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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 | This document 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. This document 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: a) contamination by bacteria, moulds or yeasts; b) contamination by viruses; c) contamination by agents causing transmissible spongiform encephalopathies (TSE); d) material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply. This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids. This document does not specify a quality management system for the control of all stages of production of medical devices. This document does not cover the utilization of human tissues in medical devices. NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture. However, attention is drawn to international standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. NOTE 2 For guidance on the application of this document, see Annex A. |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 26 |
| Edition | 3 |
| 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 22442-2:2020 - Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling 상세보기
ISO 22442-2:2020 - Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling 상세보기
ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice 상세보기
ISO 10993-12:2021 - Biological evaluation of medical devices — Part 12: Sample preparation and reference materials 상세보기
ISO/IEEE 11073-40102:2022 - Health informatics — Device interoperability — Part 40102: Foundational — Cybersecurity — Capabilities for mitigatio 상세보기
ISO/IEEE 11073-40101:2022 - Health informatics — Device interoperability — Part 40101: Foundational — Cybersecurity — Processes for vulnerability assessment 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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