ISO 22466:2021
(Main)Traditional Chinese medicine — Laser acupoint devices
Traditional Chinese medicine — Laser acupoint devices
This document specifies requirements and test methods for laser acupoint devices. This document is not applicable to carbon-dioxide-type lasers. In the case of combined devices, it is applicable only to the laser features.
Médecine traditionnelle chinoise — Dispositifs laser pour traitement par acuponcture
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INTERNATIONAL ISO
STANDARD 22466
First edition
2021-05
Traditional Chinese medicine — Laser
acupoint devices
Médecine traditionnelle chinoise — Dispositifs laser pour traitement
par acuponcture
Reference number
ISO 22466:2021(E)
©
ISO 2021
---------------------- Page: 1 ----------------------
ISO 22466:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 22466:2021(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Configuration and classification . 2
4.1 Configuration . 2
4.2 Classification . 2
5 Requirements and test methods . 3
5.1 Wavelength . 3
5.2 Spot size . 3
5.3 Pulse repetition rate . 3
5.4 Output power . 4
5.5 Energy density . 4
5.6 Output independency . 4
5.7 Laser emission indicators . 4
5.8 Power stability of continuous wave laser . 5
5.9 Energy stability of pulsed laser . 5
5.10 Target-indicating function . 5
5.11 Probe fixing unit . 5
5.12 Eye protection . 5
6 Biological evaluation . 5
7 Electrical safety . 5
8 Electromagnet disturbances . 6
9 Instructions for use (IFU) . 6
Bibliography . 7
© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 22466:2021(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 2021 – All rights reserved
---------------------- Page: 4 ----------------------
INTERNATIONAL STANDARD ISO 22466:2021(E)
Traditional Chinese medicine — Laser acupoint devices
1 Scope
This document specifies requirements and test methods for laser acupoint devices. This document is
not applicable to carbon-dioxide-type lasers. In the case of combined devices, it is applicable only to the
laser features.
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 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11145, Optics and photonics — Lasers and laser-related equipment — Vocabulary and symbols
ISO 11146-1, Lasers and laser-related equipment — Test methods for laser beam widths, divergence angles
and beam propagation ratios — Part 1: Stigmatic and simple astigmatic beams
ISO 11554, Optics and photonics — Lasers and laser-related equipment — Test methods for laser beam
power, energy and temporal characteristics
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
IEC 60601-1-2
...
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 22466
ISO/TC 249
Traditional Chinese medicine — Laser
Secretariat: SAC
acupoint devices
Voting begins on:
20210219
Médecine traditionnelle chinoise — Dispositifs laser pour traitement
par acuponcture
Voting terminates on:
20210416
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 22466:2021(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 2021
---------------------- Page: 1 ----------------------
ISO/FDIS 22466:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 22466:2021(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Configuration and classification . 2
4.1 Configuration . 2
4.2 Classification . 2
5 Requirements and test methods . 3
5.1 Wavelength . 3
5.2 Spot size . 3
5.3 Pulse repetition rate . 3
5.4 Output power . 4
5.5 Energy density . 4
5.6 Output independency . 4
5.7 Laser emission indicators . 4
5.8 Power stability of continuous wave laser . 5
5.9 Energy stability of pulsed laser . 5
5.10 Targetindicating function . 5
5.11 Probe fixing unit . 5
5.12 Eye protection . 5
6 Biological evaluation . 5
7 Electrical safety . 5
8 Electromagnet disturbances . 6
9 Instructions for use (IFU) . 6
Bibliography . 7
© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 22466:2021(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 nongovernmental, 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 2021 – All rights reserved
---------------------- Page: 4 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 22466:2021(E)
Traditional Chinese medicine — Laser acupoint devices
1 Scope
This document specifies requirements and test methods for laser acupoint devices. This document is
not applicable to carbon-dioxide-type lasers. In the case of combined devices, it is applicable only to the
laser features.
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 109931, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11145, Optics and photonics — Lasers and laser-related equipment — Vocabulary and symbols
ISO 111461, Lasers and laser-related equipment — Test methods for laser beam widths, divergence angles
and beam propagation ratios — Part 1: Stigmatic and simple astigmatic beams
ISO
...
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