BS EN ISO 10993-18:2009 - Biological evaluation of medical devices. Chemical characterization of materials – BSI British Standards

BS EN ISO 10993-18:2009

Biological evaluation of medical devices. Chemical characterization of materials

Status : Superseded, Withdrawn   Published : June 2009 Replaced By : BS EN ISO 10993-18:2020

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BS EN ISO 10993-18:2009 Biological evaluation of medical devices. Chemical characterization of materials

BS EN ISO 10993-18 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)
  • 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)
  • Judging equivalence of a proposed material to a clinically established material
  • 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
  • Screening of potential new materials for suitability in a medical device for a proposed clinical application.

BS EN ISO 10993-18 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 10993-1:2003). This part of ISO 10993 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.

Contents of BS EN ISO 10993-18:

  • Foreword
  • Introduction
  • Scope
  • Normative references
  • Terms and definitions
  • Symbols and abbreviated terms
  • General principles
  • Characterization procedure
  • General
  • Step 1 — Qualitative information
  • Step 2 — Material equivalence
  • Step 3 — Quantitative information
  • Step 4 — Quantitative risk assessment
  • Step 5 — Estimated clinical exposure to chemicals present Chemical characterization parameters and methods
  • General
  • Polymers
  • Metals and alloys
  • Ceramics
  • Natural macromolecules
  • Reporting of data obtained
  • Flowchart summarizing the stepwise generation of chemical characterization data for use in toxicological risk assessment Information sources for chemical characterization
  • Principles for judging toxicological equivalency
  • Bibliography

Standard NumberBS EN ISO 10993-18:2009
TitleBiological evaluation of medical devices. Chemical characterization of materials
StatusSuperseded, Withdrawn
Publication Date30 June 2009
Withdrawn Date01 June 2020
Normative References(Required to achieve compliance to this standard)ISO 10993-17, ISO 10993-1:2003, ISO 14971:2000
Informative References(Provided for Information)ISO 10993-15:2000, 90/385/EEC, ISO 10993-14:2001, ISO 10993-13:1998, ISO 10993-2, 93/42/EEC, ISO 10993-9:1999, EN 455-3:1999, ISO 5725-1:1994, ISO 5832-1:1997, EN 12442-1:2000, EN 12442-3:2000, EN 12442-2:2000
Replaced ByBS EN ISO 10993-18:2020
ReplacesBS EN ISO 10993-18:2005
International RelationshipsEN ISO 10993-18:2009,ISO 10993-18:2005
DescriptorsQuality assurance, Chemical analysis and testing, Safety measures, Conformity, Equipment safety, Identification methods, Alloys, Health and safety requirements, Metals, Ceramics, Chemical properties, Polymers, Chemical composition, Biological analysis and testing, Medical equipment
Title in FrenchÉvaluation biologique des dispositifs médicaux. Caractérisation chimique des matériaux
Title in GermanBiologische Beurteilung von Medizinprodukten. Chemische Charakterisierung von Werkstoffen
ISBN978 0 580 65822 8
File Size622 KB

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