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| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| YY/T 1292.2—2015 |
Reproductive and Developmental Toxicity Tests for Medical Devices Part 2: Embryo Developmental Toxicity Tests {译} 医疗器械生殖和发育毒性试验 第2部分:胚胎发育毒性试验 |
China Pharmaceutics Industry
Standards Development medical |
 English PDF |
| YY/T 1292.1—2015 |
Reproductive and Developmental Toxicity Tests for Medical Devices Part 1: Screening Tests {译} 医疗器械生殖和发育毒性试验 第1部分：筛选试验 |
China Pharmaceutics Industry
Standards Development medical |
English PDF |
| YY/T 0466.2—2015 |
Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 2: Development, selection and validation of symbols {译} 医疗器械 用于医疗器械标签、标记和提供信息的符号 第2部分：符号的制订、选择和确认 |
China Pharmaceutics Industry
Standards Development medical |
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 Development medical |
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 Development medical |
English PDF |
| YY/T 9706.110-2021 |
Medical Electrical Equipment Part 1-10: General Requirements for Basic Safety and Essential Performance Collateral Standard: Requirements for the Development of Physiological Closed-Loop Controllers {译} 医用电气设备 第1-10部分：基本安全和基本性能的通用要求 并列标准：生理闭环控制器开发要求 |
China Pharmaceutics Industry
Standards Development medical |
English PDF |
| YY/T 1276-2016 |
(Development of medical devices dry heat sterilization process, validation and routine control) 医疗器械干热灭菌过程的开发、确认和常规控制要求 |
China Medicine & Medical Device
Standards Development medical |
English PDF |
| YY/T 1464-2016 |
(Development of medical devices - Low temperature steam sterilization formaldehyde sterilization process, validation and routine control) 医疗器械灭菌低温蒸汽甲醛灭菌过程的开发、确认和常规控制要求 |
China Medicine & Medical Device
Standards Development medical |
English PDF |
| YY/T 1292.3-2016 |
(Reproductive and developmental toxicity of medical devices - Part 3: generation reproductive toxicity study) 医疗器械生殖和发育毒性试验 第3部分：一代生殖毒性试验 |
China Medicine & Medical Device
Standards Development medical |
English PDF |
| YY/T 0466.2-2015 |
Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 2: Symbol development, selection and validation 医疗器械 用于医疗器械标签、标记和提供信息的符号 第2部分：符号的制订、选择和确认 |
China Medicine & Medical Device
Standards Development medical |
English PDF |
| YY/T 1292.2-2015 |
Test for reproductive and developmental toxicity of medical devices. Part 2:Prenatal developmental toxicity test 医疗器械生殖和发育毒性试验 第2部分:胚胎发育毒性试验 |
China Medicine & Medical Device
Standards Development medical |
English PDF |
| YY/T 1292.1-2015 |
Test for reproductive and developmental toxicity of medical devices. Part 1:Screening test 医疗器械生殖和发育毒性试验 第1部分：筛选试验 |
China Medicine & Medical Device
Standards Development medical |
English PDF |
| YY/T 1000.2-2005 |
Development of medical devices industrial standards. Part 2: Guidance for work 医疗器械行业标准的制定 第2部分：工作指南 |
China Medicine & Medical Device
Standards Development medical |
English PDF |
| YY/T 1000.1-2005 |
Development of medical devices industrial standards. Part 1: Stage division, code and procedure 医疗器械行业标准的制定第1部分：阶段划分、代码和程序 |
China Medicine & Medical Device
Standards Development medical |
English PDF |
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