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Normas DIN – AENOR
DIN EN ISO 11607-1:2006-07

DIN EN ISO 11607-1:2006-07

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); German version EN ISO 11607-1:2006 / Note: A transition period, as set out in DIN EN ISO 11607-1 (2009-09), exists until 2010-03-21.

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 allemande EN ISO 11607-1:2006 / Attention: Il existe un délai de transition comme fixé en DIN EN ISO 11607-1 (2009-09) jusqu'à 2010-03-21.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2006); Deutsche Fassung EN ISO 11607-1:2006 / Achtung: Übergangsfrist, festgelegt durch DIN EN ISO 11607-1 (2009-09), bis 2010-03-21 beachten.

Fecha Anulación:
2019-09 /Withdrawn
Equivalencias internacionales:

EN ISO 11607-1 (2006-04)

ISO 11607-1 (2006-04)

Relación con otras normas DIN:
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.
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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