{"id":2336,"date":"2026-07-04T17:08:13","date_gmt":"2026-07-04T17:08:13","guid":{"rendered":"https:\/\/www.fhysilicone.com\/?p=2336"},"modified":"2026-07-04T17:12:36","modified_gmt":"2026-07-04T17:12:36","slug":"medical-grade-silicone-components","status":"publish","type":"post","link":"https:\/\/www.fhysilicone.com\/ja\/medical-grade-silicone-components\/","title":{"rendered":"\u533b\u7642\u7528\u30b7\u30ea\u30b3\u30fc\u30f3\u90e8\u54c1\uff1a\u533b\u7642\u7528\u9014\u306b\u304a\u3051\u308b\u4e3b\u8981\u306a\u8981\u4ef6"},"content":{"rendered":"<h2 class=\"wp-block-heading\">1. \u306f\u3058\u3081\u306b<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u7528\u30b7\u30ea\u30b3\u30fc\u30f3\u90e8\u54c1\u306f\u3001\u305d\u306e\u512a\u308c\u305f\u751f\u4f53\u9069\u5408\u6027\u3001\u5316\u5b66\u7684\u5b89\u5b9a\u6027\u3001\u304a\u3088\u3073\u9577\u671f\u7684\u306a\u4fe1\u983c\u6027\u304b\u3089\u3001\u73fe\u4ee3\u306e\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u3067\u5e83\u304f\u4f7f\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u7528\u9014\u306b\u306f\u3001\u624b\u8853\u5668\u5177\u3001\u85ac\u5264\u9001\u9054\u30b7\u30b9\u30c6\u30e0\u3001\u30ab\u30c6\u30fc\u30c6\u30eb\u3001\u30b7\u30fc\u30eb\u90e8\u54c1\u3001\u547c\u5438\u5668\u3001\u304a\u3088\u3073\u57cb\u3081\u8fbc\u307f\u7528\u30b0\u30ec\u30fc\u30c9\u306e\u88dc\u52a9\u90e8\u54c1\u306a\u3069\u304c\u542b\u307e\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5de5\u696d\u7528\u30b7\u30ea\u30b3\u30fc\u30f3\u3068\u306f\u7570\u306a\u308a\u3001, <strong>\u533b\u7642\u7528\u30b7\u30ea\u30b3\u30fc\u30f3\u306f\u3001\u53b3\u3057\u3044\u898f\u5236\u3001\u6750\u6599\u3001\u304a\u3088\u3073\u88fd\u9020\u57fa\u6e96\u3092\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044<\/strong> \u60a3\u8005\u306e\u5b89\u5168\u3068\u533b\u7642\u6a5f\u5668\u306e\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-image aligncenter size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"819\" src=\"https:\/\/www.fhysilicone.com\/wp-content\/uploads\/2026\/07\/cf1b5f3e-6c47-4848-80a3-8bd2e4711ba0-1024x819.png\" alt=\"\" class=\"wp-image-2337\" srcset=\"https:\/\/www.fhysilicone.com\/wp-content\/uploads\/2026\/07\/cf1b5f3e-6c47-4848-80a3-8bd2e4711ba0-1024x819.png 1024w, https:\/\/www.fhysilicone.com\/wp-content\/uploads\/2026\/07\/cf1b5f3e-6c47-4848-80a3-8bd2e4711ba0-300x240.png 300w, https:\/\/www.fhysilicone.com\/wp-content\/uploads\/2026\/07\/cf1b5f3e-6c47-4848-80a3-8bd2e4711ba0-768x615.png 768w, https:\/\/www.fhysilicone.com\/wp-content\/uploads\/2026\/07\/cf1b5f3e-6c47-4848-80a3-8bd2e4711ba0-15x12.png 15w, https:\/\/www.fhysilicone.com\/wp-content\/uploads\/2026\/07\/cf1b5f3e-6c47-4848-80a3-8bd2e4711ba0-600x480.png 600w, https:\/\/www.fhysilicone.com\/wp-content\/uploads\/2026\/07\/cf1b5f3e-6c47-4848-80a3-8bd2e4711ba0.png 1402w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">2. \u533b\u7642\u7528\u30b7\u30ea\u30b3\u30fc\u30f3\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u7528\u30b7\u30ea\u30b3\u30fc\u30f3\u306f\u3001\u901a\u5e38\u3001\u4ee5\u4e0b\u306e\u6210\u5206\u3092\u4e3b\u6210\u5206\u3068\u3057\u3066\u3044\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30d7\u30e9\u30c1\u30ca\u786c\u5316\u578b\u6db2\u4f53\u30b7\u30ea\u30b3\u30fc\u30f3\u30b4\u30e0\uff08LSR\uff09<\/li>\n\n\n\n<li>\u9ad8\u7d14\u5ea6\u30a8\u30e9\u30b9\u30c8\u30de\u30fc\u30b7\u30b9\u30c6\u30e0<\/li>\n\n\n\n<li>\u62bd\u51fa\u7269\u304c\u5c11\u306a\u304f\u3001\u63ee\u767a\u6027\u306e\u4f4e\u3044\u88fd\u5264<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e3b\u306a\u7279\u5fb4\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u751f\u4f53\u9069\u5408\u6027<\/li>\n\n\n\n<li>\u7121\u6bd2\u3067\u3001\u5316\u5b66\u7684\u306b\u53cd\u5fdc\u3057\u306a\u3044<\/li>\n\n\n\n<li>\u6ec5\u83cc\u5de5\u7a0b\u4e0b\u3067\u3082\u5b89\u5b9a\u3057\u3066\u3044\u308b<\/li>\n\n\n\n<li>\u4f53\u6db2\u304a\u3088\u3073\u5316\u5b66\u7269\u8cea\u306b\u5bfe\u3059\u308b\u8010\u6027<\/li>\n\n\n\n<li>\u9577\u671f\u7684\u306a\u6a5f\u68b0\u7684\u5b89\u5b9a\u6027<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u306f\u3001\u53cc\u65b9\u3067\u5e83\u304f\u5229\u7528\u3055\u308c\u3066\u3044\u307e\u3059 <strong>\u77ed\u671f\u4f7f\u7528\u306e\u60a3\u8005\u7528\u63a5\u89e6\u30c7\u30d0\u30a4\u30b9\u304a\u3088\u3073\u9577\u671f\u4f7f\u7528\u306e\u533b\u7642\u7528\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. \u4e3b\u8981\u306a\u898f\u5236\u57fa\u6e96<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u7528\u30b7\u30ea\u30b3\u30fc\u30f3\u90e8\u54c1\u306f\u3001\u56fd\u969b\u7684\u306a\u533b\u7642\u95a2\u9023\u898f\u5236\u306b\u6e96\u62e0\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\uff1a<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3.1 ISO 10993\uff08\u751f\u4f53\u9069\u5408\u6027\uff09<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306e\u751f\u7269\u5b66\u7684\u8a55\u4fa1\u3092\u5b9a\u7fa9\u3057\u3001\u3053\u308c\u306b\u306f\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u7d30\u80de\u6bd2\u6027<\/li>\n\n\n\n<li>\u611f\u4f5c<\/li>\n\n\n\n<li>\u523a\u6fc0<\/li>\n\n\n\n<li>\u9577\u671f\u57cb\u8fbc\u306e\u5b89\u5168\u6027<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">3.2 USP\u30af\u30e9\u30b9VI<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u7528\u30dd\u30ea\u30de\u30fc\u306b\u304a\u3051\u308b\u6700\u9ad8\u6c34\u6e96\u306e\u4e00\u3064\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6025\u6027\u5168\u8eab\u6bd2\u6027\u8a66\u9a13<\/li>\n\n\n\n<li>\u76ae\u5185\u53cd\u5fdc\u6027<\/li>\n\n\n\n<li>\u7740\u5e8a\u8a55\u4fa1<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">3.3 FDA\u306e\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u7528\u9014\u306b\u4f7f\u7528\u3055\u308c\u308b\u30b7\u30ea\u30b3\u30fc\u30f3\u6750\u6599\u306f\u3001\u4ee5\u4e0b\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA 21 CFR 177.2600\uff08\u98df\u54c1\u304a\u3088\u3073\u533b\u7642\u7528\u63a5\u89e6\u30a8\u30e9\u30b9\u30c8\u30de\u30fc\uff09<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">3.4 EU MDR\uff08\u533b\u7642\u6a5f\u5668\u898f\u5247\uff09<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u4ee5\u4e0b\u3092\u4fdd\u8a3c\u3057\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6750\u6599\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/li>\n\n\n\n<li>\u30ea\u30b9\u30af\u7ba1\u7406<\/li>\n\n\n\n<li>\u81e8\u5e8a\u7684\u5b89\u5168\u6027\u306e\u691c\u8a3c<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">4. \u91cd\u8981\u8cc7\u6750\u306e\u8981\u4ef6<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">4.1 \u8d85\u9ad8\u7d14\u5ea6\u30b7\u30ea\u30b3\u30fc\u30f3<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u7528\u9014\u3067\u306f\u3001\u4ee5\u4e0b\u306e\u8981\u4ef6\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6b8b\u7559\u89e6\u5a92\u304c\u6975\u3081\u3066\u5c11\u306a\u3044<\/li>\n\n\n\n<li>\u63ee\u767a\u6027\u6709\u6a5f\u5316\u5408\u7269\uff08VOC\uff09\u306e\u542b\u6709\u91cf\u304c\u6700\u5c0f\u9650<\/li>\n\n\n\n<li>\u5206\u5b50\u91cf\u5206\u5e03\u306e\u5236\u5fa1<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4.2 \u30d7\u30e9\u30c1\u30ca\u786c\u5316\u30b7\u30b9\u30c6\u30e0<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u904e\u9178\u5316\u7269\u786c\u5316\u6cd5\u3068\u6bd4\u8f03\u3059\u308b\u3068\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u904e\u9178\u5316\u7269\u306e\u6b8b\u7559\u7269\u306a\u3057<\/li>\n\n\n\n<li>\u751f\u4f53\u9069\u5408\u6027\u306e\u5411\u4e0a<\/li>\n\n\n\n<li>\u5149\u5b66\u7d14\u5ea6\u304a\u3088\u3073\u5316\u5b66\u7d14\u5ea6\u304c\u9ad8\u3044<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4.3 \u62bd\u51fa\u7269\u304a\u3088\u3073\u6eb6\u51fa\u7269\u306e\u7ba1\u7406<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306f\u3001\u4ee5\u4e0b\u306e\u70b9\u3092\u78ba\u4fdd\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4eba\u4f53\u306e\u7d44\u7e54\u3084\u4f53\u6db2\u3078\u306e\u6709\u5bb3\u306a\u79fb\u884c\u306f\u306a\u3044<\/li>\n\n\n\n<li>\u6ec5\u83cc\u6761\u4ef6\u4e0b\u3067\u3082\u5b89\u5b9a\u3057\u305f\u6027\u80fd\u3092\u767a\u63ee\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">5. \u88fd\u9020\u8981\u4ef6<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">5.1 \u30af\u30ea\u30fc\u30f3\u306a\u751f\u7523\u74b0\u5883<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u7528\u30b7\u30ea\u30b3\u30fc\u30f3\u90e8\u54c1\u306b\u306f\u3001\u591a\u304f\u306e\u5834\u5408\u3001\u4ee5\u4e0b\u306e\u8981\u4ef6\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3067\u306e\u88fd\u9020\uff08ISO\u30af\u30e9\u30b97\uff5e8\u4ee5\u4e0a\uff09<\/li>\n\n\n\n<li>\u7121\u5875\u6210\u5f62\u74b0\u5883<\/li>\n\n\n\n<li>\u6e7f\u5ea6\u3068\u6e29\u5ea6\u306e\u7ba1\u7406<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">5.2 LSR\u5c04\u51fa\u6210\u5f62<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u6db2\u4f53\u30b7\u30ea\u30b3\u30fc\u30f3\u30b4\u30e0\uff08LSR\uff09\u304c\u597d\u307e\u308c\u308b\u7406\u7531\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u9ad8\u7cbe\u5ea6\u6210\u5f62<\/li>\n\n\n\n<li>\u91cf\u7523\u306b\u304a\u3051\u308b\u518d\u73fe\u6027<\/li>\n\n\n\n<li>\u77ed\u3044\u786c\u5316\u30b5\u30a4\u30af\u30eb<\/li>\n\n\n\n<li>\u512a\u308c\u305f\u5bc6\u9589\u6027\u80fd<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">5.3 \u5f8c\u786c\u5316\u5de5\u7a0b<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5f8c\u786c\u5316\u306b\u3088\u308a\u3001\u4ee5\u4e0b\u306e\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u63ee\u767a\u6027\u5316\u5408\u7269\u306e\u9664\u53bb<\/li>\n\n\n\n<li>\u81ed\u3044\u306e\u4e2d\u548c\u6027\u80fd\u304c\u5411\u4e0a<\/li>\n\n\n\n<li>\u9577\u671f\u5b89\u5b9a\u6027\u306e\u5411\u4e0a<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">5.4 \u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30b7\u30b9\u30c6\u30e0<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5404\u30d0\u30c3\u30c1\u306f\u8ffd\u8de1\u53ef\u80fd\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u539f\u6750\u6599\u306e\u30ed\u30c3\u30c8\u756a\u53f7<\/li>\n\n\n\n<li>\u751f\u7523\u30d1\u30e9\u30e1\u30fc\u30bf<\/li>\n\n\n\n<li>\u54c1\u8cea\u7ba1\u7406\u8a18\u9332<\/li>\n\n\n\n<li>\u6ec5\u83cc\u9069\u5408\u6027\u30c7\u30fc\u30bf<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">6. \u4ee3\u8868\u7684\u306a\u533b\u7642\u7528\u9014<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u7528\u30b7\u30ea\u30b3\u30fc\u30f3\u90e8\u54c1\u306f\u3001\u4ee5\u4e0b\u306e\u7528\u9014\u306b\u4f7f\u7528\u3055\u308c\u3066\u3044\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30ab\u30c6\u30fc\u30c6\u30eb\u7528\u30b7\u30fc\u30eb\u304a\u3088\u3073\u30d0\u30eb\u30d6<\/li>\n\n\n\n<li>\u547c\u5438\u7528\u30de\u30b9\u30af\u304a\u3088\u3073\u30b3\u30cd\u30af\u30bf\u30fc<\/li>\n\n\n\n<li>\u85ac\u7269\u9001\u9054\u30b7\u30b9\u30c6\u30e0<\/li>\n\n\n\n<li>\u30dd\u30f3\u30d7\u7528\u30c0\u30a4\u30e4\u30d5\u30e9\u30e0<\/li>\n\n\n\n<li>\u624b\u8853\u5668\u5177\u7528\u30b7\u30fc\u30eb<\/li>\n\n\n\n<li>\u533b\u7642\u7528\u30c1\u30e5\u30fc\u30d6\u306e\u30b3\u30cd\u30af\u30bf<\/li>\n\n\n\n<li>\u57cb\u3081\u8fbc\u307f\u578b\u88dc\u52a9\u90e8\u54c1<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">7. \u5de5\u5b66\u5206\u91ce\u306b\u304a\u3051\u308b\u4e00\u822c\u7684\u306a\u8ab2\u984c<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">7.1 \u5bf8\u6cd5\u5b89\u5b9a\u6027<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u7528\u90e8\u54c1\u306b\u306f\u3001\u6975\u3081\u3066\u53b3\u3057\u3044\u516c\u5dee\uff08\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u00b10.02\uff5e0.05 mm\uff09\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">7.2 \u6ec5\u83cc\u8010\u6027<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u90e8\u54c1\u306f\u3001\u4ee5\u4e0b\u306e\u6761\u4ef6\u306b\u8010\u3048\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30aa\u30fc\u30c8\u30af\u30ec\u30fc\u30d6\uff08\u84b8\u6c17\u6ec5\u83cc\uff09<\/li>\n\n\n\n<li>\u30ac\u30f3\u30de\u7dda<\/li>\n\n\n\n<li>\u30a8\u30c1\u30ec\u30f3\u30aa\u30ad\u30b7\u30c9\uff08EtO\uff09<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">7.3 \u6750\u6599\u306e\u7d4c\u5e74\u52a3\u5316<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u4ee5\u4e0b\u306e\u3082\u306e\u3078\u306e\u9577\u671f\u7684\u306a\u66dd\u9732\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6e29\u5ea6\u30b5\u30a4\u30af\u30eb<\/li>\n\n\n\n<li>\u5316\u5b66\u6d88\u6bd2\u5264<\/li>\n\n\n\n<li>\u6a5f\u68b0\u7684\u5fdc\u529b<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3092\u4f4e\u4e0b\u3055\u305b\u3066\u306f\u306a\u3089\u306a\u3044\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">8. \u533b\u7642\u7528\u30b7\u30ea\u30b3\u30fc\u30f3\u306e\u4eca\u5f8c\u306e\u52d5\u5411<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u7528\u30b7\u30ea\u30b3\u30fc\u30f3\u696d\u754c\u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u65b9\u5411\u3078\u3068\u9032\u3093\u3067\u3044\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>LSR\u5fae\u7d30\u7cbe\u5bc6\u6210\u5f62<\/li>\n\n\n\n<li>\u591a\u6750\u6599\u30aa\u30fc\u30d0\u30fc\u30e2\u30fc\u30eb\u30c9\uff08\u30b7\u30ea\u30b3\u30fc\u30f3\uff0b\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\uff0b\u91d1\u5c5e\uff09<\/li>\n\n\n\n<li>\u30b9\u30de\u30fc\u30c8\u533b\u7642\u6a5f\u5668\u306e\u7d71\u5408<\/li>\n\n\n\n<li>\u898f\u5236\u306e\u900f\u660e\u6027\u306e\u5411\u4e0a<\/li>\n\n\n\n<li>\u4f4e\u4fb5\u8972\u533b\u7642\u6a5f\u5668\u306e\u69cb\u6210\u90e8\u54c1<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">9. \u7d50\u8ad6<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u7528\u30b7\u30ea\u30b3\u30fc\u30f3\u90e8\u54c1\u306f\u3001\u73fe\u4ee3\u306e\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u306b\u304a\u3044\u3066\u6975\u3081\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u958b\u767a\u3092\u6210\u529f\u3055\u305b\u308b\u306b\u306f\u3001\u5148\u9032\u7684\u306a\u6750\u6599\u3060\u3051\u3067\u306a\u304f\u3001\u4ee5\u4e0b\u306e\u8981\u4ef6\u3092\u53b3\u683c\u306b\u9075\u5b88\u3059\u308b\u3053\u3068\u3082\u5fc5\u8981\u3067\u3059\u3002 <strong>ISO\u3001USP\u3001FDA\u3001\u304a\u3088\u3073EU MDR\u306e\u898f\u683c<\/strong>, \u3001\u304a\u3088\u3073\u7cbe\u5bc6\u306a\u88fd\u9020\u7ba1\u7406\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">LSR\u306b\u95a2\u3059\u308b\u512a\u308c\u305f\u6280\u8853\u529b\u3068\u30af\u30ea\u30fc\u30f3\u306a\u751f\u7523\u4f53\u5236\u3092\u5099\u3048\u305f\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u4e16\u754c\u306e\u533b\u7642\u6a5f\u5668\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u304a\u3044\u3066\u5927\u304d\u306a\u512a\u4f4d\u6027\u3092\u6301\u3064\u3053\u3068\u306b\u306a\u308b\u3067\u3057\u3087\u3046\u3002.<\/p>","protected":false},"excerpt":{"rendered":"<p>1. Introduction Medical grade silicone components are widely used in modern healthcare systems due to their excellent biocompatibility, chemical stability, and long-term reliability. Applications include surgical instruments, drug delivery systems, catheters, sealing components, respiratory devices, and implantable-grade auxiliary parts. Unlike industrial silicone, medical-grade silicone must meet strict regulatory, material, and manufacturing standards to ensure patient [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2337,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"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":"","ast-disable-related-posts":"","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":"","background-image":"","background-repeat":"repeat","background-position":"center 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