Norm

NEN-EN-ISO 11607-2:2004 Ontw. 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 02-05-2006

25,62

Over deze norm

Status Ingetrokken
Aantal pagina's 19
Gepubliceerd op 01-05-2004
Taal Engels
This International Standard specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. This International Standard is applicable to industry, health care facilities, and wherever medical devices are packaged and sterilized. This International Standard 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: Requirements for forming and sealing and assembly processes
Vervangen door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

Winkelwagen

Subtotaal:

Ga naar winkelwagen