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Normas DIN – AENOR
DIN EN ISO 11607-1:2017-11

DIN EN ISO 11607-1:2017-11

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO/DIS 11607-1:2017); German and English version prEN ISO 11607-1:2017 / Note: Date of issue 2017-10-27

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/DIS 11607-1:2017); Version allemande et anglaise prEN ISO 11607-1:2017 / Attention: Date de parution 2017-10-27

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO/DIS 11607-1:2017); Deutsche und Englische Fassung prEN ISO 11607-1:2017 / Achtung: Erscheinungsdatum 2017-10-27

Fecha Anulación:
2020-05 /Withdrawn
Equivalencias internacionales:

ISO/DIS 11607-1 (2017-09)

prEN ISO 11607-1 (2017-09)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 11607-1:2020-05

Resumen:
This part of ISO 11607 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. This part of ISO 11607 does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
Keywords:
Applications, Aseptic, Biocompatibility, Biological hazards, CE marking, Closures, Compatibility, Conditioning, Covers, Definitions, Density, Design, Disposables, 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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