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Normas DIN – AENOR
DIN EN ISO 11607-1/A1:2009-03

DIN EN ISO 11607-1/A1:2009-03

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); English version prEN ISO 11607-1:2009; Amendment 1 / Note: Date of issue 2009-02-23

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage (ISO 11607-1:2006); Version anglaise prEN ISO 11607-1:2009, Amendement 1 / Attention: Date de parution 2009-02-23

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2006); Englische Fassung prEN ISO 11607-1:2009, Änderung 1 / Achtung: Erscheinungsdatum 2009-02-23

Fecha Anulación:
2019-09 /Withdrawn
Equivalencias internacionales:

ISO 11607-1 (2006-04)

prEN ISO 11607-1 (2009-01)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 11607-1:2009-09

Resumen:
This standard specifies the requirements and test methods for packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of the terminally sterilized medical devices to the point of use.
Diese Norm legt die Anforderungen und Prüfverfahren für Materialien, vorgefertigte Sterilbarrieresysteme, Sterilbarrieresysteme und Verpackungssysteme fest, die dazu vorgesehen sind, die Sterilität der in der Endverpackung zu sterilisierenden Medizinprodukte bis zum Anwendungszeitpunkt aufrechtzuerhalten.
Keywords:
Applications, Biocompatibility, Biological hazards, CE marking, Closures, Compatibility, Conditioning, Covers, Definitions, Density, Design, Disposables, English language, Forming, General conditions, Germs, Hygiene, Information, Inspection, Marking, Materials specification, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Methods, Packages, Packaging material, Packaging tests, Performance, Permability, Physical testing, Products, Public health, Qualifications, Quality, Quality assurance, Quality management, Rating tests, Reagents, Reuse, Safety, Safety requirements, Sampling methods, Sealing, Sequence of operations, Shaping, Specification, Specification (approval), Stability, Sterile barrier systems, Sterility, Sterilization (birth control), Sterilization (hygiene), Sterilized goods, Sterilizers, Storage, Systems, Testing, Toxicity, Transport, Use, Validation, Visual inspection (testing)
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