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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.100 Laboratory medicine>11.100.20 Biological evaluation of medical devices>20/30377819 DC BS EN ISO 10993-10. Biological evaluation of medical devices Part 10. Tests for skin sensitization
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immediate downloadReleased: 2020-02-17
20/30377819 DC BS EN ISO 10993-10. Biological evaluation of medical devices Part 10. Tests for skin sensitization

20/30377819 DC

BS EN ISO 10993-10. Biological evaluation of medical devices Part 10. Tests for skin sensitization

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Standard number:20/30377819 DC
Pages:61
Released:2020-02-17
Status:Draft for Comment
DESCRIPTION

20/30377819 DC


This standard 20/30377819 DC BS EN ISO 10993-10. Biological evaluation of medical devices is classified in these ICS categories:
  • 11.100.20 Biological evaluation of medical devices

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.

This document includes:

  • details of in vivo sensitization test procedures;

  • key factors for the interpretation of the results.

NOTE

Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.


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