11.100.20 标准查询与下载
共找到 320 条与 相关的标准，共 22 页
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 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 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 9. Framework for identification and quantification of potential degradation products
- 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 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 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 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 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 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 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 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 7. Ethylene oxide sterilization residuals
- ICS
- 11.100.20
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
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
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 무생육성이거나 무생육성으로 만들어진 동물 조직 또는 동물 조직에서 파생된 제품을
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
- ICS
- 11.100.20
- CCS
- C37
- 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 생체외 진단의료기기 외 동물 기원 물질을 사용하는 의료기기의 제조를 목적으로 동
Medical devices utilizing animal tissues and their derivatives－Part 2：Controls on sourcing, collection and handling
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2010-12-30
- 实施
- 2010-12-30
This Technical Report offers suggestions for designing and conducting validation assays to help determine if processes used in the manufacture of medical devices derived from non-viable animal tissues might serve to reduce the risk of iatrogenic transmission of transmissible spongiform encephalopathies (TSEs). The TSE-removal methods used to process animal tissues should also reduce the risk of transmitting TSE infections via non-viable tissues of human origin; this Technical Report does not address this issue. Some current information on human tissues and TSEs is presented which may be applied by analogy to other animal tissues. This Technical Report does not intend to imply a need for validation of methods involving specific materials identified as having a “negligible risk” of contamination with TSE agents as listed in Annex C of ISO 22442-1:2007. This Technical Report is intended to clarify final draft international standards included in the ISO 22442 series, as well as in ISO 14160. This Technical Report builds upon the specific discussion in ISO 22442-3 relative to TSE agents and attempts to summarize the current state of the art in the arena of TSE agent elimination. As the understanding of inactivation and elimination of TSE agents evolves, this document will be revised when possible.
Medical devices utilizing animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2010-12-01
- 实施
- 2010-12-01
