ISO 20495:2018
(Amendment)Traditional Chinese medicine — Skin electrical resistance measurement devices
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
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
---------------------- Page: 1 ----------------------
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
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, 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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
---------------------- Page: 2 ----------------------
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---------------------- Page: 3 ----------------------
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---------------------- Page: 4 ----------------------
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 processIEC 60601-1, Medical electric equipment — Part 1: General requirements for basic safety and essential
performanceIEC 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 definitionsFor 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
---------------------- Page: 5 ----------------------
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
detection3.4
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 detection3.5
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
3.6detection voltage
root mean square (RMS) of maximum open-circuit voltage between the auxiliary electrode and the
exploratory electrode in the detection electrical signal3.7
detection current
RMS of maximum current between the auxiliary electrode and the exploratory electrode in detection of
the electrical signal3.8
electrode force indication device
device on the exploratory electrode or auxiliary electrode whose function is to control or display the
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.