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| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| YY/T 1914-2023 |
Medical devices for human assisted reproductive technology - General requirements for device products {译} 人类辅助生殖技术用医疗器械 器具类产品通用要求 |
China Pharmaceutics Industry
Standards Medical Products |
 English PDF |
| YY 0970-2023 |
Sterilization of healthcare products - Liquid chemical sterilants for single-use medical devices of animal origin - Requirements for the characterization, development, validation and routine control of medical device sterilization processes {译} 医疗保健产品灭菌 一次性使用动物源性医疗器械的液体化学灭菌剂 医疗器械灭菌过程的特征、开发、确认和常规控制的要求 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 1876-2023 |
Tissue-engineered Medical Products-Determination of DNA residues in biological materials of animal origin: fluorescent staining {译} 组织工程医疗产品 动物源性生物材料DNA残留量测定法：荧光染色法 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 0606.15-2023 |
Tissue-engineered Medical Products-Test method for evaluating the immune response of matrices and scaffolds: Lymphocyte proliferation assay {译} 组织工程医疗产品 评价基质及支架免疫反应的试验方法：淋巴细胞增殖试验 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 1810-2022 |
Tissue-engineered Medical Products Quantitative detection of sulfated glycosaminoglycans (sGAG) for evaluation of cartilage formation {译} 组织工程医疗产品 用以评价软骨形成的硫酸糖胺聚糖(sGAG)的定量检测 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 1464-2022 |
Sterilization of healthcare products - Low temperature steam formaldehyde - Requirements for the development, validation and routine control of medical device sterilization processes {译} 医疗保健产品灭菌 低温蒸汽甲醛 医疗器械灭菌过程的开发、确认和常规控制要求 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 1805.3-2022 |
Tissue engineering medical device products - Collagen - Part 3: Detection of collagen content based on the determination of characteristic peptides - Liquid chromatography-mass spectrometry{译} {译} 组织工程医疗器械产品 胶原蛋白 第3部分：基于特征多肽测定的胶原蛋白含量检测——液相色谱-质谱法 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 1805.2-2021 |
Tissue Engineering Medical Device Products-Collagen Part 2: Molecular Weight Detection of Type I Collagen-Sodium Lauryl Sulfate Polyacrylamide Gel Electrophoresis {译} 组织工程医疗器械产品 胶原蛋白 第2部分：I型胶原蛋白分子量检测-十二烷基硫酸钠聚丙烯酰胺凝胶电泳法 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 1802-2021 |
Additively manufactured Medical Products - Evaluation method for metal ion precipitation of 3D printed titanium alloy implants {译} 增材制造医疗产品 3D打印钛合金植入物金属离子析出评价方法 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 1679-2021 |
Tissue-engineered medical device products Bone-In vivo guidelines for the preclinical evaluation of bone defects of critical size {译} 组织工程医疗器械产品 骨 体内临界尺寸骨缺损的临床前评价指南 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 1744-2020 |
Tissue engineered medical device products Bioactive ceramics Measurement method of cell migration in porous materials {译} 组织工程医疗器械产品 生物活性陶瓷 多孔材料中细胞迁移的测量方法 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 1716-2020 |
Tissue engineered medical device products Characterization of ceramic and mineral scaffolds {译} 组织工程医疗器械产品 陶瓷和矿物质支架的表征 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 1699-2020 |
Tissue Engineering Medical Device Products Chitosan {译} 组织工程医疗器械产品 壳聚糖 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 0878.3—2019 |
Complement activation test for medical devices Part 3: Determination of complement activation products (C3a and SC5b-9) {译} 医疗器械补体激活试验 第3部分：补体激活产物（C3a和SC5b-9）的测定 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 1654—2019 |
Tissue Engineering Medical Device Products Sodium Alginate {译} 组织工程医疗器械产品 海藻酸钠 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 1649.2-2019 |
Medical device and platelet interaction test Part 2: Determination of platelet activation products (β-TG, PF4 and TxB2) in vitro {译} 医疗器械与血小板相互作用试验 第2部分：体外血小板激活产物（β-TG、PF4和TxB2）的测定 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 0606.20-2014 |
Tissue engineered Medical Products. Part 20:Standard practice for evaluation of immune responses of substrate and scaffold products:Cell migration tests 组织工程医疗产品 第20部分:评价基质及支架免疫反应的试验方法:细胞迁移试验 |
China Medicine & Medical Device
Standards Medical Products |
English PDF |
| YY/T 0606.15-2014 |
Tissue engineered Medical Products. Part 15: Standard practice for evaluation of immune responses of substrate and scaffolds products: Lymphocyte proliferation tests 组织工程医疗产品 第15部分:评价基质及支架免疫反应的实验方法--淋巴细胞增殖试验 |
China Medicine & Medical Device
Standards Medical Products |
English PDF |
| YY/T 0606.14-2014 |
Tissue engineered Medical Products. Part 14: Standard practice for evaluation of immune responses of substrate and scaffolds products: ELISA tests 组织工程医疗产品 第14部分:评价基质及支架免疫反应的实验方法--ELISA法 |
China Medicine & Medical Device
Standards Medical Products |
English PDF |
| YY/T 0313-2014 |
Medical polymer products. Requirement for package and information supplied by manufacturer 医用高分子产品 包装和制造商提供信息的要求 |
China Medicine & Medical Device
Standards Medical Products |
English PDF |
| YY/T 0606.25-2014 |
Tissue Engineering Medical Products Part 25: Determination of DNA Residues in Biological Materials of Animal Origin: Fluorescence Staining{译} {译} 组织工程医疗产品 第25部分：动物源性生物材料DNA残留量测定法：荧光染色法 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 0606.20-2014 |
Tissue Engineered Medical Products Part 20: Test Methods for Assessing Matrix and Scaffold Immune Response: Cell Migration Assays{译} {译} 组织工程医疗产品 第20部分： 评价基质及支架免疫反应的试验方法：细胞迁移试验 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 0606.15-2014 |
Tissue Engineered Medical Products Part 15: Test Methods for Evaluating the Immune Response of Matrix and Scaffolding: Lymphocyte Proliferation Test{译} {译} 组织工程医疗产品 第15部分：评价基质及支架免疫反应的试验方法：淋巴细胞增殖试验 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 0606.14-2014 |
Tissue-engineered Medical Products Part 14: Test methods for evaluating the immune response of matrices and scaffolds: ELISA method{译} {译} 组织工程医疗产品 第14部分：评价基质及支架免疫反应的试验方法：ELISA法 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 0313-2014 |
Medical polymer products - Requirements for packaging and manufacturer's information{译} {译} 医用高分子产品 包装和制造商提供信息的要求 |
China Pharmaceutics Industry
Standards Medical Products |
English PDF |
| YY/T 1119-2008 |
Terminology relating to medical polymer products 医用高分子制品术语 |
China Medicine & Medical Device
Standards Medical Products |
English PDF |
| YY/T 0606.8-2008 |
Tissue engineered Medical Products. Part 8: Alginate 组织工程医疗产品 第8部分：海藻酸钠 |
China Medicine & Medical Device
Standards Medical Products |
English PDF |
| YY/T 0606.7-2008 |
Tissue engineered Medical Products. Part 7: Chitosan 组织工程医疗产品 第7部分：壳聚糖 |
China Medicine & Medical Device
Standards Medical Products |
English PDF |
| YY/T 0606.9-2007 |
Tissue engineered Medical Products. Part 9: Sodium hyaluronate 组织工程医疗产品 第9部分：透明质酸钠 |
China Medicine & Medical Device
Standards Medical Products |
English PDF |
| YY/T 0606.5-2007 |
Tissue engineered Medical Products-Part 5: Characterization and testing of substrates and scaffolds 组织工程医疗产品 第5部分：基质及支架的性能和测试 |
China Medicine & Medical Device
Standards Medical Products |
English PDF |
| YY/T 0606.3-2007 |
Tissue engineered Medical Products. Part 3: General classification 组织工程医疗产品 第3部分：通用分类 |
China Medicine & Medical Device
Standards Medical Products |
English PDF |
| YY/T 0606.12-2007 |
Tissue engineered Medical Products. Part 12: Guide for processing cells, tissues, and organs 组织工程医疗产品 第12部分：细胞、组织、器官的加工处理指南 |
China Medicine & Medical Device
Standards Medical Products |
English PDF |
| YY/T 0507.2-2005 |
(Medical Products - Sterile Processing - Part 2: Filter) |
China Medicine & Medical Device
Standards Medical Products |
English PDF |
| YY/T 0507.1-2005 |
(Medical Products - Sterile Processing - Part 1: General requirements) |
China Medicine & Medical Device
Standards Medical Products |
English PDF |
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