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DIN EN ISO 11608-1:2010-11
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO/DIS 11608-1:2010); German version prEN ISO 11608-1:2010 / Note: Date of issue 2010-11-22
| Fecha edición: |
2012-12-01
Anulada
|
|---|---|
| Fecha cancelación: | 2012-12-01 |
| Idiomas disponibles: | Alemán |
| Resumen: | This part of ISO 11608 specifies requirements and test methods for NISs intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in this standard include single and multi-dose syringe-based and cartridge-based systems; either filled by the manufacturer or by the end-user. NISs which are equipped with electronic or electromechanical components are covered by this standard as referenced by ISO 11608-4. NISs which are equipped with automated functions are also covered by this standard, as referenced by ISO 11608-5. |
| Keywords: | Cannulas|Data of the manufacturer|Definitions|Design|Designations|Dosage|Drug administration|Electromagnetic compatibility|EMC|Hypodermic needles|Injection instruments|Injection syringes|Injectors|Instructions for use|Marking|Medical devices|Medical equipment|Medical products|Medical technology|Needles|Pen-injectors|Performance requirements|Precision|Replaceability|Specification (approval)|Testing|User information |
| ICS: | 11.040.25 - Jeringuillas, agujas y catéteres |
| CTN: | |
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Reemplazo Normas |
Es reemplazada por DIN EN ISO 11608-1:2012-12 |










