ISO 21366:2019

INTERNATIONAL ISO
STANDARD 21366
First edition
2019-05
Traditional Chinese medicine —
General requirements for smokeless
moxibustion devices
Médecine traditionnelle chinoise — Exigences générales relatives à la
moxibustion sans fumée
Reference number
©
ISO 2019
© ISO 2019
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ii © ISO 2019 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test methods for smokeless moxibustion devices . 3
4.1 General . 3
4.2 Smoke density test . 3
4.3 Smoke generation test . 3
5 Safety requirements . 3
5.1 Noxious gas . 3
5.1.1 General. 3
5.1.2 Carbon monoxide (CO) . 4
5.1.3 Nitrogen dioxide (NO ) . 4
5.1.4 Total volatile organic compounds (tVOCs) . 4
5.1.5 Aldehyde . 4
5.2 Moxibustion temperature . 4
5.3 Device materials . 4
6 Packaging and labelling . 4
6.1 General . 4
6.2 Smokeless statement . 4
6.3 Protection of products . 4
Annex A (informative) WHO guidelines for indoor air quality . 5
Annex B (normative) Test method for moxibustion smoke density measurement.7
Annex C (normative) Test method for moxibustion smoke generation .11
Bibliography .14
Foreword
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iv © ISO 2019 – All rights reserved

Introduction
Moxibustion is one of the major traditional medical therapies. Smokeless moxibustion is an emerging
form of moxibustion therapy. However, smokeless moxibustion devices have different forms or are
composed of the materials used in conventional moxibustion without additional materials or processing
needed for their safe use.
The standardization of smokeless moxibustion devices will enhance the efficacy and improve the
quality and safety of moxibustion treatments using smokeless moxibustion devices, especially in regard
to biocompatibility with the human body and indoor air quality.
INTERNATIONAL STANDARD ISO 21366:2019(E)
Traditional Chinese medicine — General requirements for
smokeless moxibustion devices
1 Scope
This document specifies general requirements to ensure the performance and safety of smokeless
moxibustion devices. It covers smoke density, moxibustion temperature, noxious gas and test methods
for smokeless moxibustion devices.
This document is applicable to any combustion-type device that claims to provide smokeless
moxibustion.
This document does not apply to devices that imitate moxibustion, such as electro moxibustion and
infrared moxibustion devices.
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 2248, Packaging — Complete, filled transport packages — Vertical impact test by dropping
ISO 5659-2:2017, Plastics — Smoke generation — Part 2: Determination of optical density by a single-
chamber test
ISO 7240-2, Fire detection and alarm systems — Part 2: Fire detection control and indicating equipment
ISO 7240-7:2018, Fire detection and alarm systems — Part 7: Point-type smoke detectors using scattered
light, transmitted light or ionization
ISO/TS 7240-9, Fire detection and alarm systems — Part 9: Test fires for fire detectors
ISO 15011-2, Health and safety in welding and allied processes — Laboratory method for sampling fume
and gases — Part 2: Determination of the emission rates of carbon monoxide (CO), carbon dioxide (CO2),
nitrogen monoxide (NO) and nitrogen dioxide (NO2) during arc welding, cutting and gouging
ISO 16000-4, Indoor air — Part 4: Determination of formaldehyde — Diffusive sampling method
ISO 16000-6, Indoor air — Part 6: Determination of volatile organic compounds in indoor and test chamber
air by active sampling on Tenax TA sorbent, thermal desorption and gas chromatography using MS or MS-FID
ISO 18666:2015, Traditional Chinese medicine — General requirements of moxibustion devices
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 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 moxibustion device.
[SOURCE: ISO 18666:2015, 3.1]
3.2
smokeless moxibustion device
moxibustion device (3.1) intended to reduce the smoke and bad odour caused by combustion
Note 1 to entry: Carbonized moxa floss, carbonized mugwort leaves or other carbonized materials may be used
as the main combustion material.
3.3
smoke density
aerosol density
number of particulates per volume as described operationally by one of two parameters:
— m, an absorbance index, used in the testing of smoke detectors using scattered or transmitted light;
— y, a dimensionless variable, used in the testing of smoke detectors using ionization
Note 1 to entry: These parameters are not concentrations, strictly speaking, but represent values that are
proportional to the concentration and have been shown to function in lieu of a true concentration value for the
purposes of these tests.
[SOURCE: ISO 7240-1:2014, 2.1.5, modified — The order of the terms has been switched so that "smoke
density" is the preferred term.]
3.4
carbon monoxide
CO
gas formed by the combination of one atom of carbon and one atom of oxygen
Note 1 to entry: In its chemical formula, C stands for carbon and O for oxygen. For the purposes of this document,
the CO level is always expressed in terms of mass fraction of CO in air.
[SOURCE: ISO 12133:2011, 3.1]
3.5
volatile organic compound
VOC
organic compound where the boiling point is in the range from (50 to 100) °C to (240 to 260) °C
[SOURCE: ISO 12219-2:2012, 3.4]
2 © ISO 2019 – All rights reserved

3.6
total volatile organic compound
tVOC
®1)
sum of volatile organic compounds (3.5) sampled on Tenax TA and eluting between and including
n-hexane and n-hexadecane, detected with a flame ionization detector (tVOC ) or mass spectrometric
FID
detector (tVOC ), and quantified by converting the total area of the chromatogram in that analytical
MS
window to toluene equivalents
[SOURCE: ISO 12219-2:2012, 3.5, modified — Note 1 to entry has been removed.]
3.7
moxibustion smoke
visible suspension of solid and/or liquid particles in gases, which is generated by the use of a moxibustion
device (3.1)
3.8
aldehyde
organic compounds containing formyl families
Note 1 to entry: Formaldehyde, acetaldehyde and vanillin are members of aldehyde families.
4 Test methods for smokeless moxibustion devices
4.1 General
A device that makes moxibustion smoke under the density levels described in Annexes B and C may be
labelled as a smokeless moxibustion devi
...