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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 | This document 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 Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats. This document does not cover the utilization of human tissues in medical devices. This document does not specify a quality management system for the control of all stages of production of medical devices. |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 15 |
| Edition | 3 |
| 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 22442-1:2020 - Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management 상세보기
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