ISO/FDIS 18615-1

DRAFT
International
Standard
ISO/DIS 18615-1
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Electric radial pulse tonometric
Voting begins on:
devices —
2025-04-11
Part 1:
Voting terminates on:
2025-07-04
General requirements
ICS: 11.040.55
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Reference number
ISO/DIS 18615-1:2025(en)
DRAFT
ISO/DIS 18615-1:2025(en)
International
Standard
ISO/DIS 18615-1
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Electric radial pulse tonometric
Voting begins on:
devices —
Part 1:
Voting terminates on:
General requirements
ICS: 11.040.55
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
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Published in Switzerland Reference number
ISO/DIS 18615-1:2025(en)
ii
ISO/DIS 18615-1:2025(en)
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 .4
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 .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) . 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 .7
16 ME systems . 7
17 Electromagnetic compatibility of ME equipment and ME systems . 7
18 Requirements of transducer and transducer module of ME 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
ISO/DIS 18615-1:2025(en)
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 documents 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. 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.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
This second edition cancels and replaces the first edition (ISO 18615:2020), which has been technically
revised.
The main changes are as follows:
— The document number has been changed as the document has been expanded into a series.
— Performance test methods are moved to ISO 18615-2.
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
DRAFT International Standard ISO/DIS 18615-1:2025(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: availab
...