China National Standards

China Biological Evaluation Industry Standards English PDF List


  •  China "Biological Evaluation" Industry Standards English PDF List:
  • 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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    English PDF
    RB/T 037-2020 Guidelines for the Evaluation of Equivalence of Standard Methods for Microbiological Testing of Foods {译}
    食品微生物检测标准方法等效性评估指南
    China Certification and Accreditation Industry Standards
    Biological Evaluation

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    English PDF
    YY 0719.7-2011 Ophthalmic optics. Contact lens care products. Part 7: Biological Evaluation test methods
    眼科光学 接触镜和接触镜护理产品 第7部分:生物学评价试验方法
    China Medicine & Medical Device Standards
    Biological Evaluation

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    English PDF
    YY/T 0127.8-2001 Biological Evaluation of dental materials. Part 2: Biological evaluation test method of dental materials. Subcutaneous implant test
    口腔材料生物学评价 第二单:口腔材料生物试验方法——皮下植入试验
    China Medicine & Medical Device Standards
    Biological Evaluation

    English PDF
    YY/T 0127.6-1999 Biological Evaluation of dental materials. Unit 2:Biological test methods of dental materials. Dominant lethal test
    口腔材料生物学评价 第2单:口腔材料生物试验方法 显性致死试验
    China Medicine & Medical Device Standards
    Biological Evaluation

    English PDF

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