{"id":4249,"date":"2024-05-15T11:25:13","date_gmt":"2024-05-15T03:25:13","guid":{"rendered":"https:\/\/www.qualitester.com\/?p=4249"},"modified":"2024-05-15T11:44:19","modified_gmt":"2024-05-15T03:44:19","slug":"needle-penetration-test-for-vial-stopper","status":"publish","type":"post","link":"https:\/\/www.qualitester.com\/ja\/needle-penetration-test-for-vial-stopper\/","title":{"rendered":"\u30d0\u30a4\u30a2\u30eb\u30b9\u30c8\u30c3\u30d1\u30fc\u54c1\u8cea\u4fdd\u8a3c\u306e\u305f\u3081\u306e\u91dd\u8cab\u5165\u8a66\u9a13 ISO 8871-5"},"content":{"rendered":"<h1>\u30d0\u30a4\u30a2\u30eb\u6813\u54c1\u8cea\u4fdd\u8a3c\u306e\u305f\u3081\u306e\u91dd\u8cab\u901a\u8a66\u9a13<\/h1>\n<h2>I.\u91dd\u4fb5\u5165\u30c6\u30b9\u30c8\u3068\u306f\u4f55\u304b\uff1f<\/h2>\n<h3><strong>\u5b9a\u7fa9\u3068\u76ee\u7684<\/strong><\/h3>\n<p>\u91dd\u523a\u3057\u8a66\u9a13\u306f\u3001\u30d0\u30a4\u30a2\u30eb\u30b9\u30c8\u30c3\u30d1\u30fc\u306e\u8010\u7a7f\u523a\u6027\u3068\u6ce8\u5c04\u91dd\u306e\u7a7f\u523a\u80fd\u529b\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u91cd\u8981\u306a\u65b9\u6cd5\u3067\u3059\u3002\u3053\u306e\u8a66\u9a13\u306b\u3088\u308a\u3001\u533b\u7642\u7528\u304a\u3088\u3073\u533b\u85ac\u54c1\u5305\u88c5\u306b\u4f7f\u7528\u3055\u308c\u308b\u6750\u6599\u304c\u3001\u91dd\u3067\u8cab\u901a\u3055\u308c\u305f\u5834\u5408\u3067\u3082\u305d\u306e\u5b8c\u5168\u6027\u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u304c\u4fdd\u8a3c\u3055\u308c\u307e\u3059\u3002.<\/p>\n<h3><strong>\u57fa\u6e96\u3068\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/strong><\/h3>\n<p>\u3053\u306e\u691c\u67fb\u306f\u3001ISO 8871-5\u3084USP 381\u3068\u3044\u3063\u305f\u53b3\u683c\u306a\u898f\u683c\u306b\u3088\u3063\u3066\u898f\u5b9a\u3055\u308c\u3066\u3044\u308b\u3002\u3053\u308c\u3089\u306e\u898f\u683c\u306f\u3001\u4e00\u8cab\u6027\u3068\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u8a66\u9a13\u306e\u624b\u9806\u3068\u57fa\u6e96\u3092\u6982\u8aac\u3057\u3066\u3044\u307e\u3059\u3002ISO 8871-5\u306f\u3001\u975e\u7d4c\u53e3\u5264\u304a\u3088\u3073\u533b\u7642\u7528\u5668\u5177\u306b\u4f7f\u7528\u3055\u308c\u308b\u30a8\u30e9\u30b9\u30c8\u30de\u30fc\u90e8\u54c1\u306b\u5bfe\u3059\u308b\u8981\u6c42\u4e8b\u9805\u3092\u5177\u4f53\u7684\u306b\u8a73\u8ff0\u3057\u3066\u304a\u308a\u3001USP 381\u306f\u6ce8\u5c04\u7528\u30a8\u30e9\u30b9\u30c8\u30de\u30fc\u88fd\u30af\u30ed\u30fc\u30b8\u30e3\u30fc\u306e\u54c1\u8cea\u7279\u6027\u3092\u53d6\u308a\u4e0a\u3052\u3066\u3044\u307e\u3059\u3002.<\/p>\n<h2>II. \u306f\u3058\u3081\u306b<\/h2>\n<h3><strong>\u30d0\u30a4\u30a2\u30eb\u6813\u54c1\u8cea\u4fdd\u8a3c\u306e\u6982\u8981<\/strong><\/h3>\n<p>\u30d0\u30a4\u30a2\u30eb\u30b9\u30c8\u30c3\u30d1\u30fc\u306f\u3001\u30d0\u30a4\u30a2\u30eb\u74f6\u306e\u5185\u5bb9\u7269\u3092\u6c5a\u67d3\u304b\u3089\u4fdd\u8b77\u3057\u3001\u7121\u83cc\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u88fd\u85ac\u304a\u3088\u3073\u533b\u7642\u7523\u696d\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30b9\u30c8\u30c3\u30d1\u30fc\u304c\u3001\u305d\u306e\u5b8c\u5168\u6027\u3092\u640d\u306a\u3046\u3053\u3068\u306a\u304f\u91dd\u523a\u3057\u30b9\u30c8\u30ec\u30b9\u306b\u8010\u3048\u3089\u308c\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u306b\u306f\u3001\u53b3\u5bc6\u306a\u8a66\u9a13\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002.<\/p>\n<h3><strong>\u30d0\u30a4\u30a2\u30eb\u30b9\u30c8\u30c3\u30d1\u30fc\u306e\u91cd\u8981\u6027<\/strong><\/h3>\n<p>\u88fd\u85ac\u30fb\u533b\u7642\u5206\u91ce\u3067\u306f\u3001\u30d0\u30a4\u30a2\u30eb\u306e\u5185\u5bb9\u7269\u306e\u7121\u83cc\u6027\u3068\u5b8c\u5168\u6027\u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u304c\u6700\u3082\u91cd\u8981\u3067\u3059\u3002\u85ac\u5264\u306e\u6709\u52b9\u6027\u3084\u60a3\u8005\u306e\u5b89\u5168\u6027\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3059\u53ef\u80fd\u6027\u306e\u3042\u308b\u6c5a\u67d3\u3084\u6f0f\u308c\u3092\u9632\u3050\u305f\u3081\u3001\u30b9\u30c8\u30c3\u30d1\u30fc\u306f\u8010\u7a7f\u523a\u6027\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u305d\u306e\u305f\u3081\u3001\u91dd\u523a\u3057\u8a66\u9a13\u3092\u542b\u3080\u53b3\u683c\u306a\u54c1\u8cea\u4fdd\u8a3c\u63aa\u7f6e\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>\n<h2>III.\u30d0\u30a4\u30a2\u30eb\u6813\u54c1\u8cea\u4fdd\u8a3c\u306b\u304a\u3051\u308b\u91dd\u4fb5\u5165\u8a66\u9a13\u306e\u91cd\u8981\u6027<\/h2>\n<h3><strong>\u7121\u83cc\u6027\u3068\u5b8c\u5168\u6027\u306e\u78ba\u4fdd<\/strong><\/h3>\n<p>\u91dd\u523a\u3057\u8a66\u9a13\u306f\u3001\u6c5a\u67d3\u3084\u6f0f\u308c\u3092\u9632\u6b62\u3059\u308b\u4e0a\u3067\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002\u30d0\u30a4\u30a2\u30eb\u306e\u30b9\u30c8\u30c3\u30d1\u30fc\u304c\u91dd\u306e\u8cab\u901a\u306b\u8010\u3048\u3089\u308c\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3067\u3001\u30d0\u30a4\u30a2\u30eb\u306e\u5185\u5bb9\u7269\u306e\u7121\u83cc\u6027\u3092\u7dad\u6301\u3057\u3001\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n<h3><strong>\u898f\u5236\u9075\u5b88<\/strong><\/h3>\n<p>\u306a\u3069\u306e\u898f\u683c\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3002 <a href=\"https:\/\/www.iso.org\/standard\/68560.html\" target=\"_blank\" rel=\"noopener nofollow\">8871-5 \u898f\u683c<\/a> \u304a\u3088\u3073USP 381\u306f\u3001\u533b\u85ac\u54c1\u306e\u627f\u8a8d\u3068\u5e02\u5834\u6027\u306e\u305f\u3081\u306b\u5fc5\u9808\u3067\u3059\u3002\u6d78\u900f\u6027\u8a66\u9a13\u306f\u3001\u3053\u308c\u3089\u306e\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3053\u3068\u306b\u3088\u308a\u3001\u65b0\u88fd\u54c1\u306e\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u3092\u4fc3\u9032\u3057\u307e\u3059\u3002.<\/p>\n<h3><strong>\u65b0\u88fd\u54c1\u306e\u7814\u7a76\u958b\u767a<\/strong><\/h3>\n<p>\u91dd\u5165\u5ea6\u8a66\u9a13\u306f\u3001\u65b0\u88fd\u54c1\u306e\u7814\u7a76\u958b\u767a\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u3066\u3044\u308b\u3002\u73fe\u5b9f\u7684\u306a\u6761\u4ef6\u4e0b\u3067\u65b0\u7d20\u6750\u3084\u8a2d\u8a08\u306e\u6027\u80fd\u3092\u8a55\u4fa1\u3059\u308b\u3053\u3068\u3067\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u88fd\u54c1\u304c\u6700\u9ad8\u6c34\u6e96\u306e\u54c1\u8cea\u3068\u5b89\u5168\u6027\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002.<\/p>\n<h2>IV.\u8a66\u9a13\u624b\u9806\u3068\u65b9\u6cd5\u8ad6<\/h2>\n<h3><strong>\u30b5\u30f3\u30d7\u30eb\u306e\u6e96\u5099<\/strong><\/h3>\n<p>\u6b63\u78ba\u306a\u91dd\u5165\u5ea6\u8a66\u9a13\u306b\u306f\u3001\u9069\u5207\u306a\u8a66\u6599\u8abf\u88fd\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u9069\u5207\u306a\u30d0\u30a4\u30a2\u30eb\u30b9\u30c8\u30c3\u30d1\u30fc\u3068\u91dd\u3092\u9078\u629e\u3057\u3001\u8a66\u9a13\u898f\u683c\u306b\u5f93\u3063\u3066\u6e96\u5099\u3059\u308b\u3053\u3068\u304c\u542b\u307e\u308c\u307e\u3059\u3002.<\/p>\n<h3><strong>\u8a66\u9a13\u88c5\u7f6e<\/strong><\/h3>\n<figure id=\"attachment_4251\" aria-describedby=\"caption-attachment-4251\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/www.qualitester.com\/ja\/%e8%a3%bd%e5%93%81\/medical-needle-puncture-tester\/\" target=\"_blank\" rel=\"noopener\"><img fetchpriority=\"high\" decoding=\"async\" class=\"wp-image-4251 size-full\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/05\/needle-penetration-test-for-vial-stopper.jpg\" alt=\"\u30d0\u30a4\u30a2\u30eb\u6813\u306e\u91dd\u523a\u3057\u8a66\u9a13\" width=\"600\" height=\"600\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/05\/needle-penetration-test-for-vial-stopper.jpg 600w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/05\/needle-penetration-test-for-vial-stopper-300x300.jpg 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/05\/needle-penetration-test-for-vial-stopper-150x150.jpg 150w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/05\/needle-penetration-test-for-vial-stopper-100x100.jpg 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/a><figcaption id=\"caption-attachment-4251\" class=\"wp-caption-text\"><span style=\"text-decoration: underline; color: #99ccff;\"><a style=\"color: #99ccff; text-decoration: underline;\" href=\"https:\/\/www.qualitester.com\/ja\/%e8%a3%bd%e5%93%81\/medical-needle-puncture-tester\/\" target=\"_blank\" rel=\"noopener\">\u6d78\u900f\u6027\u8a66\u9a13\u6a5f NPT-01<\/a><\/span><\/figcaption><\/figure>\n<p>\u30bb\u30eb\u30a4\u30f3\u30b9\u30c4\u30eb\u30e1\u30f3\u30c4\u3067\u306f\u3001NPT-01\u30da\u30cd\u30c8\u30e9\u30d3\u30ea\u30c6\u30a3\u30fc\u30c6\u30b9\u30bf\u30fc\u306e\u3088\u3046\u306a\u9ad8\u5ea6\u306a\u8a66\u9a13\u88c5\u7f6e\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u88c5\u7f6e\u306f\u3001\u30d0\u30a4\u30a2\u30eb\u306e\u30b9\u30c8\u30c3\u30d1\u30fc\u3092\u8cab\u901a\u3059\u308b\u306e\u306b\u5fc5\u8981\u306a\u529b\u3092\u6b63\u78ba\u306b\u6e2c\u5b9a\u3059\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u304a\u308a\u3001\u54c1\u8cea\u4fdd\u8a3c\u306e\u305f\u3081\u306e\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u30c7\u30fc\u30bf\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002NPT-01\u306f\u3001\u81ea\u52d5\u8a66\u9a13\u6a5f\u80fd\u3001\u6b63\u78ba\u306a\u529b\u6e2c\u5b9a\u3001\u30c7\u30fc\u30bf\u89e3\u6790\u7528\u306e\u4f7f\u3044\u3084\u3059\u3044\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u5099\u3048\u3066\u3044\u307e\u3059\u3002.<\/p>\n<h3><strong>\u30c6\u30b9\u30c8\u5b9f\u884c<\/strong><\/h3>\n<div class=\"ast-oembed-container\" style=\"height: 100%;\"><iframe title=\"\u533b\u7642\u7528\u6ce8\u5c04\u91dd\u7a7f\u523a\u8a66\u9a13 | \u8a66\u9a13\u6a5f\u5668\u306e\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\" width=\"500\" height=\"281\" src=\"https:\/\/www.youtube.com\/embed\/6D2saICCxCA?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe><\/div>\n<p>\u6d78\u900f\u6027\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u306f\u3044\u304f\u3064\u304b\u306e\u30b9\u30c6\u30c3\u30d7\u304c\u3042\u308b\uff1a<\/p>\n<ol>\n<li>\u30b5\u30f3\u30d7\u30eb\u306e\u6e96\u5099\u3068NPT-01\u6d78\u900f\u6027\u8a66\u9a13\u6a5f\u306e\u8a2d\u7f6e\u3002.<\/li>\n<li>\u91dd\u3092\u30d0\u30a4\u30a2\u30eb\u306e\u6813\u306b\u633f\u5165\u3057\u3001\u8cab\u901a\u529b\u3092\u8a18\u9332\u3059\u308b\u3002.<\/li>\n<li>\u8907\u6570\u306e\u30b5\u30f3\u30d7\u30eb\u3067\u30c6\u30b9\u30c8\u3092\u7e70\u308a\u8fd4\u3057\u3001\u4e00\u8cab\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3002.<\/li>\n<\/ol>\n<h2>V.\u7d50\u679c\u306e\u5206\u6790\u3068\u89e3\u91c8<\/h2>\n<h3><strong>\u30c7\u30fc\u30bf\u53ce\u96c6\u3068\u5206\u6790<\/strong><\/h3>\n<p>\u8a66\u9a13\u4e2d\u3001\u30d0\u30a4\u30a2\u30eb\u306e\u30b9\u30c8\u30c3\u30d1\u30fc\u3092\u8cab\u901a\u3059\u308b\u306e\u306b\u5fc5\u8981\u306a\u529b\u304c\u8a18\u9332\u3055\u308c\u308b\u3002\u3053\u306e\u30c7\u30fc\u30bf\u3092\u5206\u6790\u3057\u3001\u30b9\u30c8\u30c3\u30d1\u30fc\u306e\u8010\u7a7f\u523a\u6027\u3068\u91dd\u306e\u6027\u80fd\u3092\u8a55\u4fa1\u3059\u308b\u3002.<\/p>\n<h3><strong>\u3088\u304f\u3042\u308b\u554f\u984c\u3068\u89e3\u6c7a\u7b56<\/strong><\/h3>\n<p>\u3088\u304f\u3042\u308b\u554f\u984c\u306b\u306f\u3001\u4e0d\u9069\u5207\u306a\u30b5\u30f3\u30d7\u30eb\u524d\u51e6\u7406\u3084\u6a5f\u5668\u306e\u6821\u6b63\u306b\u3088\u308b\u7d50\u679c\u306e\u4e00\u8cab\u6027\u306e\u6b20\u5982\u304c\u3042\u308b\u3002\u3053\u308c\u3089\u306f\u3001\u6a19\u6e96\u5316\u3055\u308c\u305f\u624b\u9806\u306b\u5f93\u3044\u3001\u691c\u67fb\u6a5f\u5668\u3092\u5b9a\u671f\u7684\u306b\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u3059\u308b\u3053\u3068\u3067\u5bfe\u51e6\u3067\u304d\u307e\u3059\u3002.<\/p>\n<h3><strong>\u5408\u5426\u5224\u5b9a\u57fa\u6e96<\/strong><\/h3>\n<p>\u5408\u5426\u5224\u5b9a\u57fa\u6e96\u306f\u3001ISO 8871-5\u304a\u3088\u3073USP 381\u306b\u57fa\u3065\u3044\u3066\u8a2d\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u57fa\u6e96\u306b\u3088\u308a\u3001\u6700\u9ad8\u6c34\u6e96\u306e\u8010\u7a7f\u523a\u6027\u3092\u6e80\u305f\u3059\u30d0\u30a4\u30a2\u30eb\u30b9\u30c8\u30c3\u30d1\u30fc\u306e\u307f\u304c\u4f7f\u7528\u3092\u627f\u8a8d\u3055\u308c\u307e\u3059\u3002.<\/p>\n<h2>VI.\u30cb\u30fc\u30c9\u30eb\u30fb\u30da\u30cd\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3\u30fb\u30c6\u30b9\u30c8\u306e\u7528\u9014\u3068\u5229\u70b9<\/h2>\n<h3><strong>\u3055\u307e\u3056\u307e\u306a\u696d\u754c\u3078\u306e\u5fdc\u7528<\/strong><\/h3>\n<p>\u91dd\u5165\u5ea6\u8a66\u9a13\u306f\u3001\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u3001\u5305\u88c5\u3092\u542b\u3080\u69d8\u3005\u306a\u7523\u696d\u3067\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u3002\u3053\u308c\u3089\u306e\u7523\u696d\u3067\u4f7f\u7528\u3055\u308c\u308b\u6750\u6599\u304c\u3001\u305d\u306e\u5b8c\u5168\u6027\u3092\u640d\u306a\u3046\u3053\u3068\u306a\u304f\u3001\u91dd\u523a\u3057\u8a66\u9a13\u306e\u53b3\u3057\u3055\u306b\u8010\u3048\u3089\u308c\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002.<\/p>\n<h3><strong>\u54c1\u8cea\u4fdd\u8a3c\u3068\u88fd\u54c1\u958b\u767a<\/strong><\/h3>\n<p>\u8010\u8cab\u901a\u6027\u8a66\u9a13\u306f\u3001\u8010\u8cab\u901a\u6027\u306b\u95a2\u3059\u308b\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u30c7\u30fc\u30bf\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3067\u3001\u88fd\u54c1\u306e\u4fe1\u983c\u6027\u3092\u9ad8\u3081\u3001\u9867\u5ba2\u306e\u4fe1\u983c\u3092\u7bc9\u304d\u307e\u3059\u3002\u307e\u305f\u3001\u7814\u7a76\u958b\u767a\u306b\u304a\u3044\u3066\u3082\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u6700\u9ad8\u6c34\u6e96\u306e\u54c1\u8cea\u3068\u5b89\u5168\u6027\u3092\u6e80\u305f\u3059\u65b0\u88fd\u54c1\u3092\u958b\u767a\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>\n<h2>VII.\u30ab\u30b9\u30bf\u30e0\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3068\u9ad8\u5ea6\u306a\u30c6\u30b9\u30c8\u80fd\u529b<\/h2>\n<h3><strong>\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3068\u81ea\u52d5\u5316<\/strong><\/h3>\n<p>\u30bb\u30eb\u30a4\u30f3\u30b9\u30c4\u30eb\u30e1\u30f3\u30c4\u3067\u306f\u3001\u304a\u5ba2\u69d8\u306e\u30cb\u30fc\u30ba\u306b\u5408\u308f\u305b\u3066\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3057\u305f\u8a66\u9a13\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002NPT-01\u30da\u30cd\u30c8\u30e9\u30d3\u30ea\u30c6\u30a3\u30fc\u30fb\u30c6\u30b9\u30bf\u30fc\u306f\u3001\u69d8\u3005\u306a\u30bf\u30a4\u30d7\u306e\u30d0\u30a4\u30a2\u30eb\u30b9\u30c8\u30c3\u30d1\u30fc\u3084\u30cb\u30fc\u30c9\u30eb\u306e\u30c6\u30b9\u30c8\u306b\u5bfe\u5fdc\u3067\u304d\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u81ea\u52d5\u5316\u306b\u3088\u308a\u8a66\u9a13\u306e\u52b9\u7387\u3068\u7cbe\u5ea6\u304c\u5411\u4e0a\u3057\u3001\u624b\u4f5c\u696d\u306b\u3088\u308b\u8a66\u9a13\u306b\u5fc5\u8981\u306a\u6642\u9593\u3068\u52b4\u529b\u304c\u524a\u6e1b\u3055\u308c\u307e\u3059\u3002.<\/p>\n<h2>VIII.\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n<p><strong>Q1\uff1a\u91dd\u4fb5\u5165\u30c6\u30b9\u30c8\u306e\u76ee\u7684\u306f\u4f55\u3067\u3059\u304b\uff1f<\/strong><\/p>\n<p>A1: \u6d78\u900f\u6027\u8a66\u9a13\u306f\u3001\u88fd\u54c1\u306e\u5b8c\u5168\u6027\u3068\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001\u30d0\u30a4\u30a2\u30eb\u30b9\u30c8\u30c3\u30d1\u30fc\u306e\u8010\u7a7f\u523a\u6027\u3068\u6ce8\u5c04\u91dd\u306e\u7a7f\u523a\u80fd\u529b\u3092\u8a55\u4fa1\u3057\u307e\u3059\u3002.<\/p>\n<p><strong>Q2: \u91dd\u306e\u4fb5\u5165\u30c6\u30b9\u30c8\u306b\u306f\u3069\u306e\u3088\u3046\u306a\u898f\u683c\u304c\u3042\u308a\u307e\u3059\u304b\uff1f<\/strong><\/p>\n<p>A2: \u6d78\u900f\u6027\u8a66\u9a13\u306f\u3001ISO 8871-5\u3068USP 381\u306b\u3088\u3063\u3066\u898f\u5b9a\u3055\u308c\u3066\u304a\u308a\u3001\u8a66\u9a13\u306e\u624b\u9806\u3068\u57fa\u6e96\u304c\u6982\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>\n<p><strong>Q3\uff1a\u91dd\u306e\u4fb5\u5165\u30c6\u30b9\u30c8\u306b\u304a\u3044\u3066\u3001\u306a\u305c\u898f\u5236\u9075\u5b88\u304c\u91cd\u8981\u306a\u306e\u3067\u3059\u304b\uff1f<\/strong><\/p>\n<p>A3: \u898f\u5236\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306f\u3001\u88fd\u54c1\u304c\u696d\u754c\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u78ba\u4fdd\u3057\u306a\u304c\u3089\u3001\u627f\u8a8d\u3068\u5e02\u5834\u6027\u3092\u4fc3\u9032\u3059\u308b\u3002.<\/p>\n<p><strong>Q4\uff1a\u6d78\u900f\u6027\u8a66\u9a13\u306b\u306f\u3069\u306e\u3088\u3046\u306a\u88c5\u7f6e\u304c\u63a8\u5968\u3055\u308c\u307e\u3059\u304b\uff1f<\/strong><\/p>\n<p>A4: \u30bb\u30eb\u30a4\u30f3\u30b9\u30c4\u30eb\u30e1\u30f3\u30c4\u793e\u306eNPT-01\u30da\u30cd\u30c8\u30e9\u30d3\u30ea\u30c6\u30a3\u30fc\u30fb\u30c6\u30b9\u30bf\u30fc\u306f\u3001\u305d\u306e\u7cbe\u5ea6\u3001\u81ea\u52d5\u5316\u6a5f\u80fd\u3001\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u30c7\u30fc\u30bf\u51fa\u529b\u304c\u63a8\u5968\u3055\u308c\u307e\u3059\u3002.<\/p>\n<p><strong>Q5: \u6d78\u900f\u6027\u8a66\u9a13\u306b\u304a\u3051\u308b\u4e00\u822c\u7684\u306a\u554f\u984c\u306f\u3001\u3069\u306e\u3088\u3046\u306b\u5bfe\u51e6\u3059\u308c\u3070\u3088\u3044\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/strong><\/p>\n<p>A5: \u4e00\u822c\u7684\u306a\u554f\u984c\u306f\u3001\u6a19\u6e96\u5316\u3055\u308c\u305f\u624b\u9806\u306b\u5f93\u3046\u3053\u3068\u3001\u9069\u5207\u306a\u8a66\u6599\u8abf\u88fd\u3092\u78ba\u5b9f\u306b\u884c\u3046\u3053\u3068\u3001\u691c\u67fb\u6a5f\u5668\u3092\u5b9a\u671f\u7684\u306b\u4fdd\u5b88\u3059\u308b\u3053\u3068\u3067\u5bfe\u51e6\u3067\u304d\u307e\u3059\u3002.<\/p>\n<p><!--more--><\/p>\n<h2>\u3055\u3089\u306b\u8aad\u3080<\/h2>\n<p><em><span style=\"text-decoration: underline; color: #99ccff;\"><a style=\"color: #99ccff; text-decoration: underline;\" href=\"https:\/\/www.qualitester.com\/ja\/penetration-force-tester-to-meet-iso-8871-5\/\" target=\"_blank\" rel=\"noopener\">\u6d78\u900f\u529b\u8a66\u9a13\u6a5f<\/a><\/span><\/em><\/p>\n<p><em><span style=\"text-decoration: underline; color: #99ccff;\"><a style=\"color: #99ccff; text-decoration: underline;\" href=\"https:\/\/www.qualitester.com\/ja\/needle-penetration-test-equipment\/\" target=\"_blank\" rel=\"noopener\">\u91dd\u4fb5\u5165\u8a66\u9a13\u88c5\u7f6e<\/a><\/span><\/em><\/p>\n<p><em><span style=\"text-decoration: underline; color: #99ccff;\"><a style=\"color: #99ccff; text-decoration: underline;\" href=\"https:\/\/www.qualitester.com\/ja\/puncture-performance-testing-for-medicinal-rubber-stopper\/\" target=\"_blank\" rel=\"noopener\">\u4fb5\u5165\u6027\u30c6\u30b9\u30c8<\/a><\/span><\/em><\/p>\n<p><em><span style=\"text-decoration: underline; color: #99ccff;\"><a style=\"color: #99ccff; text-decoration: underline;\" href=\"https:\/\/www.qualitester.com\/ja\/penetrability-tester-for-vial-stopper-iso-8871-5\/\" target=\"_blank\" rel=\"noopener\">\u6d78\u900f\u6027\u8a66\u9a13\u88c5\u7f6e<\/a><\/span><\/em><\/p>\n<p><em><span style=\"text-decoration: underline; color: #99ccff;\"><a style=\"color: #99ccff; text-decoration: underline;\" href=\"https:\/\/www.qualitester.com\/ja\/what-is-penetrability-testing-iso-8871-5\/\" target=\"_blank\" rel=\"noopener\">\u4fb5\u5165\u6027\u30c6\u30b9\u30c8<\/a><\/span><\/em><\/p>\n<p><em><span style=\"text-decoration: underline; color: #99ccff;\"><a style=\"color: #99ccff; text-decoration: underline;\" href=\"https:\/\/www.qualitester.com\/ja\/3-reasons-to-test-needle-puncture-resistance\/\" target=\"_blank\" rel=\"noopener\">\u91dd\u523a\u3057\u62b5\u6297\u8a66\u9a13<\/a><\/span><\/em><\/p>\n<h2>\u53c2\u8003\u6587\u732e<\/h2>\n<p><span style=\"color: #99ccff;\"><a style=\"color: #99ccff;\" href=\"https:\/\/www.iso.org\/standard\/68560.html\" target=\"_blank\" rel=\"noopener nofollow\"><em><span style=\"text-decoration: underline;\">8871-5 \u898f\u683c<\/span><\/em><\/a><\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>\u30d0\u30a4\u30a2\u30eb\u30b9\u30c8\u30c3\u30d1\u30fc\u306e\u54c1\u8cea\u4fdd\u8a3c\u306e\u305f\u3081\u306e\u91dd\u8cab\u5165\u8a66\u9a13 I. \u91dd\u8cab\u5165\u8a66\u9a13\u3068\u306f? \u5b9a\u7fa9\u3068\u76ee\u7684 \u91dd\u8cab\u5165\u8a66\u9a13\u306f\u3001\u30d0\u30a4\u30a2\u30eb\u30b9\u30c8\u30c3\u30d1\u30fc\u306e\u7a7f\u523a\u62b5\u6297\u3068\u91dd\u306e\u7a7f\u523a\u80fd\u529b\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3059\u308b\u91cd\u8981\u306a\u65b9\u6cd5\u3067\u3059\u3002 \u3053\u306e\u8a66\u9a13\u306f\u3001\u533b\u7642\u304a\u3088\u3073\u533b\u85ac\u54c1\u306e\u5305\u88c5\u306b\u4f7f\u7528\u3055\u308c\u308b\u6750\u6599\u304c\u91dd\u3067\u8cab\u5165\u3055\u308c\u305f\u3068\u304d\u306b\u5b8c\u5168\u6027\u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002 \u6a19\u6e96\u3068\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3 \u3053\u306e\u8a66\u9a13\u306f\u3001ISO 8871-5 \u3084 USP 381 \u306a\u3069\u306e\u53b3\u683c\u306a\u6a19\u6e96\u306b\u3088\u3063\u3066\u7ba1\u7406\u3055\u308c\u3066\u3044\u307e\u3059\u3002 \u3053\u308c\u3089\u306e\u6a19\u6e96\u306f\u3001\u4e00\u8cab\u6027\u3068\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u8a66\u9a13\u306e\u624b\u9806\u3068\u57fa\u6e96\u3092\u6982\u8aac\u3057\u3066\u3044\u307e\u3059\u3002 ISO 8871-5 \u306f\u3001\u975e\u7d4c\u53e3\u85ac\u306b\u4f7f\u7528\u3055\u308c\u308b\u30a8\u30e9\u30b9\u30c8\u30de\u30fc\u90e8\u54c1\u3068\u533b\u7642\u7528\u30c7\u30d0\u30a4\u30b9\u306b\u5bfe\u3059\u308b\u8981\u4ef6\u3092\u5177\u4f53\u7684\u306b\u8a73\u7d30\u306b\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/www.qualitester.com\/ja\/needle-penetration-test-for-vial-stopper\/\"> <span class=\"screen-reader-text\">\u30d0\u30a4\u30a2\u30eb\u30b9\u30c8\u30c3\u30d1\u30fc\u54c1\u8cea\u4fdd\u8a3c\u306e\u305f\u3081\u306e\u91dd\u8cab\u5165\u8a66\u9a13 ISO 8871-5<\/span> \u3082\u3063\u3068\u8aad\u3080 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