2013年1月24日付けのEU公報にて、欧州能動埋込形医療機器指令90/385/EC、
医療機器指令93/42/EEC、インビトロ医療機器指令98/79/ECの
整合規格リストが公表されましたのでお知らせします。
整合規格リストは、下記リンク先からダウンロードできます。
●2013/C 22/01
Commission communication in the framework of the implementation of the Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (Publication of titles and references of harmonised standards under the directive)(能動埋込形医療機器指令の整合規格リスト)
URL:<http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:022:0001:0006:EN:PDF>
●2013/C 22/02
Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(1)(Publication of titles and references of harmonised standards under the directive)(医療機器指令の整合規格リスト)
URL:
<http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:022:0007:0029:EN:PDF>
●2013/C 22/03
Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (1) (Publication of titles and references of harmonised standards under the directive)(インビトロ医療機器指令の整合規格リスト)
URL:
<http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:022:0030:0034:EN:PDF>