ISO 18615-1:2026

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
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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
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
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with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
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
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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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
...