ISO 22236:2020

INTERNATIONAL ISO
STANDARD 22236
First edition
2020-06
Traditional Chinese medicine —
Thread-embedding acupuncture
needle for single use
Médecine traditionnelle chinoise — Aiguille d'acupuncture à usage
unique incorporant un fil
Reference number
©
ISO 2020
© ISO 2020
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ii © ISO 2020 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification and configuration . 2
4.1 Configuration . 2
4.2 Classification . 4
5 Material . 4
5.1 Plunger type thread-embedding needle . 4
5.1.1 Thread plunger handle . 4
5.1.2 Thread plunger body . 4
5.1.3 Handle of the needle . 4
5.1.4 Needle tube . 4
5.2 Pre-installed type thread-embedding needle . 5
5.2.1 Handle of the needle . 5
5.2.2 Needle tube . 5
5.2.3 Thread holder . 5
5.2.4 Thread . 5
6 Requirements . 5
6.1 Surface finish and visual appearance . 5
6.2 Needle tube construction . 5
6.3 Handle of the needle and thread plunger . 6
7 Sterility and biocompatibility . 6
7.1 Sterility assurance . 6
7.2 Biocompatibility . 6
8 Package . 6
8.1 Primary packaging . 6
8.2 Secondary packaging . 7
8.3 Storage packaging . 7
9 Inspection . 7
9.1 Production batch . 7
9.2 Factory inspection . 7
10 Information supplied by the manufacturer . 8
10.1 General . 8
10.2 Primary package . 8
10.3 Secondary package . 8
10.4 Storage container . 8
10.5 Instructions for use . 9
10.6 Inspection certificate . 9
Bibliography .10
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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iv © ISO 2020 – All rights reserved

Introduction
Thread-embedding acupuncture therapy is an innovative treatment method within the scope of
traditional Chinese medicine. This method of treatment is also known as “long-term” acupuncture.
Following the same principles of acupuncture and channel meridians, thread-embedding therapy is the
method for preventing and treating disease by the continuous stimulating effect of the thread in the
acupoints.
In recent years, the sustainability and effectiveness of acupuncture have been demonstrated by the
publication of numerous clinical research studies. Alternative acupuncture treatment methods, such as
thread-embedding acupuncture, have seen an increase in popularity and demand.
The purpose of this document is to ensure the safety of the thread-embedding acupuncture needle
through standardization of this device. It is also intended to promote the international trade of thread-
embedding acupuncture needle devices.
INTERNATIONAL STANDARD ISO 22236:2020(E)
Traditional Chinese medicine — Thread-embedding
acupuncture needle for single use
1 Scope
This document specifies the safety requirements for the thread-embedding acupuncture needle.
It is applicable to only the needle part of thread-embedding acupuncture needles and excludes
medical thread.
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 7864:2016, Sterile hypodermic needles for single use — Requirements and test methods
ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices — Requirements and
test methods
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 15510, Stainless steels — Chemical composition
ANSI/ASQ Z1.4-2003 (R2013) Sampling Procedures and Tables for Inspection by Attributes
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization a
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