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Standards Development
This document specifies particular requirements for the basic safety and essential performance of noninvasive arterial tonometer equipment and their parts or accessories. Devices that measure vessels
other than vascular smooth muscle arteries are excluded.
The intended use of non-invasive arterial tonometer equipment includes, but is not limited to, the
analysis of pulse waveform contours for estimating hemodynamic parameters (e.g.: blood pressure,
blood vessel function, blood flow and circulation condition such as stroke volume, systemic vascular
resistance, etc.) and pulse rate of patients in professional healthcare institutes.
This document is not applicable to non-invasive arterial tonometer equipment intended for use in
laboratory research. Clinical performance verification of physiological parameters is not addressed.
This document is a particular standard in the IEC60601-1 and ISO and IEC80601 series of standards.
Growth of the Non-Invasive Arterial Tonometer Equipment market
According to recent market reports, the global medical device market is projected to grow from
approximately USD 518.46 billion in 2023 to USD 886.8 billion by 2032, with a compound annual
growth rate (CAGR) of 6.3%. This growth is driven by the rising prevalence of chronic diseases such as cardiovascular disease, renal disease, and diabetes, as well as advancements in non-invasive
diagnostic and monitoring technologies.
Among these technologies, the non-invasive arterial tonometer equipment market is expected to
expand from USD 104.3 million in 2022 to approximately USD 194 million by 2032, with a CAGR of
5.8%. Non-invasive arterial tonometer equipment plays a crucial role in non-invasive hemodynamic
monitoring, offering key functionalities such as arterial stiffness assessment, tonometry-based blood
pressure measurement, blood flow estimation and central blood pressure analysis. These devices are
widely used for early diagnosis and treatment monitoring in various conditions, including hypertension,
renal disease, chronic obstructive pulmonary disease (COPD), diabetes, and heart failure.
Performance and Safety Challenges in Non-Invasive Arterial Tonometer Equipment
Non-invasive arterial tonometer equipment is applied to major arteries such as radial, carotid, and
femoral arteries, enabling precise measurement of blood pressure, stroke volume, cardiac output, and
arterial stiffness. However, the accuracy and safety of these devices depend significantly on precise
pressure control, accurate identification of vascular locations, and reliable pulse wave analysis.
Despite their increasing adoption, there is currently no international standard for evaluating the
performance and safety of these devices. As a result, many manufacturers rely on existing related
medical device standards or adopt relevant clauses to demonstrate compliance, leading to challenges
in performance comparison and clinical reliability.
The Need for an International Standard in Non-Invasive Arterial Tonometer Equipment
To support the continued growth of the non-invasive arterial tonometer equipment market and enhance
product reliability, the development of international medical device standards is essential.
• Establishing international standard for performance validation, safety evaluation, and regulatory
compliance will improve global market accessibility, product reliability, and fair competition.
• The use of pulse waveform simulators, in-silico research methods and other advanced validation
techniques can further refine testing protocols and enhance trust in clinical applications.
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