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Normas DIN – AENOR
DIN EN ISO 8871-4:2006-09

DIN EN ISO 8871-4:2006-09

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006); German version EN ISO 8871-4:2006

Éléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique - Partie 4: Exigences biologiques et méthodes d'essais (ISO 8871-4:2006); Version allemande EN ISO 8871-4:2006

Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 4: Biologische Anforderungen und Prüfverfahren (ISO 8871-4:2006); Deutsche Fassung EN ISO 8871-4:2006

Fecha:
2016-09 /Active
Equivalencias internacionales:

EN ISO 8871-4 (2006-06)

ISO 8871-4 (2006-06)

TS EN ISO 8871-4 (2008-04-10)

Relación con otras normas DIN:
Resumen:
This Standard specifies biological requirements for elastomeric parts for parenterals and for devices for pharmaceutical use. It also specifies the test methods, i. e. offers the extraction procedures for elastomeric parts, and it makes reference to relevant biological test instructions in Pharmacopeias and standards.
Keywords:
Aqueous, Bacterial count, Biological tests, Blood transfusion equipment, Classification, Cytotoxicity, Definitions, Designations, Drug administration, Drugs, Elastomers, Endotoxins, Evaluations, Extraction, Germs, Identification, Infusions, Injection instruments, Injections, Inspection, Marking, Materials, Means of packaging, Medical equipment, Medical sciences, Medical technology, Packages, Parenteral infusion equipment, Preparation, Rubber, Rubber products, Specification (approval), Specifications, Storage, Testing, Toxicity, Transfusions, Vulcanized rubber
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