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Normas DIN – AENOR
DIN EN 12442-1:1998-05

DIN EN 12442-1:1998-05

Animal tissue and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk; German version prEN 12442-1:1998

Tissus animaux et leurs dérivés utilisés dans la fabrication des dispositifs médicaux - Partie 1: Analyse et gestion des risques; Version allemande prEN 12442-1:1998

Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden - Teil 1: Analyse und Handhabung von Risiken; Deutsche Fassung prEN 12442-1:1998

Fecha Anulación:
2011-01 /Withdrawn
Equivalencias internacionales:

prEN 12442-1 (1998-02)

Relación con otras normas DIN:

Reemplaza a: DIN EN 12442-1:1996-09

Reemplazada por: DIN EN 12442-1:2001-01

Resumen:
The document applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, non-viable or rendered non-viable. It specifies, in conjunction with EN 1441, a procedure to investigate, using available information, the safety of such devices by identifying hazards and estimates the risks associated with the device (risk analysis). It is of particular assistance in areas where appropriate harmonized standards are not available or not used.
Das Dokument bezieht sich auf Medizinprodukte (mit Ausnahme der in-vitro-Diagnostik) hergestellt unter Verwendung nicht lebensfähiger oder abgetöteter tierischer Gewebe oder von deren Derivaten.
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, Impurities, Information, Interaction, Life (durability), Loss, Maintenance, Materials, Measurement, Medical devices, Medical products, Medical sciences, Medicaments, Methods, Organisms, Pathogenic bacteria, People, Production, Products, Properties, Qualitative, Quantitative, Reuse, Risk, Risk analysis, Sterile, Sterilization (birth control), Storage time, Tissue, Use, Viruses
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