{"id":331,"date":"2013-09-19T14:00:51","date_gmt":"2013-09-19T05:00:51","guid":{"rendered":"http:\/\/scctest.azurewebsites.net\/?page_id=331"},"modified":"2023-12-28T13:30:55","modified_gmt":"2023-12-28T04:30:55","slug":"scc%e3%81%b8%e3%82%88%e3%81%86%e3%81%93%e3%81%9d%ef%bc%81","status":"publish","type":"page","link":"https:\/\/md-guidelines.pj.aist.go.jp\/?page_id=331","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u958b\u767a\u30ac\u30a4\u30c0\u30f3\u30b9\u7b56\u5b9a\u4e8b\u696d\u3068\u306f"},"content":{"rendered":"<p>\u8d85\u9ad8\u9f62\u793e\u4f1a\u3092\u8fce\u3048\u305f\u308f\u304c\u56fd\u306b\u304a\u3044\u3066\u3001\u300c\u56fd\u6c11\u306e\u9577\u5bff\u300d\u3068\u300c\u8cea\u306e\u9ad8\u3044\u751f\u6d3b\u300d\u3092\u5b9f\u73fe\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u30fb\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306e\u958b\u767a\u3068\u533b\u7642\u73fe\u5834\u3078\u306e\u5186\u6ed1\u306a\u5c0e\u5165\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u3053\u306e\u5206\u91ce\u306e\u6d3b\u6027\u5316\u30fb\u56fd\u969b\u7af6\u4e89\u529b\u306e\u5f37\u5316\u3092\u56f3\u308a\u3001\u8fc5\u901f\u306a\u958b\u767a\u3068\u5be9\u67fb\u3092\u5b9f\u73fe\u3057\u3001\u307e\u305f\u3001\u7523\u696d\u306e\u80b2\u6210\u306e\u89b3\u70b9\u304b\u3089\u3001\u533b\u7642\u6a5f\u5668\u30fb\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u53ca\u3073\u3053\u308c\u3089\u306b\u95a2\u9023\u3059\u308b\u7814\u7a76\u958b\u767a\u306e\u6307\u91dd\u3092\u660e\u78ba\u5316\u3059\u308b\u3053\u3068\u304c\u5fc5\u8981\u3068\u8003\u3048\u307e\u3059\u3002<\/p>\n<p>\u3053\u308c\u3089\u306e\u76ee\u7684\u306e\u305f\u3081\u306b\u3001\u5e73\u621017\u5e74\u5ea6\u304b\u3089<a href=\"http:\/\/www.aist.go.jp\/pdf\/aist_j\/iryoukiki\/2009\/introduction-GuideLineAIST.pdf\" target=\"_blank\" rel=\"noopener\">\u7d4c\u6e08\u7523\u696d\u7701\u306b\u300c\u533b\u7642\u6a5f\u5668\u958b\u767a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u8a55\u4fa1\u691c\u8a0e\u59d4\u54e1\u4f1a\u300d\u3068\u539a\u751f\u52b4\u50cd\u7701\u306b\u300c\u6b21\u4e16\u4ee3\u533b\u7642\u6a5f\u5668\u30fb\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u8a55\u4fa1\u6307\u6a19\u691c\u8a0e\u4f1a\u300d\u304c\u8a2d\u7f6e[PDF\uff1a87KB]<\/a>\u3055\u308c\u3001\u4ee5\u964d\u3001\u3053\u308c\u3089\u306e\u691c\u8a0e\u4f1a\u306e\u9023\u643a\uff08\u5408\u540c\u691c\u8a0e\u4f1a\uff09\u306b\u3088\u3063\u3066\u3001\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u7b49\u306e\u958b\u767a\u4fc3\u9032\u53ca\u3073\u8fc5\u901f\u306a\u85ac\u4e8b\u627f\u8a8d\u5be9\u67fb\u306b\u6d3b\u7528\u3067\u304d\u308b\u958b\u767a\u30ac\u30a4\u30c0\u30f3\u30b9\u53ca\u3073\u8a55\u4fa1\u6307\u6a19\u304c\u7b56\u5b9a\u3055\u308c\u3066\u304a\u308a\u307e\u3059\u3002<\/p>\n<p>\u958b\u59cb\u304b\u308915\u5e74\u3092\u7d4c\u3066\u533b\u7642\u6a5f\u5668\u7523\u696d\u3092\u53d6\u308a\u5dfb\u304f\u60c5\u52e2\u3082\u5909\u5316\u3057\u305f\u3053\u3068\u304b\u3089\u3001\u958b\u767a\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u76ee\u7684\u3001\u7b56\u5b9a\u30d7\u30ed\u30bb\u30b9\u306e\u5927\u5e45\u898b\u76f4\u3057\u3092\u884c\u3044\u307e\u3057\u305f\u3002\u4ee4\u548c5\u5e74\u5ea6\u304b\u3089\u65b0\u898f\u306b\u7b56\u5b9a\u3059\u308b\u6587\u66f8\u306b\u3064\u304d\u300c\u533b\u7642\u6a5f\u5668\u958b\u767a\u30ac\u30a4\u30c0\u30f3\u30b9\u300d\u306b\u547c\u79f0\u3092\u5909\u66f4\u3057\u307e\u3057\u305f\u3002\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306e\u76ee\u7684\u3092\uff14\u985e\u578b\u306b\u5206\u985e\u3057\u3001\u30c6\u30fc\u30de\u9078\u5b9a\u30fb\u7b56\u5b9a\u30d7\u30ed\u30bb\u30b9\u306e\u900f\u660e\u5316\u3092\u56f3\u3063\u3066\u3044\u304d\u307e\u3059\u3002<\/p>\n<ul>\n<li><a href=\"https:\/\/www.amed.go.jp\/content\/000115177.pdf\" target=\"_blank\" rel=\"noopener\">\u533b\u7642\u6a5f\u5668\u958b\u767a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u7b56\u5b9a\u4e8b\u696d\u306b\u304a\u3051\u308b\u524d\u634c\u304d\u6a5f\u80fd\u3068\u81ea\u7acb\u5316\u306b\u95a2\u3059\u308b\u696d\u52d9\u5831\u544a\u66f8<\/a><br \/>\n(2023\/3 \u682a\u5f0f\u4f1a\u793e\u30c9\u30a5\u30ea\u30b5\u30fc\u30c1\u7814\u7a76\u6240\u30fbAMED)<\/li>\n<li><a href=\"https:\/\/www.amed.go.jp\/content\/000115176.pdf\" target=\"_blank\" rel=\"noopener\">\u533b\u7642\u6a5f\u5668\u958b\u767a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3(\u624b\u5f15\u304d)\u306e\u305f\u3081\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u7b56\u5b9a\u8abf\u67fb\u5831\u544a\u66f8<\/a><br \/>\n(2023\/3 \u682a\u5f0f\u4f1a\u793e\u30c9\u30a5\u30ea\u30b5\u30fc\u30c1\u7814\u7a76\u6240\u30fbAMED)<\/li>\n<li><a href=\"https:\/\/www.amed.go.jp\/content\/000101886.pdf\" target=\"_blank\" rel=\"noopener\">\u300c\u533b\u7642\u6a5f\u5668\u958b\u767a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u4eca\u5f8c\u306e\u3042\u308a\u65b9\u306b\u95a2\u3059\u308b\u8abf\u67fb\u300d \u8abf\u67fb\u5831\u544a\u66f8<\/a><br \/>\n(2022\/3 \u682a\u5f0f\u4f1a\u793e\u30c9\u30a5\u30ea\u30b5\u30fc\u30c1\u7814\u7a76\u6240\u30fbAMED)<\/li>\n<\/ul>\n<p>\u3053\u308c\u307e\u3067\u7b56\u5b9a\u3057\u305f\u533b\u7642\u6a5f\u5668\u958b\u767a\u30ac\u30a4\u30c0\u30f3\u30b9\u306f<a href=\"https:\/\/www.meti.go.jp\/policy\/mono_info_service\/healthcare\/report_iryou_fukushi.html\" target=\"_blank\" rel=\"noopener\">\u7d4c\u6e08\u7523\u696d\u7701\u306e\u30db\u30fc\u30e0\u30da\u30fc\u30b8<\/a>\u3092\u3054\u53c2\u7167\u304f\u3060\u3055\u3044\u3002\u6a5f\u5668\u306e\u958b\u767a\u3001\u85ac\u4e8b\u7533\u8acb\u306a\u3069\u306b\u3054\u6d3b\u7528\u304f\u3060\u3055\u3044\u3002<\/p>\n<div align=\"center\">\n<p><a href=\"https:\/\/www.aist.go.jp\/Portals\/0\/resource_images\/aist_j\/aistinfo\/report\/entrust\/iryoukiki\/2018\/fig1.jpg\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/www.aist.go.jp\/Portals\/0\/resource_images\/aist_j\/aistinfo\/report\/entrust\/iryoukiki\/2018\/fig1_s.jpg\" alt=\"\u533b\u7642\u6a5f\u5668\u958b\u767a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u30fb\u8a55\u4fa1\u6307\u6a19\u306e\u7b56\u5b9a\u306e\u8aac\u660e\u56f3\" \/><\/a><br \/>\n\uff08\u56f3\u3092\u30af\u30ea\u30c3\u30af\u3059\u308b\u3068\u5927\u304d\u306a\u56f3\u3092\u53c2\u7167\u3067\u304d\u307e\u3059\uff09<\/p>\n<\/div>\n<p>\u539a\u751f\u52b4\u50cd\u7701\u306e\u300c\u6b21\u4e16\u4ee3\u533b\u7642\u6a5f\u5668\u30fb\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u8a55\u4fa1\u6307\u6a19\u691c\u8a0e\u4f1a\u300d\u306b\u304a\u3044\u3066\u3001\u8fc5\u901f\u306a\u5be9\u67fb\u306b\u5fc5\u8981\u306a\u8a55\u4fa1\u6307\u6a19\u306b\u95a2\u3057\u3066\u691c\u8a0e\u304c\u306a\u3055\u308c\u3066\u304a\u308a\u307e\u3059\u3002\u56fd\u7acb\u533b\u85ac\u54c1\u98df\u54c1\u885b\u751f\u7814\u7a76\u6240\u304c\u4e8b\u52d9\u5c40\u3068\u306a\u308a\u3001\u5be9\u67fb\u30ef\u30fc\u30ad\u30f3\u30b0\u30b0\u30eb\u30fc\u30d7\u3092\u8a2d\u7f6e\u3057\u3066\u5be9\u67fb\u306e\u8fc5\u901f\u5316\u3068\u3044\u3046\u89b3\u70b9\u304b\u3089\u7a2e\u3005\u306e\u691c\u8a0e\u304c\u9032\u3081\u3089\u308c\u3066\u304a\u308a\u307e\u3059\u3002\u540c\u7814\u7a76\u6240\u306e\u30db\u30fc\u30e0\u30da\u30fc\u30b8\u306b\u63b2\u8f09\u3055\u308c\u308b\u5be9\u67fb\u30ef\u30fc\u30ad\u30f3\u30b0\u30b0\u30eb\u30fc\u30d7\u306e\u5831\u544a\u66f8(<a href=\"https:\/\/dmd.nihs.go.jp\/jisedai\/\" target=\"_blank\" rel=\"noopener\">https:\/\/dmd.nihs.go.jp\/jisedai\/<\/a>)\u3082\u4f75\u305b\u3066\u3054\u89a7\u304f\u3060\u3055\u3044<\/p>\n<div align=\"center\">\n<p><a href=\"https:\/\/www.aist.go.jp\/Portals\/0\/resource_images\/aist_j\/aistinfo\/report\/entrust\/iryoukiki\/2018\/fig2.jpg\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/www.aist.go.jp\/Portals\/0\/resource_images\/aist_j\/aistinfo\/report\/entrust\/iryoukiki\/2018\/fig2_s.jpg\" alt=\"\u533b\u7642\u6a5f\u5668\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u8a55\u4fa1\u6307\u6a19\u3068\u306e\u9023\u643a\u306e\u8aac\u660e\u56f3\" \/><\/a><br \/>\n\uff08\u56f3\u3092\u30af\u30ea\u30c3\u30af\u3059\u308b\u3068\u5927\u304d\u306a\u56f3\u3092\u53c2\u7167\u3067\u304d\u307e\u3059\uff09<\/p>\n<h2 style=\"text-align: left;\">\u95a2\u9023\u30ea\u30f3\u30af<\/h2>\n<ul>\n<li style=\"text-align: left;\">\u65e5\u672c\u533b\u7642\u7814\u7a76\u958b\u767a\u6a5f\u69cb\u3000(<a href=\"https:\/\/www.amed.go.jp\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.amed.go.jp\/<\/a>)<\/li>\n<li style=\"text-align: left;\">\u7d4c\u6e08\u7523\u696d\u7701\u3000(<a href=\"https:\/\/www.meti.go.jp\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.meti.go.jp\/<\/a>)<br \/>\n\u533b\u7642\u6a5f\u5668\u958b\u767a\u30ac\u30a4\u30c0\u30f3\u30b9\uff08METI\/\u7d4c\u6e08\u7523\u696d\u7701\uff09(<a href=\"https:\/\/www.meti.go.jp\/policy\/mono_info_service\/healthcare\/report_iryou_fukushi.html\" target=\"_blank\" rel=\"noopener\">https:\/\/www.meti.go.jp\/policy\/mono_info_service\/healthcare\/report_iryou_fukushi.html<\/a>)<\/li>\n<li style=\"text-align: left;\">\u539a\u751f\u52b4\u50cd\u7701\u3000(<a href=\"https:\/\/www.mhlw.go.jp\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.mhlw.go.jp\/<\/a>)<\/li>\n<li style=\"text-align: left;\">\u56fd\u7acb\u533b\u85ac\u54c1\u98df\u54c1\u885b\u751f\u7814\u7a76\u6240\u3000(<a href=\"https:\/\/www.nihs.go.jp\/index-j.html\" target=\"_blank\" rel=\"noopener\">https:\/\/www.nihs.go.jp\/index-j.html<\/a>)<br \/>\n\u5be9\u67fb\u30ef\u30fc\u30ad\u30f3\u30b0\u30b0\u30eb\u30fc\u30d7\u5831\u544a\u66f8\u3000(<a href=\"https:\/\/dmd.nihs.go.jp\/jisedai\/\" target=\"_blank\" rel=\"noopener\">https:\/\/dmd.nihs.go.jp\/jisedai\/<\/a>)<\/li>\n<li style=\"text-align: left;\">\u72ec\u7acb\u884c\u653f\u6cd5\u4eba\u3000\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\u3000(<a href=\"https:\/\/www.pmda.go.jp\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.pmda.go.jp\/<\/a>)<\/li>\n<li style=\"text-align: left;\">\u65e5\u672c\u533b\u7642\u6a5f\u5668\u7523\u696d\u9023\u5408\u4f1a\uff08\u533b\u6a5f\u9023\uff09\uff08<a href=\"https:\/\/www.jfmda.gr.jp\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.jfmda.gr.jp\/<\/a>\uff09<\/li>\n<li style=\"text-align: left;\">IMDRF\uff08The International Medical Device Regulators Forum\uff09(<a href=\"http:\/\/www.imdrf.org\/\" target=\"_blank\" rel=\"noopener\">http:\/\/www.imdrf.org\/<\/a>)<\/li>\n<\/ul>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u8d85\u9ad8\u9f62\u793e\u4f1a\u3092\u8fce\u3048\u305f\u308f\u304c\u56fd\u306b\u304a\u3044\u3066\u3001\u300c\u56fd\u6c11\u306e\u9577\u5bff\u300d\u3068\u300c\u8cea\u306e\u9ad8\u3044\u751f\u6d3b\u300d\u3092\u5b9f\u73fe\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u30fb\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306e\u958b\u767a\u3068\u533b\u7642\u73fe\u5834\u3078\u306e\u5186\u6ed1\u306a\u5c0e\u5165\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u3053\u306e\u5206\u91ce\u306e\u6d3b\u6027\u5316\u30fb\u56fd\u969b\u7af6\u4e89\u529b\u306e\u5f37\u5316\u3092\u56f3\u308a\u3001\u8fc5\u901f\u306a\u958b\u767a\u3068\u5be9\u67fb\u3092 [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":0,"parent":0,"menu_order":1,"comment_status":"closed","ping_status":"open","template":"","meta":{"footnotes":""},"class_list":["post-331","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/md-guidelines.pj.aist.go.jp\/index.php?rest_route=\/wp\/v2\/pages\/331","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/md-guidelines.pj.aist.go.jp\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/md-guidelines.pj.aist.go.jp\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/md-guidelines.pj.aist.go.jp\/index.php?rest_route=\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/md-guidelines.pj.aist.go.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=331"}],"version-history":[{"count":21,"href":"https:\/\/md-guidelines.pj.aist.go.jp\/index.php?rest_route=\/wp\/v2\/pages\/331\/revisions"}],"predecessor-version":[{"id":154261,"href":"https:\/\/md-guidelines.pj.aist.go.jp\/index.php?rest_route=\/wp\/v2\/pages\/331\/revisions\/154261"}],"wp:attachment":[{"href":"https:\/\/md-guidelines.pj.aist.go.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=331"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}