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Normas DIN – AENOR
DIN EN ISO 9187-1:2007-10

DIN EN ISO 9187-1:2007-10

Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2006); German version prEN ISO 9187-1:2007

Matériel d'injection à usage médical - Partie 1: Ampoules pour produits injectables (ISO 9187-1:2006); Version allemande prEN ISO 9187-1:2007

Injektionsgeräte zur medizinischen Verwendung - Teil 1: Ampullen für Injektionspräparate (ISO 9187-1:2006); Deutsche Fassung prEN ISO 9187-1:2007

Fecha Anulación:
2018-06 /Withdrawn
Equivalencias internacionales:

ISO 9187-1 (2006-04)

prEN ISO 9187-1 (2007-09)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 9187-1:2008-06

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, Multilingual, Packages, Packaging, Quality assurance, Specification (approval), Specifications, Testing
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