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Standard

NS-EN ISO 11607-2:2006

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN ISO 11607-2:2020

Forhåndsvisning

Rettelser og tillegg kjøpes separat.

Språk
Tjenester

Omfang

ISO 11607-2:2006 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 2006-04
  • Versjon: 1
  • Varetype: NAT
  • Products.Specs.pages
  • ICS 11.080.30
  • National Committee SN/K 108

Referanser i lov

EU lov:
Lov referanseRestriksjoner
93/42/EEC

Produktrelasjon

Produkt livssyklus