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
