ISO INTERNATIONAL STANDARD 16671 Second edition 2015-08-01 Ophthalmic implants Irrigating solutions for ophthalmic surgery Implants ophtalmiques Solutions d'irrigation pour la chirurgie ophtalmique Reference number IS0 16671:2015(E) ISO IS02015 IS0 16671:2015(E) COPYRIGHT PROTECTED DOCUMENT @ IS0 2015, Published in Switzerland 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. ISO copyright office Ch. de Blandonnet 8. CP 401 CH-1214 Vernier, Geneva, Switzerland Tel.+4122 749 0111 Fax +4122 749 09 47 [email protected] www.iso.org @ IS0 2015 - All rights reserved IS0 16671:2015(E) Contents Page Foreword ..iv 1 Scope 2 Normative references 3 Terms and definitions ..1 4 Intended performance .2 5 Design attributes .2 5.1 General. .2 5.2 Concentration of the components .2 5.3 Waterused 3 5.4 Characterization of the finished product 33 5.4.1 General. 5.4.2 pH and buffering capacity 3 5.4.3 Chemical and biological contaminants 3 5.4.4 Osmolality. 4 5.4.5 Spectral transmittance .4 5.4.6 Particulates .4 6 Design evaluation .5 6.1 General .5 6.2 Preclinical evaluation of biological safety .5 6.2.1 General .5 6.2.2 Bacterial endotoxins test 5 6.2.3 Intraocular irritation and inflammation .5 6.3 Clinical evaluation. .6 7 Sterilization ..6 8 Product stability ..6 9 Packaging .7 9.1 Protection from damage during storage and transport. ..7 9.2 Maintenance of sterility in transit 10 Information supplied by the manufacturer 7 Annex A (informative) Example of a suitable method for pH measurement and buffer capacity determination 9 Annex B (normative) Particulate contamination: Visible particulates. ..10 Annex C (informative) Light obscuration test method for particulate contamination: sub- visibleparticles ..11 Annex D (informative) Microscopic test method for particulate contamination: sub- visible particles.. ..13 Annex E (normative) Intraocular irrigation test ..18 Annex F (informative) Clinical investigation ..19 Bibliography. ..22 sn Sandardizan rights reserved ii