{"id":10267,"date":"2026-05-28T11:25:52","date_gmt":"2026-05-28T03:25:52","guid":{"rendered":"https:\/\/rysilicone.com\/?p=10267"},"modified":"2026-08-26T18:13:26","modified_gmt":"2026-08-26T10:13:26","slug":"medical-grade-silicone","status":"publish","type":"post","link":"https:\/\/rysilicone.com\/ja\/medical-grade-silicone\/","title":{"rendered":"\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u30b7\u30ea\u30b3\u30fc\u30f3\uff1aFDA\u3001USP\u30af\u30e9\u30b9VI\u3001ISO 10993\u306b\u3064\u3044\u3066\u89e3\u8aac"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u201c\u300c\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u30b7\u30ea\u30b3\u30fc\u30f3\u300d\u306f\u3001B2B\u8abf\u9054\u306b\u304a\u3044\u3066\u6700\u3082\u8aa4\u7528\u3055\u308c\u3066\u3044\u308b\u30e9\u30d9\u30eb\u306e\u4e00\u3064\u3067\u3059\u3002\u540c\u3058\u6587\u8a00\u304c\u3001\u304a\u3057\u3083\u3076\u308a\u3001\u8f38\u6db2\u30c1\u30e5\u30fc\u30d6\u3001\u9577\u671f\u57cb\u3081\u8fbc\u307f\u578b\u533b\u7642\u6a5f\u5668\u306a\u3069\u306b\u3082\u4f7f\u308f\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u305d\u308c\u305e\u308c\u7570\u306a\u308b\u57fa\u6e96\u304c\u9069\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u4e00\u822c\u7684\u306a\u8a18\u4e8b\u3067\u306f\u3001\u3053\u306e\u9055\u3044\u304c\u307b\u3068\u3093\u3069\u89e6\u308c\u3089\u308c\u3066\u3044\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306e\u30b7\u30ea\u30b3\u30fc\u30f3\u306f <a href=\"https:\/\/rysilicone.com\/ja\/platinum-vulcanization\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u767d\u91d1\u786c\u5316\u30b7\u30ea\u30b3\u30fc\u30f3<\/a> \u5c11\u306a\u304f\u3068\u30821\u3064\u306e\u516c\u8a8d\u751f\u4f53\u9069\u5408\u6027\u898f\u683c\uff08\u901a\u5e38\u306fFDA 21 CFR 177.2600\uff08\u63a5\u89e6\uff09\u3001USP\u30af\u30e9\u30b9VI\uff08\u77ed\u671f\u533b\u7642\u7528\u9014\uff09\u3001\u307e\u305f\u306fISO 10993\uff08\u81e8\u5e8a\u6a5f\u5668\u5206\u985e\uff09\uff09\u306b\u5408\u683c\u3057\u3066\u3044\u308b\u3053\u3068\u3002\u9069\u7528\u3055\u308c\u308b\u898f\u683c\u306f\u3001\u30b7\u30ea\u30b3\u30fc\u30f3\u81ea\u4f53\u3067\u306f\u306a\u304f\u3001\u63a5\u89e6\u306e\u7a2e\u985e\u3068\u63a5\u89e6\u6642\u9593\u306b\u3088\u3063\u3066\u6c7a\u307e\u308a\u307e\u3059\u3002.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3082\u3057\u3042\u306a\u305f\u306e\u4ed5\u4e8b\u304c\u3001\u898b\u7a4d\u4f9d\u983c\u66f8\u3092\u9001\u308b\u524d\u306b\u3001\u88fd\u54c1\u306b\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306e\u7d20\u6750\u304c\u5fc5\u8981\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u3053\u3068\u3067\u3042\u308c\u3070\u3001\u4ee5\u4e0b\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306b\u305d\u306e\u5224\u65ad\u57fa\u6e96\u3068\u306a\u308b\u5883\u754c\u7dda\u304c\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u300c\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u30b7\u30ea\u30b3\u30f3\u300d\u3068\u306f\u5b9f\u969b\u306b\u306f\u3069\u3046\u3044\u3046\u610f\u5473\u306a\u306e\u304b<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e16\u754c\u5171\u901a\u306e\u5b9a\u7fa9\u306f\u5b58\u5728\u3057\u306a\u3044\u3002\u5de5\u5834\u304c\u5316\u5408\u7269\u3092\u300c\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u300d\u3068\u547c\u3076\u5834\u5408\u3001\u901a\u5e38\u306f\u6b21\u306e3\u3064\u306e\u6761\u4ef6\u304c\u540c\u6642\u306b\u6e80\u305f\u3055\u308c\u308b\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u904e\u9178\u5316\u7269\u786c\u5316\u3067\u306f\u306a\u304f\u3001\u30d7\u30e9\u30c1\u30ca\u786c\u5316\uff08\u4ed8\u52a0\u786c\u5316\uff09\u3055\u308c\u3066\u3044\u308b\u305f\u3081\u3001\u904e\u9178\u5316\u7269\u306e\u526f\u751f\u6210\u7269\u304c\u306a\u304f\u3001\u6b8b\u7559\u81ed\u304c\u306a\u304f\u3001\u9ec4\u5909\u3082\u3042\u308a\u307e\u305b\u3093\u3002.<\/li>\n\n\n\n<li>\u751f\u4f53\u9069\u5408\u6027\u306b\u95a2\u3059\u308b\u8a8d\u5b9a\u57fa\u6e96\uff08FDA\u3001USP\u3001\u307e\u305f\u306fISO 10993\uff09\u306b\u57fa\u3065\u3044\u3066\u8a66\u9a13\u3055\u308c\u305f\u30d9\u30fc\u30b9\u30dd\u30ea\u30de\u30fc\u304b\u3089\u914d\u5408\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/li>\n\n\n\n<li>\u7ba1\u7406\u3055\u308c\u305f\u6761\u4ef6\u4e0b\u3067\u751f\u7523\u3055\u308c\u3001\u901a\u5e38\u306f <a href=\"https:\/\/www.iso.org\/standard\/53394.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 14644-1 \u30af\u30e9\u30b98<\/a> \u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\uff08\u7d04\u30af\u30e9\u30b9100,000\uff09\u307e\u305f\u306f\u305d\u308c\u4ee5\u4e0a\u306e\u53b3\u683c\u306a\u57fa\u6e96\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u30893\u3064\u306e\u8981\u7d20\u306e\u3046\u3061\u3044\u305a\u308c\u304b1\u3064\u3067\u3082\u6b20\u3051\u3066\u3044\u308b\u5316\u5408\u7269\u306f\u3001\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u4e0a\u306e\u6587\u8a00\u306b\u95a2\u308f\u3089\u305a\u3001\u8abf\u9054\u306e\u89b3\u70b9\u304b\u3089\u306f\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u3068\u306f\u8a00\u3048\u306a\u3044\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3\u3064\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ec\u30d9\u30eb\uff08\u304a\u3088\u3073\u305d\u308c\u305e\u308c\u306e\u9069\u7528\u7bc4\u56f2\uff09<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u7528\u9014\u306b\u3088\u3063\u3066\u5fc5\u8981\u306a\u8a8d\u8a3c\u30ec\u30d9\u30eb\u306f\u7570\u306a\u308a\u307e\u3059\u3002\u30ec\u30d9\u30eb\u3092\u9593\u9055\u3048\u308b\u3068\u3001\u6559\u6750\u8cbb\u304c\u7121\u99c4\u306b\u306a\u3063\u305f\u308a\u3001\u767b\u9332\u6642\u306e\u76e3\u67fb\u306b\u5408\u683c\u3067\u304d\u306a\u304b\u3063\u305f\u308a\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>\u6a19\u6e96<\/strong><\/th><th><strong>\u7bc4\u56f2<\/strong><\/th><th><strong>\u5178\u578b\u7684\u306a\u63a5\u89e6<\/strong><\/th><th><strong>\u53c2\u8003\u6750\u6599\u8cbb\u3068\u5de5\u696d\u7528HTV\u306e\u6bd4\u8f03<\/strong><\/th><\/tr><\/thead><tbody><tr><td><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-177\/subpart-C\/section-177.2600\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">FDA 21 CFR 177.2600<\/a><\/td><td>\u98df\u54c1\uff0f\u7d4c\u53e3\uff0f\u76ae\u819a\u63a5\u89e6\u306e\u5b89\u5168\u6027<\/td><td>\u304a\u3057\u3083\u3076\u308a\u3001\u4e73\u9996\u3001\u53f0\u6240\u7528\u54c1<\/td><td>+10\u201320%<\/td><\/tr><tr><td><a href=\"https:\/\/doi.usp.org\/USPNF\/USPNF_M98834_01_01.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">USP\u30af\u30e9\u30b9VI<\/a> (USP &lt;87&gt; \/ &lt;88&gt;)<\/td><td>\u77ed\u671f\u7684\u306a\u533b\u7642\u63a5\u89e6\uff0830\u65e5\u4ee5\u5185\uff09<\/td><td>\u30c1\u30e5\u30fc\u30d6\u3001\u30de\u30b9\u30af\u3001\u77ed\u671f\u4f7f\u7528\u30ab\u30c6\u30fc\u30c6\u30eb<\/td><td>+30\u201350%<\/td><\/tr><tr><td><a href=\"https:\/\/www.iso.org\/standard\/68936.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 10993\u30b7\u30ea\u30fc\u30ba<\/a><\/td><td>\u5305\u62ec\u7684\u306a\u81e8\u5e8a\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\uff08\u7d30\u80de\u6bd2\u6027\u3001\u611f\u4f5c\u6027\u3001\u523a\u6fc0\u6027\u3001\u5168\u8eab\u6bd2\u6027\uff09<\/td><td>\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u9577\u671f\u63a5\u89e6\u578b\u30c7\u30d0\u30a4\u30b9<\/td><td>+50\u2013100%<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"450\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison.jpg\" alt=\"\u533b\u7642\u7528\u30b7\u30ea\u30b3\u30fc\u30f3\u306e\u9069\u5408\u6027\u30ec\u30d9\u30eb3\u6bb5\u968e\u306e\u6bd4\u8f03\" class=\"wp-image-16312\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison.jpg 800w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison-600x338.jpg 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u91cd\u8981\u306a\u5883\u754c: FDA 21 CFR 177.2600 \u306f\u98df\u54c1\u63a5\u89e6\u306b\u95a2\u3059\u308b\u898f\u5247\u3067\u3042\u308a\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u898f\u5247\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u300cFDA \u627f\u8a8d\u30b7\u30ea\u30b3\u30fc\u30f3\u300d\u3068\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u5316\u5408\u7269\u306f\u3001\u81ea\u52d5\u7684\u306b\u533b\u7642\u7528\u9014\u3068\u3057\u3066\u627f\u8a8d\u3055\u308c\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u5b8c\u6210\u54c1\u306e\u8a55\u4fa1\u306b\u3064\u3044\u3066\u306f\u3001\u4ee5\u4e0b\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/rysilicone.com\/ja\/biocompatibility-silicone\/\">ISO 10993\u306b\u304a\u3051\u308b\u30b7\u30ea\u30b3\u30fc\u30f3\u306e\u751f\u4f53\u9069\u5408\u6027\u306e\u8a55\u4fa1\u65b9\u6cd5<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u5b9f\u969b\u306b\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u304c\u5fc5\u8981\u306a\u5834\u5408<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u8abf\u9054\u5be9\u67fb\u306b\u304a\u3044\u3066\u306f\u3001\u88fd\u54c1\u30ab\u30c6\u30b4\u30ea\u30fc\u540d\u3067\u306f\u306a\u304f\u3001\u9023\u7d61\u306e\u7a2e\u985e\u3068\u9023\u7d61\u671f\u9593\u306b\u57fa\u3065\u3044\u3066\u5224\u65ad\u304c\u4e0b\u3055\u308c\u308b\u3002.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u76ae\u819a\u3084\u53e3\u3068\u306e\u63a5\u89e6\u306f\u907f\u3051\u3066\u304f\u3060\u3055\u3044\u3002<\/strong> \uff08\u5de5\u696d\u7528\u30b7\u30fc\u30eb\u3001\u5916\u90e8\u30cf\u30a6\u30b8\u30f3\u30b0\u3001\u69cb\u9020\u90e8\u54c1\uff09\uff1a\u6a19\u6e96\u7684\u306aHTV\u30b7\u30ea\u30b3\u30fc\u30f3\u3067\u5341\u5206\u3067\u3059\u3002\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306f\u30aa\u30fc\u30d0\u30fc\u30b9\u30da\u30c3\u30af\u3067\u3059\u3002.<\/li>\n\n\n\n<li><strong>\u7e70\u308a\u8fd4\u3057\u53e3\u3084\u76ae\u819a\u306b\u63a5\u89e6\u3059\u308b<\/strong> \uff08\u3088\u3060\u308c\u304b\u3051\u3001\u30de\u30c3\u30c8\u3001\u53f0\u6240\u7528\u54c1\u3001\u304a\u3057\u3083\u3076\u308a\uff09\uff1aFDA 21 CFR 177.2600 \u30d7\u30e9\u30b9 <a href=\"https:\/\/www.bfr.bund.de\/en\/product-safety\/health-assessment-of-food-contact-materials\/\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">LFGB<\/a> \uff08EU\u5e02\u5834\uff09\u304c\u4f5c\u696d\u57fa\u6e96\u3068\u306a\u308a\u307e\u3059\u3002USP\u30af\u30e9\u30b9VI\u306f\u30b3\u30b9\u30c8\u5897\u306b\u3064\u306a\u304c\u308a\u3001\u76e3\u67fb\u4e0a\u306e\u30e1\u30ea\u30c3\u30c8\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/li>\n\n\n\n<li><strong>\u77ed\u671f\u7684\u306a\u533b\u7642\u6a5f\u5668\u3068\u306e\u63a5\u89e6<\/strong> \uff0830\u65e5\u4ee5\u5185\u3001\u76ae\u819a\u307e\u305f\u306f\u7c98\u819c\u304c\u640d\u50b7\u3057\u3066\u3044\u306a\u3044\u72b6\u614b\u3001\u4f8b\uff1a. <a href=\"https:\/\/rysilicone.com\/ja\/silicone-tubing-manufacturer\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u8f38\u6db2\u30c1\u30e5\u30fc\u30d6<\/a>, \uff08\u547c\u5438\u7528\u30de\u30b9\u30af\uff09\uff1aUSP\u30af\u30e9\u30b9VI\u304c\u6700\u4f4e\u9650\u306e\u57fa\u6e96\u3067\u3059\u3002.<\/li>\n\n\n\n<li><strong>\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u307e\u305f\u306f <a href=\"https:\/\/rysilicone.com\/ja\/silicone-strips-used-in-the-medical-and-pharmaceutical-fields\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u9577\u671f\u306b\u308f\u305f\u308b\u7d44\u7e54\u63a5\u89e6<\/a><\/strong> \uff0830\u65e5\u4ee5\u4e0a\uff09\uff1aISO 10993\u304c\u5fc5\u9808\u3067\u3059\u3002; <a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions-selecting-and-preparing-correct-submission\/premarket-notification-510k\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">FDA 510(k)<\/a> \u30c7\u30d0\u30a4\u30b9\u306e\u627f\u8a8d\u306f\u3001\u6750\u6599\u30ec\u30d9\u30eb\u3067\u306f\u306a\u304f\u3001\u30c7\u30d0\u30a4\u30b9\u30ec\u30d9\u30eb\u3067\u884c\u308f\u308c\u308b\u5225\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u88fd\u54c1\u304c\u533b\u7642\u6a5f\u5668\u306e\u5883\u754c\u3092\u4e0b\u56de\u308b\u5834\u5408\u3001USP\u30af\u30e9\u30b9VI\u306e\u539f\u6750\u6599\u306b\u8cbb\u7528\u3092\u304b\u3051\u308b\u3053\u3068\u306f\u8ca9\u58f2\u3092\u6539\u5584\u3059\u308b\u3053\u3068\u306f\u307b\u3068\u3093\u3069\u306a\u304f\u3001\u6750\u6599\u8cbb\u304c30\uff5e50%\u5897\u52a0\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u5de5\u5834\u5074\u3067\u3069\u306e\u3088\u3046\u306a\u5909\u5316\u304c\u8d77\u3053\u308b\u306e\u304b<\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"800\" height=\"450\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production.jpg\" alt=\"ISO\u30af\u30e9\u30b98\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3067\u306e\u6db2\u4f53\u30b7\u30ea\u30b3\u30fc\u30f3\u5c04\u51fa\u6210\u5f62\" class=\"wp-image-16311\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production.jpg 800w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production-600x338.jpg 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u304c\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306b\u78ba\u5b9a\u3059\u308b\u3068\u3001\u898b\u7a4d\u3082\u308a\u6bb5\u968e\u30673\u3064\u306e\u3053\u3068\u304c\u5909\u308f\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u6750\u6599<\/strong>: \u904e\u9178\u5316\u7269\u786c\u5316HTV\u304b\u3089\u30d7\u30e9\u30c1\u30ca\u786c\u5316HTV\u306b\u5207\u308a\u66ff\u3048\u308b\u304b\u3001 <a href=\"https:\/\/rysilicone.com\/ja\/liquid-silicone-rubber\/\" target=\"_blank\" rel=\"noreferrer noopener\">LS-R \u306e<\/a>. \u539f\u6750\u6599\u4fa1\u683c\u306f\u7d0425\uff5e40%\u4e0a\u6607\u3059\u308b\u3002.<\/li>\n\n\n\n<li><strong>\u5de5\u5177\u3068\u30e9\u30a4\u30f3<\/strong>\u88fd\u9020\u306f\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\uff08ISO 14644-1 \u30af\u30e9\u30b98\u4ee5\u4e0a\uff09\u3067\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4ea4\u5dee\u6c5a\u67d3\u306e\u30ea\u30b9\u30af\u304c\u3042\u308b\u305f\u3081\u3001\u904e\u9178\u5316\u7269\u786c\u5316\u7528\u6cbb\u5177\u306e\u5171\u6709\u306f\u8a8d\u3081\u3089\u308c\u307e\u305b\u3093\u3002.<\/li>\n\n\n\n<li><strong>\u30ea\u30fc\u30c9\u30bf\u30a4\u30e0<\/strong>\u6750\u6599\u306e\u5206\u6790\u8a3c\u660e\u66f8\u3001\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u5831\u544a\u66f8\u3001\u30ed\u30c3\u30c8\u8ffd\u8de1\u60c5\u5831\u306f\u901a\u5e38\u3001\u6700\u521d\u306e\u88fd\u54c1\u304c\u627f\u8a8d\u3055\u308c\u308b\u307e\u3067\u306b1\uff5e2\u9031\u9593\u304b\u304b\u308a\u307e\u3059\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u3089\u306f\u6a19\u6e96\u898f\u683c\u306b\u3088\u308b\u76f4\u63a5\u7684\u306a\u7d50\u679c\u3067\u3042\u308a\u3001\u4efb\u610f\u3067\u8a2d\u5b9a\u3067\u304d\u308b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u8ffd\u52a0\u6599\u91d1\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u5f15\u7528\u3059\u308b\u524d\u306b\u907f\u3051\u308b\u3079\u304d\u3088\u304f\u3042\u308b\u8aa4\u89e3<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u201c\u300c\u201c<a href=\"https:\/\/rysilicone.com\/ja\/food-grade-silicone\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u98df\u54c1\u30b0\u30ec\u30fc\u30c9<\/a>\u201d \u2260 \u533b\u7642\u7528\u30b0\u30ec\u30fc\u30c9\u3002FDA 21 CFR 177.2600 \u306f\u533b\u7642\u7528\u9014\u306b\u304a\u3051\u308b\u751f\u4f53\u9069\u5408\u6027\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u305b\u3093\u3002.<\/li>\n\n\n\n<li>\u201c\u300c\u30d7\u30e9\u30c1\u30ca\u786c\u5316\u300d\u3060\u3051\u3067\u306f\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u3068\u306f\u8a00\u3048\u307e\u305b\u3093\u3002\u5316\u5408\u7269\u306f\u3001\u8a72\u5f53\u3059\u308bUSP\u307e\u305f\u306fISO 10993\u306e\u8a66\u9a13\u30bb\u30c3\u30c8\u306b\u3082\u5408\u683c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/li>\n\n\n\n<li>\u201c\u300cLSR\u300d\u2260\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u3002LSR\u3068\u306f\u30d7\u30ed\u30bb\u30b9\uff08\u6db2\u72b6\u30b7\u30ea\u30b3\u30fc\u30f3\u5c04\u51fa\u6210\u5f62\uff09\u3092\u6307\u3057\u3001\u305d\u306e\u88fd\u9020\u30e9\u30a4\u30f3\u306f\u3001\u4f7f\u7528\u3059\u308b\u5316\u5408\u7269\u3084\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306e\u30af\u30e9\u30b9\u306b\u3088\u3063\u3066\u3001\u5de5\u696d\u7528\u306b\u3082\u533b\u7642\u7528\u306b\u3082\u306a\u308a\u5f97\u308b\u3002.<\/li>\n\n\n\n<li>\u6750\u6599CoA\u306f\u751f\u306e\u30b7\u30ea\u30b3\u30fc\u30f3\u306e\u307f\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u6700\u7d42\u30c7\u30d0\u30a4\u30b9\u8a8d\u8a3c\uff08FDA 510(k)\u3001, <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\/eng\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">CE MDR<\/a>) \u306f\u8cfc\u5165\u8005\u306e\u8cac\u4efb\u3067\u3042\u308a\u3001\u30b7\u30ea\u30b3\u30fc\u30f3\u4f9b\u7d66\u696d\u8005\u306e\u8cac\u4efb\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u5f53\u793e\u304c\u88fd\u9020\u3059\u308b\u4ee3\u8868\u7684\u306a\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u88fd\u54c1<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5f53\u793e\u304c\u898b\u7a4d\u308a\u3092\u884c\u3046\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u88fd\u54c1\u306e\u307b\u3068\u3093\u3069\u3092\u30013\u3064\u306e\u88fd\u54c1\u30e9\u30a4\u30f3\u3067\u30ab\u30d0\u30fc\u3057\u3066\u3044\u307e\u3059\u3002\u305d\u308c\u305e\u308c\u306e\u88fd\u54c1\u30e9\u30a4\u30f3\u306f\u7570\u306a\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ec\u30d9\u30eb\u306b\u5206\u985e\u3055\u308c\u3001\u305d\u308c\u306b\u3088\u3063\u3066\u5fc5\u8981\u306a\u8a66\u9a13\u5831\u544a\u66f8\u3001\u4f7f\u7528\u3059\u308b\u30e9\u30a4\u30f3\u3001\u304a\u3088\u3073\u5358\u4fa1\u304c\u6c7a\u307e\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"800\" height=\"450\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview.jpg\" alt=\"\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u30b7\u30ea\u30b3\u30fc\u30f3\u88fd\u54c1\u30b7\u30ea\u30fc\u30ba\u306e\u6982\u8981\" class=\"wp-image-16310\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview.jpg 800w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview-600x338.jpg 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ec\u30d9\u30eb<\/strong><\/th><th><strong>\u4ee3\u8868\u7684\u306a\u88fd\u54c1\u30e9\u30a4\u30f3<\/strong><\/th><th><strong>\u3053\u306e\u30c6\u30a3\u30a2\u304c\u9069\u7528\u3055\u308c\u308b\u7406\u7531<\/strong><\/th><\/tr><\/thead><tbody><tr><td>FDA 21 CFR 177.2600<\/td><td><a href=\"https:\/\/rysilicone.com\/ja\/silicone-baby-pacifier\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u30b7\u30ea\u30b3\u30f3\u88fd\u306e\u304a\u3057\u3083\u3076\u308a<\/a> \u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u98df\u54c1\u63a5\u89e6\u90e8\u54c1<\/td><td>\u7e70\u308a\u8fd4\u3057\u53e3\u306b\u63a5\u89e6\u3059\u308b\u304c\u3001\u767b\u9332\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u3067\u306f\u306a\u3044 \u2015 \u98df\u54c1\u30b0\u30ec\u30fc\u30c9\u306e\u9069\u5408\u6027\u304c\u4f5c\u696d\u57fa\u6e96\u3068\u306a\u308b<\/td><\/tr><tr><td>USP\u30af\u30e9\u30b9VI\uff0830\u65e5\u4ee5\u5185\uff09<\/td><td><a href=\"https:\/\/rysilicone.com\/ja\/silicone-hoses-manufacturer\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u30b7\u30ea\u30b3\u30f3\u30db\u30fc\u30b9<\/a> \u81e8\u5e8a\u6a5f\u5668\u7528\u306e\u30c1\u30e5\u30fc\u30d6<\/td><td>\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u8868\u9762\u63a5\u89e6\u307e\u305f\u306f\u77ed\u6642\u9593\u306e\u6d41\u4f53\u7d4c\u8def\u63a5\u89e6\uff1bUSP &lt;87&gt; \/ &lt;88&gt; \u7d30\u80de\u6bd2\u6027\u5831\u544a\u66f8\u304c\u5fc5\u8981<\/td><\/tr><tr><td>ISO 10993\uff08\u9577\u671f\uff0f\u7c98\u819c\uff09<\/td><td><a href=\"https:\/\/rysilicone.com\/ja\/silicone-menstrual-cup\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306e\u30b7\u30ea\u30b3\u30f3\u88fd\u6708\u7d4c\u30ab\u30c3\u30d7<\/a><\/td><td>\u81a3\u5185\u63a5\u89e6\u306e\u7d2f\u7a4d\u671f\u9593\u304c30\u65e5\u3092\u8d85\u3048\u305f\u5834\u5408\u3001ISO 10993-5\u304a\u3088\u3073-10\u306e\u5b8c\u5168\u306a\u8a66\u9a13\u304c\u5fc5\u8981\u3068\u306a\u308b\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u306f\u5b8c\u5168\u306a\u30ab\u30bf\u30ed\u30b0\u3067\u306f\u306a\u304f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ec\u30d9\u30eb\u304c\u898b\u7a4d\u3082\u308a\u306b\u6700\u3082\u76f4\u63a5\u7684\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u90e8\u5206\u306e\u307f\u3092\u307e\u3068\u3081\u305f\u3082\u306e\u3067\u3059\u3002\u305d\u306e\u4ed6\u306e\u30ab\u30c6\u30b4\u30ea\u306b\u3064\u3044\u3066\u3082\u540c\u69d8\u3067\u3001\u88fd\u54c1\u540d\u3067\u306f\u306a\u304f\u3001\u5951\u7d04\u306e\u7a2e\u985e\u3068\u671f\u9593\u306b\u3088\u3063\u3066\u6a19\u6e96\u304c\u6c7a\u5b9a\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n\n\n<div id=\"rank-math-faq\" class=\"rank-math-block\">\n<div class=\"rank-math-list\">\n<div id=\"faq-question-1779947514422\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\"><strong>FDA\u627f\u8a8d\u306e\u30b7\u30ea\u30b3\u30fc\u30f3\u306f\u3001\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306e\u30b7\u30ea\u30b3\u30fc\u30f3\u3068\u540c\u3058\u3067\u3059\u304b\uff1f<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u3044\u3044\u3048\u3002FDA 21 CFR 177.2600\u306f\u98df\u54c1\u63a5\u89e6\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u898f\u5b9a\u3067\u3059\u3002\u533b\u7642\u7528\u9014\u306b\u306fUSP\u30af\u30e9\u30b9VI\u307e\u305f\u306fISO 10993\u8a66\u9a13\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1779947524182\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\"><strong>\u533b\u7642\u7528\u30b7\u30ea\u30b3\u30fc\u30f3\u306f\u30d7\u30e9\u30c1\u30ca\u786c\u5316\u51e6\u7406\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u5b9f\u969b\u306b\u306f\u3001\u305d\u3046\u3067\u3059\u3002\u904e\u9178\u5316\u7269\u6b8b\u7559\u7269\u306fUSP\u30af\u30e9\u30b9VI\u306e\u7d30\u80de\u6bd2\u6027\u8a66\u9a13\u306b\u5408\u683c\u3057\u306a\u3044\u305f\u3081\u3001\u73fe\u5728\u88fd\u9020\u3055\u308c\u3066\u3044\u308b\u533b\u7642\u7528\u5316\u5408\u7269\u306f\u30d7\u30e9\u30c1\u30ca\u3067\u786c\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1779947533763\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\"><strong>\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306e\u30b7\u30ea\u30b3\u30fc\u30f3\u90e8\u54c1\u306e\u4e00\u822c\u7684\u306a\u6700\u5c0f\u6ce8\u6587\u6570\u91cf\uff08MOQ\uff09\u306f\u3069\u308c\u304f\u3089\u3044\u3067\u3059\u304b\uff1f<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u307b\u3068\u3093\u3069\u306e\u5de5\u5834\u3067\u306f\u3001\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306eLSR\uff08\u6db2\u72b6\u30b7\u30ea\u30b3\u30fc\u30f3\u30b4\u30e0\uff09\u306e\u898b\u7a4d\u3082\u308a\u30925,000\uff5e10,000\u500b\u5358\u4f4d\u3067\u884c\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u5c11\u91cf\u751f\u7523\u306e\u5834\u5408\u3001\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306e\u751f\u7523\u30e9\u30a4\u30f3\u3092\u8a2d\u7f6e\u3059\u308b\u3053\u3068\u304c\u7d4c\u6e08\u7684\u3067\u306f\u306a\u3044\u305f\u3081\u3067\u3059\u3002.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1779947545615\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\"><strong>\u5f8c\u304b\u3089\u30b3\u30b9\u30c8\u524a\u6e1b\u306e\u305f\u3081\u306b\u3001\u533b\u7642\u7528\u30b0\u30ec\u30fc\u30c9\u304b\u3089\u98df\u54c1\u7528\u30b0\u30ec\u30fc\u30c9\u306b\u30b0\u30ec\u30fc\u30c9\u3092\u4e0b\u3052\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u3059\u304b\uff1f<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u88fd\u54c1\u306b\u533b\u7642\u4e0a\u306e\u52b9\u80fd\u8868\u793a\u304c\u4e00\u5207\u542b\u307e\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u306b\u9650\u308a\u307e\u3059\u3002FDA 510(k)\u307e\u305f\u306fCE MDR\u306b\u57fa\u3065\u3044\u3066\u6a5f\u5668\u304c\u767b\u9332\u3055\u308c\u308b\u3068\u3001\u6750\u6599\u306e\u5909\u66f4\u306b\u306f\u518d\u691c\u8a3c\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">RFQ\u3092\u9001\u4fe1\u3059\u308b\u524d\u306b<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306e\u898b\u7a4d\u3082\u308a\u3092\u53d6\u5f97\u3059\u308b\u306b\u306f\u3001\u4ee5\u4e0b\u306e3\u3064\u306e\u9805\u76ee\u3092\u4e8b\u524d\u306b\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u63a5\u89e6\u306e\u7a2e\u985e\u3068\u63a5\u89e6\u671f\u9593\uff08\u76ae\u819a\uff0f\u7c98\u819c\uff0f\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\uff1b30\u65e5\u4ee5\u5185\u307e\u305f\u306f30\u65e5\u8d85\uff09\u3002.<\/li>\n\n\n\n<li>\u5bfe\u8c61\u5e02\u5834\u304a\u3088\u3073\u5fc5\u8981\u306a\u8a8d\u8a3c\uff08FDA 21 CFR 177.2600\u3001USP\u30af\u30e9\u30b9VI\u3001ISO 10993-5 \/ -10\uff09\u3002.<\/li>\n\n\n\n<li>\u8cfc\u5165\u8005\u304c\u6a5f\u5668\u767b\u9332\uff08510(k) \/ CE MDR\uff09\u3092\u4fdd\u6709\u3057\u3066\u3044\u308b\u304b\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u30b5\u30dd\u30fc\u30c8\u3092\u671f\u5f85\u3057\u3066\u3044\u308b\u304b\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u30893\u3064\u306e\u60c5\u5831\u304c\u306a\u3051\u308c\u3070\u3001\u53d7\u3051\u53d6\u3063\u305f\u300c\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u300d\u306e\u898b\u7a4d\u3082\u308a\u306f\u5358\u306a\u308b\u4eee\u306e\u91d1\u984d\u3067\u3042\u308a\u3001\u5b9f\u969b\u306e\u4fa1\u683c\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>&#8220;Medical grade silicone&#8221; is one of the most misused labels in B2B procurement. The same wording appears on baby pacifiers, infusion tubing, and long-term implants \u2014 but each one is held to a different standard. Most generic articles skip that distinction. Medical-grade silicone is platinum-cured silicone that has passed at least one recognized biocompatibility standard \u2014 typically FDA 21 CFR 177.2600 (contact), USP Class VI (short-term medical use), or ISO 10993 (clinical device classification). The applicable standard depends on contact type and contact duration, not on the silicone itself. If your job is to decide whether a product even needs medical-grade material before sending an RFQ, the sections below give [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":16313,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1045],"tags":[],"class_list":["post-10267","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-silicone-materials"],"_links":{"self":[{"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/posts\/10267","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/comments?post=10267"}],"version-history":[{"count":7,"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/posts\/10267\/revisions"}],"predecessor-version":[{"id":20802,"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/posts\/10267\/revisions\/20802"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/media\/16313"}],"wp:attachment":[{"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/media?parent=10267"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/categories?post=10267"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/tags?post=10267"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}