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Components: |
- Spike or perforator |
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- Air inlet with air filter and protective cap. |
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- Drip-counting chamber. |
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- Flow regulator. |
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- Y-injection site. |
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- Luer-lock connection to vascular system. |
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Materials: |
The material components must not modify the properties of the fluids or solutions passing through the infusion set. |
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Tubing: |
- Medical grade materials, PVC-based. |
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- Transparent (allowing bubble detection), supple and resistant to kinking. |
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- Minimum length: 150cm, giving the IV set an overall length of 170-180cm. |
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- ID 3mm, OD 4.1mm |
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Perforator or Spike: |
- Materials: plastic ABS (Acrylonitrile Butadiene Styrene), POM (polyacetal), polystirole. |
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- Hollow device, double channel with sharp tapering cannulae, located at the proximal end of the IV set, ensuring a safe seal between the IV line and the fluid container (bottle or bag). |
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- Spike can be moulded as part of the infusion chamber or connected by non-kinking tubing. |
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Air inlet:
(for gravity infusions) |
- Open air inlet for glass bottle or rigid plastic container. |
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- Closed air inlet for plastic bag or pouch. |
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- Incorporated into the spike or perforator base with bacteria filter and closable Eurocap system. |
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Drip-counting chamber: |
- Materials: medical-grade PVC and polypropylene. |
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- Transparent, supple, compressible bag with calibrated tube (upper end) providing even drop formation: 20 drops of ±1ml. |
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- Bacterial filter 15-20µm (chamber, lower end) designed to retain particles. |
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Flow regulator: |
- Material: (ABS, PE, polystyrene.) |
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- Small wheel referred to as a roller clamp situated between the drip-counting chamber and the IV connector. |
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A good quality roller clamp enables precise fluid regulation by narrowing the tube lumen by compression, without damaging the tubing and allows to stop the drip when needed. |
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Y injection site: |
- Allows the injection of emergency drugs into the flow. The Y site is located at +/-20cm from the IV connection. |
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- A Y-shaped rigid plastic tube, with a minimum length of 40mm to avoid perforating the tube when inserting a needle. |
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- The injection site is closed with a tight, non-removable rubber membrane. |
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Note: The self-sealing bung, close to the IV line’s proximal end, have been cancelled due to its needle-sticking hazard. |
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Terminal connection: |
- Male Luer lock, preferably mobile. |
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- Protection cap. |
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- With or without a purging filter. |
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Unit presentation: |
1 infusion set, single-use, sterile, individually peel packed. |
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Primary packaging: |
Labelling should indicate: Manufacture’s name and/or trademark, product description and reference number, "sterile" and method, lot number, expiry date by year and month, "for single use", CE mark and reference number of notifying body, and instructions for use. Must be multilingual: English, French and Spanish, others when available. |
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Secondary packaging: |
Protected unit, one (1) box 100 or 200-unit presentation, labelling is the same as that of 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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Other requirements: |
Quality must comply with Medical Device Directive 93/42/EEC (class risk IIa) or equivalent. |