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Norma Técnica
Código
ISO 10993-18:2005   CANCELADA
Data de Publicação : 30/06/2005
Título : Biological evaluation of medical devices — Part 18: Chemical characterization of materials
Título Idioma Sec. : Évaluation biologique des dispositifs médicaux — Partie 18: Caractérisation chimique des matériaux
Comitê : ISO/TC 194 Biological evaluation of medical devices
Páginas : 17
Status : Cancelada em 13/01/2020  Substituída por : ISO 10993-18:2020
Idioma : Inglês
Motivo do Cancelamento :
Organismo : ISO - International Organization for Standardization
Objetivo : 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.
Normas Necessárias para a aplicação da ISO 10993-18:2005
ISO 10993-1:1992
ISO 10993-1:1992/Cor 1:1992
ISO 10993-1:1997
ISO 10993-1:2003
ISO 10993-1:2009
ISO 10993-1:2009/Cor 1:2010
ISO 10993-10:1995
ISO 10993-10:2002
ISO 10993-10:2002/Amd 1:2006
ISO 10993-10:2010
ISO 10993-11:1993
ISO 10993-11:2006
ISO 10993-12:1996
ISO 10993-12:2002
ISO 10993-12:2007
ISO 10993-12:2012
ISO 10993-13:1998
ISO 10993-13:2010
ISO 10993-14:2001
ISO 10993-15:2000
ISO 10993-16:1997
ISO 10993-16:2010
ISO 10993-17:2002
ISO 10993-18:2005
ISO 10993-2:1992
ISO 10993-2:2006
ISO 10993-3:1992
ISO 10993-3:2003
ISO 10993-4:1992
ISO 10993-4:2002
ISO 10993-4:2002/Amd 1:2006
ISO 10993-5:1992
ISO 10993-5:1999
ISO 10993-5:2009
ISO 10993-6:1994
ISO 10993-6:2007
ISO 10993-7:1995
ISO 10993-7:2008
ISO 10993-7:2008/Cor 1:2009
ISO 10993-8:2000
ISO 10993-9:1999
ISO 10993-9:2009
ISO/DIS 10993-11:2016
ISO/TR 10993-9:1994
ISO/TS 10993-19:2006
ISO/TS 10993-20:2006
Normas Substitutas da ISO 10993-18:2005
ISO 10993-18:2020
ICS/CIN
11.100.20 - Avaliação biológica dos dispositivos médicos
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