ISO/TS 25198

• Abstract:

  This document provides sample preparation method and provide test result of smoke density test for smokeless moxibustion devices specified in the Annex B of ISO 21366 General requirements for smokeless moxibustion devices. This document contains sample preparation methods in accordance with the shape of smokeless moxibustion device and smoke density of moxa wool, carbonized moxa wool and smokeless moxibustion device products.

• Status: Not Published
• 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: 6000 - International Standard under publication
• Start Date: 01-Sep-2026
• Completion Date: 05-Sep-2026

Overview

ISO/TS 25198:2026 specifies the sample preparation methods for smoke density tests of smokeless moxibustion devices, an important aspect of quality and safety evaluation for products used in traditional Chinese medicine (TCM). Aligned with Annex B of ISO 21366, this technical specification focuses on the preparation of specimens according to the shape and materials of smokeless moxibustion devices, including moxa floss, carbonized moxa floss, and device-specific configurations. By providing standardized guidance for specimen preparation and smoke density measurement, ISO/TS 25198 enhances the consistency, comparability, and reliability of test results across the moxibustion industry.

Key Topics

• Definition and Scope: The standard defines key terms such as moxibustion device, smokeless moxibustion device, and smoke density (aerosol density).
• Specimen Preparation:
  • Procedures for selecting, forming, and storing samples before testing.
  • Instructions for preparing specimens according to the device type and size.
  • Use of subsidiary materials (e.g., thin papers, glue) and guidance on correcting their influence on testing results.
• Smoke Density Test Methods:
  • Reference to ISO 21366 for calculation methodologies.
  • Correction formulas to adjust for the presence of non-active materials in the sample.
  • Controlled storage requirements for specimen conditioning (18–24°C temperature, <40% relative humidity).
• Example Preparations:
  • Detailed examples in Annex A for forming test specimens of moxa floss, carbonized moxa floss, and multiple types of smokeless moxibustion devices.

Applications

For Manufacturers

• Ensures consistent assessment of smokeless moxibustion device emissions.
• Assists in qualifying products for international markets by aligning with recognized ISO standards.
• Guides R&D and quality assurance teams in validating device compliance with indoor air quality objectives.

For Laboratories & Test Facilities

• Provides standardized workflow for specimen preparation and environmental control before smoke density testing.
• Supports compatibility with existing procedures and equipment referenced in ISO 21366.

For Regulatory and Certification Bodies

• Supplies a reference method for verifying compliance with smoke emission regulations and safety criteria in TCM environments.
• Facilitates harmonized product evaluations and certification within the global TCM sector.

For Practitioners and Healthcare Providers

• Contributes to improved indoor air quality in clinical and wellness settings by enabling the selection of certified low-emission moxibustion devices.
• Supports evidence-based selection of safer and more effective moxibustion therapy tools.

Related Standards

• ISO 21366: General requirements for smokeless moxibustion devices - foundational reference for device performance and safety, particularly Annex B which outlines general test requirements.
• ISO 7240-1: Fire detection and alarm systems - referenced for smoke density definitions and measurement approaches.
• ISO 18666: Traditional Chinese medicine - cited for terminology related to TCM devices.
• WHO Guidelines for Indoor Air Quality: Offers further background and context on acceptable levels of airborne pollutants and their impact on health.

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Keywords: ISO/TS 25198, smokeless moxibustion device, traditional Chinese medicine, smoke density test, sample preparation, smoke emission, moxa floss, carbonized moxa, indoor air quality, ISO 21366.

Implementing ISO/TS 25198 drives reliability and comparability in evaluating emission characteristics of TCM smokeless moxibustion devices, supporting health, regulatory compliance, and product innovation in the field.

FINAL DRAFT
Technical
Specification
ISO/DTS 25198
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Sample preparation methods for
Voting begins on:
smoke density test of smokeless
2026-07-06
moxibustion device
Voting terminates on:
2026-08-31
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/DTS 25198:2026(en) © ISO 2026

FINAL DRAFT
ISO/DTS 25198:2026(en)
Technical
Specification
ISO/DTS 25198
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Sample preparation methods for
Voting begins on:
smoke density test of smokeless
moxibustion device
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DTS 25198:2026(en) © ISO 2026

ii
ISO/DTS 25198:2026(en)
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 result of smokeless moxibustion device specimen . 9
Bibliography .11

iii
ISO/DTS 25198:2026(en)
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
ISO/DTS 25198:2026(en)
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
FINAL DRAFT Technical Specification ISO/DTS 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 21366:2023, Annex B.
Also, this document provides the test results of smoke density of moxa floss, carbonized moxa floss and
smokeless moxibustion device products as an 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 21366:2019, 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 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 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 combustio
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Traditional chineseChinese medicine —Method of sample Sample .
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St l D fi iti
ISO/DTS 25198:(en)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
E-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO/DTS 25198:(en)
Contents
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
5 Calculation of smoke density . 3
5.1 Smoke density . 3
5.2 Correction of subsidiary materials . 3
Annex A (informative) Specimen formation . 4
Annex B (informative) Test result of smokeless moxibustion device specimen . 13
Bibliography . 15

iii
ISO/DTS 25198:(en)
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Foreword
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ISO (the International Organization for Standardization) is a worldwide federation of national standards
Adjust space between Asian text and numbers
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 documentsdocument should be noted. This document was drafted in accordance with the editorial rules Formatted: Font color: Auto
of the ISO/IEC Directives, Part 2 (see www.iso.org/directiveswww.iso.org/directives).
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Attention is drawnISO draws attention to the possibility that some of the elementsimplementation of this Formatted: Font color: Auto
document may beinvolve the subjectuse of (a) patent(s). ISO takes no position concerning the evidence,
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validity or applicability of any claimed patent rights. in respect thereof. As of the date of publication of this
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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
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obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for
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identifying any or all such patent rights. Details of any patent rights identified during the development of the
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document will be in the Introduction and/or on the ISO list of patent declarations received (see
www.iso.org/patents).
Formatted: Font color: Auto
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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),
see www.iso.org/iso/foreword.html. Formatted: Font color: Auto, English (United Kingdom)
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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC1,
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Traditional Chinese medicine.
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Any feedback or questions on this document should be directed to the user’s national standards body. A
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complete listing of these bodies can be found at www.iso.org/members.htmlwww.iso.org/members.html.
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iv
ISO/DTS 25198:(en)
Introduction
Moxibustion is one of the major traditional medical therapies which is usingused worldwide despite the Formatted: Font color: Auto
limitationlimitations of smoke. Smokeless moxibustion is an emerging form of moxibustion therapy. However,
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smokeless moxibustion devices have different forms or additional components and thus, it requires guideline
require guidelines for testing of smokeless moxibustion devices. Formatted: Font color: Auto
Formatted: Font color: Auto
ISO 21366 has been developed to improve the quality and safety of moxibustion treatments using smokeless
moxibustion devices, especially in regardsregard to the biocompatibility with the human body and indoor air
Formatted: Font color: Auto
quality. ISO 25198 defines detailed test methods and sample preparation methods for the various forms of
moxibustion devices. Formatted: Font color: Auto
v
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ISO/DTS 25198:(en)
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Traditional Chinese medicine — Method of sample — Sample
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preparation methods for smoke density test of smokeless .
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moxibustion device
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1 Scope
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This document provides sample preparation method and provide test result ofmethods according to the shape
of the smokeless moxibustion device for the application of the smoke density test for smokeless moxibustion Formatted
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devices specified in the Annex B of ISO 21366 General requirements for smokeless moxibustion devices:2023,
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Annex B.
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ThisAlso, this document contains sample preparation methods in accordance with the shape of smokeless
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moxibustion device, andprovides the test resultresults of smoke density of moxa floss, carbonized moxa floss
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and smokeless moxibustion device products. as an information, in Annex B.
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32 Normative references
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The following documents are referred to in the text in such a way that some or all of their content constitutes
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requirements of this document. For dated references, only the edition cited applies. For undated references,
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the latest edition of the referenced document (including any amendments) applies.
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ISO 21366; :2019, Traditional Chinese medicine — General requirements for smokeless moxibustion devices .
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53 Terms and definitions .
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For the purposes of this document, the following terms and definitions apply.
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ISO and IEC maintain terminological databases for use in standardization at the following addresses: Formatted
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— — ISO Online browsing platform: available at https://www.iso.org/obphttps://www.iso.org/obp
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— — IEC Electropedia: available at http://www.electropedia.org/https://www.electropedia.org/
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3.1 3.1
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moxibustion device
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apparatus that uses moxa floss as the main combustion material and intended for single or repeated usage
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EXAMPLE Moxibustion with tube is a type of moxibustion device, such as a short moxa roll with a cardboard base
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and a moxa tube (made of cardboard) that is single-use and developed as an alternative to direct moxibustion.
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Note 1 to entry: Moxibustion device includesdevices include those accessories as defined by the
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manufacturers that are necessary to enable the normal use of the moxibustion device.
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[SOURCE: ISO 18666:2021, 3.1]
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© ISO 2018 2026 – All rights reserved
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3.2 3.2
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smokeless moxibustion device
A variant of the moxibustion device (3.1)(3.1) aiming to reduce the smoke and bad odour caused by combustion Formatted: Font color: Auto
by processingprocess of changing main combustion material.
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Note 1 to entry: Carbonized moxa floss, carbonized mugwort leaves or other carbonized materials
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maycan 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.
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3.3 3.3
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smoke density (aerosol density)
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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; Formatted: Font: Italic, Font color: Auto
— — y, a dimensionless variable, used in the testing of smoke detectors using ionization Formatted: Font: Italic, Font color: Auto
Note 1 to entry: These parameters are not concentrations sensu stricto,in the strict sense but represent Formatted: Font color: Auto
values which 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]-1:2025, 3.5, modified —"amount" revised to "number" in definition, and
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Note 1 to entry modified.]
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74 Specimen
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7.14.1 General Not at 0.71 cm
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Test samples shall be prepared in accordance inwith the shape or size of each productsproduct.
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7.24.2 Specimen preparation
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7.2.14.2.1 Sample selection
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SmokeA smoke density test requires at least 5 specimen andspecimens. Sufficient samples shall be selected
Not at 0.71 cm + 0.99 cm + 1.27 cm
enough to form 5 specimenspecimens specified in 4.2.2 in accordance with the size and shape of each
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productsproduct. Each specimen shall be made by samplesconsist of a composite sample collected from at
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least 10 primary packagepackages. If the samples were selected in the manufacturing line, samples shall be
selected over 10 different days.
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7.2.24.2.2 Specimen formation
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For the smoke density test, samplethe specimen shall be formed in the size of 75 × mm × 75 mm mm in width
and length and the depth of the sample shall not be overmore than 25 mm. AThe formation of the sample may Formatted: Font color: Auto
require subsidiary materials (e.g. glue or paper) and in this case, the sameAn equivalent amount of subsidiary
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materials used in forming the test sample shall be tested.
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separately. For further exampleexamples of sample formation, see Annex AAnnex A.
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7.2.34.2.3 Specimen storage
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Formed samplesPrepared specimens shall be stored in thea controlled environment for more thanat least 72
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hours before the test h prior to testing.
spacing: single, Tab stops: Not at 17.2 cm
2 © ISO #### 2026 – All rights reserved
ISO/DTS 25198:(en)
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Specimens shall be stored under the following controlled conditions:
-— A temperature : fromof 18 °C to 24 °C, Formatted: Font color: Auto
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-— relative humidity: of less than 40 % %.
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95 Calculation of smoke density Formatted: Font color: Auto
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9.15.1 Smoke density
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1)
Calculation of smoke density followsshall follow the formulas in the B.4, Annex B, ISO 21366. (Test: — ,
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Annex B.4. For the test result, see Annex B)Annex B, Table B.1.
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9.25.2 Correction of subsidiary materials
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The effect of subsidiary materials shall be removedcorrected if it wasthey were used while forming the
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specimen. The formula for correct the effect fromof subsidiary materials is as following;shall be corrected
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using Formula (1):
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𝑠𝑠
𝐷𝐷 =𝐷𝐷 −𝐷𝐷 ( )
𝑎𝑎 𝑚𝑚 𝑝𝑝
𝐴𝐴
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𝐴𝐴
s
𝐷𝐷 =𝐷𝐷 −𝐷𝐷 ( ) (1)
a m p
𝐴𝐴
c
where Formatted: Font color: Auto
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Da is the corrected real smoke density
Latin and Asian text, Adjust space between Asian text and
Dm is the smoke density measured from the specimen with subsidiary materials
numbers
Dp is the smoke density measured from the subsidiary materials
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A is the amount of subsidiary materials used in the specimen
s
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A is the amount of subsidiary materials used for the smoke density measurement
c
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1)
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Under preparation. Stage at time of publication: ISO/FDIS 21366:2026.
stops: Not at 17.2 cm
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Annex A
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(informative)
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Specimen formation .
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