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

General Information

Status
Published
Publication Date
02-Feb-2014
Current Stage
9093 - International Standard confirmed
Start Date
18-Jun-2019
Completion Date
18-Jun-2019
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ISO 17218:2014 - Sterile acupuncture needles for single use
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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 17218:2014(E)
ISO 2014
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ISO 17218:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2014

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

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Published in Switzerland
ii © ISO 2014 – All rights reserved
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ISO 17218:2014(E)
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

© ISO 2014 – All rights reserved iii
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ISO 17218:2014(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 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
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ISO 17218:2014(E)
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.

© ISO 2014 – All rights reserved v
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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.
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ISO 17218:2014(E)
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
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ISO 17218:2014(E)
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, the plain handle, the flower handle, the metal tube

handle, and the plastic handle, etc. The types of needle handles are not limited to those shown in the

Figure 3.
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ISO 17218:2014(E)
Key
1 ring handle l length of the needle body
2 plain handle l length of the needle handle
3 flower handle ⌀d diameter of the needle body
4 metal tube handle
5 plastic handle
Figure 3 — Example of types of handles of acupuncture needles
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ISO 17218:2014(E)
5 Requirements
5.1 Materials

The biocompatibility of the body of the needle shall be assessed and documented according to the

guidance and principles given in ISO 10993-1.
Compliance is demonstrated by:
a) analogy with published data; or

b) the selection of materials already shown to be biocompatible by proven clinical use in a similar

application; or

c) experience with similar devices already on the market together with evidence of traceability to the

materials used in the acupuncture needle; or
d) compliance with published procedures for biological evaluation of:
1) Cytotoxicity;
2) Sensitization;
3) Intracutaneous reactivity;
4) Ethylene oxide sterilization residuals (if using EO. to sterilize).

If the material of the body of the needle is changed and/or if there is a new coating on the surface of the

needle body, and if there is risk indicating that these may cause side-effects to the human body, then

testing should be in accordance with ISO 10993 series.

NOTE There is no uniform regulation regarding materials of the needle handle and body. Currently, the

popularly used material of the needle body is made of X5CrNil8–9, X7CrNil8–9 Austenite Stainless Steel, etc.

which are given in ISO 15510:2010.
5.2 Dimensions
5.2.1 Size designation
The size of the acupuncture needle shall be designated by the following:

a) the nominal diameter of the body of acupuncture needle, expressed in millimetres; and

b) the nominal length of the body of acupuncture needle, expressed in millimetres.

The size of acupuncture needle shall be referred to as “the designated metric size” and specified as the

diameter of the needle body × the length of the needle body.
EXAMPLE Ø 0,30 × 40 mm
5.2.2 Tolerance of dimensions
5.2.2.1 Diameter of the needle body

When measured by a micrometer or similar equipment, the nominal diameter of the body of acupuncture

needle shall comply with Table 1.
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ISO 17218:2014(E)
Table 1 — Nominal diameter of needle body
Dimensions in millimetres
Nominal diameter of needle body
Tolerance
0,10 ≤ d < 0,25 ±0,008
0,25 ≤ d ≤ 0,45 ±0,015
0,45 < d ≤ 0,80 ±0,020
5.2.2.2 Length of body of the needle

When measured by vernier calipers or similar equipment, the nominal length of the body of acupuncture

needle shall comply with Table 2.
Table 2 — Nominal length of needle body
Dimensions in millimetres
Nominal length of needle body
Tolerance
5 ≤ l ≤ 25 ±0,50
25 < l ≤ 60 ±1,00
60 < l ≤ 100 ±2,00
100 < l ≤ 200 ±3,00
5.2.3 Dimensions of needle handle

The handle of acupuncture needles shall be of suitable diameter and length for the intended purpose or

manipulation.

The length of the handle of acupuncture needles (l ) shall be no less than 13 mm.

The dimensions of the coiling handle wire used in the manufacturing of ring handles, plain handles and

flower handles should comply with Table 3. The diameter of the plastic handle and the metal tube handle

should comply with Table 4.
Table 3 — Diameter of the coiling handle wire
Dimensions in millimetres
Nominal diameter of needle body
Diameter of the coiling handle wire
0,10 ≤ d < 0,20 0,30
0,20 ≤ d < 0,30 0,35
0,30 ≤ d < 0,40 0,40
0,40 ≤ d < 0,50 0,45
0,50 ≤ d ≤ 0,80 0,50
6 © ISO 2014 – All rights reserved
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ISO 17218:2014(E)

Table 4 — Diameter of the plastic handle and the metal tube handle and coiling handle which

are joined by other method than coiling around the needle body
Dimensions in millimetres
Type of needle handle Diameter of needle handle
Metal tube handle, Plastic handle, etc. 0,80 – 2,50
NOTE These diameters are only applicable to “Cylinder-shaped” handle.
5.3 Performance requirements
5.3.1 Appearance and cleanliness
5.3.1.1 When inspected by normal or corrected-to-normal vision:

a) the surface of the acupuncture needles shall appear free from particles and extraneous matter;

b) the body of the needle shall be straight and there shall be neither breakage nor unevenness; and

c) the handle of needle shall not have any protuberances that could cause a scratch or cut, etc. If the

handle of the needle is made of winding coils, the spiral loop should be arranged symmetrically

without obvious gaps and the colour and lustre of the surface of the needle handle should be even.

If the handle is plated, it shall not exhibit layering or shedding.
5.3.1.2 When examined under x 10 magnification:

a) the body of the needle shall be straight and there shall be neither breakage nor unevenness;

b) the body of the needle shall be smooth and clean:

1) shall appear free from particles or extraneous matter produced during the metal processing

course;

2) shall not have any obvious defects such as ruggedness, scars, bends, grooves, rust or twist.

c) the tip of needle shall be sharp-edged, polished sharply and has no deficiencies of scars, fringes,

spikes or hooks.

If the body of the acupuncture needle is lubricated, the lubricant shall not be visible under normal or

corrected-to-normal vision as droplets of fluid on the surface of the needle body.

5.3.2 Drawing strength

The body of the needle shall be solidly joined to the handle of the needle at the root of the needle.

When the minimum static force given in Table 5 is applied in the direction of the centre axis of the body

of the needle depending on the nominal diameter of the body of the needle, it shall not be drawn out of

the handle of the needle. Axial displacement of the handle of the needle from the body of the needle of

more than 3 mm is not permitted.
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ISO 17218:2014(E)
Table 5 — Force to test drawing strength
Nominal diameter of needle body
Force
0,10 5
0,10 < d ≤ 0,16 5,5
0,16 < d ≤ 0,20 7
0,20 < d ≤ 0,25 8
0,25 < d ≤ 0,35 15
0,35 < d ≤ 0,45 20
0,45 < d ≤ 0,55 25
0,55 < d ≤ 0,80 30
5.3.3 Hardness of the needle body

To assess the hardness test according to the requirements given in ISO 6507-1:2005 or other equivalent

methods, the hardness of the body of the needle shall comply with Table 6.
Table 6 — Hardness of the needle body
Nominal diameter of needle body
Hardness
0.2kg
0,10 ≤ d < 0,25 ≥ 480, ≤ 680
0,25 ≤ d < 0,30 ≥ 460, ≤ 655
0,30 ≤ d < 0,45 ≥ 450, ≤ 655
0,45 ≤ d ≤ 0,80 ≥ 420, ≤ 630
The hardness can also be converted into tensile strength.

NOTE This hardness is only applicable to the stainless steel body of the needle.

5.3.4 Resistance to breakage of the needle body
The body of the needle shall be of sufficient resistance to breakage.

After a body of the needle is coiled tightly around a mandrel which diameter is 3 times larger than the

needle body, the body of the needle shall be free from any crack, break or separation of layers. In case

of a body of the needle no more than 15 mm in length, the needle body shall be tested by being coiled

twice circles around the mandrel tightly and a body of the needle longer than 15 mm shall be coiled five

circles.
5.3.5 Intensity and puncture performance of the needle tip
5.3.5.1 General
The tip of the needle shall have good intensity and puncture performance.
5.3.5.2 Intensity and sharpness of the needle tip

When tested in accordance with Annex A, the tip of the needle shall have good intensity. The needle tips

shall not have any hooks or bends after a set amount of pressure has been applied. The puncture force

shall not exceed the values set forth in Table 7. The other equivalent method is available.

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ISO 17218:2014(E)
Table 7 — Pressure and puncture force
Nominal diameter of needle body
Pressure Puncture force
N N
0,10 ≤ d ≤ 0,12 0,2 0,5
0,12 < d ≤ 0,25 0,4 0,7
0,25 < d ≤ 0,35 0,5 0,8
0,35 < d ≤ 0,45 0,6 0,9
0,45 < d ≤ 0,80 0,7 1,0
5.3.5.3 Puncture performance of the needle tip

When tested in accordance with Annex B, the tip of the needle should have good puncture performance.

If the puncture force is low, this indicates that the needle tip is sharp. This can be selected for the

performance of each manufacturer’s needle tip.
5.3.6 Resistance to corrosion of the needle body

The body of the needle shall have good resistance to corrosion. If the conditions of storage have been

met, there shall be no corrosion of the body of the needle before the expiry date.

When tested in accordance with Annex C, the partially immersed body of the needle shall show no

evidence of corrosion resulting from the test. Annex C shall be applied only to the stainless steel body

of the needle.
5.4 Sterility assurance

Sterile acupuncture needles for single use shall be sterilized through a validated sterilization process in

order to ensure that the products are sterile.

NOTE For appropriate sterilization methods, see Bibliography. The requirements for validation and routine

control of a sterilization process for medical devices are provided in ISO 11135-1, ISO 11137-1 and ISO 17665-1.

6 Package
6.1 Primary package

Sterile acupuncture needle shall be sealed in a primary package. There shall be no foreign matter within

the primary package under visual inspection.

The material and design of this primary package shall not have detrimental effects on the contents. The

material and design of this primary package should be such as to ensure:

a) the maintenance of sterility of the contents under dry, clean and adequately ventilated storage

conditions;

b) the minimum risk of contamination of the contents during removal from the package;

c) adequate protection of the contents during normal handling, transit and storage; and

d) that once opened, the package cannot be easily resealed, and it shall be obvious that the package has

been opened.

NOTE The requirements of materials, sterile barrier systems and packaging systems for terminally sterilized

medical devices are provided by ISO 11607-1.
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ISO 17218:2014(E)
6.2 Secondary package
One or more primary packages shall be packaged in a secondary package.

The secondary package shall be sufficiently robust to protect the contents during handling, transit and

storage.

One or more secondary packages may be packaged in a storage or a transit package.

7 Labelling
7.1 General

The symbols to be used with medical device labels, labelling, and information to be supplied on the

package shall comply with ISO 15223-1.
7.2 Primary package
The primary package shall be marked with at least the following information:
a) the name or trade-mark or logo of the manufacturer and/or supplier;

b) a description of the contents, including the designated metric size in accordance with 5.2;

c) the lot number, prefixed by the word “LOT”, and/or date of manufacture;
d) expiry date;
e) method of sterilization, the word “STERILE” or symbol;
f) the words “For single use” or “Do not reuse” or symbol.
7.3 Secondary package
The secondary package shall be marked with at least the following information:
a) the name, address and trademark of the manufacturer and/or supplier;

b) description of the contents, including the designated metric size in accordance with 5.2, the quantity

and the type;
c) the lot number, prefixed by the word “LOT”, and/or date of manufacture;
d) expiry date;
e) method of sterilization, the word “STERILE” or symbol;
f) the words “For single use” or “Do not reuse” or symbol;

g) if appropriate, the licensed certificate number according to the requirements of the regulations;

h) information for handling, storage and transportation;

i) a warning to check the integrity of each primary package before use, such as “Do not use if package

is damaged” or symbol;

j) a warning that excessive electrical stimulation may cause corrosion to needles;

k) if used, the names or composition of additives (such as lubricant) used as a coating on the surface of

needle body;
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ISO 17218:2014(E)

l) if appropriate, indication that the needles are not for use in moxibustion if the handle of the needle

cannot tolerate the heat from the burning of moxa; and

m) if appropriate, those who are allergic to the material of the needle body should use with caution or

follow the instruction of an acupuncture physician.
8 Transit and storage
8.1 The transport requirements should comply with the order contract.

8.2 The acupuncture needles should have sufficient protection from damage. Once the acupuncture

needles are packaged, they should be stored in a clean, well-ventilated and non-contaminated environment.

The storage environment should have controls in place for humidity, temperature and exposure to direct

sunlight.
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ISO 17218:2014(E)
Annex A
(informative)
Test methods for the intensity and sharpness of the tip of the
needle
A.1 General

The intensity of the tip of the needle: refers to the needle tip ability to resist breakage when thrust

vertically on the steel block.

The sharpness of the tip of the needle: refers to the force required by the needle tip to vertically pierce

aluminium foil.
A.2 Apparatus for measuring

A.2.1 The typical apparatus for measuring the intensity and sharpness of the tip of the needle as shown

in Figure A.1 and Figure A.2, they can also use the other equipment with the same performance, precision

(including measuring amplifier installed on the equipment, data processing and display units, printers

and floppy disks and other devices).
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ISO 17218:2014(E)
Key
1 power button (on and off) 5 aluminium foil clamping apparatus
2 function control button (on and off) 6 needle clamping apparatus
3 function control button (on and off) 7 adjustment rod
4 function control button (on and off) 8 (carpenter’s) level
Figure A.1 — Example of typical apparatus for measuring
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ISO 17218:2014(E)
Intensity test Sharpness test
Key
1 clamped head
2 needle body
3 stee
...

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