Norm

NEN-EN-ISO 11607-2:2017 en

Verpakkingsmateriaal ten behoeve van steriele medische hulpmiddelen die gesteriliseerd worden in de verpakking - Deel 2: Eisen voor vorming, afdichting en assemblageprocessen

  • Deze norm is ingetrokken sinds 01-11-2017

53,43 64,65 Incl BTW

Over deze norm

Status Ingetrokken
Aantal pagina's 11
Gepubliceerd op 01-07-2017
Taal Engels
NEN-EN-ISO 11607-2 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. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

Details

ICS-code 11.080.30
Nederlandse titel Verpakkingsmateriaal ten behoeve van steriele medische hulpmiddelen die gesteriliseerd worden in de verpakking - Deel 2: Eisen voor vorming, afdichting en assemblageprocessen
Engelse titel Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
Vervangt
Vervangen door

Winkelwagen

Subtotaal:

Ga naar winkelwagen