ISO/TS 25198:2026

• Abstract:

  This document provides sample preparation methods according to the shape of the smokeless moxibustion device for the application of the smoke density test for smokeless moxibustion devices specified in ISO 21366:2026, Annex B. This document also provides the smoke density test results of moxa floss, carbonized moxa floss and smokeless moxibustion device products for information, in Annex B.

• Status: Published
• Publication Date: 02-Nov-2026
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 4 - Quality and safety of medical devices other than acupuncture needles
• Current Stage: 6060 - International Standard published
• Start Date: 03-Nov-2026
• Completion Date: 03-Nov-2026

ISO/TS 25198 is an ISO technical specification for preparing specimens for the smoke density test of smokeless moxibustion devices. It is written for use with the smoke density test framework in ISO 21366 and gives preparation methods for moxa floss, carbonized moxa floss, and smokeless moxibustion device products. For laboratories and manufacturers, it shows how to form comparable test specimens so smoke density results can be measured on the same basis.

What does ISO/TS 25198 specify?

ISO/TS 25198 specifies how to prepare specimens for smoke density testing of smokeless moxibustion devices. The document is organized into Scope, Normative references, Terms and definitions, Specimen, Calculation of smoke density, two informative annexes, and a bibliography.

Annex	What it covers
Annex A	Specimen formation examples
Annex B	Test result of smokeless moxibustion device specimen

The scope ties the document to the smokeless moxibustion devices covered in Annex B of ISO 21366 and to sample preparation by device shape. In practice, this means the document is about preparing the test article, not describing the full smoke density test method itself.

What are the key requirements of ISO/TS 25198?

ISO/TS 25198 focuses on representative sampling, specimen forming, conditioning before test, and correcting the measured smoke density when subsidiary materials are used.

• Clause 4.1 - General: test samples shall be prepared according to the shape or size of each product. This matters because different device forms need different specimen handling if the smoke result is to reflect the actual product.
• Clause 4.2.1 - Sample selection: a smoke density test requires at least 5 specimens. Each specimen is made from a composite sample taken from at least 10 primary packages, or from material selected over 10 different days if taken from the manufacturing line. This helps avoid testing a non-representative sample.
• Clause 4.2.2 - Specimen formation: the specimen is formed to 75 mm by 75 mm, with depth not more than 25 mm. If glue, paper, or other subsidiary materials are needed, an equivalent amount of those materials is tested separately. This is what allows later correction for the support materials.
• Clause 4.2.3 - Specimen storage: prepared specimens are stored for at least 72 hours in a controlled environment at 18 °C to 24 °C and relative humidity below 40 %. This conditioning reduces variation caused by moisture and handling.
• Clause 5.1 - Smoke density: smoke density is calculated using the formulas in ISO 21366 Annex B. In practice, the same calculation basis is used so results can be compared with the parent standard.
• Clause 5.2 - Correction of subsidiary materials: the effect of subsidiary materials is removed using the stated correction formula. This matters when glue or paper contributes smoke and would otherwise distort the result for the combustion material itself.
• Annex A - Specimen formation: Annex A gives formation examples for moxa floss, carbonized moxa floss, and smokeless moxibustion device types 1, 2, and 3. It is practical guidance for building the specimen to the required shape.

What terms does ISO/TS 25198 define?

ISO/TS 25198 formally defines three terms in Clause 3 and uses two specimen-preparation terms throughout the document.

• moxibustion device - an apparatus that uses moxa floss as the main combustion material and is intended for single or repeated use, including the accessories needed for normal use.
• smokeless moxibustion device - a variant of a moxibustion device intended to reduce smoke and bad odour by changing the main combustion material.
• smoke density (aerosol density) - an operational measure of particulates per volume used in smoke testing, expressed through the test parameters named in the definition.
• specimen - the prepared test sample formed from the product material before smoke density testing.
• subsidiary materials - added materials such as glue or paper used to form the specimen and later corrected out of the result.

Who uses ISO/TS 25198?

ISO/TS 25198 is used by manufacturers and product developers of smokeless moxibustion devices, test laboratories running smoke density measurements, and quality managers checking how specimens are prepared. It is also relevant to buyers and technical reviewers who need to understand whether a test report was made from a specimen prepared in a consistent way. The document sits in the Traditional Chinese medicine device area and supports work linked to ISO 21366.

Which standards are used with ISO/TS 25198?

• ISO 21366 - the referenced standard for smokeless moxibustion devices; its Annex B provides the smoke density calculation basis used here.
• ISO 18666:2021 - source of the definition of moxibustion device used in Clause 3.
• ISO 7240-1:2025 - source of the definition of smoke density used in Clause 3.

What does the ISO/TS 25198 document contain?

ISO/TS 25198 contains specimen-preparation guidance for different product shapes, plus calculation and correction steps for smoke density. Annex A gives illustrated examples of specimen formation, including mould-based preparation and device-specific preparation for types 1 to 3. Annex B gives example test results for moxa floss, carbonized moxa floss, subsidiary materials, and specimens 1 to 4. The document also includes a table of results and figures showing how the specimens are formed and assembled.

Technical
Specification
ISO/TS 25198
First edition
Traditional Chinese medicine —
2026-11
Sample preparation methods for
smoke density test of smokeless
moxibustion device
Médecine traditionnelle chinoise — Méthodes de préparation
des échantillons pour l'essai de densité de fumée du dispositif de
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 Specimen . 2
4.1 General .2
4.2 Specimen preparation .2
4.2.1 Sample selection .2
4.2.2 Specimen formation .2
4.2.3 Specimen storage .2
5 Calculation of smoke density . 2
5.1 Smoke density .2
5.2 Correction of subsidiary materials .2
Annex A (informative) Specimen formation . 4
Annex B (informative) Test results of smokeless moxibustion device specimen . 9
Bibliography .11

iii
Foreword
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iv
Introduction
Moxibustion is one of the major traditional medical therapies which is used worldwide despite the limitations
of smoke. Smokeless moxibustion is an emerging form of moxibustion therapy. However, smokeless
moxibustion devices have different forms or additional components and thus require guidelines for testing.
ISO 21366 has been developed to improve the quality and safety of moxibustion treatments using smokeless
moxibustion devices, especially in regard to the biocompatibility with the human body and indoor air
quality. ISO 25198 defines detailed test methods and sample preparation methods for the various forms of
moxibustion devices.
v
Technical Specification ISO/TS 25198:2026(en)
Traditional Chinese medicine — Sample preparation methods
for smoke density test of smokeless moxibustion device
1 Scope
This document provides sample preparation methods according to the shape of the smokeless moxibustion
device for the application of the smoke density test for smokeless moxibustion devices specified in
ISO 21366:2026, Annex B.
This document also provides the smoke density test results of moxa floss, carbonized moxa floss and
smokeless moxibustion device products for information, in Annex B.
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 21366:2026, Traditional Chinese medicine — General requirements for smokeless moxibustion devices
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 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 devices include those accessories as defined by the manufacturers that are necessary to
enable the normal use of the moxibustion device.
[SOURCE: ISO 18666:2021, 3.1]
3.2
smokeless moxibustion device
variant of the moxibustion device (3.1) aiming to reduce the smoke and bad odour caused by combustion by
process of changing main combustion material
Note 1 to entry: Carbonized moxa floss, carbonized mugwort leaves or other carbonized materials can be used as the
main combustion material.
Note 2 to entry: Not all moxibustion devices use moxa floss and the intended use is not definitional.
3.3
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;
...