ISO 20487:2019

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
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 6060 - International Standard published
• Due Date: 18-Mar-2019
• Completion Date: 14-May-2019

Standards Content (Sample)

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

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ISO 20487:2019(E)

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© ISO 2019
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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.
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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.
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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
...