Traditional Chinese medicine -- Test method of single-use acupuncture needles for electrical stimulation

This document specifies a test method for characterizing the corrosion resistance of single-use acupuncture needles intended for use in electro-acupuncture treatment. This document is applicable only to testing of acupuncture needles that conform with ISO 17218. This document does not specify pass/fail criteria. Also, it is not intended to provide safety information for real clinical practice.

Médecine traditionnelle chinoise -- Méthode d'essai pour les aiguilles d'acuponcture à usage unique pour la stimulation électrique

General Information

Status
Published
Publication Date
13-May-2019
Current Stage
6060 - International Standard published
Start Date
16-Apr-2019
Completion Date
14-May-2019
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ISO 20487:2019 - Traditional Chinese medicine -- Test method of single-use acupuncture needles for electrical stimulation
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INTERNATIONAL ISO
STANDARD 20487
First edition
2019-05
Traditional Chinese medicine — Test
method of single-use acupuncture
needles for electrical stimulation
Médecine traditionnelle chinoise — Méthode d'essai pour les aiguilles
d'acuponcture à usage unique pour la stimulation électrique
Reference number
ISO 20487:2019(E)
ISO 2019
---------------------- Page: 1 ----------------------
ISO 20487:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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
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Phone: +41 22 749 01 11
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Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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ISO 20487:2019(E)
Contents Page

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

Introduction ..................................................................................................................................................................................................................................v

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

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

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

4 Principle ........................................................................................................................................................................................................................ 2

5 Reagents and materials ................................................................................................................................................................................. 2

6 Apparatus ..................................................................................................................................................................................................................... 2

6.1 Pulse generator ....................................................................................................................................................................................... 2

6.2 Recorder ....................................................................................................................................................................................................... 2

6.3 Water bath .................................................................................................................................................................................................. 2

6.4 Resistor .......................................................................................................................................................................................................... 2

7 Procedure..................................................................................................................................................................................................................... 3

7.1 Test environment .................................................................................................................................................................................. 3

7.2 Test set-up ................................................................................................................................................................................................... 3

7.3 Temperature of the simulated body fluid ........................................................................................................................ 3

7.4 Test condition ........................................................................................................................................................................................... 3

7.4.1 Position of acupuncture needles ........................................................................................................................ 3

7.4.2 Parameters of pulse generator ............................................................................................................................ 3

7.5 Number of tests ...................................................................................................................................................................................... 4

7.6 Optional test .............................................................................................................................................................................................. 4

8 Test report ................................................................................................................................................................................................................... 4

Annex A (normative) Set-up, conditions and procedure ................................................................................................................. 5

Annex B (informative) Optional test for comparison .......................................................................................................................... 7

Annex C (informative) Test result chart for corrosion ....................................................................................................................... 8

Annex D (informative) Background and utilization of the test method ........................................................................... 9

Bibliography .............................................................................................................................................................................................................................10

© ISO 2019 – All rights reserved iii
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ISO 20487:2019(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 2019 – All rights reserved
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ISO 20487:2019(E)
Introduction

Electro-acupuncture is a form of acupuncture treatment that is used in many parts of the world.

However, the electrical current produced by the electrical acupuncture stimulator could cause

corrosion of the acupuncture needles. There are also some reports regarding possible harm to patients

as a result of acupuncture needle corrosion and corrosion residuals. Therefore, it is necessary to check

the corrosion resistance of the needles to ensure the safety of patients.

However, ISO 17218 does not include a test method for determining the corrosion resistance of needles

used in electro-acupuncture treatment.

This document establishes a uniform test method with simulated body fluid to characterize the

corrosion resistance of acupuncture needles to be used in electro-acupuncture treatment.

The use of this test method can provide useful data for comparison of different devices, materials,

designs or manufacturing processes. However, it cannot provide safety information for real clinical

practices. This in vitro test method is intended for artificial body fluids used for other similar standards,

but the round-robin test to verify the validity and repeatability has not been done, and there are no

studies on human subjects in clinical practice yet.

Accordingly, the result of this test method cannot be used to evaluate the safety of needles for clinical

use and does not determine the quality of needles in clinical use directly.

The ultimate aim of this document is to protect patients who receive electro-acupuncture treatment

from the potential risk of the side-effects of needle corrosion caused by electrical conduction.

This document is a necessary step toward establishing a guideline for the safe use of electro-

acupuncture in clinics when a correlation between the human body and the simulated body fluid is

known in the future.
© ISO 2019 – All rights reserved v
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INTERNATIONAL STANDARD ISO 20487:2019(E)
Traditional Chinese medicine — Test method of single-use
acupuncture needles for electrical stimulation
1 Scope

This document specifies a test method for characterizing the corrosion resistance of single-use

acupuncture needles intended for use in electro-acupuncture treatment.

This document is applicable only to testing of acupuncture needles that conform with ISO 17218.

This document does not specify pass/fail criteria. Also, it is not intended to provide safety information

for real clinical practice.
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 17218, Sterile acupuncture needles for single use

IEC 60601-2-10, Medical electrical equipment — Part 2-10: Particular requirements for the basic safety and

essential performance of nerve and muscle stimulators
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 17218 and IEC 60601-2-10

and the following 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
test method

process that conducts electricity from pulse generator to acupuncture needle in simulated body fluid

Note 1 to entry: This document established this methodology and refers to a shortened term – test method.

3.2
pulse generator
device for supplying electrical energy in the form of pulses to the acupunc
...

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