Norm

NEN-EN-ISO 11607-1:2017 (Cor. 2017-11) en

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

124,99 151,24 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 35
Gepubliceerd op 01-11-2017
Taal Engels
NEN-EN-ISO 11607-1 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 until the point of use. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations. This part of ISO 11607 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 barriƫresystemen en verpakkingssystemen
Engelse titel Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
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