Figure 1 Structure of Spigot
2.3 Dimension of product Table 1: Dimensions of Spigot| Name | Length 1 | Length 2 | Diameter |
| Spigot | 54.7±0.2mm | 32.7±0.1mm | 12.0±0.1mm |
- 100% silicone, medical-grade - Length of 410mm - Catheter with X-ray line - Available with balloon in variety of capacity - Monitor patient's bladder temperature to assist clinical diagnosis- Cleanse the drainage funnel of the catheter using a sterile towelette packet - Take out one sterile single packed spigot - Open the sterile packaging - Insert the spigot into the drainage funnel of the catheter- For single patient use only. - Not intended for reprocessing. - Do not re-sterilize. - Store in a dry, cool and dark place.| List | Test Item | Requirements | |
| 1 | Surface finish | The surface shall appear free from extraneous matter | |
| 2 | Dimensions (mm) | Length 1 | 54.7±0.2mm |
| Length 2 | 32.7±0.1mm | ||
| Diameter | 12.0±0.1mm | ||
| 3 | Connection security | When tested in accordance with the method given in annex B of EN1616 ( a tensile force of 0.7kg is applied), the spigot shall not part from the drainage funnel of the catheter. | |
| 4 | Biocompatibility | Free from biological hazard. | |
| 5 | Sterility | Comply with EN556 | |
| 6 | EO Residue | ≤10ug/g 0.0592ug/g | |
| 7 | Symbols & Labeling | Comply with EN980 & prEN1041EN980 & prEN1041. | |