014 |
Biological Evaluation of Oral Medical Devices Part 5: Inhalation Toxicity Test{译} {译} 口腔医疗器械生物学评价 第5部分:吸入毒性试验 |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.3-2014 |
Biological Evaluation of Oral Medical Devices Part 3: Endodontic Application Test{译} {译} 口腔医疗器械生物学评价 第3部分:根管内应用试验 |
China Pharmaceutics Industry
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.9-2009 |
Biological evaluation of medical devices used in dentistry. Part 2: Test method. Cytotoxicity tests:Agar diffusion test and filter diffusion test 口腔医疗器械生物学评价 第2单元: 试验方法 细胞毒性试验:琼脂扩散法及滤膜扩散法 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.4-2009 |
Biological evaluation of medical devices used in dentistry - Part 2: Test method - Bone implant test 口腔医疗器械生物学评价 第2单元: 试验方法 骨埋植试验 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.16-2009 |
Biological evaluation of medical devices used in dentistry. Part 2: Test method. In Vitro mammalian chromosome aberration test 口腔医疗器械生物学评价 第2单元:试验方法 哺乳动物细胞体外染色体畸变试验 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.15-2009 |
Biological evaluation of medical devices used in dentistry. Part 2: Test method. Subacute and subchronic systemic toxicity test:oral route 口腔医疗器械生物学评价 第2单元:试验方法 亚急性和亚慢性全身毒性试验:经口途径 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.2-2009 |
Biological evaluation of medical devices used in dentistry. Part 2: Test method. Acute systemic toxicity:intravenous path 口腔医疗器械生物学评价 第2单元:试验方法 急性全身毒性试验:静脉途径 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.10-2009 |
Biological evaluation of medical devices used in dentistry. Part 2: Test method. Salmonella typhimurium reverse mutation assay (Ames mutagenicity test) 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) |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.14-2009 |
Biological evaluation of medical devices used in dentistry. Part 2: Test method. Acute oral toxicity test 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 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.13-2009 |
Biological evaluation of medical devices used in dentistry. Part 2: Tset method. Oral mucous membrane irritation test 口腔医疗器械生物学评价 第2单元:试验方法 口腔粘膜刺激试验 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0268-2008 |
Dentistry. Biological evaluation of medical devices used in dentistry. Part 1: Evaluation and test 牙科学 口腔医疗器械生物学评价 第1单元:评价与试验 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0127.12-2008 |
Dentistry. Biological evaluation of medical devices used in dentistry. Part 2: Test method. Micronucleus test 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 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
YY/T 0616-2007 |
Medical gloves for single use. Requirements and testing for biological evaluation 一次性使用医用手套生物学评价要求与试验 |
China Medicine & Medical Device
Standards Biological Evaluation Medical |
English PDF |
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