Traditional Chinese medicine — Dermal needles for single use — Part 2: Roller-type

This document specifies the particular requirements for the basic safety and essential performance of roller-type dermal needles for single use. It applies to roller-type dermal needles that have the capacity to penetrate the skin. It specifies structure and dimension, materials, and performance requirements for appearance and cleanliness, corrosion resistance, sterility, packaging and identification, transit and storage of roller-type dermal needles. It does not apply to tapping-type dermal needles or reusable roller-type dermal needles.

Médecine traditionnelle chinoise — Aiguilles dermiques à usage unique — Partie 2: Type rouleau

General Information

Status
Published
Publication Date
24-May-2022
Current Stage
4099 - Full report circulated: DIS approved for registration as FDIS
Start Date
02-Aug-2021
Completion Date
02-Aug-2021
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ISO 23958-2:2022 - Traditional Chinese medicine — Dermal needles for single use — Part 2: Roller-type Released:5/25/2022
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INTERNATIONAL ISO
STANDARD 23958-2
First edition
2022-05
Traditional Chinese medicine —
Dermal needles for single use —
Part 2:
Roller-type
Médecine traditionnelle chinoise — Aiguilles dermiques à usage
unique —
Partie 2: Type rouleau
Reference number
ISO 23958-2:2022(E)
© ISO 2022
---------------------- Page: 1 ----------------------
ISO 23958-2:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022

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.
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Email: copyright@iso.org
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Published in Switzerland
© ISO 2022 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 23958-2:2022(E)
Contents Page

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

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

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

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

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

4 Structure and dimension of roller-type dermal needle ............................................................................................ 3

4.1 Size designation ..................................................................................................................................................................................... 3

4.2 Structure and dimension of roller-type dermal needle ..................................................................................... 3

4.2.1 Structure of roller-type dermal needle .......................................................................................................... 3

4.2.2 Dimensions of roller-type dermal needle .................................................................................................... 4

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

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

5.2 Needle body ............................................................................................................................................................................................... 5

5.3 Handle and roller head .................................................................................................................................................................... 6

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

6.1 Appearance and cleanliness ....................................................................................................................................................... 6

6.1.1 Needle body and needle tip....................................................................................................................................... 6

6.1.2 Handle .......................................................................................................................................................................................... 6

6.1.3 Roller ............................................................................................................................................................................................. 6

6.2 Surface treatment of needle body ......................................................................................................................................... 6

6.3 Puncture performance of needle tip ................................................................................................................................... 6

6.4 Hardness of needle body ............................................................................................................................................................... 6

6.5 Resistance to corrosion .................................................................................................................................................................. 6

6.6 Sterility .......................................................................................................................................................................................................... 6

7 Packaging and identification ..................................................................................................................................................................7

7.1 Primary packaging ............................................................................................................................................................................. 7

7.1.1 General ........................................................................................................................................................................................ 7

7.1.2 Packing method ................................................................................................................................................................... 7

7.1.3 Identification ......................................................................................................................................................................... 7

7.2 Secondary package ............................................................................................................................................................................. 7

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

7.2.2 Identification ......................................................................................................................................................................... 8

8 Transit and storage ...........................................................................................................................................................................................8

8.1 Transit ............................................................................................................................................................................................................ 8

8.2 Storage ........................................................................................................................................................................................................... 8

Bibliography ................................................................................................................................................................................................................................ 9

iii
© ISO 2022 – All rights reserved
---------------------- Page: 3 ----------------------
ISO 23958-2:2022(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.

A list of all parts in the ISO 23958 series can be found on the ISO website.

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.
© ISO 2022 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 23958-2:2022(E)
Introduction

A dermal needle is a traditional Chinese medicine device for stimulating acupuncture points, meridians

or skin by tapping or rolling. It is composed of a group of needles which stimulate a wide area of skin

effectively. The stimulating strength of dermal needles depends on the density of the needles, the

sharpness of the needle tips and the length of the needle body, among other things.

Dermal needles are widely used in East and Southeast Asia, the Americas, Europe and Oceania.

According to different operation modes, dermal needles for single use may be divided into two types:

tapping-type and roller-type.
This document applies to roller-type dermal needles for single use.
© ISO 2022 – All rights reserved
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 23958-2:2022(E)
Traditional Chinese medicine — Dermal needles for single
use —
Part 2:
Roller-type
1 Scope

This document specifies the particular requirements for the basic safety and essential performance of

roller-type dermal needles for single use. It applies to roller-type dermal needles that have the capacity

to penetrate the skin.

It specifies structure and dimension, materials, and performance requirements for appearance and

cleanliness, corrosion resistance, sterility, packaging and identification, transit and storage of roller-

type dermal needles.

It does not apply to tapping-type dermal needles or reusable roller-type dermal needles.

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 6507-1, Metallic materials — Vickers hardness test — Part 1: Test method

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 information to be supplied by the manufacturer

— 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.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: avail
...

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