ISO 18666:2015
(Main)Traditional Chinese medicine — General requirements of moxibustion devices
Traditional Chinese medicine — General requirements of moxibustion devices
ISO 18666:2015 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 uses 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. ISO 18666:2015 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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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 18666
First edition
2015-11-01
Traditional Chinese medicine —
General requirements of
moxibustion devices
Médecine traditionnelle chinoise — Exigences générales concernant
les dispositifs de moxibustion
Reference number
ISO 18666:2015(E)
©
ISO 2015
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ISO 18666:2015(E)
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© ISO 2015, Published in Switzerland
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ii © ISO 2015 – All rights reserved
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ISO 18666:2015(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. 2
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 . 4
8.1 Primary packaging . 4
8.2 Secondary packaging . 5
9 Labelling . 5
9.1 Primary label . 5
9.2 Secondary label . 5
10 Transport and storage . 5
11 Instructions for use (to be provided by the manufacturer) . 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
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ISO 18666:2015(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.
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ISO 18666:2015(E)
Introduction
This International Standard 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 growing patients’ expectations and concerns 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 International Standard is to ensure 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.
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INTERNATIONAL STANDARD ISO 18666:2015(E)
Traditional Chinese medicine — General requirements of
moxibustion devices
1 Scope
This International Standard 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 uses 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 International Standard 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, 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 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
ISO/TS 10993-19, 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.
3.1
moxibustion device
apparatus that uses moxa floss as the main combustion material and intended for single or repeated usage
EXAMPLE Moxibustion with tube is a type of moxibustion device, 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 device includes those accessories as defined by the manufacturers that are
necessary to enable the normal use of the moxibuston device.
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
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ISO 18666:2015(E)
3.4
moxibustion temperature
temperature at the human body surface during treatment 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, medicinal moxa stick (with additives) or
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 sizes and shapes of moxibustion devices can be different to perform moxibustion at a single point
or over 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 could 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, be well ventilated to facilitate combustion and it should also contain the following:
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.
4.2 Expression of dimensions
The moxibustion device shall be easy to manipulate in size and applicable to various parts of human
body. The dimensions of the moxibustion device shall be expressed in centimetres and specified
as length × breadth × height for a rectangular shaped device, or diameter × height for a circular
shaped device.
EXAMPLE 1 For a rectangular device, 15 cm × 10 cm × 8 cm.
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ISO 18666:2015(E)
EXAMPLE 2 For a circular shaped device, ⌀ 4 cm × 6 cm.
5 Materials
5.1 General
The materials of the moxibustion device in contact with the human body surface shall be assessed for
their biological safety and physico-chemical, morphological and topographical (PMT) characteristics in
accordance with ISO 10993-1 and ISO/TS 10993-19.
5.2 Body of moxibustion dev
...
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