Traditional Chinese medicine — Sterile intradermal acupuncture needles for single use

ISO 18746:2016 specifies the requirements of sterile intradermal acupuncture needle for single use as a medical device, including the following factors: a) size; b) material; c) quality; d) testing methods; e) packing; f) identification.

Médecine traditionnelle chinoise — Aiguilles d'acupuncture intradermiques stériles à usage unique

General Information

Status
Published
Publication Date
14-Aug-2016
Current Stage
9093 - International Standard confirmed
Completion Date
12-Jul-2022
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INTERNATIONAL ISO
STANDARD 18746
First edition
2016-08-15
Traditional Chinese medicine —
Sterile intradermal acupuncture
needles for single use
Médecine traditionnelle chinoise — Aiguilles d’acupuncture
intradermiques stériles à usage unique
Reference number
ISO 18746:2016(E)
ISO 2016
---------------------- Page: 1 ----------------------
ISO 18746:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 18746:2016(E)
Contents Page

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

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

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

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

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

4 Structure and dimension of intradermal acupuncture needles ......................................................................... 2

4.1 Size designation ..................................................................................................................................................................................... 2

4.2 Structure and dimension of intradermal granule type needle ...................................................................... 3

4.2.1 Structure of intradermal granule type needle ........................................................................................ 3

4.2.2 Dimension of intradermal granule type needle .................................................................................... 3

4.3 Structure and dimension of intradermal thumbtack type needle .............................................................. 4

4.3.1 Structure of intradermal thumbtack type needle ................................................................................ 4

4.3.2 Dimension of intradermal thumbtack type needle ............................................................................ 4

5 Materials ....................................................................................................................................................................................................................... 5

5.1 General ........................................................................................................................................................................................................... 5

5.2 Body of intradermal acupuncture needle ........................................................................................................................ 5

6 Performance requirements ....................................................................................................................................................................... 5

6.1 Appearance and cleanliness ........................................................................................................................................................ 5

6.2 Drawing strength .................................................................................................................................................................................. 5

6.3 Hardness of the needle body ....................................................................................................................................................... 6

6.4 Intensity and puncture performance of the needle tip ........................................................................................ 6

6.5 Sterility .......................................................................................................................................................................................................... 6

7 Packing and identification ......................................................................................................................................................................... 6

7.1 Primary packaging ............................................................................................................................................................................... 6

7.1.1 Packing method ................................................................................................................................................................ 6

7.1.2 Identification ....................................................................................................................................................................... 6

7.2 Secondary packaging ......................................................................................................................................................................... 7

7.2.1 Packing method ................................................................................................................................................................ 7

7.2.2 Identification ....................................................................................................................................................................... 7

Bibliography ................................................................................................................................................................................................................................ 8

© ISO 2016 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 18746:2016(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 on 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 the following URL: www.iso.org/iso/foreword.html.

The committee responsible for this document is ISO/TC 249, Traditional Chinese medicine.

iv © ISO 2016 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 18746:2016(E)
Introduction

As one of several different needling approaches, intradermal acupuncture needles are recognized as

an effective treatment for various disorders. Intradermal acupuncture needles are easy to use and

especially effective when relatively long-lasting stimulation to a needling site is needed. Therefore,

safety and sanitation considerations of intradermal acupuncture needles should be more carefully

reviewed as well as their compatibility to human body.

As a biomaterial, acupuncture needles can be corrosive and have potential to lose some of their

mechanical characteristics. Furthermore, leachable substances can affect human tissue in any

unintended, yet potentially harmful way. To address this problem, biomaterials should have no toxicity

or produce any adverse effects, and should have appropriate mechanical characteristics such as tensile

strength, elasticity, durability of abrasion and fatigue strength. In addition, the material should have a

strong corrosion resistantability.

This International Standard establishes an international standard for intradermal acupuncture needles.

The characteristics of intradermal acupuncture needles include size, material, quality, tests, packing

and identification through regulating marking methods. The standardization of the characteristics of

intradermal acupuncture needles has potential to enhance the efficacy and improve the quality and

safety of acupuncture treatments using intradermal acupuncture needles especially in regard to the

biocompatibility for human body.
© ISO 2016 – All rights reserved v
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 18746:2016(E)
Traditional Chinese medicine — Sterile intradermal
acupuncture needles for single use
1 Scope

This International Standard specifies the requirements of sterile intradermal acupuncture needle for

single use as a medical device, including the following factors:
a) size;
b) material;
c) quality;
d) testing methods;
e) packing;
f) identification.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

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 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to

be supplied — Part 1: General requirements
ISO 17218:2014, Sterile acupuncture needles for single use
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
intradermal acupuncture needles
small needling instrument for embedding in the skin

Note 1 to entry: There are two types of intradermal acupuncture needles. One is termed an intradermal

thumbtack type needle and the other is intradermal granule type needle.

[SOURCE: WHO International Standard Terminologies on Traditional Medicine in the Western Pacific

Region, 5.1.29, modified — Note 1 to entry has been added.]
3.2
intradermal granule type needle

intradermal acupuncture needle inserted obliquely or horizontally into subcutaneous tissue often

across various sites on the human body
© ISO 2016 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO 18746:2016(E)
3.3
intradermal thumbtack type needle
intradermal acupuncture needle resembling a thumbtack

[SOURCE: WHO International Standard Terminologies on Traditional Medicine in the Western Pacific

Region, 5.1.28]
3.4
body of the needle
part of the intradermal acupuncture needle that is inserted into the human body
[SOURCE: ISO 17218:2014, 3.1, modified]
3.5
handle of the needle

part of the intradermal acupuncture needle that is not inserted into the human body and is often used

to manipulate the needle during insertion
[SOURCE: ISO 17218:2014, 3.2, modified]
3.6
tip of the needle

sharp apex at the end of the acupuncture needle body that is inserted into the human body

[SOURCE: ISO 17218:2014, 3.3]
3.7
primary package

sealed or closed packaging system that forms a microbial barrier, directly enclosing the acupuncture

needle
[SOURCE: ISO 17218:2014, 3.9]
3.8
secondary package
package containing one or more primary packages for transportation and storage
[SOURCE: ISO 17218:2014, 3.10, modified]
4 Structure and dimension of intradermal acupuncture needles
4.1 Size designation
The size of the body of the needle shall be designated by the following:
a) the nominal diameter
...

DRAFT INTERNATIONAL STANDARD
ISO/DIS 18746
ISO/TC 249 Secretariat: SAC
Voting begins on: Voting terminates on:
2015-06-24 2015-08-24
Traditional Chinese Medicine — Intradermal
acupuncture needles
La médecine traditionnelle chinoise — Aiguilles d’acupuncture intradermiques
ICS: 11.040.25
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 18746:2015(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2015
---------------------- Page: 1 ----------------------
ISO/DIS 18746:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland

All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DIS 18746:2015(E)
Contents Page

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

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

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

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

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

4 Structure and dimension of intradermal acupuncture needles ......................................................................... 2

4.1 Size designation ..................................................................................................................................................................................... 2

4.2 Structure and dimension of intradermal granule type needle ...................................................................... 3

4.2.1 Structure of intradermal granule type needle ........................................................................................ 3

4.2.2 Dimension of intradermal granule type needle .................................................................................... 3

4.3 Structure and dimension of intradermal thumbtack type needle .............................................................. 4

4.3.1 Structure of intradermal thumbtack type needle ................................................................................ 4

4.3.2 Dimension of intradermal thumbtack type needle ............................................................................ 4

5 Materials ....................................................................................................................................................................................................................... 5

5.1 General ........................................................................................................................................................................................................... 5

5.2 Body of intradermal acupuncture needle ........................................................................................................................ 5

6 Performance requirements ....................................................................................................................................................................... 5

6.1 Appearance and cleanliness ........................................................................................................................................................ 5

6.2 Drawing strength .................................................................................................................................................................................. 5

6.3 Hardness of the needle body ....................................................................................................................................................... 6

6.4 Intensity and puncture performance of the needle tip ........................................................................................ 6

6.5 Sterility .......................................................................................................................................................................................................... 6

7 Packing and Identification ......................................................................................................................................................................... 6

7.1 Primary packaging ............................................................................................................................................................................... 6

7.1.1 Identification ....................................................................................................................................................................... 6

7.2 Secondary packaging ......................................................................................................................................................................... 7

7.2.1 Packing method ................................................................................................................................................................ 7

7.2.2 Identification ....................................................................................................................................................................... 7

Bibliography ................................................................................................................................................................................................................................ 8

© ISO 2015 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/DIS 18746:2015(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. 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. 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 on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers

to Trade (TBT), see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 249, Traditional Chinese medicine.

iv © ISO 2015 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/DIS 18746:2015(E)
Introduction

As one of several different needling approaches, intradermal acupuncture needles are recognized as

an effective treatment for various disorders. Intradermal acupuncture needles are easy to use, and

especially effective when relatively long-lasting stimulation to a needling site is needed. Therefore,

safety, sanitation consideration of intradermal acupuncture needles should be more carefully reviewed

as well as their compatibility to human body.

As a biomaterial, acupuncture needles can be corrosive and have potential to lose some of their mechanic

characteristics. Furthermore, leachable substances can affect human tissue in any unintended, yet

potentially harmful way. To address this problem, biomaterials should have no toxicity or produce

any adverse effects and should have appropriate mechanical characteristics such as tensile strength,

elasticity, durability of abrasion and fatigue strength. In addition, the material should have a strong

corrosion-resistantability.

This standard establishes an international standard for intradermal acupuncture needles. The

characteristics of intradermal acupuncture needles include size, material, quality, tests, packing, and

identification through regulating marking methods. The standardization of the characteristics of

intradermal acupuncture needles has potential to enhance the efficacy and improve the quality and

safety of acupuncture treatments using intradermal acupuncture needles especially in regards to the

biocompatibility for human body.
© ISO 2015 – All rights reserved v
---------------------- Page: 5 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 18746:2015(E)
Traditional Chinese Medicine — Intradermal
acupuncture needles
1 Scope

This International standard specifies the requirements of sterile intradermal acupuncture needle for

single use as a medical device, including the following factors:
a) size;
b) material;
c) quality;
d) testing methods;
e) packing; and
f) Identification.
2 Normative references

The following referenced documents are indispensable for the application 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 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 17218, Sterile acupuncture needles for single use

ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to

be supplied – Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
intradermal acupuncture needles
a small needling instrument for embedding in the skin.

There are two types of intradermal acupuncture needles. One is termed an intradermal thumbtack type

needle and the other is intradermal granule type needle.

[SOURCE: WHO International Standard terminologies on traditional medicine in the Western Pacific

region, 5.1.29, modified – 2nd sentence has been added.]
3.2
intradermal granule type needle

an intradermal needle inserted obliquely or horizontally into subcutaneous tissue often across various

sites on the human body
© ISO 2015 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO/DIS 18746:2015(E)
3.3
intradermal thumbtack type needle
an intradermal needle resembling a thumbtack

Inserted perpendicularly into subcutaneous tissue, often into the auricular region

[SOURCE: WHO International Standard terminologies on traditional medicine in the Western Pacific

region, 5.1.28, modified – 2nd sentence has been added.]
3.4
body of the needle
part of the intradermal acupuncture needle that is inserted into the human body
[SOURCE: ISO 17218:2014, 3.1]
3.5
handle of the needle

part of the intradermal acupuncture needle that is not inserted into the human body and is often used

to manipulate the needle during insertion
[SOURCE: ISO 17218:2014, 3.2]
3.6
tip of the needle

sharp apex at the end of the acupuncture needle body that is inserted into the human body

[SOURCE: ISO 17218:2014, 3.3]
3.7
primary package

sealed or closed packaging system that forms a microbial barrier, directly enclosing the acupuncture needle

[SOURCE: ISO 17218:2014, 3.9]
3.8
secondary package
package containing one or more primary packages for transportation and storage
[SOURCE: ISO 17218:2014, 3.10]
4 Structure and dimension of intradermal acupuncture needles
4.1 Size designation
The size of the body of the needle shall be designated by the following:
...

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