The ISO 10993-10 standard, developed by the International Standards Organization (ISO), describes a test method for the evaluation of medical devices and their components according to their potential to induce skin sensitization. This standard includes:
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In particular, the instructions for the preparation of materials regarding these tests are included in the standard annex (Annex A). The full name of this standard is: ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization.
This standard assesses potential contact hazards from chemicals released from medical devices that cause sensitization to the skin. Some materials found in medical devices have been tested and documented for their skin sensitization potential. Sensitizing properties have been reported especially for dental materials. Other materials and their chemical components have not been tested and may cause adverse effects in contact with human tissue. For this reason, the manufacturer is responsible for evaluating each device for potential adverse effects prior to marketing.
Traditionally, small animal tests are conducted before testing on humans to help predict human response. However, in recent years, various chemical and in vitro tests have been validated to assess the potential for skin sensitization by chemicals, and OECD testing guidelines have been published.
An overview of available alternative skin sensitization tests for pure chemicals is included in the standard appendix (Appendix C). These test methods, each developed to address a particular significant event, should be evaluated with integrated approaches to assessment and by combining them with other complementary information. Assays need to be validated to confirm that they are applicable to the assessment of skin sensitization potential of medical devices.
Where appropriate, the use of in vitro methods for screening prior to animal testing is encouraged. To reduce the number of animals used, this standard provides a step-by-step approach with review and analysis of test results at each stage.
Our organization also provides sensitization testing services within the scope of the GEN 163 standard, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.
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