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Normas DIN – AENOR
DIN ISO 13022:2013-07

DIN ISO 13022:2013-07

Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012) / Note: Date of issue 2013-07-01

Produits médicaux contenant des cellules viables d'origine humaine - Application du management du risque et exigences relatives aux pratiques de préparation (ISO 13022:2012) / Attention: Date de parution 2013-07-01

Medizinische Produkte, die lebende Zellen menschlichen Ursprungs beinhalten - Anwendung des Risikomanagements und Anforderungen an die Praxis der Handhabung (ISO 13022:2012) / Achtung: Erscheinungsdatum 2013-07-01

Fecha Anulación:
2014-06 /Withdrawn
Equivalencias internacionales:

ISO 13022 (2012-04)

Relación con otras normas DIN:

Reemplazada por: DIN ISO 13022:2014-06

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
124,02
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