ISO 18615-1:2026

• Abstract:

  This document specifies the general requirements for basic safety and essential performance of electric radial pulse tonometric devices. This document does not apply to the accuracy of differential diagnosis or interpretation of the diagnostic data obtained from the use of such devices. This document applies to pressure-based radial pulse tonometric devices.

• Status: Published
• Publication Date: 17-Sep-2026
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 6060 - International Standard published
• Start Date: 18-Sep-2026
• Due Date: 12-Jun-2026
• Completion Date: 18-Sep-2026

• Revises: ISO 18615:2020 - Traditional Chinese medicine — General requirements of electric radial pulse tonometric devices
• Effective Date: 17-Jun-2023

ISO 18615-1:2026 is an International Standard from ISO for electric radial pulse tonometric devices used in traditional Chinese medicine. It specifies general requirements for basic safety and essential performance for pressure-based devices. The standard is aimed at manufacturers, test laboratories, and others who need to design, verify, label, or assess these devices.

What does ISO 18615-1:2026 specify?

ISO 18615-1:2026 applies to pressure-based radial pulse tonometric devices and sets out their general safety and performance framework. It excludes the accuracy of differential diagnosis and the interpretation of the diagnostic data produced by the device.

The document is organized into clauses 1 to 18, covering scope, references, terms, general requirements, testing, classification, identification and marking, electrical and mechanical hazards, radiation and temperature hazards, measurement accuracy, fault and hazardous situation handling, PEMS, construction, systems, EMC, and transducer requirements. Annex A is informative and shows the radial pulse waveform and pulse parameter.

What are the key requirements of ISO 18615-1:2026?

ISO 18615-1:2026 builds on IEC 60601-1 and adds device-specific requirements for measuring radial pulse with applied pressure. The most important points are the pressure limits, the measurement accuracy limits, the marking and IFU content, and the checks for faults and mechanical safety.

Safety, protection, and actuator limits

Clauses 4 to 17 of IEC 60601-1:2005/AMD1:2012 apply across the standard, covering general safety, testing, classification, electrical hazards, radiation, temperature, hazardous situations, PEMS, systems, and EMC. In practice, this means the device is expected to be handled like medical electrical equipment with the same safety discipline used for other patient-contacting equipment.

For actuators, the patient safety pressure is limited to 600 mmHg. Non-automatic actuators need a mechanical limiter that stays within that limit, and automatic actuators need both a mechanical limiter and a single-fault limit of 660 mmHg. This matters because the device applies pressure directly to the wrist, so overshoot has to be controlled by design.

The actuator movement also has to remain stable, without baseline fluctuation noise that could disturb the pulse signal. That requirement connects mechanical behavior with signal quality, so the pressure mechanism has to support the measurement rather than distort it.

Measurement performance

The standard sets minimum ranges, resolution, and accuracy for applied pressure, pulse pressure, and pulse rate. Applied pressure measurement must cover at least 0 mmHg to 120 mmHg, and pulse pressure measurement must cover at least 0 mmHg to 105 mmHg, with stated resolution and accuracy limits. Pulse rate measurement must cover at least 40 bpm to 150 bpm.

For pulse pressure, the document defines the measurement as the amplitude of the first peak of the radial pulse waveform shown in Annex A. That gives a common basis for comparing devices and for test methods used in verification.

For array transducers, the standard also sets requirements for geometric measurements of pulsation contact length, width, area, and volume, and it requires position accuracy within ±1 mm when the device confirms the measurement position. In practice, these requirements help ensure that the device is measuring the intended wrist location and that array sensors are aligned consistently.

Marking, instructions, construction, and fault handling

Clause 7 requires visible marks that identify the radial artery position and the pulse position, so the wrong site is less likely to be measured. The IFU has to cover intended use, accessories, connection and preparation, placement, cleaning and disinfection, reuse limits, infection precautions, ageing or environmental effects, performance specifications, and troubleshooting. The document also requires visible system, error, and fault messages unless they are self-explanatory.

Clause 15 requires a drop test for a transducer module that can be separated by the clinical operator, and it requires fault detection for transducer and cable problems. If a wire is exposed, shorted, or unplugged in a way that causes malfunction, the device must give an indicator or message. That helps users spot failures before they affect a measurement.

What terms does ISO 18615-1:2026 define?

• electric radial pulse tonometric device - Non-invasive medical electrical equipment that uses a transducer to measure the radial pulse while pressure is applied to the skin and radial artery with a rigid flat surface.
• pressure transducer - A device that converts pressure into an electrical signal.
• transducer module - The module of a tonometric device that includes the transducer, case, cable, and actuator if applicable.
• actuator - The device that applies pressure to the radial pulse, usually in an automatic pressing system.
• pulse waveform - The contour of the radial pulse, shown in Annex A.
• instruction for use (IFU) - The accompanying information needed for safe and effective use of the medical device or accessory.
• medical electrical equipment (ME equipment) - Electrical medical device with an applied part or that transfers energy or substances to or from the patient.

Who uses ISO 18615-1:2026?

ISO 18615-1:2026 is used by manufacturers and suppliers of electric radial pulse tonometric devices, especially those making pressure-based systems for traditional Chinese medicine. It is also used by test laboratories, quality and regulatory teams, and clinical operators who need clear marking, instructions, and safety expectations.

In practice, these users rely on the standard for design verification, safety testing, product documentation, purchasing specifications, and acceptance checks.

What changed in ISO 18615-1:2026 from the previous edition?

This second edition cancels and replaces ISO 18615:2020, and it has been technically revised.

The main changes stated in the foreword are:

• the document has been split into a series and renumbered accordingly;
• performance test methods have been separated from this part and are intended for a future part of ISO 18615.

Which standards are used with ISO 18615-1:2026?

• IEC 60601-1:2005/AMD1:2012 - Provides the base requirements for basic safety and essential performance, and Clauses 4 to 17 are applied throughout this standard.
• IEC 60601-1-2 - Cited in the bibliography and note as the EMC collateral standard that frames electromagnetic compatibility for medical electrical equipment.
• ISO 20417:2021 - Supplies the source definition for instruction for use, which is adapted in Clause 3.
• ISO 17510:2025 - Supplies the source definition for medical electrical equipment, which is adapted in Clause 3.
• ISO 18615 series - Clause 18.2 refers to the series standard for reliability testing, and the foreword says performance test methods are intended for a future part of the series.

What does the ISO 18615-1:2026 document contain?

The document contains the applied IEC 60601-1 clauses, the device-specific marking and IFU requirements, the pressure and pulse measurement limits, and the mechanical safety limits for actuators. It also includes requirements for drop testing, transducer fault detection, transducer lifespan disclosure, and reliability testing when such information is provided.

Annex A adds an informative figure of the radial pulse waveform, including the first peak, inflection point, second peak, and dicrotic notch. That annex supports how pulse pressure is defined and measured in practice.

International
Standard
ISO 18615-1
Second edition
Traditional Chinese medicine —
2026-09
Electric radial pulse tonometric
devices —
Part 1:
General requirements
Médecine traditionnelle chinoise — Tonomètres à impulsions
électriques radiales —
Partie 1: Exigences générales
Reference number
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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or ISO’s member body in the country of the requester.
ISO copyright office
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Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
5 General requirements for testing of equipment . 3
6 Classification of equipment and systems . 3
7 Equipment identification, marking and documents . 3
7.1 General .3
7.2 Marking on the transducer module or wristband .3
7.3 Instructions for use .4
7.4 Messages .4
8 Protection against electrical hazards from equipment . 4
9 Protection against mechanical hazards of equipment and systems . 4
9.1 General .4
9.2 Safety pressure range of actuator .5
9.3 Stability of actuator movement .5
10 Protection against unwanted and excessive radiation hazards . 5
11 Protection against excessive temperatures and other hazards . 5
12 Accuracy of controls and instruments and protection against hazardous outputs . 5
12.1 General .5
12.2 Accuracy of controls and instruments .5
12.2.1 Accuracy of applied pressure measurement .5
12.2.2 Accuracy of pulse pressure measurements .5
12.2.3 Accuracy of pulse rate measurements .6
12.2.4 Requirements of geometric measurements .6
12.2.5 Accuracy of measurement position .6
13 Hazardous situations and fault conditions . 6
14 Programmable electrical medical systems (PEMS) . 6
15 Construction of equipment . 7
15.1 General .7
15.2 Drop test .7
15.3 Detection of pressure transducer and pressure transducer cable fault .7
16 Systems . 7
17 Electromagnetic compatibility of equipment and systems . 7
18 Requirements of transducer and transducer module of equipment . 7
18.1 Lifespan of transducer .7
18.2 Reliability of transducer .7
Annex A (informative) Radial pulse waveform and pulse parameter . 8
Bibliography . 9

iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
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Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC1,
Traditional Chinese medicine.
This second edition of ISO 18615-1, cancels and replaces the first edition of ISO 18615:2020, which has been
technically revised.
The main changes are as follows:
— The document has been split into a series and renumbered accordingly.
— Performance test methods have been separated from this document and are intended to be specified in
a future part of ISO 18615.
A list of all parts in the ISO 18615 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
International Standard ISO 18615-1:2026(en)
Traditional Chinese medicine — Electric radial pulse
tonometric devices —
Part 1:
General requirements
1 Scope
This document specifies the general requirements for basic safety and essential performance of electric
radial pulse tonometric devices.
This document does not apply to the accuracy of differential diagnosis or interpretation of the diagnostic
data obtained from the use of such devices.
This document applies to pressure-based radial pulse tonometric devices.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
IEC 60601-1:2005/AMD1: 2012, Medical electric equipment — Part 1: General requirements for basic safety and
essential performance
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
electric radial pulse tonometric device
non-invasive medical electrical (ME) equipment that incorporates a transducer to measure the radial pulse
(3.5) while pressure is applied to the skin and radial artery using a rigid flat surface
Note 1 to entry: ME equipment includes all applied parts and accessories.
3.2
pulse diagnosis
examination of the pulse for diagnostic purposes
[SOURCE: WHO Guidelines, 2007, p. 101[2] modified — "for making diagnosis" has been revised to "for
diagnostic purposes"]
3.3
position
location on the wrist for pulse measurement
...