DIN EN ISO 10993-17-2009 Biological evaluation of medical devices - Part 17：Establishment of allowable limits for leachable substances 医疗器械的生物评定. 第17部分: 可浸取物质允许极限的确定.pdf

DEUTSCHE NORM August 2009 DIN EN ISO 10993-17 DIN ICS 11.100.20 Supersedes DIN EN ISO 10993- 17:2003-06 See start of va lidity Bi。l。gical evaluation of medical devices - Part 17: Establishment 。f all。wable limits for leachable substances (ISO 10993-17:2002) English versi。n 。f DIN EN ISO 10993-17:2009-08 Biologische Beurteilung von Medizinprodukten - Teil 17: Nachweis zulassiger Grenzwerte fur he「auslosba「e Bestandteile (ISO 10993-17:2002) Englische Fassung DIN EN ISO 10993-17:2009-08 Document comprises 36 pages © No part of th is stand缸。may be reproduced 叫th由此prior permissi。n of | | | | | | | || E咐，由阳i曲group t 6 DIN Deutsct晒S lnstitut filr Normung o. V .• Berlin. Beuth Vorlag GmbH。 10772 B町hn. Germany, WWWd削.de has tile 制d田，吨，，ghtof s创e fOf German Sta耐ards (DIN N目men). www.beuth.de t5J9840 DIN EN ISO 10993-17:2009-08 Start of validity Th is standa『d takes effect on 1 August 2009. DIN EN ISO 10993-17:2003-06 may be used in parallel until 21 March 2010. National f。reword This standard has been prepared by Technical Committee ISO/TC 194 ‘’ Biological evaluation of medical devices in collaboration w ith Technical Committee CEN/TC 206 “ Biologica