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

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Status
Published
Publication Date
05-Jan-2020
Current Stage
6060 - International Standard published
Start Date
22-Nov-2019
Completion Date
06-Jan-2020
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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 18615:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 18615:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 18615:2020(E)
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

© ISO 2020 – All rights reserved iii
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ISO 18615:2020(E)
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.

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 © ISO 2020 – All rights reserved
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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
© ISO 2020 – All rights reserved 1
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ISO 18615:2020(E)
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
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ISO 18615:2020(E)
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

...

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