Standard

NS-EN ISO 10993-10:1995

Withdrawn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 test methods: a) to evaluate the potential of devices and their constituent materials to produce irritation; and b) to evaluate the potential of devices and their constituent materials to produce sensitization. These test methods are recommended for most categories of device and mode of body contact given in ISO 10993-1. Of the tests listed, those appropriate to the end use of the device are to be selected. Guidance is also given for the preparation of materials specifically in relation to the above tests. Note 1: Guidance on the conduct of supplementary tests which may be required specifically for use in the oral, rectal, penile and vaginal areas is given in Annex D.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 1
  • Version: 1
  • Document type: NAT
  • ICS 11.020
  • ICS 11.040.01
  • ICS 11.100
  • ICS 11.120.01
  • National Committee SN/K 115

Legal references

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

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