DIN EN ISO 9187-1:2011-01
Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010); German version EN ISO 9187-1:2010
| Fecha edición: |
2011-01-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| 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|Tensile testing machines|Tensile tests|Testing|Volume |
| ICS: | 11.040.20 - Equipo de transfusión, perfusión e inyección |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 9187-1:2010 Idéntica ISO 9187-1:2010 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 9187-1:2008-06 Reemplaza a DIN EN ISO 9187-1:2010-06 |
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