DIN EN ISO 22442-1:2021-08
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020 / Note: Applies in conjunction with DIN EN ISO 14971 (2020-07).
| Fecha edición: |
2021-08-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This Part of ISO 22442 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 investigate, using available information, the safety of such devices by estimating and evaluating the resulting risks, controlling these risks and monitoring the effectiveness of that control. |
| Keywords: | Acceptance|Accessories|Analysis|Animal|Animal products|Animal tissues|Animals|Applications|Biological hazards|Calibration|CE marking|Collagen|Computer software|Consumption|Contact|Context|Definitions|Derivatives|Disposables|Energy|Environment|Environmental effects|Establishment|Examination (quality assurance)|Fabrics|Handling|Health protection|Impurities|Information|Interaction|Life (durability)|Loss|Maintenance|Materials|Measurement|Medical devices|Medical products|Medical sciences|Medicaments|Methods|Organisms|Origin|Pathogenic bacteria|People|Procedures|Procurements|Production|Products|Properties|Qualitative|Quantitative|Reuse|Risk|Risk analysis|Risk management|Safety|Specification (approval)|Sterile|Sterilization (birth control)|Storage time|Tissue|Use|Viruses |
| ICS: | 11.100.20 - Evaluación biológica de productos sanitarios |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 22442-1:2020 Idéntica ISO 22442-1:2020 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 22442-1:2021-04 |
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