Standard

NS-EN 556-2:2015

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN 556-2:2024

Forhåndsvisning

Rettelser og tillegg kjøpes separat.

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Omfang

This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 2015-09
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.080.01
  • Nasjonal komité CEN/TC 204

Referanser i lov

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

Produktrelasjon

Produkt livssyklus