ISO INTERNATIONAL STANDARD 19611 First edition 2017-05 Traditional Chinese medicineAir extraction cupping device Medecinetraditionnellechinoise-Dispositifdebombementa extraction d'air Referencenumber ISO19611:2017(E) Intemational Organization for Standardization @IS02017 e=ZHEJIANG INST OF STANDARDIZATION C15956617 Not for Resale, 2017/8/21 01:08:45 No reproduction or itted without license from IHS IS019611:2017(E) COPYRIGHTPROTECTEDDOCUMENT IS02017,Published inSwitzerland All rights reserved. Unless otherwise specified, 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. ISOcopyrightoffice Ch. de Blandonnet 8. CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org Intematinaibr PrganizationfoStandardization Uicensee-ZHEJIANG INSTOF STANDARDIZRoISQl.7 -All rights reserved networking permited without license from IHS NotforResale, 2017/8/21 01:08:45 IS0 19611:2017(E) Contents Page Foreword ..iv Introduction.. 1 Scope. 2 Normativereferences 3 Terms and definitions ..1 4 Configuration .2 4.1 Configuration of cupping device .2 4.2 Dimensions.. .3 4.2.1 Inner volume. .3 4.2.2 Smoothnessofthe skin contacting edge ..4 4.2.3 Diameters of air outlet 4 5 Requirements .4 5.1 Biological compatibility .4 5.2 Performance requirements 4 5.2.1 Resistingnegativepressure .4 5.2.2 Pressure maintenance 4 5.2.3 Mechanical stability .5 5.2.4 .5 Transparency 5.2.5 Repeateddisinfectionresistance 5 5.3 Sterilization and disinfection... .5 5.3.1 Sterilizationforsingle-usetypedevices .5 5.3.2 Disinfectionformultiple-usetypedevices .5 6 Package. .5 6.1 Primary package 5 Secondary package .5 6.2 Labelling. 7 7.1 General .6 7.2 Primary package 7.3 Secondary package .6 Annex A (normative) Test methods for a cupping device .7 Bibliography .9 Intematinal oganzation @stS.20.17 - All rights reserved iii icensee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 ithout license from IHS