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Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
| 분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
|---|---|
| 적용범위 | ISO 22442-1:2007 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. ISO 22442-1:2007 is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:
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| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 26 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 22442-1:2020 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management | 2020-09-15 | 표준 |
| 2 | ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management | 2015-11-02 | 구판 |
| 3 | ISO 22442-1:2007 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management | 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
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