ISO 6559:2024
(Main)Traditional Chinese medicine — Sterile three-edge needle for single use
Traditional Chinese medicine — Sterile three-edge needle for single use
This document specifies the configuration, dimensions, parameters, requirements and test methods of a sterile three-edge needle for single use. It also specifies requirements for packaging, labelling, transit and storage. This document excludes requirements for the handle of a three-edge needle, which is structurally different from the body of a three-edge needle.
Médecine traditionnelle chinoise — Aiguille stérile à trois bords à usage unique
General Information
Buy Standard
Standards Content (Sample)
International
Standard
ISO 6559
First edition
Traditional Chinese medicine —
2024-07
Sterile three-edge needle for
single use
Médecine traditionnelle chinoise — Aiguille stérile à trois bords à
usage unique
Reference number
© ISO 2024
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Specifications . 2
4.1 Configuration .2
4.2 Dimensions and parameters .3
4.2.1 Whole length of the three-edge needle .3
4.2.2 Length of the head of the three-edge needle.3
4.2.3 External diameter of the widest part of the head of the three-edge needle .3
4.2.4 External diameter of the body of the three-edge needle .3
4.3 Material .4
5 Requirements . 4
5.1 Hardness .4
5.2 Roughness .4
5.3 Puncture force .4
5.4 Corrosion resistance .4
5.5 Sterility assurance .4
5.6 Biological compatibility .4
5.7 Appearance quality .4
6 Packaging. 5
6.1 Primary package .5
6.2 Secondary package .5
7 Labelling . 5
7.1 General .5
7.2 Primary package .5
7.3 Secondary package .6
8 Transit and storage . 6
Annex A (informative) Test method for puncture force . 7
Bibliography . 9
iii
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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
Introduction
Originating in ancient China, the three-edge needle is one of major types of acupuncture needles. The
three-edge needle was originally called "Feng Zhen", which literally means “sharp-edge needle”. Its clinical
application for the specific indications was earliest recorded in Huangdi’s Canon of Medicine, which is the
earliest writing about traditional Chinese medicine. The therapy which applies the three-edge needle is
called three-edge needle therapy.
The three-edge needle has a special needle body structure like an arrow head with three sharp edges. This
structure was designed in order to meet specific clinical requirements, such as bloodletting and draining
abscesses mainly by the manipulation methods including shallow pricking, deep pricking, multi-point shallow
pricking, pricking in and edge cutting out, and needle scratching. Of the manipulation methods, pricking in
and edge cutting out (mainly for breaking the fibrous tissue) and needle scratching (leaving marks on skin)
can only be practiced by the three-edge needle, which cannot be replaced by other bloodletting medical
instruments such as the blood point lancet and the syringe.
It is due to the special structure of the three-edge needle that the practitioner can bleed the clinically
required blood amount by controlling the depth instead of repeated pricking which induces pain in patients.
This structural advantage of the three-edge needle outweighs the blood point lancet and the syringe both in
clinical function, such as draining an abscess, and in obtaining a clinically required amount of blood.
Since the three-edge needle is an invasive medical instrument, it is important to use the sterile needle only
once. The quality of the three-edge needle has a direct impact on the safety of patients and the quality of the
therapy. Therefore, this document specifies the technical parameters of the sterile three-edge needle for
single use to ensure its quality and safety.
v
International Standard ISO 6559:2024(en)
Traditional Chinese medicine — Sterile three-edge needle for
single use
1 Scope
This document specifies the configuration, dimensions, parameters, requirements and test methods of a
sterile three-edge needle for single use. It also specifies requirements for packaging, labelling, transit and
storage.
This document excludes requirements for the handle of a three-edge needle, which is structurally different
from the body of a three-edge needle.
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 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for skin sensitization
ISO 10993-18, Biological evaluation of medical devices — Part 18: Chemical characterization of medical device
materials within a risk management process
ISO/TS 10993-19, Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and
topographical characterization of materials
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part
1: General requirements
ISO 15510, Stainless steels — Chemical composition
ISO 21920-3, Geometrical product specifications (GPS) — Surface texture: Profile — Part 3: Specification
operators
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: available at https:// www .electropedia .org/
3.1
three-edge needle
needle with a head in a triangular pyramid shape, of which the three side faces form three edges extending
up to a sharp tip
3.2
head of the three-edge needle
part of the three-edge needle (3.1) with three edges
3.3
tip of the three-edge needle
sharp apex of the head of the three-edge n
...
FINAL DRAFT
International
Standard
ISO/FDIS 6559
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Sterile three-edge needle for single
Voting begins on:
use
2024-04-16
Médecine traditionnelle chinoise — Aiguille stérile à trois bords à
Voting terminates on:
usage unique
2024-06-11
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
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
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.
Reference number
ISO/FDIS 6559:2024(en) © ISO 2024
FINAL DRAFT
ISO/FDIS 6559:2024(en)
International
Standard
ISO/FDIS 6559
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Sterile three-edge needle for
Voting begins on:
single use
Médecine traditionnelle chinoise — Aiguille stérile à trois bords à
Voting terminates on:
usage unique
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.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 6559:2024(en) © ISO 2024
ii
ISO/FDIS 6559:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Specifications . 2
4.1 Configuration .2
4.2 Dimensions and parameters .3
4.2.1 Whole length of the three-edge needle .3
4.2.2 Length of the head of the three-edge needle.3
4.2.3 External diameter of the widest part of the head of the three-edge needle .3
4.2.4 External diameter of the body of the three-edge needle .3
4.3 Material .4
5 Requirements . 4
5.1 Hardness .4
5.2 Roughness .4
5.3 Puncture force .4
5.4 Corrosion resistance .4
5.5 Sterility assurance .4
5.6 Biological compatibility .4
5.7 Appearance quality .4
6 Packaging. 5
6.1 Primary package .5
6.2 Secondary package .5
7 Labelling . 5
7.1 General .5
7.2 Primary package .5
7.3 Secondary package .6
8 Transit and storage . 6
Annex A (informative) Test method for puncture force . 7
Bibliography . 9
iii
ISO/FDIS 6559:2024(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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/FDIS 6559:2024(en)
Introduction
Originating in ancient China, the three-edge needle is one of major types of acupuncture needles. The
three-edge needle was originally called "Feng Zhen", which literally means “sharp-edge needle”. Its clinical
application for the specific indications was earliest recorded in Huangdi’s Canon of Medicine, which is the
earliest writing about traditional Chinese medicine. The therapy which applies the three-edge needle is
called three-edge needle therapy.
The three-edge needle has a special needle body structure like an arrow head with three sharp edges. This
structure was designed in order to meet specific clinical requirements, such as bloodletting and draining
abscesses mainly by the manipulation methods including shallow pricking, deep pricking, multi-point shallow
pricking, pricking in and edge cutting out, and needle scratching. Of the manipulation methods, pricking in
and edge cutting out (mainly for breaking the fibrous tissue) and needle scratching (leaving marks on skin)
can only be practiced by the three-edge needle, which cannot be replaced by other bloodletting medical
instruments such as the blood point lancet and the syringe.
It is due to the special structure of the three-edge needle that the practitioner can bleed the clinically
required blood amount by controlling the depth instead of repeated pricking which induces pain in patients.
This structural advantage of the three-edge needle outweighs the blood point lancet and the syringe both in
clinical function, such as draining an abscess, and in obtaining a clinically required amount of blood.
Since the three-edge needle is an invasive medical instrument, it is important to use the sterile needle only
once. The quality of the three-edge needle has a direct impact on the safety of patients and the quality of the
therapy. Therefore, this document specifies the technical parameters of the sterile three-edge needle for
single use to ensure its quality and safety.
v
FINAL DRAFT International Standard ISO/FDIS 6559:2024(en)
Traditional Chinese medicine — Sterile three-edge needle for
single use
1 Scope
This document specifies the configuration, dimensions, parameters, requirements and test methods of a
sterile three-edge needle for single use. It also specifies requirements for packaging, labelling, transit and
storage.
This document excludes requirements for the handle of a three-edge needle, which is structurally different
from the body of a three-edge needle.
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 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993-10, Biological evaluation of medical
...
ISO/DISFDIS 6559:2023(E)
ISO/TC 249
Secretariat: SAC
Date: 2023-07-172024-03-28
Traditional Chinese medicine — Sterile three-edge needle for single
use
Médecine traditionnelle chinoise — Aiguille stérile à trois bords à usage unique
FDIS stage
ISO/DISFDIS 6559:2023(E2024(en)
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
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2023 – All rights reserved
ii
ISO/DISFDIS 6559:2023(E2024(en)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Specifications . 2
4.1 Configuration . 2
4.2 Dimensions and parameters . 3
4.2.1 Whole length of the three-edge needle . 3
4.2.2 Length of the head of the three-edge needle . 3
4.2.3 External diameter of the widest part of the head of the three-edge needle . 4
4.2.4 External diameter of the body of the three-edge needle . 4
4.3 Material . 4
5 Requirements . 4
5.1 Hardness . 4
5.2 Roughness . 4
5.3 Puncture force . 5
5.4 Corrosion resistance . 5
5.5 Sterility assurance . 5
5.6 Biological compatibility . 5
5.7 Appearance quality . 5
6 Packaging . 5
6.1 Primary package . 5
6.2 Secondary package . 6
7 Labelling . 6
7.1 General . 6
7.2 Primary package . 6
7.3 Secondary package . 6
8 Transit and storage . 7
Annex A (informative) Test method for puncture force . 8
Bibliography . 11
iii
ISO/DISFDIS 6559:2023(E2024(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 2023 – All rights reserved
iv
ISO/DISFDIS 6559:2023(E2024(en)
Introduction
Originating in ancient China, the three-edge needle is one of major types of acupuncture needles. The three-
edge needle was originally called "Feng Zhen", which literally means “sharp-edge needle”. Its clinical
application for the specific indications was earliest recorded in Huangdi’s Canon of Medicine that, which is the
earliest writing about traditional Chinese medicine. The therapy which applies the three-edge needle is called
three-edge needle therapy.
The three-edge needle has a special needle body structure like an arrow head with three sharp edges. This
structure was designed in order to meet specific clinical requirements, such as bloodletting and draining
abscesses mainly by the manipulation methods including shallow pricking, deep pricking, multi-point shallow
pricking, pricking in and edge cutting out, and needle scratching. Of the manipulation methods, pricking in and
edge cutting out (mainly for breaking the fibrous tissue) and needle scratching (leaving marks on skin) can
only be practiced by the three-edge needle, which cannot be replaced by other bloodletting medical
instruments such as the blood point lancet and the syringe.
It is due to the special structure of the three-edge needle that the practitioner can bleed the clinically required
blood amount by controlling the depth instead of repeated pricking which induces pain in patients. This
structural advantage of the three-edge needle outweighs the blood point lancet and the syringe both in clinical
function, such as draining an abscess, and in obtaining a clinically required amount of blood.
Since the three-edge needle is an invasive medical instrument, it is important to use the sterile needle only
once. The quality of the three-edge needle has a direct impact on the safety of patients and the quality of the
therapy. Therefore, this document specifies the technical parameters of the sterile three-edge needle for single
use to ensure its quality and safety.
v
DRAFT INTERNATIONAL STANDARD ISO/DIS 6559:2023(E)
Traditional Chinese medicine — Sterile three-edge needle for single
use
1 Scope
This document specifies the configuration, dimensions, parameters, requirements and test methods of a
sterile three-edge needle for single use. It also specifies requirements for packaging, labelling, transit and
storage.
This document excludes requirements for the handle of a three-edge needle, which is structurally different
from the body of a three-edge needle.
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--4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993--10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
ISO 10993--18, Biological evaluation of medical devices — Part 18: Chemical characterization of medical device
materials within a risk management process
ISO/TS 10993--19, Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and
topographical characterization of materials
ISO 15223--1, Medical devices — Symbols to be used with information to be supplied by the manufacturer —
Part 1: General requirements
ISO 15510, Stainless steels — Chemical composition
ISO 21920-3, Geometrical product specifications (GPS) — Surface texture: Profile — Part 3: Specification
operators
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
ISO/DISFDIS 6559:2023(E2024(en)
— — IEC Electropedia: available at https://www.electropedia.org/
3.1
three-edge needle
needle with a head in a triangletriangular pyramid shape, of which the three side faces form three edges
extending up to a sharp tip
3.2
head of the three-edge needle
part of the three-edge needle (3.1(3.1)) with three edges
3.3
tip of the three-edge needle
sharp apex of the head of the three-edge needle (3.2(3.2))
3.4
body of the three-edge needle
part of the three-edge needle (3.1(3.1)) excluding the head of the three-edge needle (3.2(3.2))
3.5
edge of the three-edge needle
lateral edge of the triangletriangular pyramid which forms the head of the three-edge needle (3.2(3.2))
4 Specifications
4.1 Configuration
The configuration, the basic parts and the parameters of the three-edge needle are shown in Figure 1Figure 1.
The head of the three-edge needle may vary according to the dimensions and parameters specified in 4.24.2.
Top view
L2
L1
L2
L1
Side view
2 © ISO 2023 – All rights reserved
D D
d
ISO/DISFDIS 6559:2023(E2024(en)
a) Top view
b) Side view
Key
1 tip of the three-edge needle
2 head of the three-edge needle
3 edge of the three-edge needle
4 body of the three-edge needle
d external diameter of the widest part of the head of the three-edge needle
D external diameter of the body of the three-edge needle
L1 whole length of the three-edge needle
L2 length of the head of the three-edge needle
Figure 1 — Example of a typical structure of a three-edge needle
4.2 Dimensions a
...
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