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표준
판매
ISO 10993-13:2010
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices- 발행일 : 2010-06-04
- 발행기관 : ISO
상세정보
분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
---|---|
적용범위 | ISO 10993‑13:2010 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. ISO 10993‑13:2010 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. ISO 10993‑13:2010 considers only non-resorbable polymers. Similar, but appropriately modified procedures may be applicable for resorbable polymers. ISO 10993‑13:2010 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins and cellular activity. |
국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
페이지수 | 14 |
Edition | 2 |
이력정보
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
1 | ISO 10993-13:2010상세보기 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices | 2010-06-04 | 표준 |
2 | ISO 10993-13:1998상세보기 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices | 1998-11-19 | 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/DIS 10993-6 - Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
- 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
다른 사람이 함께 구입한 상품
- ISO 10993-16:2017 - Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
- ISO 10993-11:2017 - Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
- ISO 10993-9:2019 - Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
- ISO 10993-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
- ISO 10993-14:2001 - Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
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