EN ISO 10993-18:2005

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

Publication date:   Aug 10, 2006

General information

99.60 Withdrawal effective   Apr 29, 2009

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.100   Laboratory medicine

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Scope

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.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Life cycle

NOW

WITHDRAWN
EN ISO 10993-18:2005
99.60 Withdrawal effective
Apr 29, 2009

REVISED BY

WITHDRAWN
EN ISO 10993-18:2009