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Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
| 분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
|---|---|
| 적용범위 | ISO 10993-6:2016 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. ISO 10993-6:2016 applies to materials that are - solid and non-absorbable, - non-solid, such as porous materials, liquids, gels, pastes, and particulates, and - degradable and/or absorbable, which may be solid or non-solid. The test sample is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical or functional loading. This part of ISO 10993 can also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining might have been breached, in order to evaluate local tissue responses. The local effects are evaluated by a comparison of the tissue response caused by a test sample to that caused by control materials used in medical devices whose clinical acceptability and biocompatibility characteristics have been established. The objective of the test methods is to characterize the history and evolution of the tissue response after implantation of a medical device/biomaterial including final integration or absorption/degradation of the material. In particular for degradable/absorbable materials, the degradation characteristics of the material and the resulting tissue response should be determined. ISO 10993-6:2016 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects might provide insight into some of these properties. Systemic toxicity studies conducted by implantation might satisfy the requirements of this part of ISO 10993. When conducting combined studies for evaluating local effects and systemic effects, the requirements of both standards is to be fulfilled. |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 29 |
| Edition | 3 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 10993-6:2016 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation | 2016-11-28 | 표준 |
| 2 | ISO 10993-6:2007 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation | 2007-04-04 | 구판 |
| 3 | ISO 10993-6:1994 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation | 1994-07-07 | 구판 |
| 4 | ISO/DIS 10993-6 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation | 초안 |
ISO/DIS 10993-6 - Biological evaluation of medical devices — Part 6: Tests for local effects after implantation 상세보기
ISO/DIS 10993-1 - Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process 상세보기
ISO/DIS 10993-7 - Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals 상세보기
ISO/DIS 10993-2 - Biological evaluation of medical devices — Part 2: Animal welfare requirements 상세보기
ISO 10993-4:2017/PRF Amd 1 - Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1 상세보기
ISO 10993-3:2014 - Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity 상세보기
ISO 10993-5:2009 - Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity 상세보기
ISO 10993-11:2017 - Biological evaluation of medical devices — Part 11: Tests for systemic toxicity 상세보기
ISO 10993-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process 상세보기
ISO 10993-4:2017 - Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
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