SS ISO 10993-1:2018
Biological evaluation of medical devices – Part 1 : Evaluation and testing within a risk management
OVERVIEW
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.
Applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with patient's body during intended use or user’s body, if the medical device is intended for protection (e.g., surgical gloves, masks and others).
Applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.
Excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens."
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2018 |
| No. of Pages | 62 |
| ICS Classification | 11.100.20 Biological evaluation of medical devices |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | ISO 10993-1 : 2018 IDT |