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Standard

NS-EN ISO 11607-2:2020

Publisert
Forhåndsvisning

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Omfang

This document specifies requirements for the 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.It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Utgave: 2020-01
  • 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
90/385/EEC
2017/746
2017/745
98/79/EC

Produktrelasjon

Produkt livssyklus