Superseded
Standard
Historical
DIN EN ISO 10993-18:2005-10
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2005.
Preview
Summary
This document describes a framework for the identification and, where necessary, quantification of the chemical constituents of a material to provide information required for inclusion in an assessment of the biological safety of medical devices. This part of ISO 10993 does not address the identification or quantification of degradation products, which are covered in ISO 10993 part 9, 13, 14 and 15. ISO 10993-18 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.
Notes
A transition period, as set out in DIN EN ISO 10993-18 (2009-08), exists until 2010-03-21.
Technical characteristics
| Publisher | Deutsche Institut für Normung e.V. (DIN) |
| Publication Date | 10/01/2005 |
| Page Count | 25 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
No products.
Previous versions
01/09/2018
Superseded
Historical
