DIN EN ISO 22442-3:2008 Edition

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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

Published By	Publication Date	Number of Pages
DIN	2008-03	29

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Categories: 11.100.99 - Other standards related to laboratory medicine, DIN

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Description

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.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2008-03
Pages Count	29
Language	Germany
Descriptors	Agents, Analysis, Animal, Animal products, Animals, Applications, Auxiliary devices, Biological hazards, Calibration, Causative organisms, CE marking, Cell cultures, Checks, Collections, Concentration, Control charts, Data, Definitions, Derivatives, Elimination, Equipment, Exclusion, Experiences, Fabrics, Guide books, Gullies, Handling, Health hazards, Impurities, Inactive, 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, Processes, Implementation, Netting, Exciters
File Size	389.1 KB
ICS Codes	11.100.99 - Other standards related to laboratory medicine

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DIN EN ISO 22442-3:2008 Edition

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