Standard

SN EN ISO 10993-10:2023

Current

Existing or new amendments and versions must be purchased separately.

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Abstract

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 skin 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.

Products specifications

  • Standard from INB
  • Published:
  • Effective:
  • Document type: EN
  • Pages
  • Publisher: SNV
  • Distributor: SNV
  • ICS: 11.100.20
  • National Committee: INB/NK 129

Legal references

Swiss Federal Authority: SWISSMEDIC
Designated under following Swiss law:
Law referenceRestrictions
812.213
Designated under following EU law:
Law referenceRestrictions
Regulation (EU) 2017/745

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