The COVID-19 pandemic has provoked a great impact, especially for medical devices, and there has been a much necessary adaptation effort. In this respect, the International Standards Organization (ISO) has announced the elaboration of new standards on Ventilators and Pulse Oximeters.
The new ISO/DIS 80601-2-90 standard – currently under development – addresses intensive care ventilators, for both intensive care units and transportation, and non-invasive ventilators, formed by continuous positive airway pressure (CPAP), Bilevel positive airway pressure (BiPAP/BPAP), and the High-flow nasal cannula (HFNC) (WHO, 2020).
The COVID-19 pandemic has created the need to produce considerable amounts of ventilators, namely the HFCN, designed to give patients breathing support while remaining conscious. Due to this specificity, the scarcity of devices has often led to the use of ventilators not intended as medical devices, such as those made to deal with sleep apnea.
This has also been the case of the Pulse Oximeters, covered by the new standard too, which have been substituted by pulse oximeters more referred to “general wellness products” due to the high demand during the pandemic (ISO, 2021). In this respect, the International Standards Organization (which previously published a COVID-19 related list of free ISO standards as well) is contributing to fighting the COVID-19 pandemic by publishing new set of standards for “moderately ill COVID-19 patients” (ISO, 2021). An area with no previous international or national standards.
Keeping your medical device updated with the latest ISO standards will not only help you as a manufacturer to produce it, since your product will be more keenly accepted by national regulators, but it will also benefit the final users of the product, as it will instruct them on the appropriate way of use. This is of special importance when dealing with medical devices that have a huge impact on the patient’s life and whose effectiveness is highly dependent on the use as stated by the WHO (2020).
Therefore, if your product falls under the category of medical devices, such as Ventilators or Pulse Oximeters, please take a look at the new iso standard ISO/DIS 80601-2-90 on Medical electrical equipment.
Are you a manufacturer of a device helping in the COVID-19 pandemic? Are you aware of all the applicable rules on the EU market?
Pablo DE MINGO MONGE
Regulatory Affairs department
References:
- WHO. (15 April 2020). Technical specifications for invasive and non-invasive ventilators for COVID-19. Retrieved on 02/02/2021 from https://apps.who.int/iris/bitstream/handle/10665/331792/WHO-2019-nCoV-Clinical-Ventilator_Specs-2020.1-eng.pdf
- ISO. (12 January 2021). COVID-19 pandemic triggers development of new standard for ventilators. Retrieved on 02/02/2021 from https://www.iso.org/news/ref2610.html
- ISO. (2021). ISO/DIS 80601-2-90(en) Medical electrical equipment — Part 2-90: Particular requirements for basic safety and essential performance of ventilatory high-flow therapy equipment. Retrieved on 02/02/2021 from https://www.iso.org/obp/ui/#iso:std:iso:80601:-2-90:dis:ed-1:v1:en
- ISO. (16 April 2020). COVID-19 Response: Freely available ISO standards. Retrieved on 04/02/2021 from: https://www.iso.org/covid19
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