Norm

NEN-EN-ISO 10993-18:2003 Ontw. en

Biologisch onderzoek van medische apparatuur - Deel 18: Chemische karakterisering van materialen

  • Deze norm is ingetrokken sinds 26-07-2005

25,62

Over deze norm

Status Ingetrokken
Aantal pagina's 23
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-02-2003
Taal Engels
This document describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterisation information generated can be used for a range of important applications, for example: a). As part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971). b) Measurement of the level of any 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). c) Judging equivalence of a proposed material to a clinically established material. d) 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. e) Screening of potential new materials for suitable in a medical device for a proposed clinical application. Is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.

Details

ICS-code 11.100.20
Nederlandse titel Biologisch onderzoek van medische apparatuur - Deel 18: Chemische karakterisering van materialen
Engelse titel Biological evaluation of medical devices - Part 18: Chemical characterization of materials
Vervangen door
Normatieve verwijzingen
  • 90/385/EEG, Actieve implanteerbare medische hulpmiddelen (pacemaker richtlijn)

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