ISO INTERNATIONAL STANDARD 21976 Firstedition 2018-11 Packaging Tamper verification features for medicinal product packaging Emballage - Temoins d'effraction pour emballages de medicaments Reference number IS0 21976:2018(E) so @IS02018 IS0 21976:2018(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2018 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: +4122 749 0111 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2018 - All rights reserved IS0 21976:2018(E) Contents Page Foreword ..V Introduction. ...vi 1 Scope. 2 Normative references 3 Terms and definitions 4 General requirements .2 4.1 Tamper verification features. .2 4.2 Purpose oftamper verification features. .2 4.3 Application and use of tamper verification features. 2 4.4 Check oftamperverification features... .3 5 Categories of tamper verification features .3 5.1 General .3 5.2 Folding boxes closed with glue .3 5.2.1 Description. 3 5.2.2 Criteria of tamper verification .3 5.2.3 Verification. .3 5.3 Specially constructed folding boxes 4 5.3.1 Description. .4 5.3.2 Criteria of tamper verification 5 5.3.3 .5 Verification. 5.4 Sealing labels and tapes .5 5.4.1 Description. 5.4.2 Criteria of tamper verification 6 5.4.3 Verification. . 6 5.5 Film wrappers. 7 5.5.1 Description. .7 5.5.2 Criteria of tamper verification 7 5.5.3 Verification. .7 5.6 Sleeves .7 5.6.1 Description. .7 5.6.2 Criteria of tamper verification 5.6.3 Verification. 7 5.7 Breakable or tear-away closure ..8 5.7.1 Description. .8 5.7.2 Criteria of tamper verification ..8 5.7.3 Verification .8 5.8 Container inner seal or membrane .9 5.8.1 Description. .9 5.8.2 Criteria of tamper verification .9 5.8.3 Verification .10 5.9 Display blister pack. .10 5.9.1 Description .10 5.9.2 Criteria of tamper verification ..10 5.9.3 Verification. .11 5.10 Flexible packaging.. .11 5.10.1 Description .11 5.10.2 Criteria of tamper verification .11 5.10.3 Verification. .11 5.11 Blow-fill-and-seal-container (BFS) .12 5.11.1 Description. ..12 5.11.2 Criteria of tamper verification ..12 5.11.3 Verification. ..12 IS0 2018 - All rights reserved iii