Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (Draft)
Also Known As:
SKU916324513
Published by
Deutsches Institut für Normung
DIN
Publication Date2018-09
Pages CountPages73
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.
Details
History and complementary documents
History
| Descriptors | Acceptance, Accessories, Analysis, Animal, Animal products, 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 + German |
| File Size | 2.3 MB |
Purchase
Right after completing the purchase process, you will immediately get a digital copy of this standard which is:
Not Locked
Printable
Multi-User
$
26.50
