_STP_1452-2004.pdf

STP 1452 Tissue Engineered Medical Products(TEMPs)Eliane Schutte,Grace h Picciolo,and David Kaplan,editors ASTM Stock Number:STP1452 ASTM 100 Barr Harbor Drive PO Box C700 West Conshohocken,PA 19428-2959 Printed in the U.S.A.Library of Congress Cataloging-in-Publication Data Tissue engineered medical products(TEMPs)/Eliane Schutte,Grace L.Picciolo,and David Kaplan,editors.p.;cm.-(STP;1452)RSTM Stock Humber:STP145Z.Papers presented at a symposium held in Miami Beach,Florida,on 4-5 November,2002.Includes bibfiographical references and indexes.ISBN 0-8031-3471-1(ale paper)1.Tissue engineering-Standards-Congresses.2.Medical protocols-Congresses.L Schutte,Efiane,1970-II.Picciolo,Grace Lee.HI.Kaplan,David S.,1957-IV.ASTM special technical publication;1452.DNLM:I.Tissue Engineering-standards-Congresses.2.Biocompatible Materials-standards-Congresses.QT 37 T6153 2004 R857.T55T545 2004 610.28-dc22 2004043760 Copyright O 2004 AMERICAN SOCIETY FOR TESTING AND MATERIALS INTERNATIONAL,West Conshohocken,PA.All rights reserved.This material may not be reproduced or copied,in whole or in part,in any pdnted,mechanical,electronic,film,or other distribution and storage media,without the written consent of the publisher.Photocopy Rights Authorization to photocopy items for internal,personal,or educational classroom use,or the internal,personal,or educonal classroom use of specific clients,is granted by the American Society for TeetJng and Msterials Intematmnal(ASTM)provided that the appropriate fee ie paid to the Copyright Clearance Canter,222 Rosewood Drive,Denvers,MA 01923;Tel:978-750-8400;online:http-J/www.copyrighLcomf.Peer Review Policy Each paper published in this volume was evaluated by two peer reviewers and at least one editor.The authors addressed all of the reviewers comments to the satisfaction of both the technical editor(s)and the ASTM International Committee on Publications.To make technical information available as quickly as possible,the peer-reviewed papers in this publication were prepared camera-reedy as submitted by the authors.The quality of the papers in this pubrcation reflects not only the obvious efforts of the authors and the technical editor(s),but also the work of the peer reviewers.In keeping with long-standing publication practices,ASTM International maintains the anonymity of the peer reviewem.The ASTM International Committee on Publications acknowledges with appreciation their dedication and contribution of time and effod on behaff of ASTM Intamational.Printed in Saline,M!2004 Foreword This publication,Tissue Engineered Medical Products(TEMPs),contains papers presented at the symposium of the same name held in Miami Beach,Florida,on 4-5 November,2002.The sym-posium was sponsored by the ASTM International Committee F4 on Medical and Surgical Materials and Devices and its Division IV on Tissue Engineered Medical Products,in cooperation with B,The Society for Biomaterials and The Tissue Engineering Society.The symposium co-chairpersons were Eliane Schutte,IsoTis BV,The Netherlands,Grace L.Picciolo,USFDA(Retired),Rockville,MD.,and David S.Kaplan,FDA/CDRH,Rockville,MD.iii Contents FOREWORD WHAT TECHNOLOGY DO WE HAVE AND HOW Is IT DOING?Measurement of Pore Size and Porosity of Tme Scaffolds-e.TOMUNS,P.GRAm,S.MIKHALOVSKY,S.JAMES,AND L.MIKHALOVSKA Development and Validation of a Detection Method for a Broad Range of Human Papillomavirus Types-D.N.CALBTH,T.COLLINS,J.BLACK,B.MC MANUS,D.MC MUTRIE,AND A.LDVATr Bronchoscopic Lung Volume Reduction-A Novel Tsue Engineering Treatment for Advanced Emphysema-.P.INGENno,L.A,R.L.BERGER,AND A.HOFFMAN NIST and Standards for Tissue Engineered Medical Productv-j.A.TESK AND L.R.KARAM Mechanical Evaluation of Allograft Bone-M.c.suMMrrr,D.M.K.SQUn.LAC AND J.R.BIANCI Method to Determine Germicidal Inactivation in Allograft Processing-c.R.MILLS,M.R.ROBERTS,J.Y.CHANG,J.R.BIANCHI,AND M.C.SUMMITr Towards In-Situ Monitoring of Cell Growth in Tmsue Engineering Scaffolds:High Resolution Optical Techniques-M.T.CICERONE,J.P.DUNKERS,AND N.R.WASHBURN Cartilage Mechanical Properties after Injury-o.D.DLIMA;N.STEKLOV,A.BERGULA,P.c.CEN,C.W.COLWELL,AND M.LOTZ Age Related Differences in Chondrocyte Viability and Biosynthetic Response To Mechanical Injury-D.D.DLIMA,A.BERGULA,P.C.CHEN,C.w.COLWELL AND M.LOTZ.176 111 12 20 40 47 54 59 67 77 vi CONTENTS A Comparative Study of Biomarkers of Oxidative DNA Damage Used to Detect Free Radical Damage in Ttssue-Engineered Skin-H.RODRIGUEZ,P.JARUGA,M.BIRINCIOGLU,P.E.BARKER,C.OCONNERp AND M.DIZDAROGLU Endpoint Verification of Bone Demineralization for Tssue Engineering Appllcations-c.B.THOMAS,L.JENKS,J.F.KEI_LAM,AND K.J.L.BURG Comparative Study of Bone Cell Culture Methods for Tbsue Engineering Applicatlons-c.e.THOMAS,J.F.gFJ.l AM,AND K.J.L.BURG A New Method for Real-Tnne and In-Situ Characterization of the Mechanical and Material Properties of Biological Tbsue Constructs-G.ZHANG AND J.L.GILBERT 84 90 100 120 WHAT STANDARDS EXIST AND WHAT STANDARDS ARE