Back

EVS-EN ISO 10993-18:2020

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

General information
Valid from 15.06.2020
Base Documents
ISO 10993-18:2020; EN ISO 10993-18:2020
Directives or regulations
None
Standard history
Status
Date
Type
Name
15.06.2020
Main
07.08.2009
Main

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.

*
*
*
PDF
24.89 € incl tax
Paper
24.89 € incl tax
Price: 2.40 € incl tax
Standard monitoring
Customers who bought this item also bought
Main

EVS-EN ISO 10993-5:2009

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Newest version Valid from 07.08.2009
Main

EVS-EN ISO 10993-1:2011

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
Newest version Valid from 03.02.2011
Main

EVS-EN ISO 10993-10:2013

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
Newest version Valid from 07.10.2013
Main

EVS-EN ISO 10993-6:2016

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
Newest version Valid from 03.01.2017