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Standard

NS-EN ISO 10993-23:2021

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Omfang

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2.This document includes:— pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;— details of in vitro and in vivo irritation test procedures;— key factors for the interpretation of the results.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Utgave: 2021-03
  • Versjon: 1
  • Varetype: NAT
  • Products.Specs.pages
  • ICS 11.100.20
  • National Committee SN/K 115

Referanser i lov

EU lov:
Lov referanseRestriksjoner
93/42/EEC
90/385/EEC
2017/745

Produktrelasjon

  • Adoptert fra: EN ISO 10993-23:2021 , 0