No.: 705OA149
| List | Test Item | Requirements | Test Result | |||||||||
| TESTED PRODUCTS (length，cm.) | 4.0 | 5.0 | 6.0 | 7.0 | 8.0 | 9.0 | 10.0 | 11.0 | 12.0 | |||
| 1 | Minimum I. D. (mm) | Comply with table 1 in ISO53:2001 | OK | OK | OK | OK | OK | OK | OK | OK | OK | |
| 2 | Length (mm) | 40 | 49 | 60 | 70 | 79 | 108 | 106 | 119 | |||
| 3 | Resistance to collapse of the buccal portion | When tested in accordance with the method given in annex A, the minimum I.D. of the buccal portion during compression as a percentage of that value specified in Table 1 for the size of airway being tested. | Complies | |||||||||
| 4 | Patency of lumen | When tested in accordance with the method given in annex B, the steel ball passes freely through the lumen. | Complies | |||||||||
| 5 | Biocompatibility | Free from biological hazard. | Complies | |||||||||
| 6 | Sterility | Comply with EN556 | Complies | |||||||||
| 7 | RResidual EOesidual EO | ≤10ug/g | 0.1021ug/g | |||||||||
| 8 | Symbols & Labeling | Comply with EN980& prEN1041 | Complies | |||||||||
| Conclusion | All test results comply with the requirements of standard ISO 53:2001. | |||||||||||
