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Standard in Focus: DIN EN ISO 10993-18

DIN EN ISO 10993-18

Biological evaluation of medical devices – Part 18: Chemical characterisation of materials

The German version DIN EN ISO 10993-18  was published this month and replaces the version from 2009.

It describes a procedure for identifying and, where appropriate, quantifying the constituent materials of a medical device. This procedure enables the identification of biological hazards and the assessment and control of biological risks posed by component materials. A broad stepwise approach to chemical characterisation is described, which may include one or more of the following steps:

Chemical Characterisation

  • Identification of the manufacturing materials (specifications)
  • Characterisation of the manufacturing materials by means of identification and quantification of their chemical constituents (material composition)
  • Characterisation of the medical device with respect to chemical substances introduced during manufacture (e.g., mould releasing agents, manufacturing-related impurities, sterilisation residues);
  • Estimation (under laboratory extraction conditions) of the potential of the medical device or its manufacturing materials to release chemical substances under clinical conditions of use (extractable substances);
  • Measurement of the released chemical substances within the scope of the intended purpose (extractable substances).

The DIN EN ISO 10993-n series of standards applies when the medical device comes into direct or indirect physical contact. EN ISO 10993-1 can be used for the exact assignment of contact situations and verification.

What has been changed?

Compared to the August 2009 version, the following changes have been made:

  • Better alignment with other parts of the DIN EN ISO 10993-n series of standards,
  • a revised and extended flow chart on the chemical characterisation procedure has been added,
  • an improved explanation of the circumstances under which analytical tests can be omitted,
  • a number of definitions were added (e.g., configuration of the medical device, manufacturing materials, material composition);
  • test approaches for material characterisation are explained in more detail,
  • a discussion of considerations for analytical method qualification was added,
  • informative appendices on general principles and considerations have been added.

In complex regulatory practice, chemical characterisation plays an increasingly important role, even in the low and medium risk range (Class I and II a). Manufacturers who in the past were satisfied with testing for cytotoxicity, for example, should urgently also deal with this part of the series of standards.
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