ISO 18615:2020

Traditional Chinese medicine - General requirements of electric radial pulse tonometric devices

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.

Médecine traditionnelle chinoise – Exigences générales relatives aux tonomètres à impulsions électriques radiales

General Information

• Status: Published
• Publication Date: 05-Jan-2020
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 4 - Quality and safety of medical devices other than acupuncture needles
• Current Stage: 9092 - International Standard to be revised
• Start Date: 12-Jun-2023
• Completion Date: 13-Dec-2025

Overview

ISO 18615:2020 - Traditional Chinese medicine: General requirements of electric radial pulse tonometric devices - specifies the general requirements for basic safety and essential performance of pressure‑based radial pulse tonometric devices used in Traditional Chinese Medicine (TCM). The standard applies to medical electrical (ME) equipment that measures the radial pulse using a pressure transducer and actuator. It explicitly does not cover the accuracy of differential diagnosis or interpretation of diagnostic data.

Key topics and technical requirements

• Scope and normative reference: References IEC 60601-1 for general medical electrical safety and testing requirements.
• Definitions: Key terms such as pressure transducer, transducer module, actuator, pulse waveform, and the TCM pulse positions (inch/cun, bar/guan, cubit/chi).
• Marking and identification: Transducer modules or wristbands must include a visible radial artery position mark and position identification to prevent incorrect placement; separate indicators required for one‑finger and three‑finger methods.
• Instructions for use: Must include intended use and environment, list of specified accessories, compatible equipment, connection and placement procedures, cleaning/disinfection guidance, performance specs, ageing/environmental cautions, and troubleshooting messages.
• Actuator safety: Applied pressure for patient safety limited to 600 mmHg (80 kPa); automatic actuators must have mechanical limiters and in a single‑fault condition be limited to 660 mmHg (88 kPa).
• Accuracy of applied pressure: Measurement range at least 0–120 mmHg (16 kPa); resolution ≤ 2 mmHg; accuracy within ±5% of reading or ±6 mmHg, whichever is greater.
• Mechanical and signal stability: Actuator movement (mechanical or air‑bladder) must not introduce baseline fluctuations that affect pulse signal; transducer fault detection and lifespan/reliability requirements are addressed.
• Testing and annexes: Annex A covers radial pulse waveform and parameters; Annex B gives reliability test method and reference.

Applications and practical value

• Guides manufacturers in the design, verification and documentation of radial pulse tonometric devices to meet safety and essential performance expectations.
• Used by regulatory bodies and conformity assessment bodies for device evaluation and market approval.
• Useful for clinical engineers, product designers, QA/test labs, and procurement teams assessing device specifications and compatibility with IEC 60601‑1 requirements.
• Supports clear labeling, user instructions, infection control, and safe actuator design to protect patients and operators.

Related standards

• IEC 60601‑1:2005/AMD1:2012 - Medical electrical equipment: referenced for general safety and essential performance requirements.
• WHO TCM terminology resources are used for pulse position definitions (informative reference).

Keywords: ISO 18615:2020, electric radial pulse tonometric devices, radial pulse tonometry, pressure transducer, TCM pulse diagnosis, medical electrical equipment, IEC 60601-1.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 18615
First edition
2020-01
Traditional Chinese medicine —
General requirements of electric
radial pulse tonometric devices
Médecine traditionnelle chinoise – Exigences générales relatives aux
tonomètres à impulsions électriques radiales
Reference number
©
ISO 2020
© ISO 2020
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
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below or ISO’s member body in the country of the requester.
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Published in Switzerland
ii © ISO 2020 – All rights reserved

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 ME equipment . 3
6 Classification of ME equipment and ME systems . 3
7 ME 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 . 3
7.4 Messages . 4
8 Protection against electrical hazards from ME equipment . 4
9 Protection against mechanical hazards of ME equipment and ME systems .4
9.1 General . 4
9.2 Safety pressure range of actuator . 4
9.3 Stability of actuator movement . 4
10 Protection against unwanted and excessive radiation hazards. 4
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 . 6
12.2.3 Accuracy of pulse rate measurements . 7
12.2.4 Requirements of geometric measurements . 7
12.2.5 Accuracy of measurement position . 8
13 Hazardous situations and fault conditions . 8
14 Programmable electrical medical systems (PEMS) . 8
15 Construction of ME equipment . 9
15.1 General . 9
15.2 Drop test . 9
15.3 Detection of pressure transducer and pressure transducer cable fault . 9
16 ME systems. 9
17 Electromagnetic compatibility of ME equipment and ME systems .9
18 Requirements of transducer and transducer module of ME equipment .9
18.1 Lifespan of transducer . 9
18.2 Reliability of transducer .10
Annex A (informative) Radial pulse waveform and pulse parameter .11
Annex B (informative) Reliability test method and reference .12
Bibliography .13
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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iv © ISO 2020 – All rights reserved

INTERNATIONAL STANDARD ISO 18615:2020(E)
Traditional Chinese medicine — General requirements of
electric radial pulse tonometric devices
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 http:// 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 diagnosistic purposes
[SOURCE: Adapted from WHO International Standard Terminologies on Traditional Medicine in the
Western Pacific Region, 2007]
3.3
position
location on the wrist for pulse measurement
3.4.1
inch/cun
section of the pulse diagnosis (3.2) position (3.3) located on the distal side of the radial artery, next to
the bar/guan (3.4.2), where the tip of the physician’s index finger rests
[SOURCE: Adapted from WHO International Standard Terminologies on Traditional Medicine in the
Western Pacific Region, 2007]
3.4.2
bar/guan
section of the pulse diagnosis (3.2) position (3.3) located just central to the radial artery at the wrist,
where the tip of the physician’s middle finger is placed
[SOURCE: Adapted from WHO International Standard Terminologies on Traditional Medicine in the
Western Pacific Region, 2007]
3.4.3
cubit/chi
section of the pulse diagnosis (3.2) position (3.3) located on the proximal side of the radial artery, where
the tip of the physician’s fourth finger is placed
[SOURCE: Adapted from WHO International Standard Terminologies on Traditional Medicine in the
Western Pacific Region, 2007]
3.5
radial pulse
pulsation of the radial artery felt at the wrist
[SOURCE: WHO International Standard Terminologies on Traditional Medicine in the Western Pacific
Region, 2007]
3.6
pressure transducer
device for converting pressure into an electrical signal
Note 1 to entry: Pressure transducer can be single or array.
3.7
transducer module
module of a tonometric device that includes a transducer, case, cable and actuator (3.8) (if applicable)
3.8
actuator
device to apply pressure to the radial pulse (3.5)
Note 1 to entry: The actuator is included in an automatic pressing system. It is not included in a non-automatic
pressing system.
3.9
pulse waveform
pulse contour of the radial pulse (3.5)
Note 1 to entry: See Figure A.1.
3.10
applied pressure
pressure applied to the pulse position (3.3) by the transducer module (3.7)
3.11
pulse pressure
measure of pulse signal when pressure is applied at the pulse diagnosis (3.2) position (3.3)
2 © ISO 2020 – All rights reserved

3.12
pulse waveform simulator
device for generating the virtual pulse waveform (3.9) and applied pressure (3.10)
3.13
static pressure
pressure applied by a pulse waveform simulator (3.12) or other mechanical tester
3.14
one-finger method
pulse-taking method using pressure from one finger at a time on each pulse section
3.15
three-finger method
pulse-taking method using pressure from three fingers simultaneously on the three pulse sections
4 General requirements
IEC 60601-1:2005/AMD1: 2012, Clause 4, applies.
5 General requirements for testing of ME equipment
IEC 60601-1:2005/AMD1: 2012, Clause 5, applies.
6 Classification of ME equipment and ME systems
IEC 60601-1:2005/AMD1: 2012, Clause 6, applies.
7 ME equipment identification, marking and documents
7.1 General
IEC 60601-1:2005/AMD1: 2012, Clause 7, applies.
7.2 Marking on the transducer module or wristband
A transducer module or wristband for electric radial pulse tonometric devices shall have a visible radial
artery position mark and a position identification mark to prevent the incorrect pulse position(s) being
measured.
For the one-finger method, ME equipment shall have a visible indicator to identify the pulse position
(e.g. left-hand, right-hand, inch/cun, bar/guan or cubit/chi) to prevent the measuring software program
measuring the pulse location at the incorrect position.
For the three-finger method, ME equipment shall have a visible indicator of the pulse position on the
t
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