Certification
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Testing and Certification for Oxygen concentrator
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- KOKILA Oxygen Concentrator is meant to be an experimental device made available for emergency use in medical care settings in the absence of availability of other solutions.
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The KOKILA Oxygen concentrator is tested at a third-party accredited laboratory for performance, safety & efficacy for following tests.
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| Sr. No. | Tests | Standard & Clause No |
| 1 | Humidity Preconditioning | ISO 80601-2-69 (Clause 201.5) IEC 60601-1 (Clause 5.7) |
| 2 | Leakage Currents and Patient Auxiliary Currents | ISO 80601-2-69 (Clause 201.8) IEC 60601-1 (Clause 8.7, 8.7.1, 8.7.3 & 8.7.4.5) |
| 3 | Leakage Currents and Patient Auxiliary Currents | ISO 80601-2-69 (Clause 201.8) IEC 60601-1 (Clause 8.7, 8.7.1, 8.7.3 & 8.7.4.6) |
| 4 | Accuracy of continuous flow rate | ISO 80601-2-69 (Clause 201.12.1.101) |
| 5 | Accuracy of concentration | ISO 80601-2-69 (Clause 201.12.1.103) |
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