ISO INTERNATIONAL STANDARD 21291 First edition 2019-05 Traditional Chinese medicine Therapeutic fumigation devices Médecine traditionnelle chinoise - Dispositifs de fumigation thérapeutique Reference number ISO 21291:2019(E) osi @IS02019 IS0 21291:2019(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 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: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2019 - All rights reserved IS0 21291:2019(E) Contents Page Foreword ..iv 1 Scope 1 2 Normative references ..1 3 Terms and definitions 4 Classification and components .2 4.1 Classification .2 4.2 Components. 5 Technological requirements and test methods .5 5.1 Temperature protection. .5 5.1.1 Temperature protection at steam outlet .5 5.1.2 Temperature protection for fumigated body areas 6 5.2 Temperature set function .6 5.3 Temperature display function. .6 5.3.1 Open devices skin temperature-sensing unit ..6 5.3.2 Closed devices - capsule temperature-sensing unit .6 5.4 Temperature consistency in steam capsule .7 5.5 Treatment timing. .7 5.6 Emergency stop function .7 5.7 Heating prevention against empty decoction container. 5.8 Mechanical strength of patient support system .7 5.9 Instructions for device use.. .8 5.10 Electrical safety 8 5.11 Electromagnet disturbances ..8 5.12 Biological evaluation .8 @ IS0 2019 - All rights reserved iii