ISO 17218:2014
(Main)Sterile acupuncture needles for single use
Sterile acupuncture needles for single use
ISO 17218:2014 specifies the requirements for the sterile acupuncture needles for single use (specialized for filiform needles).
Aiguilles d'acupuncture stériles à usage unique
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INTERNATIONAL ISO
STANDARD 17218
First edition
2014-02-01
Sterile acupuncture needles for single
use
Aiguilles d’acupuncture stériles à usage unique
Reference number
©
ISO 2014
© ISO 2014
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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Configuration . 2
4.1 Acupuncture needle configuration . 2
4.2 Acupuncture needle types . . 2
4.3 Types of needle handles . 3
5 Requirements . 5
5.1 Materials . 5
5.2 Dimensions . 5
5.3 Performance requirements . 7
5.4 Sterility assurance . 9
6 Package . 9
6.1 Primary package . 9
6.2 Secondary package .10
7 Labelling .10
7.1 General .10
7.2 Primary package .10
7.3 Secondary package .10
8 Transit and storage .11
Annex A (informative) Test methods for the intensity and sharpness of the tip of the needle .12
Annex B (informative) Test methods for the puncture performance of the tip of the needle.16
Annex C (informative) Test method for resistance to corrosion .21
Bibliography .23
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 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 2014 – All rights reserved
Introduction
This International Standard applies to sterile acupuncture needles for single use (specialized for filiform
needles) used by professional acupuncturists for acupuncture treatment. Sterile acupuncture needles
for single use are sterilized by the manufacturer, and the healthcare professional can open the sealed
package and use the needle immediately.
In order to encourage innovation, this International Standard does not enforce the combination of
the needle diameter and length. However, considering the clinical usage requirements, the standard
provides the specifications for the needle diameter and length.
The sharpness and puncture performance of the needle tip are of very important clinical significance.
Annex A states the guidelines and the evaluation methods for the intensity and the sharpness of the
needle tip, while Annex B provides two qualitative and quantitative evaluation methods to determine
the puncture performance of the needle tip.
The qualitative methods to evaluate the puncture performance of needle tip are described in Annex B.
The methods are simple, direct and practical. It makes them especially suitable for routine inspection
and for cross-comparison of the acupuncture needles’ clinical applications. They also play a very
important role in the enhancement of the quality of the needle tip. The methods to evaluate the puncture
performance of the needle tip can be used to further evaluate the puncture and puncture performance
of the acupuncture needle. Currently, the more appropriate method is to use the needle tip to pierce
through polyurethane material; however, this method has not yet been implemented internationally.
Considering the consistency of standards in the future, this standard provides the methods to evaluate
the puncture performance of the needle tip and ranks 5.3.5.2 as recommended. The standard does not
provide the sharpness index of the piercing through polyurethane material by the needle tip. This index
will be added to the standard when it becomes appropriate. To improve product quality, all inspection
reports should include the inspection information as well as the results of the performance evaluation.
Since every manufacturer’s design, production, and sterilization methods are different, no regulations
exist for the materials of the acupuncture needle handle. Still, the needle body and the needle handle of
acupuncture needle should have good biocompatibility.
In order to ensure product safety and efficacy, the manufacturer should perform risk analysis and enforce
risk management in addition to adhering to the requirements of local rules and regulations, the relevant
background data of the medical devices and clinical practice throughout the entire duration of the
product’s life cycle. ISO 14971 has provided manufacturers a framework for the effective management
of hazards associated with the use of medical devices.
In some countries, the requirements proposed here are subject to legal sanctions. Such rules and
regulations should take precedence over the standards set forth in this document.
INTERNATIONAL STANDARD ISO 17218:2014(E)
Sterile acupuncture needles for single use
1 Scope
This International Standard specifies the requirements for the sterile acupuncture needles for single
use (specialized for filiform needles).
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 6507-1:2005, 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 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
body of the needle
part of the acupuncture needle that is inserted into the human body
Note 1 to entry: See Figure 1.
3.2
handle of the needle
part of the acupuncture needle that is not inserted into the human body
Note 1 to entry: See Figure 1.
3.3
tip of the needle
sharp apex at the end of the acupuncture needle body that is inserted into the human body
Note 1 to entry: See Figure 1.
3.4
root of the needle
part of the acupuncture needle that connects the needle body to the needle handle
Note 1 to entry: See Figure 1.
3.5
tail of the needle
end part of the needle handle at the opposite side of the tip of the needle
Note 1 to entry: See Figure 1.
3.6
sterile acupuncture needle
acupuncture needle that has been sterilized
3.7
guide tube
assistant tool in the shape of a slender, long tube into which the needle is placed and used for easy
insertion
3.8
hardness of the needle body
measure of resistance of the acupuncture needle body to permanent deformation
3.9
primary package
sealed or closed packaging system that forms a microbial barrier, directly enclosing the acupuncture
needle
Note 1 to entry: The primary package is usually the smallest unit package of use and the package that is in direct
contact with one or more acupuncture needles.
3.10
secondary package
package containing one or more primary packages for distribution and storage
4 Configuration
4.1 Acupuncture needle configuration
The configuration of the acupuncture needle and the name of each of its parts are shown in Figure 1.
Key
1 tip of the needle
2 body of the needle
3 root of the needle
4 handle of the needle
5 tail of the needle
Figure 1 — Example of typical structure of acupuncture needle
4.2 Acupuncture needle types
The acupuncture needle includes two types:
— acupuncture needle with a guide tube; and
— acupuncture needle without a guide tube.
The acupuncture needle with guide tube is shown in Figure 2. However, no uniform requirement is
provided for the fixing method of the needle tube.
2 © ISO 2014 – All rights reserved
Key
1 guide tube
Figure 2 — The acupuncture needle with a guide tube
4.3 Types of needle handles
The types of needle handles include the ring handle,
...
INTERNATIONAL ISO
STANDARD 17218
First edition
2014-02-01
Sterile acupuncture needles for single
use
Aiguilles d’acupuncture stériles à usage unique
Reference number
©
ISO 2014
© ISO 2014
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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Configuration . 2
4.1 Acupuncture needle configuration . 2
4.2 Acupuncture needle types . . 2
4.3 Types of needle handles . 3
5 Requirements . 5
5.1 Materials . 5
5.2 Dimensions . 5
5.3 Performance requirements . 7
5.4 Sterility assurance . 9
6 Package . 9
6.1 Primary package . 9
6.2 Secondary package .10
7 Labelling .10
7.1 General .10
7.2 Primary package .10
7.3 Secondary package .10
8 Transit and storage .11
Annex A (informative) Test methods for the intensity and sharpness of the tip of the needle .12
Annex B (informative) Test methods for the puncture performance of the tip of the needle.16
Annex C (informative) Test method for resistance to corrosion .21
Bibliography .23
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 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 2014 – All rights reserved
Introduction
This International Standard applies to sterile acupuncture needles for single use (specialized for filiform
needles) used by professional acupuncturists for acupuncture treatment. Sterile acupuncture needles
for single use are sterilized by the manufacturer, and the healthcare professional can open the sealed
package and use the needle immediately.
In order to encourage innovation, this International Standard does not enforce the combination of
the needle diameter and length. However, considering the clinical usage requirements, the standard
provides the specifications for the needle diameter and length.
The sharpness and puncture performance of the needle tip are of very important clinical significance.
Annex A states the guidelines and the evaluation methods for the intensity and the sharpness of the
needle tip, while Annex B provides two qualitative and quantitative evaluation methods to determine
the puncture performance of the needle tip.
The qualitative methods to evaluate the puncture performance of needle tip are described in Annex B.
The methods are simple, direct and practical. It makes them especially suitable for routine inspection
and for cross-comparison of the acupuncture needles’ clinical applications. They also play a very
important role in the enhancement of the quality of the needle tip. The methods to evaluate the puncture
performance of the needle tip can be used to further evaluate the puncture and puncture performance
of the acupuncture needle. Currently, the more appropriate method is to use the needle tip to pierce
through polyurethane material; however, this method has not yet been implemented internationally.
Considering the consistency of standards in the future, this standard provides the methods to evaluate
the puncture performance of the needle tip and ranks 5.3.5.2 as recommended. The standard does not
provide the sharpness index of the piercing through polyurethane material by the needle tip. This index
will be added to the standard when it becomes appropriate. To improve product quality, all inspection
reports should include the inspection information as well as the results of the performance evaluation.
Since every manufacturer’s design, production, and sterilization methods are different, no regulations
exist for the materials of the acupuncture needle handle. Still, the needle body and the needle handle of
acupuncture needle should have good biocompatibility.
In order to ensure product safety and efficacy, the manufacturer should perform risk analysis and enforce
risk management in addition to adhering to the requirements of local rules and regulations, the relevant
background data of the medical devices and clinical practice throughout the entire duration of the
product’s life cycle. ISO 14971 has provided manufacturers a framework for the effective management
of hazards associated with the use of medical devices.
In some countries, the requirements proposed here are subject to legal sanctions. Such rules and
regulations should take precedence over the standards set forth in this document.
INTERNATIONAL STANDARD ISO 17218:2014(E)
Sterile acupuncture needles for single use
1 Scope
This International Standard specifies the requirements for the sterile acupuncture needles for single
use (specialized for filiform needles).
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 6507-1:2005, 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 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
body of the needle
part of the acupuncture needle that is inserted into the human body
Note 1 to entry: See Figure 1.
3.2
handle of the needle
part of the acupuncture needle that is not inserted into the human body
Note 1 to entry: See Figure 1.
3.3
tip of the needle
sharp apex at the end of the acupuncture needle body that is inserted into the human body
Note 1 to entry: See Figure 1.
3.4
root of the needle
part of the acupuncture needle that connects the needle body to the needle handle
Note 1 to entry: See Figure 1.
3.5
tail of the needle
end part of the needle handle at the opposite side of the tip of the needle
Note 1 to entry: See Figure 1.
3.6
sterile acupuncture needle
acupuncture needle that has been sterilized
3.7
guide tube
assistant tool in the shape of a slender, long tube into which the needle is placed and used for easy
insertion
3.8
hardness of the needle body
measure of resistance of the acupuncture needle body to permanent deformation
3.9
primary package
sealed or closed packaging system that forms a microbial barrier, directly enclosing the acupuncture
needle
Note 1 to entry: The primary package is usually the smallest unit package of use and the package that is in direct
contact with one or more acupuncture needles.
3.10
secondary package
package containing one or more primary packages for distribution and storage
4 Configuration
4.1 Acupuncture needle configuration
The configuration of the acupuncture needle and the name of each of its parts are shown in Figure 1.
Key
1 tip of the needle
2 body of the needle
3 root of the needle
4 handle of the needle
5 tail of the needle
Figure 1 — Example of typical structure of acupuncture needle
4.2 Acupuncture needle types
The acupuncture needle includes two types:
— acupuncture needle with a guide tube; and
— acupuncture needle without a guide tube.
The acupuncture needle with guide tube is shown in Figure 2. However, no uniform requirement is
provided for the fixing method of the needle tube.
2 © ISO 2014 – All rights reserved
Key
1 guide tube
Figure 2 — The acupuncture needle with a guide tube
4.3 Types of needle handles
The types of needle handles include the ring handle,
...
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