ISO 21292:2020

Traditional Chinese medicine — Electric heating moxibustion equipment

This document specifies general requirements for electrical heating moxibustion equipment. It is not applicable to infrared moxibustion equipment covered by ISO 20493 and smokeless moxibustion devices covered by ISO 21366.

Médecine traditionnelle chinoise — Équipements de moxibustion par chauffage électrique

General Information

• Status: Published
• Publication Date: 07-Jul-2020
• 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: 08-Jul-2020
• Due Date: 06-Apr-2020
• Completion Date: 08-Jul-2020

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 21292
First edition
2020-07
Traditional Chinese medicine —
Electric heating moxibustion
equipment
Médecine traditionnelle chinoise — Équipements de moxibustion par
chauffage électrique
Reference number
ISO 21292:2020(E)
©
ISO 2020

---------------------- Page: 1 ----------------------
ISO 21292:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 21292:2020(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Components . 2
5 Requirements and test methods . 2
5.1 Preparation . 2
5.2 Heating unit temperature . 2
5.3 Timing function . 3
5.4 Safety requirements . 3
5.5 Biocompatibility . 3
5.6 Instructions for use . 3
6 Package . 4
6.1 Primary packaging . 4
6.2 Secondary packaging . 4
7 Labelling . 4
7.1 General . 4
7.2 Primary and secondary packages . 4
Bibliography . 5
© ISO 2020 – All rights reserved iii

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ISO 21292:2020(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 2020 – All rights reserved

---------------------- Page: 4 ----------------------
INTERNATIONAL STANDARD ISO 21292:2020(E)
Traditional Chinese medicine — Electric heating
moxibustion equipment
1 Scope
This document specifies general requirements for electrical heating moxibustion equipment.
It is not applicable to infrared moxibustion equipment covered by ISO 20493 and smokeless moxibustion
devices covered by ISO 21366.
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) appli
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 21292
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Electric heating moxibustion
Voting begins on:
2020­04­01 equipment
Voting terminates on:
Médecine traditionnelle chinoise — Équipements de moxibustion par
2020­05­27
chauffage électrique
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
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 21292:2020(E)
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. ISO 2020

---------------------- Page: 1 ----------------------
ISO/FDIS 21292:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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
CH­1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/FDIS 21292:2020(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Components . 2
5 Requirements and test methods . 2
5.1 Preparation . 2
5.2 Heating unit temperature . 2
5.3 Timing function . 3
5.4 Safety requirements . 3
5.5 Biocompatibility . 3
5.6 Instructions for use . 3
6 Package . 4
6.1 Primary packaging . 4
6.2 Secondary packaging . 4
7 Labelling . 4
7.1 General . 4
7.2 Primary and secondary packages . 4
Bibliography . 5
© ISO 2020 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO/FDIS 21292:2020(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 2020 – All rights reserved

---------------------- Page: 4 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 21292:2020(E)
Traditional Chinese medicine — Electric heating
moxibustion equipment
1 Scope
This document specifies general requirements for electrical heating moxibustion equipment.
It is not applicable to infrared moxibustion equipment covered by ISO 20493 and smokeless moxibustion
devices covered by ISO 21366.
2 Normative references
T
...