관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
PDF : 직접 파일 다운로드 및 인쇄 (마이페이지 확인)
PRINT : 인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)
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 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
1 | ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices | 2010-06-04 | 표준 |
2 | ISO 10993-13:1998 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices | 1998-11-19 | 구판 |
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 10993-4:2017/DAmd 1 - Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1 상세보기
ISO 10993-23:2021/DAmd 1 - Biological evaluation of medical devices — Part 23: Tests for irritation — Amendment 1: Additional in vitro reconstructed human epidermis models 상세보기
ISO 10993-16:2017 - Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables 상세보기
ISO 10993-11:2017 - Biological evaluation of medical devices — Part 11: Tests for systemic toxicity 상세보기
ISO 10993-9:2019 - Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products 상세보기
ISO 10993-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process 상세보기
ISO 10993-14:2001 - Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics 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