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 utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2015-12-31
- 实施
- 2015-12-31
Scope is not provided for this standard
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
- ICS
- 11.100.20
- CCS
- 发布
- 2015-12-21
- 实施
Scope is not provided for this standard
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ICS
- 11.100.20
- CCS
- 发布
- 2015-12-21
- 实施
Scope is not provided for this standard
Clinical investigation of medical devices for human subjects -- Good clinical practice
- ICS
- 11.100.20
- CCS
- 发布
- 2015-12-21
- 实施
Scope is not provided for this standard
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
- ICS
- 11.100.20
- CCS
- 发布
- 2015-12-21
- 实施
Scope is not provided for this standard
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
- ICS
- 11.100.20
- CCS
- 发布
- 2015-12-21
- 实施
Scope is not provided for this standard
Biological evaluation of medical devices -- Part 2: Animal welfare requirements
- ICS
- 11.100.20
- CCS
- 发布
- 2015-12-21
- 实施
Scope is not provided for this standard
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ICS
- 11.100.20
- CCS
- 发布
- 2015-12-21
- 实施
Scope is not provided for this standard
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
- ICS
- 11.100.20
- CCS
- 发布
- 2015-12-21
- 实施
为帮助确定无活力动物组织来源的医疗器械的加工过程是否有助于减少传播性海绵状脑病(TSEs)的医源性传播的风险,本部分为设计和开展确认分析提供建议。加工动物组织所使用的TSE去除方法也宜减少通过人源性无活力组织传播TSE感染的风险;本部分不涉及这一方面。一些关于人体组织和TSEs的当前信息可通过类推适用于其他动物组织。本部分不预期为ISO 22442-1:2007的附录C中所列出的已识别出的具有TSE因子污染的“可忽略风险”的特定材料提供方法的确认要求。本部分预期用于解释ISO 22442系列中最终国际标准草案以及ISO 14160标准。本部分是建立在对ISO 22442-3中与TSE因子相关的特定讨论的基础之上并努力总结TSE因子去除领域内当前最新技术水平。随着对TSE因子的灭活和去除的深入理解,可行时将会对本文件进行修订。
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
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2015-03-02
- 实施
- 2016-01-01
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2015-02
- 实施
Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
- ICS
- 11.100.20
- CCS
- 发布
- 2015
- 实施
- 2016-06-01
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
- 2015
- 实施
- 2016-06-01
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
- ICS
- 11.100.20
- CCS
- 发布
- 2014-12-01
- 实施
- 2014-12-01
Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2014-10-31
- 实施
- 2014-10-31
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2014-10-01
- 实施
Dieser Teil der ISO 10993 legt spezifische Strategien fur die Risikoabschatzung, die Auswahl der Prufverfahren zur Gefahrenerkennung und das Risikomanagement fest, unter Berucksichtigung der Moglichkeit, der nachfolgenden, potenziellen irreversiblen biologischen Effekte, die als Ergebnis der Exposition durch Medizinprodukte auftreten konnen: Genotoxizitat; Karzinogenitat; Reproduktions- und Entwicklungstoxizitat. Dieser Teil der ISO 10993 ist anwendbar, sobald die Notwendigkeit festgestellt wurde, ein Medizinprodukt auf potenzielle Genotoxizitat, Karzinogenitat oder Reproduktionstoxizitat zu untersuchen. ANMERKUNG Eine Anleitung zur Auswahl der Prufungen ist in ISO 10993-1 enthalten.
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2014-10
- 实施
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: — genotoxicity; — carcinogenicity; — reproductive and developmental toxicity. This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established. NOTE Guidance on selection of tests is provided in ISO 10993-1.
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2014-10
- 实施
BS ISO 16782. Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
- ICS
- 11.100.20
- CCS
- 发布
- 2014-06-26
- 实施
- 2014-06-26
Biological evaluation of medical devices. Tests for irritation and skin sensitization
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2014-02-28
- 实施
- 2014-02-28
