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: 9093 - International Standard confirmed
• Completion Date: 30-Jan-2024

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: [phone]
Fax: [phone]
Email: [e-mail]
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
...