ANSI/AAMI/ISO 10993-1:2018
Current
The latest, up-to-date edition.
Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
English
27-04-2020
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
|
| ISBN |
978-1-57020-755-6
|
| Pages |
53
|
| ProductNote |
THIS STANDARD IS ALSO REFERS TO ISO/TR 10993-19
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-1:2018 | Identical |
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