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ISO/TS 10993-19:2020
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials- 발행일 : 2020-03-12
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
|---|---|
| 적용범위 | This document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. physico‑chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device's intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness. This document does neither address the identification or quantification of degradation products nor the evaluation of the physico-chemical properties of the degraded materials, which are covered in ISO 10993‑9, ISO 10993‑13, ISO 10993‑14 and ISO 10993‑15. Chemical characterization of materials is covered by ISO 10993‑18. The ISO 10993 series is not applicable when the material or device is not in contact with the body directly or indirectly. |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 13 |
| Edition | 2 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO/TS 10993-19:2020상세보기 | Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials | 2020-03-12 | 표준 |
| 2 | ISO/TS 10993-19:2006상세보기 | Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials | 2006-05-19 | 구판 |
관련상품
- ISO/DIS 10993-18 - Biological evaluation of medical devices — Part 18: Chemical characterization of materials
- ISO/DIS 10993-6 - Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
- ISO 10993-12:2002/DAmd 1 - Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1
- ISO/FDIS 10993-6 - Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
- ISO/FDIS 10993-1 - Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
다른 사람이 함께 구입한 상품
- ISO 10993-18:2020 - Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
- ISO 10993-9:2019 - Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
- ISO 10993-12:2021 - Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
- ISO 10993-16:2017 - Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
- ISO 10993-15:2019 - Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
추천 상품
- IEC TS 63134:2020 - Active assisted living (AAL) use cases
- 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
- KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs)
- KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs)
- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
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