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Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
| 분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
|---|---|
| 적용범위 | This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series. Specifically, this document addresses the following: — test sample selection; — selection of representative portions from a medical device; — test sample preparation; — experimental controls; — selection of, and requirements for, reference materials; — preparation of extracts. This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells. Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant. |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 21 |
| Edition | 5 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 10993-12:2021 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials | 2021-01-20 | 표준 |
| 2 | ISO 10993-12:2012 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials | 2012-06-29 | 구판 |
| 3 | ISO 10993-12:2007 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials | 2007-10-31 | 구판 |
| 4 | ISO 10993-12:2002 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials | 2002-12-11 | 구판 |
| 5 | ISO 10993-12:1996 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials | 1996-09-05 | 구판 |
| 6 | ISO 10993-12:2021/DAmd 1 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1 | 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 10993-10:2021 - Biological evaluation of medical devices — Part 10: Tests for skin sensitization 상세보기
ISO 10993-23:2021 - Biological evaluation of medical devices — Part 23: Tests for irritation 상세보기
ISO 10993-18:2020 - Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process 상세보기
ISO 10993-9:2019 - Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products 상세보기
ISO 15223-1:2021 - Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements 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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