NEN-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
01-12-2020
NEN-EN-ISO 10993-1 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.
| DocumentType |
Standard
|
| Pages |
41
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-1:2018 | Identical |
| EN ISO 10993-1:2020 | Identical |
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