Biological evaluation of medical devices - Chemical characterization of materials

Biological evaluation of medical devices - Chemical characterization of materials

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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