ÖNORM EN ISO 10993-1:2021 04 15
Current
The latest, up-to-date edition.
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
Hardcopy
German - English
15-04-2021
Important note : All end users must be registered with an Account prior to user licenses being assigned.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 |
TC 194
|
| DocumentType |
Standard
|
| Pages |
0
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-1:2018 | Identical |
| EN ISO 10993-1:2020 | Identical |
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