Norm

NEN-EN-ISO 11607-1:2004 Ontw. en

Verpakkingsmateriaal ten behoeve van steriele medische hulpmiddelen die gesteriliseerd worden in de verpakking - Deel 1: Materiaaleisen, steriele onderbrekingssystemen en verpakkingssystemen

  • Deze norm is ingetrokken sinds 02-05-2006

31,83

Over deze norm

Status Ingetrokken
Aantal pagina's 32
Gepubliceerd op 01-05-2004
Taal Engels
This International Standard specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. This International Standard is applicable to industry, health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. This International Standard does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations. This International Standard does not describe a quality assurance system for control of all stages of manufacture.

Details

ICS-code 11.080.30
Nederlandse titel Verpakkingsmateriaal ten behoeve van steriele medische hulpmiddelen die gesteriliseerd worden in de verpakking - Deel 1: Materiaaleisen, steriele onderbrekingssystemen en verpakkingssystemen
Engelse titel Packaging for terminally sterilized medical devices - Part 1: Requirements for materials and final packages (ISO/AWI 11607-1:2003)
Vervangen door
Normatieve verwijzingen
  • 90/385/EEG, Actieve implanteerbare medische hulpmiddelen (pacemaker richtlijn)

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