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Normas DIN – AENOR
DIN EN ISO 22442-1:2015-08

DIN EN ISO 22442-1:2015-08

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO/FDIS 22442-1:2015); German and English version FprEN ISO 22442-1:2015 / Note: Date of issue 2015-07-31*Applies in conjunction with DIN EN ISO 14971 (2013-04).

Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 1: Application de la gestion des risques (ISO/FDIS 22442-1:2015); Version allemande et anglaise FprEN ISO 22442-1:2015 / Attention: Date de parution 2015-07-31*Valable en conjointement avec DIN EN ISO 14971 (2013-04).

Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden - Teil 1: Anwendung des Risikomanagements (ISO/FDIS 22442-1:2015); Deutsche und Englische Fassung FprEN ISO 22442-1:2015 / Achtung: Erscheinungsdatum 2015-07-31*Gilt in Verbindung mit DIN EN ISO 14971 (2013-04).

Fecha Anulación:
2016-05 /Withdrawn
Equivalencias internacionales:

FprEN ISO 22442-1 (2015-07)

ISO/FDIS 22442-1 (2015-07)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 22442-1:2016-05

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, Animals, Applications, Biological hazards, Calibration, Cloth, 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
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