DIN EN ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2005
This part of ISO 10993 describes a framework for the identification of a material and the identification and
quantification of its chemical constituents. The chemical characterization information generated can be used
for a range of important applications, for example:
-- As part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971).
Measurement of the level of a leachable substance in a medical device in order to allow the assessment
of compliance with the allowable limit derived for that substance from health based risk assessment
(ISO 10993-17).
-- Judging equivalence of a proposed material to a clinically established material.
-- Judging equivalence of a final device to a prototype device to check the relevance of data on the latter to
be used to support the assessment of the former.
-- Screening of potential new materials for suitability in a medical device for a proposed clinical application.
This part of ISO 10993 does not address the identification or quantification of degradation products, which is
A
covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series of standards is applicable when the material or device comes into contact with the body
directly or indirectly (see 4.2.1 of ISO 10993-1:2003).
This part of ISO 10993 is intended for suppliers of materials and manufacturers of medical devices, when
carrying out a biological safety assessment.
DIN EN ISO 10993-18:2005 history
2021DIN EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020); German version EN ISO 10993-18:2020
1970DIN EN ISO 10993-18 E:2018-09 Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials during risk management (draft)
2018DIN EN ISO 10993-18 E:2018 Draft Document - Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO/DIS 10993-18:2018); German and English version prEN ISO 10993-18:2018
2005DIN EN ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2005