ISO 21366:2026

International
Standard
ISO 21366
Second edition
Traditional Chinese medicine —
2026-09
General requirements for
smokeless moxibustion devices
Médecine traditionnelle chinoise — Exigences générales relatives
à la moxibustion sans fumée
Reference number
© ISO 2026
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ii
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 .15

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
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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
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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
Traditional Chinese medicine.
This second edition cancels and replaces the first edition (ISO 21366:2019), which has been technically
revised.
The main changes are as follows:
— Changed limit value of smoke density for the statement of 'smokeless' from 200 to 50.
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
Moxibustion is one of the major traditional medical therapies. Smokeless moxibustion is an emerging form
of the moxibustion therapy. Smokeless moxibustion devices have different forms or are composed of the
materials used in conventional moxibustion without additional materials or processing for their safe use.
The standardization of smokeless moxibustion devices can 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.

v
International Standard ISO 21366:2026(en)
Traditional Chinese medicine — General requirements for
smokeless moxibustion devices
1 Scope
This document specifies general requirements for 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 7240-2, Fire detection and alarm systems — Part 2: Fire detection control and indicating equipment
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 organic compounds (VVOC, VOC, SVOC) in indoor and test
chamber air by active sampling on sorbent tubes, thermal desorption and gas chromatography using MS or MS
FID
ISO 18666, Traditional Chinese medicine — General requirements of moxibustion devices
ISO 18666:2021, Traditional Chinese medicine — General requirements of moxibustion devices
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
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
moxibustion device
apparatus that uses moxa floss as the main combustion material and is intended for single or repeated usage
EXAMPLE Moxibustion with tube shape 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.
[1]
[SOURCE: ISO 18666:2021 , 3.1]
3.2
smokeless moxibustion device
variant of the moxibustion device (3.1) designed to reduce the smoke and bad odour caused by combustion by
processing or changing main combustion material from moxa floss
Note 1 to entry: Carbonized moxa floss, carbonized mugwort leaves or other carbonized materials may be used as the
main combustion material.
3.3
aerosol density
smoke 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.
[2]
[SOURCE: ISO 7240-1:2025 , 3.5, 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.
[3]
[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
[4]
[SOURCE: ISO 12219-2:2012 , 3.4]

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 dete
...