DIN EN ISO 22442-3:2005-10

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO/DIS 22442-3:2005); German version prEN ISO 22442-3:2005

Tissus animaux et leurs dérivé utilisés dans la fabrication des dispositifs médicaux - Partie 3: Validation de l'èlimination et/ou de l'inactivation des virus et autres agents responsables d'encéphalopathie spongiforme transmissibles (EST)(ISO/DIS 22442-3:2005); Version allemande prEN ISO 22442-3:2005

Tierische Gewebe und deren Derivate nutzende Medizinprodukte - Teil 3: Validierung der Abreicherung und/oder Inaktivierung von Viren und Erregern der übertragbaren spongiösen Enzephalopathie (TSE) (ISO/DIS 22442-3:2005); Deutsche Fassung prEN ISO 22442-3:2005

Información:

Fecha Anulación:

2016-09 /Withdrawn

ICS:

11.100.99 - Other standards related to laboratory medicine

Equivalencias internacionales:

ISO/DIS 22442-3 (2005-07)

prEN ISO 22442-3 (2005-07)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 22442-3:2006-09

Resumen:

This Part of ISO 22442 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in-vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It does not cover other transmissible and non-transmissible agents.

Keywords:

Agents, Analysis, Animal, Animal products, Animals, Applications, Auxiliary devices, Biological hazards, Calibration, Causative organisms, Cell cultures, Checks, Collections, Concentration, Control charts, Data, Definitions, Derivatives, Equipment, Exclusion, Experiences, Fabrics, Guide books, Gullies, Handling, Health hazards, Impurities, Medical devices, Medical products, Medical sciences, Methods, Pathogenic bacteria, Personnel, Procedures, Process, Production, Risk, Risk analysis, Safety, Specification (approval), Tissue, Training, TSE, Use, Validation, Viruses, Winning

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