General information
For injection of a local anaesthetic and for spinal anaesthesia.
For taking spinal fluid samples.
Specifications
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Components & materials: |
Cannula: stainless steel, without silicone. |
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Stylet: stainless steel, without silicone. |
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Base: polypropylene or polyamide. |
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Cap: rigid plastic. |
- The cannula is cylindrical; at one end it has a base that is either opaque or translucent, and at the other end a short bevelled tip, called a "Quinck".
This short spine bevelled tip, used around the spine, is designed to separate the dural fibres rather than cutting them, thus reducing damage and the loss of cerebrospinal fluid.
- The stylet is the same length as the tube; it fits properly into the needle lumen and indicates the bevel position of the needle.
- The base allows the needle to be connected to a syringe and is formed by a conical female Luer connection. Colour-coding permits easy identification of the needle’s external diameter.
Spinal needles, identified according to their gauge (18G, 9G, etc), have 2 measurements: the first indicates the external diameter and the second the length of the cannula (both in mm).
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Size: |
22G: 0.7 x 75mm, black |
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25G: 0.5 x 75mm, orange |
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Quality requirements: |
EN-ISO 20594-1: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986 |
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EN-ISO 7864-1: Sterile hypodermic needles for single use |
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Unit presentation: |
One needle, sterile, individually packed in semi-hard peel pack, single-use. |
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Primary packaging: |
Labelling: Manufacture’s name and/or trademark, product description and reference number, "sterile" with sterilization method, lot number, expiry date by year and month, "for single use", and CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available. |
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Secondary packaging: |
Protected unit, one (1) box 25-unit presentation; labelling is the same as that of the primary packaging; includes multilingual user instructions: English, French and Spanish, others when available. |
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Additional required information: Number of units per secondary packaging, information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.). |
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Transport package: |
Labelling is the same as that of the secondary packaging. Product-specific transport instructions, when applicable, and quantity of secondary packages. |