{"id":2734,"date":"2025-11-03T04:02:10","date_gmt":"2025-11-03T04:02:10","guid":{"rendered":"https:\/\/uhmwpemanufacture.com\/?p=2734"},"modified":"2025-11-03T04:02:11","modified_gmt":"2025-11-03T04:02:11","slug":"food-contact-compliance-for-uhmwpe-hdpe-sheets-a-quick-checklist","status":"publish","type":"post","link":"https:\/\/uhmwpemanufacture.com\/ja\/food-contact-compliance-for-uhmwpe-hdpe-sheets-a-quick-checklist\/","title":{"rendered":"UHMWPE\/HDPE\u30b7\u30fc\u30c8\u306e\u98df\u54c1\u63a5\u89e6\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\uff1a\u7c21\u5358\u306a\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8"},"content":{"rendered":"<p>UHMWPE\u307e\u305f\u306fHDPE\u30b7\u30fc\u30c8\u304c\u98df\u54c1\u306b\u89e6\u308c\u308b\u5834\u5408\u3001\u305d\u306e\u30cf\u30fc\u30c9\u30eb\u306f\u9ad8\u304f\u3001\u5f53\u7136\u305d\u3046\u306a\u308a\u307e\u3059\u3002\u3053\u306e\u30af\u30a4\u30c3\u30af\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u30d5\u30ec\u30f3\u30c9\u30ea\u30fc\u306a\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306f\u3001\u8907\u96d1\u306a\u898f\u5236\u3092\u4eca\u65e5\u304b\u3089\u884c\u52d5\u3067\u304d\u308b\u5b9f\u7528\u7684\u306a\u30b9\u30c6\u30c3\u30d7\u306b\u5909\u3048\u307e\u3059\u3002.<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u76ee\u6b21<\/h2><nav><ul><li><a href=\"#fda-21-cfr-177-1520-compliance-checklist\">FDA 21 CFR 177.1520\u6e96\u62e0\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/a><ul><li><a href=\"#confirm-polymer-category-and-intended-use\">\u30dd\u30ea\u30de\u30fc\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u3068\u4f7f\u7528\u76ee\u7684\u3092\u78ba\u8a8d\u3059\u308b<\/a><\/li><li><a href=\"#verify-additive-clearances-in-21-cfr-part-178\">21 CFR Part 178\u306e\u6dfb\u52a0\u7269\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u3092\u78ba\u8a8d\u3059\u308b\u3002<\/a><\/li><li><a href=\"#align-with-the-food-contact-notification-framework\">\u98df\u54c1\u63a5\u89e6\u901a\u77e5\u306e\u67a0\u7d44\u307f\u3068\u306e\u6574\u5408<\/a><\/li><\/ul><\/li><li><a href=\"#eu-10-2011-plastics-regulation-essentials\">EU 10\/2011\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u898f\u5236\u306e\u8981\u70b9<\/a><ul><li><a href=\"#check-the-union-list-and-specific-migration-limits\">\u30e6\u30cb\u30aa\u30f3\u30ea\u30b9\u30c8\u3068\u7279\u5b9a\u306e\u79fb\u4f4f\u5236\u9650\u3092\u30c1\u30a7\u30c3\u30af\u3059\u308b<\/a><\/li><li><a href=\"#meet-the-overall-migration-limit\">\u5168\u4f53\u7684\u306a\u79fb\u884c\u5236\u9650\u3092\u6e80\u305f\u3059<\/a><\/li><li><a href=\"#define-conditions-of-use-and-test-design\">\u4f7f\u7528\u6761\u4ef6\u3068\u8a66\u9a13\u8a2d\u8a08\u306e\u5b9a\u7fa9<\/a><\/li><\/ul><\/li><li><a href=\"#material-and-formulation-controls\">\u6750\u6599\u3068\u914d\u5408\u306e\u7ba1\u7406<\/a><ul><li><a href=\"#choose-food-contact-appropriate-resin\">\u98df\u54c1\u63a5\u89e6\u306b\u9069\u3057\u305f\u6a39\u8102\u3092\u9078\u3076<\/a><\/li><li><a href=\"#lock-down-additives-pigments-and-colorants\">\u6dfb\u52a0\u7269\u3001\u9854\u6599\u3001\u7740\u8272\u6599\u306e\u30ed\u30c3\u30af\u30c0\u30a6\u30f3<\/a><\/li><\/ul><\/li><li><a href=\"#manufacturing-and-hygiene-under-gmp\">GMP\u306e\u4e0b\u3067\u306e\u88fd\u9020\u3068\u885b\u751f<\/a><ul><li><a href=\"#implement-contamination-controls-and-sanitation\">\u6c5a\u67d3\u7ba1\u7406\u3068\u885b\u751f\u7ba1\u7406\u306e\u5b9f\u65bd<\/a><\/li><li><a href=\"#control-processing-parameters-that-affect-migration\">\u30de\u30a4\u30b0\u30ec\u30fc\u30b7\u30e7\u30f3\u306b\u5f71\u97ff\u3059\u308b\u51e6\u7406\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u5236\u5fa1<\/a><\/li><\/ul><\/li><li><a href=\"#testing-and-documentation-package\">\u30c6\u30b9\u30c8\u304a\u3088\u3073\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u30fb\u30d1\u30c3\u30b1\u30fc\u30b8<\/a><ul><li><a href=\"#perform-migration-testing-or-conservative-calculations\">\u79fb\u884c\u30c6\u30b9\u30c8\u307e\u305f\u306f\u4fdd\u5b88\u7684\u306a\u8a08\u7b97\u306e\u5b9f\u884c<\/a><\/li><li><a href=\"#issue-an-eu-declaration-of-compliance\">EU\u9069\u5408\u5ba3\u8a00\u66f8\u306e\u767a\u884c<\/a><\/li><li><a href=\"#maintain-traceability-from-resin-to-finished-sheet\">\u6a39\u8102\u304b\u3089\u5b8c\u6210\u30b7\u30fc\u30c8\u307e\u3067\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u7dad\u6301<\/a><\/li><\/ul><\/li><li><a href=\"#conditions-of-use-and-labeling\">\u4f7f\u7528\u6761\u4ef6\u304a\u3088\u3073\u8868\u793a<\/a><ul><li><a href=\"#define-allowable-temperatures-and-contact-duration\">\u8a31\u5bb9\u6e29\u5ea6\u3068\u63a5\u89e6\u6642\u9593\u306e\u5b9a\u7fa9<\/a><\/li><li><a href=\"#provide-clear-labeling-and-instructions\">\u660e\u78ba\u306a\u30e9\u30d9\u30ea\u30f3\u30b0\u3068\u6307\u793a\u306e\u63d0\u4f9b<\/a><\/li><\/ul><\/li><li><a href=\"#rapid-buyer-s-checklist\">\u8fc5\u901f\u306a\u30d0\u30a4\u30e4\u30fc\u306e\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/a><\/li><li><a href=\"#helpful-uhmwpe-and-hdpe-resources-on-our-site\">UHMWPE\u3068HDPE\u306b\u95a2\u3059\u308b\u304a\u5f79\u7acb\u3061\u60c5\u5831<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"fda-21-cfr-177-1520-compliance-checklist\">FDA 21 CFR 177.1520\u6e96\u62e0\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"confirm-polymer-category-and-intended-use\">\u30dd\u30ea\u30de\u30fc\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u3068\u4f7f\u7528\u76ee\u7684\u3092\u78ba\u8a8d\u3059\u308b<\/h3>\n\n\n\n<p>\u30dd\u30ea\u30a8\u30c1\u30ec\u30f3\u306e\u30b0\u30ec\u30fc\u30c9\u3068\u7528\u9014\u309221 CFR 177.1520\u306e\u6b63\u3057\u3044\u30aa\u30ec\u30d5\u30a3\u30f3\u30dd\u30ea\u30de\u30fc\u306e\u898f\u5b9a\u306b\u5408\u308f\u305b\u3066\u304f\u3060\u3055\u3044\u3002\u6b63\u78ba\u306a\u54c1\u756a\u3092\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u4fdd\u8a3c\u66f8\u3068\u3068\u3082\u306b\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u306b\u4fdd\u7ba1\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"verify-additive-clearances-in-21-cfr-part-178\">21 CFR Part 178\u306e\u6dfb\u52a0\u7269\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u3092\u78ba\u8a8d\u3059\u308b\u3002<\/h3>\n\n\n\n<p>\u9178\u5316\u9632\u6b62\u5264\u3001\u5b89\u5b9a\u5264\u3001\u30b9\u30ea\u30c3\u30d7\u5264\u3001\u6f64\u6ed1\u5264\u3001\u9632\u9306\u5264\u3001\u9854\u6599\u306f\u8a8d\u53ef\u3092\u53d7\u3051\u3001\u8a18\u8f09\u3055\u308c\u305f\u5236\u9650\u306e\u7bc4\u56f2\u5185\u3067\u4f7f\u7528\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u7d44\u6210\u660e\u7d30\u66f8\u3068\u30d0\u30c3\u30c1\u4f7f\u7528\u91cf\u3092\u628a\u63e1\u3059\u308b\u3053\u3068\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"align-with-the-food-contact-notification-framework\">\u98df\u54c1\u63a5\u89e6\u901a\u77e5\u306e\u67a0\u7d44\u307f\u3068\u306e\u6574\u5408<\/h3>\n\n\n\n<p>\u6dfb\u52a0\u7269\u307e\u305f\u306f\u4f7f\u7528\u6761\u4ef6\u304c\u3059\u3067\u306b\u30ab\u30d0\u30fc\u3055\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u306f\u3001\u65e2\u5b58\u306e\u898f\u5247\u307e\u305f\u306fFCN\u3092\u901a\u3058\u3066\u3069\u306e\u3088\u3046\u306b\u8a8d\u53ef\u3055\u308c\u3066\u3044\u308b\u304b\u3092\u6587\u66f8\u5316\u3059\u308b\u3002\u6dfb\u52a0\u7269\u3092\u4f7f\u7528\u3057\u3066\u3044\u306a\u3044\u5834\u5408\u306f\u3001\u305d\u306e\u65e8\u3092\u30d5\u30a1\u30a4\u30eb\u306b\u660e\u8a18\u3059\u308b\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"800\" height=\"550\" src=\"https:\/\/uhmwpemanufacture.com\/wp-content\/uploads\/2025\/11\/Customized-High-Density-Polyethylene-Sheet-3.jpg\" alt=\"\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3055\u308c\u305f\u9ad8\u5bc6\u5ea6\u30dd\u30ea\u30a8\u30c1\u30ec\u30f3\u30b7\u30fc\u30c8\" class=\"wp-image-2731\" srcset=\"https:\/\/uhmwpemanufacture.com\/wp-content\/uploads\/2025\/11\/Customized-High-Density-Polyethylene-Sheet-3.jpg 800w, https:\/\/uhmwpemanufacture.com\/wp-content\/uploads\/2025\/11\/Customized-High-Density-Polyethylene-Sheet-3-300x206.jpg 300w, https:\/\/uhmwpemanufacture.com\/wp-content\/uploads\/2025\/11\/Customized-High-Density-Polyethylene-Sheet-3-768x528.jpg 768w, https:\/\/uhmwpemanufacture.com\/wp-content\/uploads\/2025\/11\/Customized-High-Density-Polyethylene-Sheet-3-18x12.jpg 18w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"eu-10-2011-plastics-regulation-essentials\">EU 10\/2011\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u898f\u5236\u306e\u8981\u70b9<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"check-the-union-list-and-specific-migration-limits\">\u30e6\u30cb\u30aa\u30f3\u30ea\u30b9\u30c8\u3068\u7279\u5b9a\u306e\u79fb\u4f4f\u5236\u9650\u3092\u30c1\u30a7\u30c3\u30af\u3059\u308b<\/h3>\n\n\n\n<p>\u3059\u3079\u3066\u306e\u30e2\u30ce\u30de\u30fc\u3001\u6dfb\u52a0\u5264\u3001\u52a0\u5de5\u52a9\u5264\u304c\u8a8d\u53ef\u3055\u308c\u3066\u304a\u308a\u3001\u7279\u5b9a\u306e\u79fb\u884c\u5236\u9650\u307e\u305f\u306f\u6570\u91cf\u5236\u9650\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002\u5404\u6210\u5206\u306b\u3064\u3044\u3066\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9\u3092\u4fdd\u7ba1\u3059\u308b\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"meet-the-overall-migration-limit\">\u5168\u4f53\u7684\u306a\u79fb\u884c\u5236\u9650\u3092\u6e80\u305f\u3059<\/h3>\n\n\n\n<p>\u5ba3\u8a00\u3055\u308c\u305f\u7528\u9014\u306b\u9069\u3057\u305f\u98df\u54c1\u30b7\u30df\u30e5\u30e9\u30f3\u30c8\u3068\u30ef\u30fc\u30b9\u30c8\u30b1\u30fc\u30b9\u306e\u6642\u9593\u3068\u6e29\u5ea6\u3092\u4f7f\u7528\u3057\u30011\u5e73\u65b9\u30c7\u30b7\u30e1\u30fc\u30c8\u30eb\u3042\u305f\u308a10mg\u306e\u5168\u4f53\u7684\u306a\u79fb\u884c\u9650\u754c\u307e\u3067\u8a66\u9a13\u3092\u8a08\u753b\u3059\u308b\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"define-conditions-of-use-and-test-design\">\u4f7f\u7528\u6761\u4ef6\u3068\u8a66\u9a13\u8a2d\u8a08\u306e\u5b9a\u7fa9<\/h3>\n\n\n\n<p>\u5b9f\u4e16\u754c\u306e\u6761\u4ef6\u3092\u5b9f\u9a13\u5ba4\u3067\u306e\u30c6\u30b9\u30c8\u306b\u7d50\u3073\u3064\u3051\u308b\u3002\u98df\u54c1\u306e\u7a2e\u985e\u3001\u63a5\u89e6\u6642\u9593\u3001\u63a5\u89e6\u6e29\u5ea6\u3001\u518d\u4f7f\u7528\u306e\u671f\u5f85\u5024\u3092\u5ba3\u8a00\u3059\u308b\u3002\u6700\u60aa\u306e\u4fe1\u983c\u3067\u304d\u308b\u30b1\u30fc\u30b9\u3092\u8868\u3059\u30b7\u30df\u30e5\u30e9\u30f3\u30c8\u3068\u8a66\u9a13\u30b5\u30a4\u30af\u30eb\u3092\u9078\u629e\u3059\u308b\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"800\" height=\"550\" src=\"https:\/\/uhmwpemanufacture.com\/wp-content\/uploads\/2025\/11\/Customized-High-Density-Polyethylene-Sheet-2.jpg\" alt=\"\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3055\u308c\u305f\u9ad8\u5bc6\u5ea6\u30dd\u30ea\u30a8\u30c1\u30ec\u30f3\u30b7\u30fc\u30c8\" class=\"wp-image-2730\" srcset=\"https:\/\/uhmwpemanufacture.com\/wp-content\/uploads\/2025\/11\/Customized-High-Density-Polyethylene-Sheet-2.jpg 800w, https:\/\/uhmwpemanufacture.com\/wp-content\/uploads\/2025\/11\/Customized-High-Density-Polyethylene-Sheet-2-300x206.jpg 300w, https:\/\/uhmwpemanufacture.com\/wp-content\/uploads\/2025\/11\/Customized-High-Density-Polyethylene-Sheet-2-768x528.jpg 768w, https:\/\/uhmwpemanufacture.com\/wp-content\/uploads\/2025\/11\/Customized-High-Density-Polyethylene-Sheet-2-18x12.jpg 18w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"material-and-formulation-controls\">\u6750\u6599\u3068\u914d\u5408\u306e\u7ba1\u7406<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"choose-food-contact-appropriate-resin\">\u98df\u54c1\u63a5\u89e6\u306b\u9069\u3057\u305f\u6a39\u8102\u3092\u9078\u3076<\/h3>\n\n\n\n<p>UHMWPE\u307e\u305f\u306fHDPE\u3067\u3042\u308b\u3053\u3068\u3001\u7c98\u5ea6\u307e\u305f\u306f\u30e1\u30eb\u30c8\u30a4\u30f3\u30c7\u30c3 \u30af\u30b9\u30af\u30e9\u30b9\u3001\u6a39\u8102\u304c\u30d0\u30fc\u30b8\u30f3\u3067\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3059\u308b\u3002\u5e02\u5834\u4e3b\u5f35\u306e\u305f\u3081\u306b\u518d\u751f\u6210\u5206\u3092\u4f7f\u7528\u3059\u308b\u5834\u5408\u306f\u3001\u305d\u308c\u304c\u98df\u54c1\u3068\u76f4\u63a5\u63a5\u89e6\u3059\u308b\u3053\u3068\u304c\u8a31\u53ef\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3001\u4fdd\u7ba1\u306e\u9023\u9396\u3092\u6587\u66f8\u5316\u3059\u308b\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"lock-down-additives-pigments-and-colorants\">\u6dfb\u52a0\u7269\u3001\u9854\u6599\u3001\u7740\u8272\u6599\u306e\u30ed\u30c3\u30af\u30c0\u30a6\u30f3<\/h3>\n\n\n\n<p>\u30ab\u30e9\u30fc\u30d1\u30c3\u30b1\u30fc\u30b8\u3068\u30b9\u30ea\u30c3\u30d7\u30b7\u30b9\u30c6\u30e0\u306b\u3064\u3044\u3066\u306f\u3001\u8a8d\u53ef\u3068\u3042\u3089\u3086\u308bSML\u5236\u9650\u3092\u78ba\u8a8d\u3059\u308b\u3002\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u3001\u5206\u6790\u8a3c\u660e\u66f8\u3001\u4f7f\u7528\u7bc4\u56f2\u3001\u9854\u6599\u306eCI\u756a\u53f7\u3092\u4fdd\u7ba1\u3059\u308b\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"manufacturing-and-hygiene-under-gmp\">GMP\u306e\u4e0b\u3067\u306e\u88fd\u9020\u3068\u885b\u751f<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"implement-contamination-controls-and-sanitation\">\u6c5a\u67d3\u7ba1\u7406\u3068\u885b\u751f\u7ba1\u7406\u306e\u5b9f\u65bd<\/h3>\n\n\n\n<p>\u9069\u6b63\u88fd\u9020\u898f\u7bc4\u306b\u5f93\u3046\u3053\u3068\u3002\u98df\u54c1\u306b\u63a5\u89e6\u3059\u308b\u6750\u6599\u3092\u5206\u5225\u3057\u3001\u6e05\u6f54\u306a\u6bb5\u53d6\u308a\u66ff\u3048\u3092\u5b9f\u65bd\u3057\u3001\u624b\u76f4\u3057\u30eb\u30fc\u30eb\u3092\u5b9a\u3081\u3001\u30b5\u30cb\u30c6\u30fc\u30b7\u30e7\u30f3\u306e\u983b\u5ea6\u3068\u65b9\u6cd5\u3092\u6587\u66f8\u5316\u3059\u308b\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"control-processing-parameters-that-affect-migration\">\u30de\u30a4\u30b0\u30ec\u30fc\u30b7\u30e7\u30f3\u306b\u5f71\u97ff\u3059\u308b\u51e6\u7406\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u5236\u5fa1<\/h3>\n\n\n\n<p>\u539a\u3055\u3001\u6e29\u5ea6\u5c65\u6b74\u3001\u51b7\u5374\u901f\u5ea6\u3001\u304a\u3088\u3073\u5f8c\u51e6\u7406\u306f\u3001\u62bd\u51fa\u7269\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3059\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002\u91cd\u8981\u306a\u30d1\u30e9\u30e1\u30fc\u30bf\u3001\u8a31\u5bb9\u7bc4\u56f2\u3001\u88c5\u7f6e\u8a2d\u5b9a\u3092\u8a18\u9332\u3057\u3001\u518d\u73fe\u53ef\u80fd\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"800\" height=\"550\" src=\"https:\/\/uhmwpemanufacture.com\/wp-content\/uploads\/2025\/11\/Customized-High-Density-Polyethylene-Sheet-1.jpg\" alt=\"\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3055\u308c\u305f\u9ad8\u5bc6\u5ea6\u30dd\u30ea\u30a8\u30c1\u30ec\u30f3\u30b7\u30fc\u30c8\" class=\"wp-image-2729\" srcset=\"https:\/\/uhmwpemanufacture.com\/wp-content\/uploads\/2025\/11\/Customized-High-Density-Polyethylene-Sheet-1.jpg 800w, https:\/\/uhmwpemanufacture.com\/wp-content\/uploads\/2025\/11\/Customized-High-Density-Polyethylene-Sheet-1-300x206.jpg 300w, https:\/\/uhmwpemanufacture.com\/wp-content\/uploads\/2025\/11\/Customized-High-Density-Polyethylene-Sheet-1-768x528.jpg 768w, https:\/\/uhmwpemanufacture.com\/wp-content\/uploads\/2025\/11\/Customized-High-Density-Polyethylene-Sheet-1-18x12.jpg 18w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"testing-and-documentation-package\">\u30c6\u30b9\u30c8\u304a\u3088\u3073\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u30fb\u30d1\u30c3\u30b1\u30fc\u30b8<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"perform-migration-testing-or-conservative-calculations\">\u79fb\u884c\u30c6\u30b9\u30c8\u307e\u305f\u306f\u4fdd\u5b88\u7684\u306a\u8a08\u7b97\u306e\u5b9f\u884c<\/h3>\n\n\n\n<p>EU\u306e\u4f9b\u7d66\u306b\u3064\u3044\u3066\u306f\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u5168\u4f53\u7684\u53ca\u3073\u7279\u5b9a\u306e\u79fb\u884c\u3092\u5b9f\u884c\u3059\u308b\u3002\u7c73\u56fd\u306b\u3064\u3044\u3066\u306f\u3001\u30ef\u30fc\u30b9\u30c8\u30b1\u30fc\u30b9\u306e\u79fb\u884c\u30e2\u30c7\u30ea\u30f3\u30b0\u3084\u88cf\u4ed8\u3051\u3068\u306a\u308b\u8a66\u9a13\u3092\u542b\u3081\u3001\u5f15\u7528\u3055\u308c\u305fCFR\u306e\u6761\u9805\u3078\u306e\u6e96\u62e0\u3092\u8a3c\u660e\u3059\u308b\u79d1\u5b66\u7684\u6839\u62e0\u3092\u7d44\u307f\u7acb\u3066\u308b\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"issue-an-eu-declaration-of-compliance\">EU\u9069\u5408\u5ba3\u8a00\u66f8\u306e\u767a\u884c<\/h3>\n\n\n\n<p>\u7d20\u6750\u3001\u5bfe\u8c61\u98df\u54c1\u306e\u7a2e\u985e\u3001\u63a5\u89e6\u6642\u9593\u3001\u63a5\u89e6\u6e29\u5ea6\u3001\u591a\u5c64\u69cb\u9020\u306e\u8a73\u7d30\u3092\u660e\u8a18\u3059\u308b\u3053\u3068\u3002\u9069\u7528\u3055\u308c\u308b\u6cd5\u4ee4\u3092\u53c2\u7167\u3057\u3001\u5fc5\u8981\u306a\u5834\u5408\u306f\u8a8d\u53ef\u7269\u8cea\u306e\u30ea\u30b9\u30c8\u3092\u6dfb\u4ed8\u3059\u308b\u3053\u3068\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"maintain-traceability-from-resin-to-finished-sheet\">\u6a39\u8102\u304b\u3089\u5b8c\u6210\u30b7\u30fc\u30c8\u307e\u3067\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u7dad\u6301<\/h3>\n\n\n\n<p>\u6a39\u8102\u30ed\u30c3\u30c8\u3001\u6dfb\u52a0\u5264\u3001\u9854\u6599\u3001\u52a0\u5de5\u6761\u4ef6\u3092\u5b8c\u6210\u30b7\u30fc\u30c8ID\u306b\u7d10\u3065\u3051\u308b\u3002\u8a66\u9a13\u5831\u544a\u66f8\u3068\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u5ba3\u8a00\u66f8\u3092\u6cd5\u5b9a\u4fdd\u5b58\u671f\u9593\u5185\u306b\u30a2\u30fc\u30ab\u30a4\u30d6\u3059\u308b\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"conditions-of-use-and-labeling\">\u4f7f\u7528\u6761\u4ef6\u304a\u3088\u3073\u8868\u793a<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"define-allowable-temperatures-and-contact-duration\">\u8a31\u5bb9\u6e29\u5ea6\u3068\u63a5\u89e6\u6642\u9593\u306e\u5b9a\u7fa9<\/h3>\n\n\n\n<p>\u30b7\u30fc\u30c8\u304c\u5e38\u6e29\u63a5\u89e6\u7528\u3001\u51b7\u8535\u4fdd\u5b58\u7528\u3001\u9ad8\u6e29\u5145\u586b\u7528\u3001\u77ed\u6642\u9593\u306e\u518d\u52a0\u71b1\u7528\u306e\u3044\u305a\u308c\u3067\u3042\u308b\u304b\u3092\u660e\u8a18\u3059\u308b\u3002\u6839\u62e0\u304c\u306a\u3044\u5834\u5408\u306f\u3001\u9ad8\u6e29\u3067\u9ad8\u8102\u80aa\u98df\u54c1\u306b\u9577\u6642\u9593\u63a5\u89e6\u3055\u305b\u308b\u306a\u3069\u306e\u9664\u5916\u4e8b\u9805\u306b\u7559\u610f\u3059\u308b\u3053\u3068\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"provide-clear-labeling-and-instructions\">\u660e\u78ba\u306a\u30e9\u30d9\u30ea\u30f3\u30b0\u3068\u6307\u793a\u306e\u63d0\u4f9b<\/h3>\n\n\n\n<p>\u9867\u5ba2\u306e\u4ed5\u69d8\u66f8\u3084\u30e9\u30d9\u30eb\u306b\u4f7f\u7528\u6761\u4ef6\u3092\u8a18\u8f09\u3059\u308b\u3002\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u3001\u521d\u56de\u4f7f\u7528\u6642\u306e\u6d17\u6d44\u30ac\u30a4\u30c0\u30f3\u30b9\u3001\u885b\u751f\u9069\u5408\u6027\u3001\u518d\u4f7f\u7528\u5236\u9650\u3092\u542b\u3081\u308b\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"rapid-buyer-s-checklist\">\u8fc5\u901f\u306a\u30d0\u30a4\u30e4\u30fc\u306e\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30dd\u30ea\u30de\u30fc\u304a\u3088\u3073\u7528\u9014\u306f 21 CFR 177.1520 \u304a\u3088\u3073 EU 10\/2011 \u306b\u9069\u5408\u3059\u308b\u3002<\/li>\n\n\n\n<li>\u3059\u3079\u3066\u306e\u6dfb\u52a0\u7269\u304c\u8a8d\u53ef\u3055\u308c\u3001\u5236\u9650\u5024\u5185\u306b\u3042\u308b<\/li>\n\n\n\n<li>SML\u3092\u6e80\u305f\u3057\u305fEU\u5168\u4f53\u306e\u79fb\u52d5\u91cf\u226610mg\/\u5e73\u65b9\u30c7\u30b7\u30e1\u30fc\u30c8\u30eb<\/li>\n\n\n\n<li>\u4f7f\u7528\u6761\u4ef6\u304c\u5b9a\u7fa9\u3055\u308c\u3001\u30c6\u30b9\u30c8\u307e\u305f\u306f\u7406\u8ad6\u7684\u6839\u62e0\u306b\u88cf\u4ed8\u3051\u3089\u308c\u305f\u3082\u306e\u3067\u3042\u308b\u3053\u3068\u3002<\/li>\n\n\n\n<li>GMP\u304a\u3088\u3073\u6c5a\u67d3\u7ba1\u7406\u306e\u6587\u66f8\u5316<\/li>\n\n\n\n<li>\u79fb\u884c\u30c6\u30b9\u30c8\u307e\u305f\u306f\u4fdd\u5b88\u7684\u306a\u8a08\u7b97<\/li>\n\n\n\n<li>EU\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u5ba3\u8a00\u304c\u767a\u8868\u3055\u308c\u3001\u7c73\u56fd\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u58f0\u660e\u304c\u5165\u624b\u53ef\u80fd\u306b<\/li>\n\n\n\n<li>\u6a39\u8102\u30ed\u30c3\u30c8\u304b\u3089\u51fa\u8377\u307e\u3067\u306e\u5b8c\u5168\u306a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/li>\n\n\n\n<li>\u30e9\u30d9\u30eb\u3068\u8aac\u660e\u66f8\u306f\u8a66\u9a13\u3055\u308c\u305f\u9650\u754c\u5024\u3092\u53cd\u6620<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"helpful-uhmwpe-and-hdpe-resources-on-our-site\">UHMWPE\u3068HDPE\u306b\u95a2\u3059\u308b\u304a\u5f79\u7acb\u3061\u60c5\u5831<\/h2>\n\n\n\n<p>\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u6e96\u62e0\u3057\u305f\u30d3\u30eb\u30c9\u3068\u30af\u30ea\u30fc\u30f3\u306a\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u7d20\u6750\u3001\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u3001\u30b5\u30fc\u30d3\u30b9\u3092\u63a2\u6c42\u3059\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/uhmwpemanufacture.com\/ja\/\">\u30db\u30fc\u30e0\u30da\u30fc\u30b8<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/uhmwpemanufacture.com\/ja\/uhmwpe-sheets\/\">UHMWPE\u30b7\u30fc\u30c8<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/uhmwpemanufacture.com\/ja\/hdpe-sheets\/\">HDPE\u30b7\u30fc\u30c8<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/uhmwpemanufacture.com\/ja\/uhmwpe-hdpe-sheets-plates\/\">UHMWPE\u304a\u3088\u3073HDPE\u30b7\u30fc\u30c8\u3068\u30d7\u30ec\u30fc\u30c8<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/uhmwpemanufacture.com\/ja\/pp-pe-products\/\">PP\u304a\u3088\u3073PE\u88fd\u54c1<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/uhmwpemanufacture.com\/ja\/products\/\">\u88fd\u54c1\u30ab\u30bf\u30ed\u30b0<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/uhmwpemanufacture.com\/ja\/industries-served\/\">\u5bfe\u8c61\u696d\u754c<\/a><\/li>\n\n\n\n<li><a 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