ISO 10993-18:2020
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
Hardcopy , PDF
French, English
13-01-2020
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).
This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).
This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
72
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DS/EN ISO 10993-18:2020 | Identical |
| I.S. EN ISO 10993-18:2020&LC:2020 | Identical |
| ÖNORM EN ISO 10993-18:2021 02 15 | Identical |
| ÖNORM EN ISO 10993-18:2021 02 15 | Identical |
| EN ISO 10993-18:2020 | Identical |
| SS-EN ISO 10993-18:2020 | Identical |
| NEN-EN-ISO 10993-18:2020 | Identical |
| I.S. EN ISO 10993-18:2020 | Identical |
| NF EN ISO 10993-18:2020 | Identical |
| BS EN ISO 10993-18:2020 | Equivalent |
| BS EN ISO 10993-18:2020 | Identical |
| UNE-EN ISO 10993-18:2021 | Identical |
| I.S. EN ISO 22442-1:2020 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management |
| I.S. EN ISO 10271:2020 | Dentistry - Corrosion test methods for metallic materials |
| ANSI/AAMI/ISO 10993-16:2017 | Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables<br> |
| ANSI/AAMI/ISO 10993-16:2020(R2022) | Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables |
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