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
Current Stage
6060 - International Standard published
Start Date
03-Nov-2026
Completion Date
03-Nov-2026

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Technical specification

ISO/TS 25198:2026 - Traditional Chinese medicine — Sample preparation methods for smoke density test of smokeless moxibustion device

Release Date:03-Nov-2026
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ISO/TS 25198:2026 is an ISO Technical Specification for traditional Chinese medicine. It gives sample preparation methods for the smoke density test of smokeless moxibustion devices, so the test specimens match the shape or size of the product before the smoke density test in ISO 21366:2026 is applied. Annex B also presents smoke density test results for moxa floss, carbonized moxa floss, and smokeless moxibustion device products for information.

What does ISO/TS 25198:2026 specify?

ISO/TS 25198:2026 specifies how to prepare specimens for smoke density testing of smokeless moxibustion devices. It focuses on specimen selection, specimen formation, storage before testing, and the calculation and correction of smoke density.

The document is organized into five clauses and two informative annexes.

PartWhat it covers
Clause 1Scope
Clause 2Normative references
Clause 3Terms and definitions
Clause 4Specimen preparation
Clause 5Calculation of smoke density
Annex AExample specimen formation
Annex BInformative smoke density test results

In practice, this structure tells a laboratory where to find the preparation rules, where to find the calculation approach, and where to look for examples of how the specimens are formed.

What are the key requirements of ISO/TS 25198:2026?

ISO/TS 25198:2026 is mainly about making test specimens in a consistent way so the smoke density result can be compared across product forms.

Specimen selection and formation

Clause 4.2.1 requires at least 5 specimens for a smoke density test. Each specimen is a composite sample made from at least 10 primary packages, or from samples selected over 10 different days if they come from the manufacturing line. This matters because the test sample has to represent normal production, not a single isolated unit.

Clause 4.2.2 sets the specimen size at 75 mm by 75 mm, with depth not more than 25 mm. If glue, paper, or another subsidiary material is needed to form the specimen, an equivalent amount of that material must be tested separately. In practice, this prevents the support material from being mixed into the product result without correction.

Storage before testing

Clause 4.2.3 requires prepared specimens to be stored for at least 72 h before testing in a controlled environment at 18 °C to 24 °C and relative humidity below 40 %. This matters because moisture and conditioning can change how the specimen burns and how much smoke it produces.

Smoke density calculation and correction

Clause 5.1 says smoke density is calculated using the formulae in ISO 21366:2026, Annex B.4. That means this document prepares the specimen, while ISO 21366 provides the calculation basis for the test result.

Clause 5.2 requires correction when subsidiary materials are used in the specimen. The measured smoke density from the formed specimen is adjusted using the smoke density of the subsidiary materials and the amount of material used. In practice, this separates the product contribution from the contribution of paper, glue, or similar materials.

Annex A examples

Annex A gives example specimen formations for moxa floss, carbonized moxa floss, and smokeless moxibustion device types 1, 2, and 3. These examples matter because they show how different product shapes can be converted into a test specimen that fits the required dimensions.

What terms does ISO/TS 25198:2026 define?

  • moxibustion device - An apparatus that uses moxa floss as the main combustion material and is intended for single or repeated use.
  • smokeless moxibustion device - A type of moxibustion device designed to reduce smoke and bad odour by changing the main combustion material.
  • smoke density - An operational measure of particles per volume, expressed using either the absorbance index m or the dimensionless variable y.
  • specimen - The prepared test sample used for the smoke density test, formed to the required size and shape.
  • subsidiary materials - Supporting materials such as glue or paper used when forming the specimen and corrected separately in the result.

Who uses ISO/TS 25198:2026?

Manufacturers of smokeless moxibustion devices use this document to prepare test specimens that match the product form. Test laboratories use it when carrying out smoke density testing under the method referenced by ISO 21366:2026.

Quality managers, technical reviewers, and certification teams use it to compare results from different device shapes and material combinations. Buyers and product assessors can also use it to understand how a product’s smoke density result was produced and whether the sample preparation approach is appropriate for the device type.

Which standards are used with ISO/TS 25198:2026?

The normative reference is ISO 21366:2026, Traditional Chinese medicine - General requirements for smokeless moxibustion devices. ISO/TS 25198:2026 uses it for the smoke density calculation in Annex B.4 and for the overall testing context of smokeless moxibustion devices.

What does the ISO/TS 25198:2026 document contain?

ISO/TS 25198:2026 contains the scope, one normative reference, three terms and definitions, and two technical clauses on specimen preparation and smoke density calculation. Clause 4 gives the specimen selection rules, the target specimen size, and the storage conditions before testing.

Annex A provides illustrated examples of how to form specimens for moxa floss and for three smokeless moxibustion device types. Annex B gives informative test results, including median values, corrected values, and values per gram for moxa floss, carbonized moxa floss, subsidiary materials, and device specimens in Table B.1.

The bibliography points to WHO indoor air quality publications that provide broader background on smoke and air quality concerns.

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Technical specification

ISO/TS 25198:2026 - Traditional Chinese medicine — Sample preparation methods for smoke density test of smokeless moxibustion device

Release Date:03-Nov-2026
English language (11 pages)
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Frequently Asked Questions

ISO/TS 25198:2026 is a technical specification published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine — Sample preparation methods for smoke density test of smokeless moxibustion device". This standard covers: 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.

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.

ISO/TS 25198:2026 is classified under the following ICS (International Classification for Standards) categories: 11.040.99 - Other medical equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

ISO/TS 25198:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


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
All rights reserved.
This ISO publication is protected by copyright and is owned by ISO and/or its licensors.
The content of this ISO publication is provided under licence, not sold. Use is subject to the applicable licence terms issued by ISO,
an ISO member body, or an authorized third-party distributor.
Except as required for implementation or expressly permitted by a separate licence, no part of this ISO publication may be
reproduced, distributed, modified, used, or made available in any form or by any means – electronic or mechanical, including
photocopying, scanning, recording, or posting on internal or external digital platforms.
Any use beyond the scope of the granted rights is prohibited and may result in legal action.
ISO copyright office
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC1,
Traditional Chinese medicine.
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 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;
...