DS/EN ISO 10993-1:2020
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
22-12-2020
07-01-2026
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 |
DS/S-258
|
| DocumentType |
Standard
|
| PublisherName |
Danish Standards
|
| Status |
Superseded
|
| Standards | Relationship |
| ISO 10993-1:2018 | Identical |
| EN ISO 10993-1:2020 | Identical |