ISO/TR TECHNICAL REPORT 37137 First edition 2014-05-15 Cardiovascular biological evaluation of medical devices Guidance for absorbable implants Evaluation biologigue cardiovasculaire des dispositifs medicaux - Directives pour les implants absorbables Reference number IS0/TR 37137:2014(E) ISO Copyright intematioal Organizatin for Standardizatin @IS02014 HS under I Not for Resale IS0/TR 37137:2014(E) COPYRIGHTPROTECTEDDOCUMENT @ISO2014 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 Case postale 56 : CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyright@iso.org Web www.iso.org Published in Switzerland @ IS0 2014 - All rights reserved or networking permited without license from IHS Not for Resale IS0/TR37137:2014(E) Contents Page Foreword ..iv 1 Scope .1 2 Terms and definitions ..1 3 General considerations. ..1 4 Sterilization considerations 2 5 Drug-device combination product considerations 3 6 Part listing and description of absorbable related issues in addition to the relevant parts of IS0 10993 series “Biological evaluation of medical devices" 4 6.1 IS0 10993-1:2009, Evaluation and testing within a risk management process. 4 6.2 IS0 10993-2:2006, Animal welfare requirements 4 6.3 Is0 10993-3:2003, Tests for genotoxicity, carcinogenicity and reproductive toxicity 4 6.4 IS0 10993-4:2002, Selection of tests for interactions with blood. 4 6.5 Is0 10993-5:2009, Tests for in vitro cytotoxicity 5 6.6 IS0 10993-6:2007, Tests for local effects after implantation 6 6.7 Is0 10993-7:2008, Ethylene oxide sterilization residuals. ..8 6.8 Is0 10993-9:2009, Framework for identification and quantification of potential degradation products 8 6.9 Is0 10993-10:2010, Tests for irritation and delayed-type hypersensitivity .8 6.10 IS0 10993-11:2006, Biological evaluation of medical devices — Part 11: Tests for systemictoxicity 9 6.11 Is0 10993-12:2012, Sample preparation and reference materials 9 6.12 Is0 10993-13:2010, Identification and quantification of degradation products from polymeric medical devices. .13 6.13 Is0 10993-14:2001, Identification and quantification of degradation products from ceramics.. .13 6.14 Is0 10993-15:2000, Identification and quantification of degradation products from metals and alloys .13 6.15 IS0 10993-16:2010, Toxicokinetic study design for degradation products andleachables .13 6.16 IS0 10993-17:2002, Establishment of allowable limits for leachable substances .13 6.17 IS0 10993-18:2005, Chemical characterization of materials. .. 13 6.18 IS0/TS 10993-19:2006, Physico-chemical, morphological and topographical characterizationofmaterials.. .14 6.19 IS0/TS 10993-20:2006, Principles and methods for immunotoxicology testing of medical devices... ..14 Annex A (informative) Nomenclature of absorb, degrade and related terms ..15 Bibliography .16 ii thout license from IHS Not for Resale