Norm

ISO 11607-2:2019 en

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

73,95 89,48 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 13
Gepubliceerd op 01-02-2019
Taal Engels
ISO 11607-2 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.

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
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