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SRPS EN ISO 10993-18:2011

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

Aug 29, 2011
95.99   Withdrawal of Standard   Nov 30, 2020

General information

95.99     Nov 30, 2020

ISS

Z076

European Norm

11.100.20  

English  

From plan 2011

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Scope

ISO 10993-18:2005 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), as a 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), for judging equivalence of a proposed material to a clinically established material, for 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, or for screening of potential new materials for suitability in a medical device for a proposed clinical application.
ISO 10993-18:2005 does not address the identification or quantification of degradation products, which is 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).
ISO 10993-18:2005 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Harmonized
90/385/EEC

Active implantable medical devices

Harmonized
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 10993-18:2008

NOW

WITHDRAWN
SRPS EN ISO 10993-18:2011
95.99 Withdrawal of Standard
Nov 30, 2020

REVISED BY

PUBLISHED
SRPS EN ISO 10993-18:2020

Related project

Adopted from EN ISO 10993-18:2009

Adopted from ISO 10993-18:2005 IDENTICAL