ISO 21366: the international standard for smokeless moxibustion
What ISO 21366 (2019, revised 2026) covers: scope, the definition of a smokeless moxibustion device, smoke-density and smoke-alarm tests, noxious gas limits, temperature and materials, packaging and labelling, what changed in 2026, and how buyers use it.
Short answer: ISO 21366, Traditional Chinese medicine — General requirements for smokeless moxibustion devices, sets the performance and safety requirements for combustion-type moxibustion devices that claim to be smokeless. It covers smoke density, moxibustion temperature, noxious gases and the test methods [1][2]. The second edition (September 2026) replaced the 2019 edition and lowered the smoke-density limit for the word “smokeless” from 200 to 50 [1].
Summary based on ISO’s published abstract and sample pages and a third-party summary of the 2026 edition. The full standard is sold by ISO and national standards bodies. Where details come from the third-party summary, we say so.
Scope
- Applies to: any combustion-type device that claims to provide smokeless moxibustion [1]. In ISO’s terms a “device” includes the moxa product itself, such as sticks and cones, together with the accessories the manufacturer defines [3].
- Does not apply to: devices that only imitate moxibustion, such as electro-moxibustion and infrared moxibustion devices [1][2].
- Committee: ISO/TC 249 (Traditional medicine), Subcommittee SC 1 (Traditional Chinese medicine) [1].
Key definitions
According to a published summary of the 2026 edition [3]:
- Moxibustion device: an apparatus that uses moxa floss as its main combustion material, for single or repeated use, including the manufacturer’s accessories.
- Smokeless moxibustion device: a moxibustion device designed to reduce smoke and bad odour by processing or changing the main combustion material.
- Smoke density: the standard’s operational measure of aerosol (smoke) density.
- Moxibustion smoke: the visible suspension of solid or liquid particles in gases produced by the device.
Structure of the standard
| Part | Content | Source |
|---|---|---|
| Clause 4 | Test methods for smokeless devices: smoke density test, smoke generation test | [1][3] |
| Clause 5 | Safety requirements: noxious gas (CO, NO₂, total VOCs, aldehyde), moxibustion temperature, device materials | [1][3] |
| Clause 6 | Packaging and labelling, including protection of products | [1][3] |
| Annex A (informative) | WHO guidelines for indoor air quality | [1] |
| Annex B (normative) | Test method for moxibustion smoke density | [1] |
| Annex C (normative) | Test method for moxibustion smoke generation | [1] |
The two smoke tests
According to the published summary [3]:
- Smoke density (Annex B). The result must not exceed an optical density of 50 ± 5. The 2019 edition referenced the ISO 5659-2 smoke chamber method [2], the same method used in a Korean study of stick-on moxa [4].
- Smoke generation (Annex C). This test asks whether the smoke is enough to set off a smoke detector. Products that trigger the alarm must be fewer than 10%. The 2019 edition referenced the ISO 7240 fire-detection standards [2].
A device may be labelled smokeless only if its smoke output stays within the levels in Annexes B and C. Test setups may be adapted to the product’s shape or size [3]. ISO/TS 25198:2026 gives sample-preparation methods for different shapes and reports, for information, smoke-density results for moxa floss, carbonized moxa floss and smokeless products [5].
Gases, temperature and materials
According to the published summary [3]:
- Noxious gases must fall within the ranges in the WHO indoor-air guidelines. The listed methods are ISO 15011-2 for CO and NO₂, ISO 16000-6 for total VOCs, and ISO 16000-4 for aldehydes.
- Moxibustion temperature follows ISO 18666:2021, clauses 6.1–6.3.
- Materials that can contact the body follow ISO 18666:2021, clause 7.
Packaging and labelling
According to the summary [3]: packaging and labelling follow ISO 18666; only products that conform to Clause 4 may carry the “smokeless” statement, on the primary or secondary package; and packaging must protect against crushing, with more than 90% of products undamaged in the ISO 2248 vertical drop test. Buyer reviews of sticks arriving “smashed” show why this matters [6].
What changed in 2026
ISO’s foreword states that the second edition “changed limit value of smoke density for the statement of ‘smokeless’ from 200 to 50” [1]. In practice, a product that passed the old 200 limit may not pass the new one.
How buyers and brands use ISO 21366
- Specification: require conformity to “ISO 21366:2026” (with the year) if the product will be labelled smokeless.
- Evidence: ask for test reports that name the edition, the laboratory, the sample type and the results for Annex B, Annex C and the gases.
- Claims: if there is no conformity evidence, describe the product as “low-smoke” rather than “smokeless”, and check local advertising rules. See Labelling and claims.
- Voluntary status: ISO standards are voluntary unless a regulation or contract makes them binding.
Related pages
FAQ: related questions
What is ISO 21366?
ISO 21366, 'Traditional Chinese medicine — General requirements for smokeless moxibustion devices', sets performance and safety requirements, covering smoke density, moxibustion temperature, noxious gas and test methods, for combustion-type devices that claim to provide smokeless moxibustion.
What changed in ISO 21366:2026?
The second edition, published in September 2026, replaced the 2019 edition and changed the limit value of smoke density for the statement 'smokeless' from 200 to 50.
Does ISO 21366 apply to electric moxa devices?
No. It does not apply to devices that imitate moxibustion, such as electro-moxibustion and infrared moxibustion devices.
Is ISO 21366 mandatory?
ISO standards are voluntary unless referenced by a regulation or contract. Buyers can require conformity in specifications and ask for test reports naming the edition.
Sources for this page
- ISO 21366:2026 sample (foreword; scope). cdn.standards.iteh.ai/samples/iso/iso-21366-2026/4e2f44fb7e3
- ISO 21366:2019 sample (scope; references). cdn.standards.iteh.ai/samples/70791/691892081e244237b1465184
- ISO 21366:2026 summary (iTeh Standards). standards.iteh.ai/catalog/standards/iso/583dce2d-623a-4279-b
- Study of the Density of Smoke and Harmful Gases of Adhesive Indirect Moxibustion (J Korean Med 2012). jkom.org/upload/33-1-4.pdf
- ISO/TS 25198:2026 sample preparation for smoke density test of smokeless moxibustion device. www.iso.org/standard/89375.html
- Moxa Sourcing review of public Amazon UK customer reviews of smokeless moxa sticks, November 2026.
Last reviewed: . Editorial note: this guide re-edits published sources; it does not provide medical advice or new research.
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