DIN EN ISO 8871-2/A1:2014-03

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization - Amendment 1 (ISO 8871-2:2003/Amd 1:2005); German version EN ISO 8871-2:2004/FprA1:2014 / Note: Date of issue 2014-02-07

Éléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique - Partie 2: Identification et caractérisation - (ISO 8871-2:2003/Amd 1:2005); Version allemande EN ISO 8871-2:2004/FprA1:2014 / Attention: Date de parution 2014-02-07

Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 2: Identifizierung und Charakterisierung (ISO 8871-2:2003/Amd 1:2005); Deutsche Fassung EN ISO 8871-2:2004/FprA1:2014 / Achtung: Erscheinungsdatum 2014-02-07

Información:

Fecha Anulación:

2014-08 /Withdrawn

ICS:

11.040.20 - Transfusion, infusion and injection equipment

Equivalencias internacionales:

EN ISO 8871-2/FprA1 (2014-01)

ISO 8871-2 AMD 1 (2005-07)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 8871-2:2014-08

Resumen:

The project specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identify between the samples evaluated in the (suitability test) acceptance process and the current supplies. Amendment 1 introdcues an informative annex on the determination of a fingerprint by surface infrared spectroscopy.

Keywords:

Analysis, Aqueous, Blood transfusion equipment, Characterisations, Chemical analysis and testing, Chemical composition, Classification, Containers, Designations, Drug administration, Drug containers, Drugs, Elastomers, Identification, Infusions, Injection instruments, Injections, Inspection, Marking, Materials, Means of packaging, Medical equipment, Medical sciences, Medical technology, Multilingual, Packages, Parenteral infusion equipment, Pharmacy, Preparation, Properties, Qualification tests, Rubber, Rubber products, Specification (approval), Specifications, Storage, Substances, Testing, Transfusions, Vulcanized rubber

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