In the ISO 23747 standard developed by the International Organization for Standardization (ISO), the performance characteristics and test methods of flowmeters related to peak exhalation are described in order to evaluate lung function in spontaneously breathing people. This standard has also been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 23747 Anesthetic and respiratory equipment - Flow meter for peak exhalation to evaluate lung function in spontaneously breathing people.
The said standard describes requirements for a peak expiratory flow meter device developed for evaluating respiratory function in spontaneously breathing persons. This standard covers all medical devices that measure peak expiratory flow rate in spontaneously breathing humans as part of medical equipment with integrated lung function or as stand-alone medical equipment. When planning and designing equipment covered by this international standard, the environmental impact of the equipment throughout its lifetime must be taken into account. Environmental requirements are included in the standard annex. In addition, additional aspects of environmental impact are addressed in the TS EN ISO 14971 Medical devices - Application of risk management to medical devices standard.
The standards that are referred to as normative in the application of this standard and indispensable for its implementation are: ISO 10993-1, ISO 14937, ISO 15223-1 and IEC 60601-1.
With the implementation of this standard, the safety and performance level of such medical equipment is increased and it is facilitated in the diagnosis and treatment of lung and respiratory diseases.
Our organization also provides performance testing services for flowmeters related to peak exhalation in order to evaluate the lung function of ISO 23747 spontaneously breathing people within the scope of laboratory services.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
