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Normas DIN – AENOR
DIN EN ISO 9187-1:2010-06

DIN EN ISO 9187-1:2010-06

Injection equipment for medical use - Part 1: Ampoules for injectables (ISO/FDIS 9187-1:2010); German version FprEN ISO 9187-1:2010 / Note: Date of issue 2010-07-26

Matériel d'injection à usage médical - Partie 1: Ampoules pour produits injectables (ISO/FDIS 9187-1:2010); Version allemande FprEN ISO 9187-1:2010 / Attention: Date de parution 2010-07-26

Injektionsgeräte zur medizinischen Verwendung - Teil 1: Ampullen für Injektionspräparate (ISO/FDIS 9187-1:2010); Deutsche Fassung FprEN ISO 9187-1:2010 / Achtung: Erscheinungsdatum 2010-07-26

Fecha Anulación:
2011-01 /Withdrawn
Equivalencias internacionales:

FprEN ISO 9187-1 (2010-06)

ISO/FDIS 9187-1 (2010-06)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 9187-1:2011-01

Resumen:
This part of ISO 9187 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products. It is applicable to ampoules with and without a colour break-ring; the provision of ampoules with a colour break-ring, and the choice of colour of the break-ring, is subject to agreement between the manufacturer and user. Ampoules complying with this part of ISO 9187 are intended for single use only.
Keywords:
Ampoules, Breaking load, Colour codes, Designations, Dimensions, Disposable, Disposables, Equipment for single use, Glass, Injection instruments, Inspection, Limit deviations, Marking, Materials, Medical equipment, Medical sciences, Packages, Packaging, Pharmaceutic packages, Pharmaceuticals, Quality assurance, Specification (approval), Specifications, Testing
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