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Normas DIN – AENOR
DIN EN ISO 22442-1:2005-10

DIN EN ISO 22442-1:2005-10

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO/DIS 22442-1:2005); German version prEN ISO 22442-1:2005

Tissus animaux et leurs dérivés utilisés dans la fabrication des dispositifs médicaux - Partie 1: Application de la gestion des risques (ISO/DIS 22442-1:2005); Version allemande prEN ISO 22442-1:2005

Tierische Gewebe und deren Derivate nutzende Medizinprodukte - Teil 1: Anwendung des Risikomanagements (ISO/DIS 22442-1:2005); Deutsche Fassung prEN ISO 22442-1:2005

Fecha Anulación:
2016-09 /Withdrawn
Equivalencias internacionales:

ISO/DIS 22442-1 (2005-07)

prEN ISO 22442-1 (2005-07)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 22442-1:2006-09

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, Pathogenic bacteria, People, Procedures, 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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