11.100.20 标准查询与下载
共找到 323 条与 相关的标准，共 22 页
This International Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes. The principles set forth in this International Standard also apply to all other clinical investigations and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations. This International Standard specifies general requirements intended to ⎯ protect the rights, safety and well-being of human subjects, ⎯ ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, ⎯ define the responsibilities of the sponsor and principal investigator, and ⎯ assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. It does not apply to in vitro diagnostic medical devices. NOTE Standards developed by ISO/TC 194 are intended to be applied to medical devices. Users of this International Standard will need to consider whether other standards and/or requirements also apply to the investigational device(s) under consideration.
Clinical investigation of medical devices for human subjects - Good clinical practice
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2011-02-01
- 实施
- 2011-02-01
Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
이 표준은 개별적 EO 멸균 의료기기의 에틸렌 옥사이드(EO) 및 에틸렌 클로로히드린(EC
Biological evaluation of medical devices－Part 7：Ethylene oxides sterilization residuals
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2010-12-30
- 实施
- 2010-12-30
이 표준은 무생육성 또는 무생육적으로 만들어졌으며 동물에 기원을 둔 물질을 이용해 제조된
Medical devices utilizing animal tissues and their derivatives-Part 1:Application of risk management
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2010-12-30
- 实施
- 2010-12-30
이 표준은 실험을 의뢰, 설계, 시행하는 사람들, 혹은 의료기기 재료 또는 의료기기 자체의
Biological evaluation of medical devices-Part 2:Animal welfare requirements
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2010-12-30
- 实施
- 2010-12-30
