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
Also Known As:
SKU111251519
Published by
Deutsches Institut für Normung
DIN
Publication Date2008-03
Pages CountPages29
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.
Details
| 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 |
| ICS Codes | 11.100.99 - Other standards related to laboratory medicine |
| Language(s) | English |
| File Size | 389.1 KB |
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