DIN EN ISO 8362-5:2016-07
Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016); German version EN ISO 8362-5:2016
| Fecha edición: |
2016-07-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of EN ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO 8362 are intended for single use only. |
| Keywords: | Accessories|Bottle closures|Closures|Contamination|Definitions|Dimensions|Disposable|Equipment for single use|Freeze-drying|Injection bottles|Injection containers|Injection plug|Injections|Marking|Materials|Medical equipment|Medical sciences|Medical technology|Moisture|Parenteral infusion equipment|Particles|Permeability|Specification (approval)|Stoppers|Storage|Vulcanized rubber |
| ICS: | 11.040.20 - Equipo de transfusión, perfusión e inyección |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 8362-5:2016 Idéntica ISO 8362-5:2016 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 8362-5:2014-10 Reemplaza a DIN ISO 8362-5:2011-06 |
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