| 标准号： |
ISO 10993-11-2017 |
| 英文名称： |
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
| 中标分类： |
医药卫生劳动保护>>医疗器械综合 |
| 发布日期： |
2017-0901 |
| 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： |
29P.;A4 |
| 附注： |
History:ISO 10993-11-2017-09;ISO/FDIS 10993-11-2017-05;ISO/DIS 10993-11-2015-11;ISO 10993-11-2006-08;ISO/FDIS 10993-11-2006-05;ISO/DIS 10993-11-2004-12;ISO 10993-11-1993-12;ISO/DIS 10993-11-1992-03 |
| 被代替标准： |
ISO 10993-11-2006;ISO/FDIS 10993-11-2017 |
| 引用标准： |
ASTM F 619-2003;ISO 10993;ISO 10993-1-2009;ISO 10993-2-2006 |
| 内容提要（EN）： |
Abbreviated description;Animal husbandry;Bioassay;Biological;Biological analysis and testing;Biological hazards;Biological tests;Cloth;Conditions;Definitions;Dental equipment;Dental materials;Design;Determination;Dosage;Dose;Evaluations;Extraction;Health protection;Implants (surgical);Information;Inhalation;Limits (mathematics);Measurement;Measuring techniques;Medical devices;Medical equipment;Medical products;Methods;Methods of analysis;Preparation;Production;Quality assurance;Quality assurance systems;Recommendation;Residual content;Residue;Residues;Samples;Selection;Specification (approval);Specimen preparation;Status;Sterilization (hygiene);Surgical equipment;Surgical implants;Testing;Toxicity;Validation;Processes;Procedures;Presentations;Substances;Requirements;Fabrics;Sample preparation;Materials |
| 归属： |
国际 |
