Standard

NS-EN ISO 11135:2014

Publisert

Rettelser og tillegg kjøpes separat.

Språk
Tjenester

Omfang

ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Utgave: 2014-07
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.080.01
  • National Committee CEN/TC 204

Referanser i lov

EU lov: 2017/745, 2017/746, 90/385/EEC, 93/42/EEC

Produktrelasjon

Produkt livssyklus