Konsolidert

NS-EN 556:1994+A1:1998

Tilbaketrukket
Forhåndsvisning

Rettelser og tillegg kjøpes separat.

Språk
Tjenester

Omfang

1.1 This European Standard specifies the requirements for a terminally-sterilized medical device to be labelled "STERILE". NOTE: For the purpose of the EC Directives for medical devices and for active implantable medical devices (see annex A), labelling a medical device "STERILE" is only permissible when a validated sterilization process has been used. Requirements for the validation and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552 and EN 554. 1.2 This European Standard is not applicable to in vitro diagnostic medical devices.

Dokumentinformasjon

  • Konsolidert fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 2
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.080
  • ICS 11.080.01
  • National Committee CEN/TC 204

Referanser i lov

EU lov: 90/385/EEC, 98/79/EC, 93/42/EEC

Produktrelasjon

Produkt livssyklus