NF EN ISO 10993-1:2020
Current
The latest, up-to-date edition.
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Hardcopy
English - French
01-12-2020
Important note : Users cannot be edited or removed once added to your Multi user PDF.This document specifies: —the general principles governing the biological evaluation of medical devices within a risk management process; —the general categorization of medical devices based on the nature and duration of their contact with the body; —the evaluation of existing relevant data from all sources; —the identification of gaps in the available data set on the basis of a risk analysis; —the identification of additional data sets necessary to analyse the biological safety of the medical device; —the assessment of the biological safety of the medical device.
| Committee |
ISO/TC 94
|
| DocumentType |
Standard
|
| Pages |
56
|
| PublisherName |
Association Francaise de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-1:2018 | Identical |
| EN ISO 10993-1:2020 | Identical |
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