1、 INTERNATIONAL STANDARD ISO 14155:2011 TECHNICAL CORRIGENDUM 1 Published 2011-07-15 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ORGANISATION INTERNATIONALE DE NORMALISATIONClinical investigation of medical devices for human subjects Good clinical practice TECHNICAL CORRIGENDUM 1 Investigation cli
2、nique des dispositifs mdicaux pour sujets humains Bonnes pratiques cliniques RECTIFICATIF TECHNIQUE 1 Technical Corrigendum 1 to ISO 14155:2011 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices. Page 12, 4.7.4 Replace “a) Potential benefits” with “b) Potential benefits”. Amend the rest of the list accordingly. Page 21, 7.3 In the first sentence, replace the word “evaluation” with “investigation”. ICS 11.100.20 Ref. No. ISO 14155:2011/Cor.1:2011(E) ISO 2011 All rights reserved Published in Switzerland
