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Components & materials: |
Base cap made of polypropylene (PP) |
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Description: |
CANNULA and TUBE |
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- Made of stainless steel. |
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- Various lengths and diameters. |
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- Normal or thin-walled. |
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- Long bevelled (angle inferior or equal to 13°), or short bevelled (angle between 13° and 19°). |
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- Silicone-coated to facilitate insertion. |
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Base: |
- Made of polypropylene (PP). |
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- Allows the needle to be connected to a syringe or other injection devices. |
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- Formed by a conical female Luer connection. |
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- Designed in such a way that it prevents the needle from rolling on a flat surface. |
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International-recognized colour code system allows easy identification of the hypodermic needle’s external diameter. |
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Cap: The cap protects the cannula and its bevel, and preserves the sterility of the needle. |
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Hypodermic needles can be identified by the following inscription: "Hypodermic needle", 2 numbers separated by a dash indicating the length and the diameter of the cannula (both in mm): long bevel (LB) or short bevel (SB): 22G: 0.7 x 75mm, black. |
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Quality requirements: |
Must comply with Medical Device Directive 93/42/EEC |
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Meets following standards: |
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EN ISO 7864-1: Sterile hypodermic needles for single use |
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EN ISO 20594: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 1: General requirements |
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Unit presentation: |
One needle, single-use, sterile, individually peel-packed in paper and/or plastic. |
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Primary packaging: |
Labelling: Manufacture’s name and/or trademark, product description and reference number, "sterile" with method used, 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 100-unit presentation; labelling is the same as that of the primary packaging. |
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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 packaging: |
Labelling is the same as secondary packaging with product-specific transport instructions and storage, where applicable, and quantity of secondary packages. |