DIN ISO 13022:2014-06
Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
| Fecha edición: |
2014-06-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This standard specifies a procedure to identify the hazards and hazardous situations and to manage the risk associated with viable cellular component (s) of products regulated as medicals products, biological, medical devices and active implantable medical devices or combination thereof. It covers viable human materials of autologous as well allogenic human origin. For the manufacturer of medical products containing viable cells of human origin, this standard specifies a procedure to identify the hazards and hazardous situations associated with such cells, to estimate and evaluate the resulting risks, to control this risk, and to monitor the effectiveness of the control. Furthermore the standard outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, and expected medical benefit as compared to available alternatives. |
| Keywords: | Cells|Cells (biology)|Definitions|Documentation|Drugs|Handling|Human biology|Human body|Human medicine|Implants (surgical)|Medical devices|Medical products|Risk analysis|Risk management|Specification (approval)|Workplace safety |
| ICS: | 11.100.20 - Evaluación biológica de productos sanitarios |
| CTN: | |
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Equivalencia Internacional |
Idéntica ISO 13022:2012 |
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Reemplazo Normas |
Reemplaza a DIN ISO 13022:2013-07 |
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