Traditional Chinese medicine -- Laser acupoint devices

Médecine traditionnelle chinoise -- Dispositifs laser pour traitement par acuponcture

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Status
Published
Publication Date
26-May-2021
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
17-Apr-2021
Completion Date
16-Apr-2021
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ISO/FDIS 22466 - Traditional Chinese medicine -- Laser acupoint devices
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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
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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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