ISO 14155 CORR 1-2011 Clinical investigation of medical devices for human subjects - Good clinical practice Technical Corrigendum 1《用于人体的医疗器械临床研究 临床实践 技术勘误1》.pdf

《ISO 14155 CORR 1-2011 Clinical investigation of medical devices for human subjects - Good clinical practice Technical Corrigendum 1《用于人体的医疗器械临床研究 临床实践 技术勘误1》.pdf》由会员分享，可在线阅读，更多相关《ISO 14155 CORR 1-2011 Clinical investigation of medical devices for human subjects - Good clinical practice Technical Corrigendum 1《用于人体的医疗器械临床研究 临床实践 技术勘误1》.pdf（1页珍藏版）》请在麦多课文档分享上搜索。

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