Standard

NS-EN ISO 10993-10:2002

Withdrawn

Note: This standard has a new edition: NS-EN ISO 10993-10:2023

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Abstract

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity. This part of ISO 10993 includes a) pretest considerations, b) details of the test procedures, and c) key factors for the interpretation of the results. Instructions are given in annex A for the preparation of materials specifically in relation to the above tests. Supplementary tests which are required specifically for devices used intradermally in the ocular, oral, rectal, penile and vaginal areas are given in annex B.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2
  • Version: 1
  • Document type: NAT
  • ICS 11.100
  • ICS 11.100.20
  • National Committee SN/K 115

Legal references

EU law: 90/385/EEC, 93/42/EEC

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