ÖNORM EN ISO 10993-18:2021 02 15
Current
The latest, up-to-date edition.
Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Hardcopy
German - English
15-02-2021
This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following: — the identification of its materials of construction (medical device configuration); — the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition); — the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues); — the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables); — the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).
| Committee |
TC 194
|
| DevelopmentNote |
New child AMD 1 2024 is added
|
| DocumentType |
Standard
|
| Pages |
13
|
| ProductNote |
New child AMD 1 2024 is added
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 10993-18:2020 | Identical |
| ISO 10993-18:2020 | Identical |
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