Traditional Chinese medicine —Thread-embedding acupuncture needle for single use

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.

Médecine traditionnelle chinoise -- Aiguille d'acupuncture à usage unique incorporant un fil

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Status
Published
Publication Date
01-Jun-2020
Current Stage
6060 - International Standard published
Start Date
02-Jun-2020
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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 22236:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 22236:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 22236:2020(E)
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

© ISO 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 22236:2020(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 of the voluntary nature of standards, 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 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 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 22236:2020(E)
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.
© ISO 2020 – All rights reserved v
---------------------- Page: 5 ----------------------
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
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 22236
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Thread-embedding acupuncture
Voting begins on:
2020­02­25 needle for single use
Voting terminates on:
2020­04­21
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 22236:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2020
---------------------- Page: 1 ----------------------
ISO/FDIS 22236:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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
CP 401 • Ch. de Blandonnet 8
CH­1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 22236:2020(E)
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 Tread .......................................................................................................................................................................................... 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

© ISO 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 22236:2020(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 of the voluntary nature of standards, 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 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 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 22236:2020(E)
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 has 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.
© ISO 2020 – All rights reserved v
---------------------- Page: 5 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 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 10993­1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process

ISO 10993­7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

ANSI/ASQ Z1.4­2003 (R2013) Sampling Procedur
...

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