Traditional Chinese medicine — General requirements of moxibustion devices

This document specifies the general requirements for configuration, materials, performance and safety requirements of moxibustion devices. It also specifies the minimum requirements for moxibustion materials used in moxibustion devices. It is applicable across a wide range of moxibustion devices that use moxa floss as the main combustion material and can remain on or over the body throughout the moxibustion process. It is applicable to moxibustion devices for both single and repeated usage. This document does not apply to devices that imitate moxibustion, such as electro-moxibustion and infrared moxibustion devices that do not involve the use of moxa floss. It also does not apply to moxa floss used in direct moxibustion.

Médecine traditionnelle chinoise — Exigences générales concernant les dispositifs de moxibustion

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Status
Published
Publication Date
15-Nov-2021
Current Stage
6060 - International Standard published
Start Date
16-Nov-2021
Completion Date
16-Nov-2021
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INTERNATIONAL ISO
STANDARD 18666
Second edition
2021-11
Traditional Chinese medicine —
General requirements of moxibustion
devices
Médecine traditionnelle chinoise — Exigences générales concernant
les dispositifs de moxibustion
Reference number
ISO 18666:2021(E)
© ISO 2021
---------------------- Page: 1 ----------------------
ISO 18666:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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
© ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 18666:2021(E)
Contents Page

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

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

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

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

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

4 Configuration...........................................................................................................................................................................................................2

4.1 Structure ...................................................................................................................................................................................................... 2

4.1.1 Size and shape ....................................................................................................................................................................... 2

4.1.2 Visual inspection ................................................................................................................................................................ 2

4.2 Expression of dimensions ............................................................................................................................................................. 3

5 Materials ....................................................................................................................................................................................................................... 3

5.1 General ........................................................................................................................................................................................................... 3

5.2 Body of moxibustion devices ..................................................................................................................................................... 3

5.3 Moxibustion materials ..................................................................................................................................................................... 3

5.3.1 Moxa floss ................................................................................................................................................................................. 3

5.3.2 Moxa sticks .............................................................................................................................................................................. 3

6 Moxibustion temperature .......................................................................................................................................................................... 4

6.1 General ........................................................................................................................................................................................................... 4

6.2 Moxibustion with tube .................................................................................................................................................................... 4

6.3 Moxibustion devices other than moxibustion with tube .................................................................................. 4

6.4 Moxibustion devices for repeated use ............................................................................................................................... 4

7 Safety requirements......................................................................................................................................................................................... 4

7.1 General ........................................................................................................................................................................................................... 4

7.2 Environmental protection ......... .................................................................................................................................. ................. 4

8 Packaging..................................................................................................................................................................................................................... 5

8.1 Primary packaging ............................................................................................................................................................................. 5

8.2 Secondary packaging ........................................................................................................................................................................ 5

9 Labelling ....................................................................................................................................................................................................................... 5

9.1 Primary label ........................................................................................................................................................................................... 5

9.2 Secondary label ...................................................................................................................................................................................... 5

10 Transport and storage ................................................................................................................................................................................... 6

11 Instructions for use ......................................................................................................................................................................................... 6

Annex A (informative) Test methods to determine the moxibustion temperature ..........................................7

Annex B (informative) Method of artificial drying of mugwort leaves by heat ..................................................10

Bibliography .............................................................................................................................................................................................................................11

iii
© ISO 2021 – All rights reserved
---------------------- Page: 3 ----------------------
ISO 18666:2021(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.

This second edition cancels and replaces the first edition (ISO 18666:2015), of which it constitutes a

minor revision. The changes to the previous edition are as follows:

— Introduction: the term 'International Standard' changed to 'document' in the first and third

paragraphs; improvement of English expression to 'increasing expectations and concerns by

patients' and the term 'ensure' changed to 'guide' in the second and third paragraphs;

— Scope: the term 'International Standard' changed to 'document' in the first and third paragraphs;

minor editorial change of the term 'uses' to 'use' in the second paragraph;

— Clause 3: addition of the introductory text according to ISO/IEC Directives, Part 2;

— 3.4: deletion of the phrase 'during treatment';
— 4.1.1: improvement of English expression for clarity;
— minor editorial changes.

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 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 18666:2021(E)
Introduction

This document specifies the general requirements for safety and quality of moxibustion devices,

including the moxibustion materials used in such devices. The safety and quality of both moxibustion

devices and materials are closely related to moxibustion safety and quality.

There is a wide variety of moxibustion devices and materials currently available commercially, but there

are no standards guiding their manufacture and finishing. Increased interest and use of moxibustion,

as well as increasing expectations and concerns by patients regarding moxibustion safety and quality,

have given rise to the need to improve safety and quality of moxibustion through implementation of an

International Standard.

The primary aim of this document is to guide the safety and quality of moxibustion devices and

materials.

Annex A gives guidance on the methods that can be used to determine the moxibustion temperature at

the human body surface during treatment using the moxibustion device.

Annex B gives guidance on the method of artificial drying of mugwort leaves by heat.

© ISO 2021 – All rights reserved
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 18666:2021(E)
Traditional Chinese medicine — General requirements of
moxibustion devices
1 Scope

This document specifies the general requirements for configuration, materials, performance and safety

requirements of moxibustion devices. It also specifies the minimum requirements for moxibustion

materials used in moxibustion devices.

It is applicable across a wide range of moxibustion devices that use moxa floss as the main combustion

material and can remain on or over the body throughout the moxibustion process. It is applicable to

moxibustion devices for both single and repeated usage.

This document does not apply to devices that imitate moxibustion, such as electro-moxibustion and

infrared moxibustion devices that do not involve the use of moxa floss. It also does not apply to moxa

floss used in direct moxibustion.
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 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing 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
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

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

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
moxibustion device

apparatus that uses moxa floss as the main combustion material and is intended for single or repeated

usage

EXAMPLE Moxibustion with tube, such as a short moxa roll with a cardboard base and a moxa tube (made of

cardboard) that is single-use and developed as an alternative to direct moxibustion.

Note 1 to entry: Moxibustion devices include those accessories as defined by the manufacturers that are

necessary to enable the normal use of the moxibustion device.
© ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
ISO 18666:2021(E)
3.2
moxibustion material
combustible material comprising mainly moxa floss and used in moxibustion
3.3
body of moxibustion device

part of the moxibustion device that is used to hold moxibustion materials and remains on or over the

human body throughout the moxibustion process
3.4
moxibustion temperature
temperature at the human body surface when using the moxibustion device
3.5
moxa floss
cotton-like material for moxibustion made from mugwort leaves
3.6
moxa stick
round long stick made of moxa floss, also called moxa roll

Note 1 to entry: Moxa sticks can be in the form of a pure moxa stick, a medicinal moxa stick (with additives) or a

smokeless moxa stick.
3.7
medicinal moxa stick
moxibustion with the moxa roll made of moxa and various substances
3.8
fineness of moxa floss

weight of the starting material (mugwort leaves) to the weight of the final product (moxa floss)

presented in the form of a ratio
4 Configuration
4.1 Structure
4.1.1 Size and shape

The size and shape of moxibustion devices can vary according to the intended use, such as on a specific

point or an area of the human body surface.
4.1.2 Visual inspection
When inspected by normal or corrected-to-normal vision:

a) the surface of the moxibustion device shall not have any obvious defects such as breakages,

protrusions, dents or rust that can cause accidental cuts or injuries to the user;

b) moxibustion devices for repeated use shall have a temperature-adjusting mechanism or other

appropriate arrangement to maintain moxibustion at an appropriate temperature;

c) except for moxibustion with tube, the body of the moxibustion device shall ensure that the removal

of ash is easy and shall be well ventilated to facilitate combustion; it should also contain:

1) a mounting base or support that can hold the stick (s) firmly;

2) a barrier or other safety arrangement to prevent ash or ember from falling onto the surface of

the human body.
© ISO 2021 – All rights reserved
---------------------- Page: 7 ----------------------
ISO 18666:2021(E)
4.2 Expression of dimensions
The moxibustion device shall be easy to manipulate in size and applicable
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 18666
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
General requirements of moxibustion
Voting begins on:
2021­08­18 devices
Voting terminates on:
Médecine traditionnelle chinoise — Exigences générales concernant
2021­10­13
les dispositifs de moxibustion
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 18666:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2021
---------------------- Page: 1 ----------------------
ISO/FDIS 18666:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH­1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 18666:2021(E)
Contents Page

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

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

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

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

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

4 Configuration ........................................................................................................................................................................................................... 2

4.1 Structure ....................................................................................................................................................................................................... 2

4.1.1 Size and shape .................................................................................................................................................................... 2

4.1.2 Visual inspection .............................................................................................................................................................. 2

4.2 Expression of dimensions.............................................................................................................................................................. 3

5 Materials ....................................................................................................................................................................................................................... 3

5.1 General ........................................................................................................................................................................................................... 3

5.2 Body of moxibustion devices ...................................................................................................................................................... 3

5.3 Moxibustion materials ...................................................................................................................................................................... 3

5.3.1 Moxa floss............................................................................................................................................................................... 3

5.3.2 Moxa sticks ............................................................................................................................................................................ 3

6 Moxibustion temperature ........................................................................................................................................................................... 4

6.1 General ........................................................................................................................................................................................................... 4

6.2 Moxibustion with tube ..................................................................................................................................................................... 4

6.3 Moxibustion devices other than moxibustion with tube .................................................................................... 4

6.4 Moxibustion devices for repeated use ................................................................................................................................ 4

7 Safety requirements ......................................................................................................................................................................................... 4

7.1 General ........................................................................................................................................................................................................... 4

7.2 Environmental protection ............................................................................................................................................................. 4

8 Packaging ..................................................................................................................................................................................................................... 5

8.1 Primary packaging ............................................................................................................................................................................... 5

8.2 Secondary packaging ......................................................................................................................................................................... 5

9 Labelling ........................................................................................................................................................................................................................ 5

9.1 Primary label ............................................................................................................................................................................................ 5

9.2 Secondary label ...................................................................................................................................................................................... 5

10 Transport and storage .................................................................................................................................................................................... 6

11 Instructions for use .......................................................................................................................................................................................... 6

Annex A (informative) Test methods to determine the moxibustion temperature .............................................7

Annex B (informative) Method of artificial drying of mugwort leaves by heat .....................................................10

Bibliography .............................................................................................................................................................................................................................11

© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 18666:2021(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.

This second edition cancels and replaces the first edition (ISO 18666:2015), of which it constitutes a

minor revision. The changes to the previous edition are as follows:

— Introduction: the term 'International Standard' changed to 'document' in the first and third

paragraphs; improvement of English expression to 'increasing expectations and concerns by

patients' and the term 'ensure' changed to 'guide' in the second and third paragraphs;

— Scope: the term 'International Standard' changed to 'document' in the first and third paragraphs;

minor editorial change of the term 'uses' to 'use' in the second paragraph;

— Clause 3: addition of the introductory text according to ISO/IEC Directives, Part 2;

— 3.4: deletion of the phrase 'during treatment';
— 4.1.1: improvement of English expression for clarity;
— minor editorial changes.

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 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 18666:2021(E)
Introduction

This document specifies the general requirements for safety and quality of moxibustion devices,

including the moxibustion materials used in such devices. The safety and quality of both moxibustion

devices and materials are closely related to moxibustion safety and quality.

There is a wide variety of moxibustion devices and materials currently available commercially, but there

are no standards guiding their manufacture and finishing. Increased interest and use of moxibustion,

as well as increasing expectations and concerns by patients regarding moxibustion safety and quality,

have given rise to the need to improve safety and quality of moxibustion through implementation of an

International Standard.

The primary aim of this document is to guide the safety and quality of moxibustion devices and

materials.

Annex A gives guidance on the methods that can be used to determine the moxibustion temperature at

the human body surface during treatment using the moxibustion device.

Annex B gives guidance on the method of artificial drying of mugwort leaves by heat.

© ISO 2021 – All rights reserved v
---------------------- Page: 5 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 18666:2021(E)
Traditional Chinese medicine — General requirements of
moxibustion devices
1 Scope

This document specifies the general requirements for configuration, materials, performance and safety

requirements of moxibustion devices. It also specifies the minimum requirements for moxibustion

materials used in moxibustion devices.

It is applicable across a wide range of moxibustion devices that use moxa floss as the main combustion

material and can remain on or over the body throughout the moxibustion process. It is applicable to

moxibustion devices for both single and repeated usage.

This document does not apply to devices that imitate moxibustion, such as electro-moxibustion and

infrared moxibustion devices that do not involve the use of moxa floss. It also does not apply to moxa

floss used in direct moxibustion.
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 10993­1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process

ISO 15223­1, Medical devices — Symbols to be used with information to be supplied by the manufacturer —

Part 1: General requirements

ISO/TS 10993­19, Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and

topographical characterization of materials
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

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

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
moxibustion device

apparatus that uses moxa floss as the main combustion material and is intended for single or repeated

usage

EXAMPLE Moxibustion with tube, such as a short moxa roll with a cardboard base and a moxa tube (made of

cardboard) that is single-use and developed as an alternative to direct moxibustion.

Note 1 to entry: Moxibustion devices include those accessories as defined by the manufacturers that are

necessary to enable the normal use of the moxibustion device.
© ISO 2021 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO/FDIS 18666:2021(E)
3.2
moxibustion material
combustible material comprising mainly moxa floss and used in moxibustion
3.3
body of moxibustion device

part of the moxibustion device that is used to hold moxibustion materials and remains on or over the

human body throughout the moxibustion process
3.4
moxibustion temperature
temperature at the human body surface when using the moxibustion device
3.5
moxa floss
cotton-like material for moxibustion made from mugwort leaves
3.6
moxa stick
round long stick made of moxa floss, also called moxa roll

Note 1 to entry: Moxa sticks can be in the form of a pure moxa stick, a medicinal moxa stick (with additives) or a

smokeless moxa stick.
3.7
medicinal moxa stick
moxibustion with the moxa roll made of moxa and various substances
3.8
fineness of moxa floss

weight of the starting material (mugwort leaves) to the weight of the final product (moxa floss)

presented in the form of a ratio
4 Configuration
4.1 Structure
4.1.1 Size and shape

The size and shape of moxibustion devices can vary according to the intended use, such as on a specific

point or an area of the human body surface.
4.1.2 Visual inspection
When inspected by normal or corrected-to-normal vision:

a) the surface of the moxibustion device shall not have any obvious defects such as breakages,

protrusions, dents or rust that can cause accidental cuts or injuries to the user;

b) moxibustion devices for repeated use shall have a temperature-adjusting mechanism or other

appropriate arrangement to maintain moxibustion at an appropriate temperature;

c) except for moxibustion with tube, the body of the moxibustion device shall ensure that the removal

of ash is easy and shall be well ventilated to facilitate combustion; it should also contain:

1) a mounting base or support that can hold the stick (s) f
...

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