관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
PDF : 직접 파일 다운로드 및 인쇄 (마이페이지 확인)
PRINT : 인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)
구판
판매
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
| 분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
|---|---|
| 적용범위 | ISO 22442-2:2015 specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442‑1. NOTE 1 Selective sourcing is considered to be especially important for transmissible spongiform encephalopathy (TSE) risk management. The manufacturers should refer to ISO 22442‑3 for information on the validation of the elimination and/or inactivation of viruses and TSE agents. ISO 22442-2:2015 does not cover the utilization of human tissues in medical devices. ISO 22442-2:2015 does not specify a quality management system for the control of all stages of production of medical devices. It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this part of ISO 22442 can form a part of a quality management system conforming to ISO 13485. NOTE 2 A general principle for the application of this International Standard is that it is advisable to give due consideration to the requirements and recommendations contained in all three parts of the standard. |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 15 |
| Edition | 2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 22442-2:2020 | Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling | 2020-09-15 | 표준 |
| 2 | ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling | 2015-11-02 | 구판 |
| 3 | ISO 22442-2:2007 | Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling | 2007-11-27 | 구판 |
ISO 22442-3:2007 - Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents 상세보기
ISO/TR 22442-4:2010 - Medical devices utilizing animal tissues and their derivatives — Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes 상세보기
ISO 22442-1:2020 - Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management 상세보기
ISO 22442-2:2020 - Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling 상세보기
ISO 22442-1:2015 - Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management 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 10993-12:2012 - Biological evaluation of medical devices — Part 12: Sample preparation and reference materials 상세보기
ISO 22442-3:2007 - Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents 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
KS표준
핸드북
