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Normas DIN – AENOR
DIN EN ISO 11607-2:2017-11

DIN EN ISO 11607-2:2017-11

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO/DIS 11607-2:2017); German and English version prEN ISO 11607-2:2017 / Note: Date of issue 2017-10-27

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage (ISO/DIS 11607-2:2017); Version allemande et anglaise prEN ISO 11607-2:2017 / Attention: Date de parution 2017-10-27

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens (ISO/DIS 11607-2:2017); Deutsche und Englische Fassung prEN ISO 11607-2:2017 / Achtung: Erscheinungsdatum 2017-10-27

Fecha Anulación:
2020-05 /Withdrawn
Equivalencias internacionales:

ISO/DIS 11607-2 (2017-09)

prEN ISO 11607-2 (2017-09)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 11607-2:2020-05

Resumen:
This part of ISO 11607 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.
Keywords:
Applications, 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)
90,09
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