标准号: |
ISO/TR 15499-2016 |
英文名称: |
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process |
中标分类: |
医药卫生劳动保护>>医疗设备通用要求 |
发布日期: |
2016-1201 |
发布单位: |
IX-ISO |
标准状态: |
请与本站工作人员进行确认 |
ICS分类: |
0>>0 |
起草单位/标准公告: |
ISO/TC 194 Biologische Beurteilung von Medizinprodukten;ISO/TC 194 Biological evaluation of medical devices;ISO/TC 194 évaluation biologique des dispositifs médicaux |
正文语言: |
英语 |
页数: |
15P.;A4 |
附注: |
History:ISO/TR 15499-2016-12;ISO/TR 15499-2012-07 |
被代替标准: |
ISO/TR 15499-2012 |
引用标准: |
ISO 10993-1-2009;ISO 10993-7-2008;ISO 10993-9-2009;ISO 10993-11-2006;ISO 10993-12-2012;ISO 10993-13-2010;ISO 10993-14-2001;ISO 10993-15-2000;ISO 10993-16-2010;ISO 10993-17-2002;ISO 10993-18-2005;ISO/TS 10993-19-2006;ISO 13485-2016;ISO 14971-2007;ISO/IEC 17025-2005 |
采用关系: |
PD ISO/TR 15499-2017,IDT;DS/ISO/TR 15499-2017,IDT;NPR-ISO/TR 15499-2017 en-2017,IDT |
内容提要(EN): |
Bioassay;Biocompatibility;Biological;Biological analysis and testing;Biological hazards;Biological tests;Categories;Classification;Compatibility;Definitions;Evaluations;Fine mechanics;Fitness for purpose;Human body;Implants (surgical);Medical devices;Medical equipment;Medical products;Medical sciences;Medical technology;Principles;Risk management;Selection;Surgical equipment;Testing;Use;Mission;Inserts |
归属: |
国际 |