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| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| YY/T 0771.3-2009 |
Medical devices of animal origin Part 3: Confirmation of removal and inactivation of viral and transmissible spongiform encephalopathy (TSE) agents {译} 动物源医疗器械 第3部分：病毒和传播性海绵状脑病（TSE）因子去除与灭活的确认 |
China Pharmaceutics Industry
Standards Medical devices animal |
 English PDF |
| YY/T 1754.3-2023 |
Preclinical Animal Studies of Medical Devices Part 3: Animal Model of Incisional Abdominal Hernia for Evaluation of Mesh Histological Response and Biomechanical Properties {译} 医疗器械临床前动物研究 第3部分：用于评价补片组织学反应与生物力学性能的动物腹壁切口疝模型 |
China Pharmaceutics Industry
Standards Medical devices animal |
English PDF |
| YY/T 0771.4—2015 |
Medical devices of animal origin - Part 4: Principles for the removal and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and their process validation analysis {译} 动物源医疗器械 第4部分：传播性海绵状脑病（TSE)因子的去除和/或灭活及其过程确认分析的原则 |
China Pharmaceutics Industry
Standards Medical devices animal |
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 devices animal |
English PDF |
| YY/T 1754.2-2020 |
Preclinical animal studies of medical devices Part 2: Rat skin defect model of induced diabetes {译} 医疗器械临床前动物研究 第2部分:诱导糖尿病大鼠皮肤缺损模型 |
China Pharmaceutics Industry
Standards Medical devices animal |
English PDF |
| YY/T 1754.1-2020 |
Preclinical animal research for medical devices Part 1: General requirements {译} 医疗器械临床前动物研究 第1部分：通用要求 |
China Pharmaceutics Industry
Standards Medical devices animal |
English PDF |
| YY/T 0771.2—2020 |
Medical Devices of Animal Origin Part 2: Control of Source, Collection and Disposal {译} 动物源医疗器械 第2部分：来源、收集与处置的控制 |
China Pharmaceutics Industry
Standards Medical devices animal |
English PDF |
| YY/T 0771.1—2020 |
Medical Devices of Animal Origin Part 1: Risk Management Applications {译} 动物源医疗器械 第1部分：风险管理应用 |
China Pharmaceutics Industry
Standards Medical devices animal |
English PDF |
| YY/T 1465.6—2019 |
Methods for evaluating the immunogenicity of medical devices - Part 6: Determination of animal spleen lymphocyte subsets by flow cytometry {译} 医疗器械免疫原性评价方法 第6部分：用流式细胞术测定动物脾脏淋巴细胞亚群 |
China Pharmaceutics Industry
Standards Medical devices animal |
English PDF |
| YY/T 0771.4-2015 |
Medical devices utilizing animal tissues and their derivatives. Part 4:Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes 动物源医疗器械 第4部分：传播性海绵状脑病（tse）因子的去除和/或灭活及其过程确认分析的原则 |
China Medicine & Medical Device
Standards Medical devices animal |
English PDF |
| YY 0970-2013 |
Sterilization of single- use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid sterilants 含动物源材料的一次性使用医疗器械的灭菌液体灭菌剂灭菌的确认与常规控制 |
China Medicine & Medical Device
Standards Medical devices animal |
English PDF |
| YY/T 0771.3-2009 |
Medical devices utilizing animal tissues and their derivatives. Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents 动物源医疗器械 第3部分：病毒和传播性海绵状脑病（tse）因子去除与灭活的确认 |
China Medicine & Medical Device
Standards Medical devices animal |
English PDF |
| YY/T 0771.2-2009 |
Medical devices utilizing animal tissues and their derivatives. Part 2: Controls on sourcing, collection and handling 动物源医疗器械 第2部分：来源、收集与处置的控制 |
China Medicine & Medical Device
Standards Medical devices animal |
English PDF |
| YY/T 0771.1-2009 |
Medical devices utilizing animal tissues and their derivatives. Part 1: Application of risk management 动物源医疗器械 第1部分 风险管理应用 |
China Medicine & Medical Device
Standards Medical devices animal |
English PDF |
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