Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
Also Known As:
SKU121838159
Published by
Deutsches Institut für Normung
DIN
Publication Date2021-08
Pages CountPages40
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.
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History and complementary documents
History
| Descriptors | Acceptance, Accessories, Analysis, Animal, Animal products, Animal tissues, Animals, Applications, Biological hazards, Calibration, Collagen, 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, Origin, Pathogenic bacteria, People, Procedures, Procurements, Production, Products, Properties, Qualitative, Quantitative, Reuse, Risk, Risk analysis, Risk management, Safety, Specification (approval), Sterile, Sterilization (birth control), Storage time, Tissue, Use, Viruses, Processes, Supplying, Netting, Software, Implementation, Substances, Reduction, Equipment for single use, Cloth |
| ICS Codes | 11.100.20 - Biological evaluation of medical devices |
| Language(s) | English |
| File Size | 1.7 MB |
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