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: 9093 - International Standard confirmed
• Start Date: 19-Feb-2025
• Completion Date: 13-Dec-2025

Overview

ISO 20487:2019 specifies an in vitro test method to characterize the corrosion resistance of single‑use acupuncture needles when used for electro‑acupuncture. The standard defines a repeatable laboratory procedure using simulated body fluid (1× PBS), electrical stimulation and visual inspection to document corrosion behavior. ISO 20487 applies only to needles that conform with ISO 17218 and does not set pass/fail criteria or provide clinical safety guidance.

Key topics and technical requirements

• Test principle: Immerse needles in simulated body fluid, apply pulsed electrical current from a pulse generator to another needle, and inspect for corrosion at specified times.
• Test solution: 1× phosphate‑buffered saline (PBS) as the simulated body fluid.
• Pulse generator: Balanced biphasic waveform, output stability ±10%, frequency ≤ 1 000 Hz. Example RMS currents in the standard: (1 ± 0.1) mA, (3 ± 0.3) mA, (5 ± 0.5) mA.
• Recorder: Voltage resolution ≥ 1 mV and sampling frequency ≥ 200 kHz to measure voltage/current between electrodes.
• Temperature control: Simulated body fluid maintained at (37 ± 1) °C (water bath or equivalent).
• Resistor: Example 10 Ω with ±1 % tolerance (allowed range 1 Ω to 500 Ω depending on generator capacity).
• Geometry and positioning: Electrode spacing and immersion depths specified (ranges given in Table 1 / Annex A; e.g., inter‑electrode distance typically in the 10–30 mm range and immersion depths provided to millimetre tolerances).
• Test duration and sample size: Example electrical quantities and durations are provided; a minimum of five sets of needles per test condition is recommended.
• Reporting: Test reports must include details such as test date, needle type/size, test solution, pulse generator settings, measured voltage/current, electrode geometry, equipment models, result charts and any deviations.

Practical applications

• Compare corrosion performance across needle materials, coatings, designs or manufacturing processes used for electro‑acupuncture.
• Provide standardized laboratory data for R&D, quality engineering and premarket characterization of single‑use acupuncture needles intended for electrical stimulation.
• Support manufacturers, test laboratories and regulatory teams in documenting electrical corrosion behavior as part of product development and technical files.

Who should use this standard

• Medical device manufacturers of acupuncture needles and electro‑acupuncture systems
• ISO/IEC‑accredited test laboratories and quality assurance teams
• Regulatory affairs professionals preparing product dossiers or comparative technical data

Related standards

• ISO 17218 - Sterile acupuncture needles for single use (applicability prerequisite)
• IEC 60601‑2‑10 - Requirements for nerve and muscle stimulators (referenced for electrical definitions)
• IEC and ISO terminologies (IEC 60050, ISO online resources)

Keywords: ISO 20487, electro‑acupuncture, acupuncture needle corrosion, corrosion resistance test, single‑use acupuncture needles, simulated body fluid, ISO 17218.

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 2019
© 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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Published in Switzerland
ii © ISO 2019 – All rights reserved

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
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
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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

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.
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
...