Traditional Chinese medicine -- General requirements for smokeless moxibustion devices

This document specifies general requirements to ensure 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.

Médecine traditionnelle chinoise -- Exigences générales relatives à la moxibustion sans fumée

General Information

Status
Published
Publication Date
09-May-2019
Current Stage
6060 - International Standard published
Start Date
09-Apr-2019
Completion Date
10-May-2019
Ref Project

Buy Standard

Standard
ISO 21366:2019 - Traditional Chinese medicine -- General requirements for smokeless moxibustion devices
English language
14 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (sample)

INTERNATIONAL ISO
STANDARD 21366
First edition
2019-05
Traditional Chinese medicine —
General requirements for smokeless
moxibustion devices
Médecine traditionnelle chinoise — Exigences générales relatives à la
moxibustion sans fumée
Reference number
ISO 21366:2019(E)
ISO 2019
---------------------- Page: 1 ----------------------
ISO 21366:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 21366:2019(E)
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 .............................................................................................................................................................................................................................14

© ISO 2019 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 21366:2019(E)
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 documents 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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/patents).

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 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 2019 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 21366:2019(E)
Introduction

Moxibustion is one of the major traditional medical therapies. Smokeless moxibustion is an emerging

form of moxibustion therapy. However, smokeless moxibustion devices have different forms or are

composed of the materials used in conventional moxibustion without additional materials or processing

needed for their safe use.

The standardization of smokeless moxibustion devices will 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.
© ISO 2019 – All rights reserved v
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 21366:2019(E)
Traditional Chinese medicine — General requirements for
smokeless moxibustion devices
1 Scope

This document specifies general requirements to ensure 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 5659-2:2017, Plastics — Smoke generation — Part 2: Determination of optical density by a single-

chamber test

ISO 7240-2, Fire detection and alarm systems — Part 2: Fire detection control and indicating equipment

ISO 7240-7:2018, Fire detection and alarm systems — Part 7: Point-type smoke detectors using scattered

light, transmitted light or ionization

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 volatile organic compounds in indoor and test chamber

air by active sampling on Tenax TA sorbent, thermal desorption and gas chromatography using MS or MS-FID

ISO 18666:2015, Traditional Chinese medicine — General requirements of 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 http: //www .electropedia .org/
© ISO 2019 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO 21366:2019(E)
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 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.
[SOURCE: ISO 18666:2015, 3.1]
3.2
smokeless moxibustion device

moxibustion device (3.1) intended to reduce the smoke and bad odour caused by combustion

Note 1 to entry: Carbonized moxa floss, carbonized mugwort leaves or other carbonized materials may be used

as the main combustion material.
3.3
smoke density
aerosol 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.

[SOURCE: ISO 7240-1:2014, 2.1.5, modified — The order of the terms has been switched so that "smoke

density" is the preferred term.]
3.4
carbon monoxide
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.
[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

[SOURCE: ISO 12219-2:2012, 3.4]
2 © ISO 2019 – All rights reserved
---------------------- Page: 7 ----------------------
ISO 21366:2019(E)
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 detector (tVOC ) or mass spectrometric

FID

detector (tVOC ), and quantified by converting the total area of the chromatogram in that analytical

window to toluene equivalents
[SOURCE: ISO 12219-2:2012, 3.5, modified — Note 1 to entry has been removed.]
3.7
moxibustion smoke

visible suspension of solid and/or liquid particles in gases, which is generated by the use of a moxibustion

device (3.1)
3.8
aldehyde
organic compounds containing formyl families
Note 1 to entry: Formaldehyde, acetaldehyde and vanillin are membe
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.