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Testing and Certification for Oxygen concentrator (to be updated)

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  • 1. KOKILA Oxygen Concentrator ( EDC_PS_K019310) 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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  • 2. EDC_PS_K019310 has been tested in-house for oxygen concentration & flow rates. The machine has the ability to continuously monitor the data and alert users & the back office of any failure.

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  • 3. As of December 2021, an oxygen concentrator is not a notified device by CDSCO Link

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  • 4. The WHO has listed guidelines for oxygen concentrators which are as mentioned below. The EDC_PS_K019310 meets the specifications & requirements of the WHO guidelines
    • -COVID-19 Technical specifications for procurement of oxygen therapy and monitoring devices Link
    • -Technical Specifications for Oxygen Concentrators (WHO Medical Device Technical Series) Link

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As additional precautions, the KOKILA Oxygen concentrators are currently under testing at a third-party accredited laboratory for their performance, safety & efficacy. 

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Sr. No.Testing and Certification
1ISO 80601-2-69:2014 Medical electrical equipment – Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment.
2IEC 60601-1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
3IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests.
4IEC 60601-1-8:2012 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems.