$137
AAMI/ISO 10993-1:2018
2020
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- Format:
- Language(s) :
- Published :
- English
- 04/27/2020
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.
| AAMI/ISO 10993-1:2018 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | AAMI/ISO 10993-1:2018 |
| Scope | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| Publisher | AAMI - Association for the Advancement of Medical Instrumentation/International Org. for Standardization |
| Languages | English |
| State | |
| Publication Year | 2020 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| ANSI | ANSI Approved |
| File Size | 1 file , 840 KB |
| Note | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages | 53 |
| Published | 04/27/2020 |
| AAMI/ISO 10993-1:2018 | ||
|---|---|---|
| History | Publisher Year | |
| AAMI/ISO 10993-1:2018 | 2020 | Current |
| AAMI/ISO 10993-1:2009/(R)2013 | 2013 | |
| AAMI/ISO 10993-1:2003 | 2003 |
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