ISO/FDIS 18615-1

FINAL DRAFT
International
Standard
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Electric radial pulse tonometric
Voting begins on:
devices —
2026-06-15
Part 1:
Voting terminates on:
2026-08-10
General requirements
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Electric radial pulse tonometric
Voting begins on:
devices —
Part 1:
Voting terminates on:
General requirements
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
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
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
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 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
FINAL DRAFT International Standard ISO/FDIS 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 tonom
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ISO/TC 249/SC 1/WG 4
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Secretariat: SAC .
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Date: YYYY-MM-DD2026-06-01
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Traditional Chinese medicine — Electric radial pulse tonometric .
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devices — — .
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Part 1:
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General requirements
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Warning for WDs and CDs
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This document is not an ISO International Standard. It is distributed for review and comment. It is subject to change
without notice and may not be referred to as an International Standard. Style Definition
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Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which
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they are aware and to provide supporting documentation. .
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St l D fi iti
A model manuscript of a draft International Standard (known as “The Rice Model”) is available at
https://www.iso.org/iso/model_document-rice_model.pdf

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
Formatted: Left: 1.5 cm, Right: 1.5 cm, Header distance
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, from edge: 1.27 cm, Footer distance from edge: 0.5 cm
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
E-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
Formatted: Font: Bold
Formatted: Font: Bold
Formatted: HeaderCentered, Line spacing: single
Contents
Foreword . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 4
5 General requirements for testing of equipment . 4
6 Classification of equipment and systems . 4
7 Equipment identification, marking and documents . 4
7.1 General . 4
7.2 Marking on the transducer module or wristband. 4
7.3 Instructions for use . 4
7.4 Messages . 5
8 Protection against electrical hazards from equipment . 5
9 Protection against mechanical hazards of equipment and systems . 5
9.1 General . 5
9.2 Safety pressure range of actuator . 5
9.3 Stability of actuator movement . 5
10 Protection against unwanted and excessive radiation hazards . 6
11 Protection against excessive temperatures and other hazards . 6
12 Accuracy of controls and instruments and protection against hazardous outputs . 6
12.1 General . 6
12.2 Accuracy of controls and instruments . 6
13 Hazardous situations and fault conditions . 8
14 Programmable electrical medical systems (PEMS) . 8
15 Construction of equipment . 8
15.1 General . 8
15.2 Drop test . 8
15.3 Detection of pressure transducer and pressure transducer cable fault . 8
16 Systems . 8
17 Electromagnetic compatibility of equipment and systems . 8
18 Requirements of transducer and transducer module of equipment . 8
18.1 Lifespan of transducer . 8
18.2 Reliability of transducer . 9
Annex A (informative) Radial pulse waveform and pulse parameter . 10
Bibliography . 12

Foreword . iv
1 Scope . 1
Formatted: Font: 11 pt
2 Normative references . 1
Formatted: FooterPageRomanNumber, Space Before: 0 pt,
3 Terms and definitions . 1
Line spacing: single, Tab stops: Not at 17.2 cm
iv © ISO 20202026 – All rights reserved
iv
Formatted: Font: Bold
Formatted: Font: Cambria, Bold
Formatted: Font: Bold
4 General requirements . 3
Formatted: Font: Bold
5 General requirements for testing of ME equipment . 3
Formatted: HeaderCentered, Left, Line spacing: single
6 Classification of ME equipment and ME systems . 4
7 ME equipment identification, marking and documents . 4
7.1 General . 4
7.2 Marking on the transducer module or wristband. 4
7.3 Instructions for use . 4
7.4 Messages . 5
8 Protection against electrical hazards from ME equipment . 5
9 Protection against mechanical hazards of ME equipment and ME systems . 5
9.1 General . 5
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 . 6
12.2.1 Accuracy of applied pressure measurement . 6
12.2.2 Accuracy of pulse pressure measurements . 6
12.2.3 Accuracy of pulse rate measurements . 6
12.2.4 Requirements of geometric measurements . 6
12.2.5 Accuracy of measurement position . 7
13 Hazardous situations and fault conditions . 7
14 Programmable electrical medical systems (PEMS) . 7
15 Construction of ME equipment . 7
15.1 General . 7
15.2 Drop test . 7
15.3 Detection of pressure transducer and pressure transducer cable fault . 8
16 ME systems . 8
17 Electromagnetic compatibility of ME equipment and ME systems . 8
18 Requirements of transducer and transducer module of ME equipment . 8
18.1 Lifespan of transducer . 8
18.2 Reliability of transducer . 8
Annex A (informative) Radial pulse waveform and pulse parameter . 9
Bibliography . 10

Formatted: Font: 11 pt
Formatted: FooterPageRomanNumber, Space Before: 0 pt,
Line spacing: single, Tab stops: Not at 17.2 cm
v
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Formatted: HeaderCentered, Line spacing: single
Foreword
Formatted: Adjust space between Latin and Asian text,
Adjust space between Asian text and numbers
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
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely 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 documentsdocument should be noted. This document was drafted in accordance with the editorial rules
of the ISO/IEC Directives, Part 2 (see www.iso.org/directiveswww.iso.org/directives).
Attention is drawnISO draws attention to the possibility that some of the elementsimplementation of this
document may beinvolve the subjectuse of (a) patent(s). ISO takes no position concerning the evidence,
validity or applicability of any claimed patent rights. in respect thereof. As of the date of publication of this
document, ISO had not received notice of (a) patent(s) which may be required to implement this document.
However, implementers are cautioned that this may not represent the latest information, which may be
obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for
identifying any or all such patent rights. Details of any patent rights identified during the development of the
document will be in the Introduction and/or on the ISO list of patent declarations received (see
www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
www.iso.org/iso/foreword.html), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC1, Formatted: Font: Not Italic
Traditional Chinese medicine.
This second edition of ISO 18615-1, cancels and replaces the first edition (ISO 18615:2020),, which has been
technically revised.
The main changes are as follows: Formatted: Font: Cambria
— — The document has been splittedsplit into a series and renumbered accordingly.
Formatted: English (United Kingdom)
Formatted: English (United Kingdom)
— — Performance test methods have been separated from this document and are intended to be specified
Formatted: List Continue 1
in a future part of ISO 18615.
ISO 18615 of the following parts, under the general title: Traditional Chinese medicine — Electric radial pulse
tonometric devices:
— Part 1: General requirements
Formatted: Adjust space between Latin and Asian text,
A list of all parts in the ISO 18615 series can be found on the ISO website.
Adjust space between Asian text and numbers
Any feedback or questions on this document should be directed to the user’s national standards body. A Formatted: Font: 11 pt
complete listing of these bodies can be found at www.iso.org/members.htmlwww.iso.org/members.html.
Formatted: FooterPageRomanNumber, Space Before: 0 pt,
Line spacing: single, Tab stops: Not at 17.2 cm
vi © ISO 20202026 – All rights reserved
vi
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Formatted: Font: Cambria, Bold
Formatted: Font: Bold
Formatted: Font: Bold
Traditional Chinese medicine — Electric radial pulse tonometric
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devices — —
Formatted: Main Title 2, Adjust space between Latin and
Part 1:
Asian text, Adjust space between Asian text and numbers
General Requirementsrequirements
Formatted: Left: 1.5 cm, Right: 1.5 cm, Section start: New
page, Header distance from edge: 1.27 cm, Footer distance
1 Scope from edge: 0.5 cm
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 Formatted: Default Paragraph Font
and essential performance
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
3 Terms and definitions
Formatted: Default Paragraph Font
For the purposes of this document, the following terms and definitions apply.
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
Formatted: Adjust space between Latin and Asian text,
— — ISO Online browsing platform: available at https://www.iso.org/obphttps://www.iso.org/obp Adjust space between Asian text and numbers, Tab stops:
Not at 0.7 cm + 1.4 cm + 2.1 cm + 2.8 cm + 3.5 cm + 4.2
cm + 4.9 cm + 5.6 cm + 6.3 cm + 7 cm
— — IEC Electropedia: available at http://www.electropedia.org/https://www.electropedia.org/
Formatted: Adjust space between Latin and Asian text,
3.1 3.1
Adjust space between Asian text and numbers
electric radial pulse tonometric device
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non-invasive medical electrical (ME) equipment that incorporates a transducer to measure the radial pulse
Adjust space between Asian text and numbers, Tab stops:
(3.5)(3.5) while pressure is applied to the skin and radial artery using a rigid flat surface
Not at 0.7 cm + 1.4 cm + 2.1 cm + 2.8 cm + 3.5 cm + 4.2
cm + 4.9 cm + 5.6 cm + 6.3 cm + 7 cm
Note 1 to entry: ME equipment includes all applied parts and accessories.
Formatted: TermNum2, Adjust space between Latin and
3.2 3.2 Asian text, Adjust space between Asian text and numbers
pulse diagnosis
Formatted: Adjust space between Latin and Asian text,
examination of the pulse for diagnosisticdiagnostic purposes
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Not at 0.7 cm + 1.4 cm + 2.1 cm + 2.8 cm + 3.5 cm + 4.2
[SOURCE: Adapted from WHO International Standard Terminologies on Traditional Medicine in the Western cm + 4.9 cm + 5.6 cm + 6.3 cm + 7 cm
Pacific Region, Geneva: World Health Organization; 2007]
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Asian text, Adjust space between Asian text and numbers
3.3
Formatted: Font: 11 pt
[SOURCE: WHO Guidelines, 2007, p. 101[2] modified — "for making diagnosis" has been revised to "for
diagnostic purposes"]
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spacing: single, Tab stops: Not at 17.2 cm
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3.3
position Formatted: Adjust space between Latin and Asian text,
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location on the wrist for pulse measurement
3.4.1
3.3.1 Inch(
inch
cun)
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section of the pulse diagnosis (3.2)(3.2) position (3.3)(3.3) located on the distal side of the radial artery, next
to the bar/guan (3.4.2),(3.4.2), where the tip of the physician’s index finger rests
Formatted: Font: Italic
[SOURCE: Adapted from WHO International Standard Terminologies on Traditional Medicine in the Western
Pacific Region, Geneva: World Health Organization; 2007]
3.4.2
3.3.2 Bar(
bar
guan) Formatted: Adjust space between Latin and Asian text,
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section of the pulse diagnosis (3.2)(3.2) position (3.3)(3.3) located just central to the radial artery at the wrist,
where the tip of the physician’s middle finger is placed
Formatted: Font: Italic
[SOURCE: Adapted from WHO International Standard Terminologies on Traditional Medicine in the Western
Pacific Region, Geneva: World Health Organization; 2007]
3.3.3 3.4.3
Formatted: TermNum3, Adjust space between Latin and
Cubit( Asian text, Adjust space between Asian text and numbers
chi)
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section of the pulse diagnosis (3.2)(3.2) position (3.3)(3.3) located on the proximal side of the radial artery,
Adjust space between Asian text and numbers
where the tip of the physician’s fourth finger is placed
Formatted: Font: Italic
[SOURCE: Adapted from WHO International Standard Terminologies on Traditional Medicine in the Western
Pacific Region, Geneva: World Health Organization; 2007]
3.4 3.5
Formatted: TermNum2, Adjust space between Latin and
radial pulse Asian text, Adjust space between Asian text and numbers
pulsation of the radial artery felt at the wrist
[SOURCE: Adapted from WHO International Standard Terminologies on Traditional Medicine in the Western
Pacific Region, Geneva: World Health Organization; 2007]
3.6
[SOURCE: WHO Guidelines, 2007, p. 101[2], modified — the term "wrist pulse" is revised to "radial pulse".]
3.5
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pressure transducer
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device for converting pressure into an electrical signal
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Note 1 to entry: Pressure transducer can be single or array.
Not at 0.7 cm + 1.4 cm + 2.1 cm + 2.8 cm + 3.5 cm + 4.2
cm + 4.9 cm + 5.6 cm + 6.3 cm + 7 cm
3.6 3.7
transducer module Formatted: TermNum2, Adjust space between Latin and
Asian text, Adjust space between Asian text and numbers
module of a tonometric device that includes a transducer, case, cable a
...