ISO 20495:2018

Traditional Chinese medicine — Skin electrical resistance measurement devices

ISO 20495:2018 specifies performance and test methods for skin electrical resistance measurement devices. ISO 20495:2018 is applicable to skin electrical resistance measurement devices through which an electrical signal is applied on acupuncture points of the human body or specific points of the body surface in a non-invasive way so as to detect the resistance of the body. ISO 20495:2018 is not applicable to software or functions for medical analysis of the test results. Additional guidance and rationale are given in Annex A.

Médecine traditionnelle chinoise — Détecteurs de résistance électrique aux points d’acuponcture

General Information

• Status: Published
• Publication Date: 19-Apr-2018
• ICS: 11.040.99 - Other medical 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: 6060 - International Standard published
• Start Date: 20-Apr-2018
• Completion Date: 20-Apr-2018

Standards Content (sample)

INTERNATIONAL ISO
STANDARD 20495
First edition
2018-04
Traditional Chinese medicine — Skin
electrical resistance measurement
devices
Médecine traditionnelle chinoise — Détecteurs de résistance
électrique aux points d’acuponcture
Reference number
ISO 20495:2018(E)
ISO 2018
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ISO 20495:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

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

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ii © ISO 2018 – All rights reserved
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ISO 20495:2018(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Technical requirements ................................................................................................................................................................................ 2

4.1 Measurable range ................................................................................................................................................................................. 2

4.2 Accuracy of measurement ............................................................................................................................................................. 2

4.3 Detection electrical signal ............................................................................................................................................................. 3

4.4 Electrode force indication device ............................................................................................................................................ 3

4.5 Force sensing switch of exploratory electrode ............................................................................................................ 3

4.6 Detection voltage .................................................................................................................................................................................. 4

4.7 Detection current .................................................................................................................................................................................. 4

4.8 Effective area of auxiliary electrode ..................................................................................................................................... 4

4.9 Electrical safety ...................................................................................................................................................................................... 4

4.10 Electromagnetic compatibility .................................................................................................................................................. 4

4.11 Biological evaluation .......................................................................................................................................................................... 4

Annex A (informative) Particular guidance and rationale ............................................................................................................. 6

Bibliography ................................................................................................................................................................................................................................ 9

© ISO 2018 – All rights reserved iii
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ISO 20495:2018(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 on 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 the following

URL: www .iso .org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.

iv © ISO 2018 – All rights reserved
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INTERNATIONAL STANDARD ISO 20495:2018(E)
Traditional Chinese medicine — Skin electrical resistance
measurement devices
1 Scope

This document specifies performance and test methods for skin electrical resistance measurement

devices.

This document is applicable to skin electrical resistance measurement devices through which an

electrical signal is applied on acupuncture points of the human body or specific points of the body

surface in a non-invasive way so as to detect the resistance of the body.

This document is not applicable to software or functions for medical analysis of the test results.

Additional guidance and rationale are given in Annex A.
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.

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process

IEC 60601-1, Medical electric equipment — Part 1: General requirements for basic safety and essential

performance

IEC 60601-1-2, Medical electric equipment — Part 1-2: General requirements for basic safety and essential

performance — Collateral standard: Electromagnetic compatibility — Requirements and tests

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 http: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
skin electrical resistance

direct current (DC) resistance value or alternating current (AC) resistance value between acupuncture

points on the skin surface of the patient (or specific points) and a reference point of the skin surface

(point on the skin in contact with auxiliary electrode)
3.2
skin electrical resistance measurement device

device that can detect electrical resistance on acupuncture points or specific points of the body surface

under the condition of electrical signals being applied to the human body
© ISO 2018 – All rights reserved 1
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ISO 20495:2018(E)
3.3
detection electrical signal

voltage signal or current signal on device or for match use applied to patient for electrical resistance

detection
3.4
auxiliary electrode

electrode that is fixed on specific points of the patient (e.g. hand-held or fixed on palm or forehead) for

reference use, which is relatively fixed during detection
3.5
exploratory electrode

electrode that directly contacts acupuncture points or specific points of the patient’s body surface,

constituting a pair of electrodes with an auxiliary electrode for resistance detection

3.6
detection voltage

root mean square (RMS) of maximum open-circuit voltage between the auxiliary electrode and the

exploratory electrode in the detection electrical signal
3.7
detection current

RMS of maximum current between the auxiliary electrode and the exploratory electrode in detection of

the electrical signal
3.8
electrode force indication device

device on the exploratory electrode or auxiliary electrode whose function is to control or display the

...