{"id":2059,"date":"2025-04-22T02:54:20","date_gmt":"2025-04-22T02:54:20","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2059"},"modified":"2025-04-22T03:29:50","modified_gmt":"2025-04-22T03:29:50","slug":"flange-breakage-resistance-iso-11040-4","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/ja\/flange-breakage-resistance-iso-11040-4\/","title":{"rendered":"\u30d5\u30e9\u30f3\u30b8\u7834\u640d\u62b5\u6297 - ISO 11040-4 Annex C1"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2059\" class=\"elementor elementor-2059\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-99d088f e-flex e-con-boxed e-con e-parent\" data-id=\"99d088f\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-43cc8ff elementor-widget elementor-widget-heading\" data-id=\"43cc8ff\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">\u30d5\u30e9\u30f3\u30b8\u7834\u640d\u62b5\u6297<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f9d7284 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"f9d7284\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1129df5 elementor-widget elementor-widget-heading\" data-id=\"1129df5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 \u9644\u5c5e\u66f8 C1<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b7ccfb2 e-flex e-con-boxed e-con e-parent\" data-id=\"b7ccfb2\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-254e154 elementor-widget elementor-widget-text-editor\" data-id=\"254e154\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"477\" data-end=\"932\"><em data-start=\"477\" data-end=\"505\">\u30d5\u30e9\u30f3\u30b8\u7834\u640d\u62b5\u6297<\/em> \u306f\u3001\u30d7\u30ec\u30d5\u30a3\u30eb\u30c9\u30b7\u30ea\u30f3\u30b8\u306e\u88fd\u9020\u306b\u304a\u3044\u3066\u975e\u5e38\u306b\u91cd\u8981\u306a\u54c1\u8cea\u7279\u6027\u3067\u3059\u3002\u3053\u306e\u8a66\u9a13\u3067\u306f\u3001\u6ce8\u5c04\u5668\u30d0\u30ec\u30eb\u306e\u30d5\u30e9\u30f3\u30b8\uff08\u81e8\u5e8a\u4f7f\u7528\u4e2d\u306b\u52a0\u3048\u3089\u308c\u308b\u529b\u306b\u8010\u3048\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u90e8\u5206\uff09\u306e\u6a5f\u68b0\u7684\u5f37\u5ea6\u3092\u6e2c\u5b9a\u3057\u307e\u3059\u3002\u533b\u7642\u898f\u5236\u304c\u4e16\u754c\u7684\u306b\u5f37\u5316\u3055\u308c\u308b\u306b\u3064\u308c\u3066\u3001\u3053\u306e\u8a66\u9a13\u3067\u6982\u8aac\u3055\u308c\u3066\u3044\u308b\u6a5f\u68b0\u7684\u6027\u80fd\u57fa\u6e96\u3092\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.pharmacopoeiatest.com\/ja\/flange-breakage-resistance-iso-11040-4\/\"><strong data-start=\"819\" data-end=\"843\">ISO 11040-4 \u9644\u5c5e\u66f8 C1<\/strong><\/a> \u306f\u3001\u30ac\u30e9\u30b9\u88fd\u30b7\u30ea\u30f3\u30b8\u3084\u6ec5\u83cc\u6e08\u307f\u30b5\u30d6\u30a2\u30c3\u30bb\u30f3\u30d6\u30ea\u30fc\u30b7\u30ea\u30f3\u30b8\u306e\u88fd\u9020\u696d\u8005\u306b\u3068\u3063\u3066\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u3002<\/p><p class=\"\" data-start=\"934\" data-end=\"1146\">\u7cbe\u5bc6\u691c\u67fb\u6a5f\u5668\u306e\u30ea\u30fc\u30c0\u30fc\u3067\u3042\u308b\u30bb\u30eb\u30a4\u30f3\u30b9\u30c4\u30eb\u30e1\u30f3\u30c4\u306f\u3001\u304a\u5ba2\u69d8\u306e\u691c\u67fb\u30cb\u30fc\u30ba\u306b\u5fdc\u3048\u308b\u5805\u7262\u306a\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002 <em data-start=\"1037\" data-end=\"1054\">\u30b7\u30ea\u30f3\u30b8\u30c6\u30b9\u30c8<\/em> \u7cbe\u5ea6\u3068\u696d\u52d9\u52b9\u7387\u3092\u6700\u5927\u9650\u306b\u9ad8\u3081\u306a\u304c\u3089\u3001\u56fd\u969b\u57fa\u6e96\u306b\u6e96\u62e0\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ededb4f elementor-widget elementor-widget-heading\" data-id=\"ededb4f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4\u3068\u30b7\u30ea\u30f3\u30b8\u8a66\u9a13\u3078\u306e\u9069\u7528<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1f63cd elementor-widget elementor-widget-text-editor\" data-id=\"a1f63cd\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"1223\" data-end=\"1586\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/ja\/iso-11040-4\/\"><strong data-start=\"1223\" data-end=\"1238\">ISO 11040-4<\/strong><\/a> \u306f\u6ce8\u5c04\u5264\u7528\u30ac\u30e9\u30b9\u30d0\u30ec\u30eb\u3092\u898f\u5b9a\u3057\u3001\u7279\u306b\u69cb\u9020\u7684\u5b8c\u5168\u6027\u3068\u6a5f\u80fd\u6027\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u3044\u308b\u3002\u7279\u306b <em data-start=\"1346\" data-end=\"1368\">ISO 11040-4 \u9644\u5c5e\u66f8 C1<\/em>\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u5177\u4f53\u7684\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u793a\u3055\u308c\u3066\u3044\u308b\u3002 <em data-start=\"1418\" data-end=\"1446\">\u30d5\u30e9\u30f3\u30b8\u7834\u640d\u62b5\u6297<\/em>.\u3053\u306e\u8a66\u9a13\u306e\u76ee\u7684\u306f\u3001\u53d6\u308a\u6271\u3044\u4e2d\u3084\u81ea\u52d5\u5145\u586b\u5de5\u7a0b\u4e2d\u306b\u30b7\u30ea\u30f3\u30b8\u306e\u30d5\u30e9\u30f3\u30b8\u304c\u7834\u640d\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u72b6\u6cc1\u3092\u30b7\u30df\u30e5\u30ec\u30fc\u30c8\u3059\u308b\u3053\u3068\u3067\u3042\u308b\u3002<\/p><p class=\"\" data-start=\"1588\" data-end=\"1752\">\u3053\u306e\u898f\u683c\u306f\u3001\u6700\u7d42\u7684\u306a\u30b7\u30ea\u30f3\u30b8\u30d0\u30ec\u30eb\u3060\u3051\u3067\u306a\u304f\u3001\u5145\u586b\u6e96\u5099\u306e\u6574\u3063\u305f\u6ec5\u83cc\u6e08\u307f\u306e\u30b5\u30d6\u30a2\u30c3\u30bb\u30f3\u30d6\u30ea\u30fc\u30b7\u30ea\u30f3\u30b8\u306b\u3082\u9069\u7528\u3055\u308c\u3001\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u5168\u4f53\u3067\u306e\u4e00\u8cab\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3002<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d261813 elementor-widget elementor-widget-heading\" data-id=\"d261813\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u30d5\u30e9\u30f3\u30b8\u7834\u640d\u62b5\u6297\u8a66\u9a13\u304c\u91cd\u8981\u306a\u7406\u7531<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f45136 elementor-widget elementor-widget-text-editor\" data-id=\"3f45136\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"1811\" data-end=\"2112\">\u30b7\u30ea\u30f3\u30b8\u306f\u3001\u8f38\u9001\u3001\u4fdd\u7ba1\u3001\u5145\u586b\u3001\u6295\u4e0e\u4e2d\u306b\u591a\u304f\u306e\u6a5f\u68b0\u7684\u5fdc\u529b\u3092\u53d7\u3051\u308b\u3002\u30b7\u30ea\u30f3\u30b8\u30d0\u30ec\u30eb\u5148\u7aef\u306e\u69cb\u9020\u90e8\u54c1\u3067\u3042\u308b\u30d5\u30e9\u30f3\u30b8\u306f\u3001\u5f31\u70b9\u3068\u3057\u3066\u77e5\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u30d5\u30e9\u30f3\u30b8\u304c\u7834\u640d\u3059\u308b\u3068\u3001\u7121\u83cc\u6027\u3001\u6295\u4e0e\u91cf\u306e\u6b63\u78ba\u6027\u3001\u3072\u3044\u3066\u306f\u60a3\u8005\u306e\u5b89\u5168\u6027\u304c\u640d\u306a\u308f\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p><p class=\"\" data-start=\"2114\" data-end=\"2168\">\u6b63\u78ba <em data-start=\"2123\" data-end=\"2151\">\u30d5\u30e9\u30f3\u30b8\u7834\u640d\u62b5\u6297<\/em> \u30c6\u30b9\u30c8\u306f\u5f79\u306b\u7acb\u3064\uff1a<\/p><ul><li data-start=\"2171\" data-end=\"2216\">\u8a2d\u8a08\u3068\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306e\u691c\u8a3c<\/li><li data-start=\"2171\" data-end=\"2216\">\u898f\u5236\u9075\u5b88<\/li><li data-start=\"2171\" data-end=\"2216\">\u73fe\u5834\u3067\u306e\u88fd\u54c1\u4e0d\u826f\u30ea\u30b9\u30af\u306e\u4f4e\u6e1b<\/li><li data-start=\"2171\" data-end=\"2216\">\u76e3\u7763\u6a5f\u95a2\u3084\u9867\u5ba2\u3068\u306e\u4fe1\u983c\u95a2\u4fc2\u306e\u69cb\u7bc9<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3fd48bf elementor-widget elementor-widget-heading\" data-id=\"3fd48bf\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 \u9644\u5c5e\u66f8 C1 \u30d5\u30e9\u30f3\u30b8\u7834\u640d\u62b5\u6297\u8a66\u9a13\u65b9\u6cd5<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ef26935 e-con-full e-flex e-con e-child\" data-id=\"ef26935\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-25fc654 e-con-full e-flex e-con e-child\" data-id=\"25fc654\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1372d22 elementor-widget elementor-widget-heading\" data-id=\"1372d22\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">\u30d5\u30e9\u30f3\u30b8\u7834\u640d\u62b5\u6297\u30c6\u30b9\u30bf\u30fc\u304c\u5fc5\u8981<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c3c025e elementor-widget elementor-widget-text-editor\" data-id=\"c3c025e\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"2399\" data-end=\"2565\">\u306b\u6982\u8aac\u3055\u308c\u3066\u3044\u308b\u65b9\u6cd5\u3067\u3042\u308b\u3002 <strong data-start=\"2422\" data-end=\"2446\">ISO 11040-4 \u9644\u5c5e\u66f8 C1<\/strong> \u3053\u308c\u306f\u3001\u30b7\u30ea\u30f3\u30b8\u30d0\u30ec\u30eb\u30d5\u30e9\u30f3\u30b8\u304c\u7834\u640d\u3059\u308b\u307e\u3067\u3001\u5236\u5fa1\u3055\u308c\u305f\u5727\u7e2e\u529b\u3092\u30b7\u30ea\u30f3\u30b8\u30d0\u30ec\u30eb\u30d5\u30e9\u30f3\u30b8\u306b\u52a0\u3048\u308b\u3053\u3068\u3067\u3042\u308b\u3002\u3053\u308c\u304c\u305d\u306e\u65b9\u6cd5\u3067\u3042\u308b\uff1a<\/p><ul data-start=\"2590\" data-end=\"2834\"><li class=\"\" data-start=\"2590\" data-end=\"2707\"><p class=\"\" data-start=\"2592\" data-end=\"2707\"><strong data-start=\"2592\" data-end=\"2645\">\u4e07\u80fd\u5f15\u5f35\u5727\u7e2e\u8a66\u9a13\u6a5f<\/strong> (\u4f8b\u3048\u3070\u3001\u30bb\u30eb\u30a4\u30f3\u30b9\u30c4\u30eb\u30e1\u30f3\u30c4\u306e <em>\u30b7\u30ea\u30f3\u30b8\u30c6\u30b9\u30bf\u30fc<\/em>)<\/p><\/li><li class=\"\" data-start=\"2708\" data-end=\"2766\"><p class=\"\" data-start=\"2710\" data-end=\"2766\"><strong data-start=\"2710\" data-end=\"2728\">\u30b7\u30ea\u30f3\u30b8\u30db\u30eb\u30c0\u30fc<\/strong> PEEK\u306e\u3088\u3046\u306a\u9069\u5207\u306a\u6750\u6599\u3067\u3067\u304d\u3066\u3044\u308b<\/p><\/li><li class=\"\" data-start=\"2767\" data-end=\"2834\"><p class=\"\" data-start=\"2769\" data-end=\"2834\"><strong data-start=\"2769\" data-end=\"2784\">\u30ed\u30fc\u30c7\u30a3\u30f3\u30b0\u30d4\u30f3<\/strong>\u597d\u307e\u3057\u304f\u306f\u30b9\u30c6\u30f3\u30ec\u30b9\u30fb\u30b9\u30c1\u30fc\u30eb\u30fb\u30b3\u30a2\u306e\u30dd\u30ea\u30a2\u30bb\u30bf\u30fc\u30eb<\/p><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1e99e9 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"a1e99e9\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"488\" height=\"1024\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-488x1024.webp\" class=\"attachment-large size-large wp-image-2048\" alt=\"ISO 11040-4 \u6ce8\u5c04\u5668\u306e\u6f0f\u308c\u8a66\u9a13\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-488x1024.webp 488w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-143x300.webp 143w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-768x1613.webp 768w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-731x1536.webp 731w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-975x2048.webp 975w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-scaled.webp 1219w\" sizes=\"(max-width: 488px) 100vw, 488px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d45498c e-con-full e-flex e-con e-child\" data-id=\"d45498c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-91d25ab elementor-widget elementor-widget-heading\" data-id=\"91d25ab\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 \u4ed8\u5c5e\u66f8 C1 \u8a66\u9a13\u624b\u9806\u66f8<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-922228a elementor-widget elementor-widget-text-editor\" data-id=\"922228a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"2858\" data-end=\"2884\"><strong data-start=\"2858\" data-end=\"2882\">1.\u8a66\u9a13\u30b5\u30f3\u30d7\u30eb\u306e\u6e96\u5099<br \/><\/strong><span style=\"font-size: 16px;\">\u30c6\u30b9\u30c8\u524d\u306e\u30b7\u30e7\u30c3\u30af\u306f\u907f\u3051\u3066\u304f\u3060\u3055\u3044\u3002\u5404\u30b7\u30ea\u30f3\u30b8\u3068\u30db\u30eb\u30c0\u30fc\u306b\u640d\u50b7\u304c\u306a\u3044\u304b\u76ee\u8996\u70b9\u691c\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/span><\/p><p class=\"\" data-start=\"2975\" data-end=\"2986\"><strong data-start=\"2975\" data-end=\"2984\">2.\u8a66\u9a13\u6a5f\u306e\u30bb\u30c3\u30c8\u30a2\u30c3\u30d7<br \/><\/strong><span style=\"font-size: 16px;\">\u30b7\u30ea\u30f3\u30b8\u30d0\u30ec\u30eb\u3092\u30db\u30eb\u30c0\u30fc\u306b\u30bb\u30c3\u30c8\u3057\u307e\u3059\u3002\u30ed\u30fc\u30c7\u30a3\u30f3\u30b0\u30d4\u30f3\u3092\u30b7\u30ea\u30f3\u30b8\u306e\u30b7\u30e7\u30eb\u30c0\u30fc\u4ed8\u8fd1\u306b\u5408\u308f\u305b\u307e\u3059\u3002 <\/span><strong style=\"font-size: 16px;\" data-start=\"3091\" data-end=\"3105\">\u56f3C.2<\/strong><span style=\"font-size: 16px;\"> ISO\u898f\u683c\u306e<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c20220 elementor-widget__width-inherit elementor-widget elementor-widget-image\" data-id=\"1c20220\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"451\" height=\"297\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Annex-C1.png\" class=\"attachment-large size-large wp-image-2064\" alt=\"ISO 11040-4 Annex C1 \u30d5\u30e9\u30f3\u30b8\u7834\u640d\u62b5\u6297\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Annex-C1.png 451w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Annex-C1-300x198.png 300w\" sizes=\"(max-width: 451px) 100vw, 451px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0bc0e73 elementor-widget elementor-widget-text-editor\" data-id=\"0bc0e73\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"3131\" data-end=\"3151\"><strong data-start=\"3131\" data-end=\"3149\">3.\u30c6\u30b9\u30c8\u306e\u5b9f\u65bd<\/strong><\/p><ul><li data-start=\"3131\" data-end=\"3151\">\u6a5f\u68b0\u901f\u5ea6\u3092 <strong data-start=\"3182\" data-end=\"3196\">100mm\/\u5206<\/strong> (\u307e\u305f\u306f\u5408\u610f\u306b\u3088\u308b\uff09\u3002<\/li><li data-start=\"3131\" data-end=\"3151\">\u8a66\u9a13\u3092\u958b\u59cb\u3057\u3001\u30d5\u30e9\u30f3\u30b8\u304c\u7834\u640d\u3059\u308b\u307e\u3067\u529b\u3092\u52a0\u3048\u308b\u3002<\/li><li data-start=\"3131\" data-end=\"3151\">\u8a18\u9332 <strong style=\"font-size: 16px;\" data-start=\"3302\" data-end=\"3328\">\u529b\u5bfe\u5909\u4f4d<\/strong><span style=\"font-size: 16px;\"> \u3067\u30ab\u30fc\u30d6\u3092\u63cf\u304f\u3002<\/span><\/li><\/ul><p class=\"\" data-start=\"3131\" data-end=\"3151\"><strong data-start=\"3352\" data-end=\"3369\">4.\u30c7\u30fc\u30bf\u5206\u6790<br \/><\/strong>\u30ab\u30fc\u30d6\u304b\u3089\u30d4\u30fc\u30af\u30d5\u30a9\u30fc\u30b9\u3092\u7279\u5b9a\u3059\u308b\u3002 <em data-start=\"3442\" data-end=\"3470\">\u30d5\u30e9\u30f3\u30b8\u7834\u640d\u62b5\u6297<\/em>.<\/p><p class=\"\" data-start=\"3478\" data-end=\"3493\"><strong data-start=\"3478\" data-end=\"3491\">5.\u5831\u544a<br \/><\/strong><span style=\"font-size: 16px;\">\u8a66\u9a13\u901f\u5ea6\u3001\u30b5\u30f3\u30d7\u30eb\u6570\u3001\u30d4\u30fc\u30af\u5024\u3001\u7570\u5e38\u5024\u3092\u542b\u3080\u3002\u6587\u66f8\u304cISO\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u8981\u4ef6\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a9006f3 elementor-widget elementor-widget-heading\" data-id=\"a9006f3\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u30bb\u30eb\u30a4\u30f3\u30b9\u30c4\u30eb\u30e1\u30f3\u30c4\u793e\u88fd\u30b7\u30ea\u30f3\u30b8\u30c6\u30b9\u30bf\u30fc<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e501b92 e-con-full e-flex e-con e-child\" data-id=\"e501b92\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7a2147d e-con-full e-flex e-con e-child\" data-id=\"7a2147d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-67dcd66 elementor-widget elementor-widget-heading\" data-id=\"67dcd66\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">\u30b7\u30ea\u30f3\u30b8\u8a66\u9a13\u6a5f\u306e\u4e3b\u306a\u5229\u70b9<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fb2553c elementor-widget elementor-widget-text-editor\" data-id=\"fb2553c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul><li data-start=\"4049\" data-end=\"4092\">\u30b7\u30ea\u30f3\u30b8\u5c02\u7528\u30d5\u30a3\u30af\u30b9\u30c1\u30e3\u30fc\u306b\u5bfe\u5fdc<\/li><li data-start=\"4049\" data-end=\"4092\">\u529b-\u5909\u4f4d\u306e\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u30b0\u30e9\u30d5\u8868\u793a<\/li><li data-start=\"4049\" data-end=\"4092\">\u8abf\u6574\u53ef\u80fd\u306a\u901f\u5ea6\u3068\u8ca0\u8377\u7bc4\u56f2<\/li><li data-start=\"4049\" data-end=\"4092\">\u30b7\u30fc\u30e0\u30ec\u30b9\u306a\u30c7\u30fc\u30bf\u30a8\u30af\u30b9\u30dd\u30fc\u30c8\u306e\u305f\u3081\u306e\u5185\u8535\u30de\u30a4\u30af\u30ed\u30d7\u30ea\u30f3\u30bf\u3068\u30aa\u30d7\u30b7\u30e7\u30f3\u306eRS232\u30dd\u30fc\u30c8<\/li><\/ul><p class=\"\" data-start=\"4258\" data-end=\"4427\">\u3053\u306e\u30b7\u30b9\u30c6\u30e0\u306f\u30e2\u30b8\u30e5\u30fc\u30eb\u5f0f\u3067\u3042\u308b\u305f\u3081\u3001\u5305\u62ec\u7684\u306a\u696d\u52d9\u306b\u643a\u308f\u308b\u4f01\u696d\u306b\u3068\u3063\u3066\u7406\u60f3\u7684\u3067\u3042\u308b\u3002 <em data-start=\"4336\" data-end=\"4353\">\u30b7\u30ea\u30f3\u30b8\u30c6\u30b9\u30c8<\/em>\u3092\u542b\u3080\u3002 <em data-start=\"4365\" data-end=\"4393\">\u30d5\u30e9\u30f3\u30b8\u7834\u640d\u62b5\u6297<\/em> \u3068\u3044\u3063\u305f\u6a5f\u68b0\u7684\u306a\u8a55\u4fa1\u3092\u884c\u3046\u3002<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9b6dbd6 e-con-full e-flex e-con e-child\" data-id=\"9b6dbd6\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c4684f elementor-widget elementor-widget-heading\" data-id=\"2c4684f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">\u30b7\u30ea\u30f3\u30b8\u8a66\u9a13\u6a5f\u306e\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f42b687 elementor-widget elementor-widget-text-editor\" data-id=\"f42b687\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul><li data-start=\"4495\" data-end=\"4556\"><strong data-start=\"4495\" data-end=\"4526\">\u9ad8\u5468\u6ce2\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u306e\u4f7f\u7528<\/strong> (\u30d4\u30fc\u30af\u7cbe\u5ea6\u306f500Hz\u4ee5\u4e0a<\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4559\" data-end=\"4584\">\u30c6\u30b9\u30c8\u306e\u30a2\u30e9\u30a4\u30e1\u30f3\u30c8\u3092\u78ba\u8a8d\u3059\u308b<\/strong><span style=\"font-size: 16px;\"> \u8aa4\u3063\u305f\u6e2c\u5b9a\u5024\u3092\u907f\u3051\u308b\u305f\u3081\u3001\u5404\u8d70\u884c\u524d\u306b<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4629\" data-end=\"4655\">\u78e8\u8017\u3057\u305f\u90e8\u54c1\u306e\u4ea4\u63db<\/strong><span style=\"font-size: 16px;\"> (\u30ed\u30fc\u30c7\u30a3\u30f3\u30b0\u30d4\u30f3\u3001\u30db\u30eb\u30c0\u30fc\uff09\u306e\u4e00\u8cab\u6027\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u5b9a\u671f\u7684\u306b<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4716\" data-end=\"4739\">\u3059\u3079\u3066\u3092\u8a18\u9332\u3059\u308b<\/strong><span style=\"font-size: 16px;\">\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u5411\u4e0a\u3055\u305b\u308b\u305f\u3081\u306b\u3001\u308f\u305a\u304b\u306a\u9038\u8131\u3082\u898b\u9003\u3055\u306a\u3044\u3002<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4792\" data-end=\"4822\">\u9867\u5ba2\u3068\u306e\u5354\u529b<\/strong><span style=\"font-size: 16px;\"> \u8a66\u9a13\u901f\u5ea6\u3068\u6a5f\u5668\u306e\u8f03\u6b63\u306b\u3064\u3044\u3066\u5408\u610f\u3059\u308b\u3002<\/span><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20579e3 elementor-widget elementor-widget-text-editor\" data-id=\"20579e3\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"4897\" data-end=\"5170\">\u30d5\u30e9\u30f3\u30b8\u7834\u640d\u8010\u6027\u8a66\u9a13\u306f\u5358\u306a\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30c1\u30a7\u30c3\u30af\u30dc\u30c3\u30af\u30b9\u3067\u306f\u306a\u304f\u3001\u30b7\u30ea\u30f3\u30b8\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u88fd\u54c1\u54c1\u8cea\u4fdd\u8a3c\u306e\u91cd\u8981\u306a\u90e8\u5206\u3067\u3059\u3002\u8a66\u9a13\u65b9\u6cd5\u3092 <strong data-start=\"5075\" data-end=\"5099\"><a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener\">ISO 11040-4<\/a> \u9644\u5c5e\u66f8C1<\/strong>\u305d\u306e\u305f\u3081\u3001\u88fd\u54c1\u306e\u8010\u4e45\u6027\u3001\u5b89\u5168\u6027\u3001\u6cd5\u898f\u5236\u3078\u306e\u9069\u5408\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p><p class=\"\" data-start=\"5172\" data-end=\"5418\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/ja\/\" target=\"_blank\" rel=\"noopener\"><strong data-start=\"5172\" data-end=\"5192\">\u30bb\u30eb\u30a4\u30f3\u30b9\u30c4\u30eb\u30e1\u30f3\u30c4<\/strong><\/a> \u306f\u3001\u5353\u8d8a\u3057\u305f\u30c6\u30b9\u30c8\u3092\u5b9f\u73fe\u3059\u308b\u305f\u3081\u306e\u4fe1\u983c\u3067\u304d\u308b\u30d1\u30fc\u30c8\u30ca\u30fc\u3067\u3059\u3002\u79c1\u305f\u3061\u306e <strong>\u30b7\u30ea\u30f3\u30b8\u30c6\u30b9\u30bf\u30fc<\/strong>\u00a0\u306f\u3001\u30b7\u30ea\u30f3\u30b8\u691c\u67fb\u306e\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u5408\u7406\u5316\u3059\u308b\u3068\u540c\u6642\u306b\u3001\u73fe\u4ee3\u306e\u533b\u7642\u6c34\u6e96\u304c\u6c42\u3081\u308b\u7cbe\u5ea6\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u5b9f\u73fe\u3057\u307e\u3059\u3002<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b3e233b elementor-widget elementor-widget-text-editor\" data-id=\"b3e233b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"5420\" data-end=\"5503\">\u9ad8\u6027\u80fd\u3067\u3001\u898f\u5236\u306b\u6e96\u62e0\u3057\u305f\u88fd\u54c1\u3065\u304f\u308a\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Flange Breakage Resistance ISO 11040-4 Annex C1 Flange breakage resistance is a critical quality attribute in prefilled syringe manufacturing. This test determines the mechanical strength of the syringe barrel\u2019s flange\u2014the portion that must withstand applied forces during clinical use. As healthcare regulations tighten globally, meeting the mechanical performance standards outlined in ISO 11040-4 Annex C1 is essential for manufacturers of glass syringes and sterilized subassembled syringes. Cell Instruments, a leader in precision testing equipment, offers robust solutions to ensure that your syringe testing complies with international standards while maximizing accuracy and operational efficiency. ISO 11040-4 and Its Application in Syringe Testing ISO 11040-4 governs glass barrels for injectables, particularly focusing [&hellip;]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[26],"tags":[],"class_list":["post-2059","post","type-post","status-publish","format-standard","hentry","category-blog"],"acf":[],"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"pharmacopoeiatest","author_link":"https:\/\/www.pharmacopoeiatest.com\/ja\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"Flange Breakage Resistance ISO 11040-4 Annex C1 Flange breakage resistance is a critical quality attribute in prefilled syringe manufacturing. This test determines the mechanical strength of the syringe barrel\u2019s flange\u2014the portion that must withstand applied forces during clinical use. As healthcare regulations tighten globally, meeting the mechanical performance standards outlined in ISO 11040-4 Annex C1&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/ja\/wp-json\/wp\/v2\/posts\/2059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/ja\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/ja\/wp-json\/wp\/v2\/comments?post=2059"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/ja\/wp-json\/wp\/v2\/posts\/2059\/revisions"}],"predecessor-version":[{"id":2072,"href":"https:\/\/www.pharmacopoeiatest.com\/ja\/wp-json\/wp\/v2\/posts\/2059\/revisions\/2072"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/ja\/wp-json\/wp\/v2\/media?parent=2059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/ja\/wp-json\/wp\/v2\/categories?post=2059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/ja\/wp-json\/wp\/v2\/tags?post=2059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}