EN
SR EN ISO 10993-18:2006
Evaluare biologică a dispozitivelor medicale. Partea 18: Caracterizare chimică a materialelor
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.
Status :
Anulat
Data aprobării : 30.01.2006
Data publicării : 01.02.2006
Data anulării : 28.02.2010
Număr de pagini : 27
ICS : 11.100.20 Evaluarea biologica a dispozitivelor medicale
Comitet tehnic : 377 - Medicale
- Inlocuit prin SR EN ISO 10993-18:2009