ISO 20487:2019

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
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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
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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 acupuncture needle
3.3
electro-acupuncture stimulator
EA stimulator
electrical medical equipment for the application of electric currents via acupuncture needles inserted
into the patient for the therapy of acupuncture
3.4
recorder
device which measures and records voltage for more than two channels
3.5
simulated body fluid
test solution which is used as a substitute for the human body
4 Principle
The test method specified in this document is intended to characterize the corrosion resistance of
acupuncture needles to be used in electro-acupuncture treatment. The test method simulates the use
of the acupuncture needle in the body by placing needles in simulated body fluid and then passing a
constant electrical current from a pulse generator or electro-acupuncture stimulator to another needle.
The needles under test are immersed at specified depths in the simulated body fluid. At specified times,
the needles under test are visually inspected for signs of corrosion. The acupuncture needle to be tested
shall either be final product, or a representative sample manufactured and processed by equivalent
methods.
NOTE 1 The test method described in this document can be amended as required, subject to substantiation
of data.
NOTE 2 For background and utilization of this test method, see Annex D.
5 Reagents and materials
5.1 Test solution (simulated body fluid) consisting of 1× phosphate-buffered saline (PBS) shall be
used as the simulated body fluid.
5.2 Acupuncture needle conforming with ISO 17218.
6 Apparatus
6.1 Pulse generator
The stability of the output shall be ± 10 %, and the output of the pulse shall be balanced biphasic
waveform.
6.2 Recorder
The recorder is used to calculate the voltage and the current flowing between the needles under test
through the simulated body fluid. The recorder shall have a voltage resolution of at least 1 mV and a
sampling frequency of at least 200 kHz.
6.3 Water bath
A water bath or other equivalent e
...