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Components & materials: |
Needle: stainless steel |
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Tube: PVC or polyurethane (PUR) |
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Connector |
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Protective cap |
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Meets specification norms: EN-ISO 10555-1, EN-ISO 6009 and EN-ISO 20594-1 |
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Needle: |
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- Length: between 10 and 30mm |
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- External diameter: between 0.3 and 2.1mm |
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- Mounted on a base, of variable size, with two flexible fins that are used for anchoring and attaching the needle. |
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- Usually triple bevelled. |
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- Silicone-coated to make insertion easier. |
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Tube: |
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- Supple |
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- Length: between 10 and 30cm |
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- Internal volume: between 0.15 and 2.5ml |
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Connector: |
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- Female Luer |
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- Usually interlocking |
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- Equipped with a bung; permits the attachment of an infusion set. |
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The sheath is open at both ends. |
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The needles are colour coded (visible on the fins), but the code has not yet been standardized. |
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The external diameter of the needle (mm and gauge), is inscribed on the fins. |
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Unit, sterile, disposable presentation. |
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21G: 0.8 x 19mm, green |
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23G: 0.6 x 19mm, blue |
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25G: 0.5 x 19mm, orange |
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Quality requirements: |
Must comply with Medical Device Directive 93/42/EEC or equivalent. |
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Meet following standards: |
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EN-ISO 20594-1: Conical fittings taper for syringes, needles and certain other with a 6% (Luer) medical equipment - Part 1: General requirements (ISO 594-1:1986) |
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EN-ISO 10555-1: Sterile, single-use intravascular catheters - Part 1: General requirements |
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Unit presentation: |
One scalp vein, 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 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 50- or 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 and storage instructions, when applicable, and quantity of secondary packages. |