{"id":5374,"date":"2022-10-12T22:50:02","date_gmt":"2022-10-13T06:50:02","guid":{"rendered":"https:\/\/zetarmoulding.com\/?p=5374"},"modified":"2022-10-12T23:13:21","modified_gmt":"2022-10-13T07:13:21","slug":"rubber-fda-grade","status":"publish","type":"post","link":"https:\/\/zetarmoulding.com\/ja\/%e3%82%b4%e3%83%a0fda%e3%82%b0%e3%83%ac%e3%83%bc%e3%83%89\/","title":{"rendered":"\u30b4\u30e0FDA\u30b0\u30ec\u30fc\u30c9\u3068\u306f\uff1f\u30b4\u30e0FDA\u98df\u54c1\u63a5\u89e6\u6750\u6599\u8a66\u9a13"},"content":{"rendered":"

FDA\u306f\u98df\u54c1\u533b\u85ac\u54c1\u5c40\u3092\u4ee3\u8868\u3057\u3066\u3001\u7c73\u56fd\u5185\u3067\u8ca9\u58f2\u307e\u305f\u306f\u88fd\u9020\u3055\u308c\u308b\u98df\u54c1\u3001\u6804\u990a\u88dc\u52a9\u98df\u54c1\u3001\u533b\u85ac\u54c1\u3001\u30ef\u30af\u30c1\u30f3\u3001\u305d\u306e\u4ed6\u306e\u751f\u7269\u5b66\u7684\u88fd\u5264\u3001\u533b\u7642\u6a5f\u5668\u3001\u653e\u5c04\u7dda\u96fb\u5b50\u6a5f\u5668\u3001\u5316\u7ca7\u54c1\u3001\u52d5\u7269\u7528\u533b\u85ac\u54c1\u3001\u30bf\u30d0\u30b3\u88fd\u54c1\u306e\u5b89\u5168\u7ba1\u7406\u306b\u8cac\u4efb\u3092\u8ca0\u3046\u7c73\u56fd\u306e\u898f\u5236\u6a5f\u95a2\u3067\u3042\u308b\u3002<\/strong><\/p>\n\n\n\n

\u3053\u308c\u3089\u306e\u8f38\u51fa FDA\u30b4\u30e0\u88fd\u54c1<\/a> FDA\u306f\u307e\u305f\u3001\u3053\u308c\u3089\u306e\u7523\u696d\u306b\u95a2\u9023\u3059\u308b\u898f\u5236\u3092\u691c\u67fb\u30fb\u57f7\u884c\u3057\u3066\u304a\u308a\u3001\u8981\u4ef6\u3092\u6e80\u305f\u3055\u306a\u3044\u3082\u306e\u306fFDA\u306b\u3088\u3063\u3066\u62d8\u7559\u3055\u308c\u308b\u3002<\/p>\n\n\n\n

\n
\n
\"\"<\/figure>\n<\/div><\/div>\n<\/div>\n\n\n\n

\u30b4\u30e0\u306eFDA\u30b0\u30ec\u30fc\u30c9\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/mark><\/h2>\n\n\n\n

FDA\u306f\u3001\u6d88\u8017\u54c1\u306b\u63a5\u89e6\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u6750\u6599\u306e\u7a2e\u985e\u306b\u95a2\u3057\u3066\u53b3\u683c\u306a\u57fa\u6e96\u3092\u8a2d\u3051\u3066\u3044\u308b\u305f\u3081\u3001\u6d88\u8017\u54c1\u306e\u88fd\u9020\u306b\u4f7f\u7528\u3055\u308c\u308b\u6750\u6599\u306f\u3001FDA\u304c\u5b9a\u3081\u308b\u57fa\u6e96\u3092\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308b\u3002 \u98df\u54c1\u7528\u30b4\u30e0 <\/a>\u306fFDA\u306b\u3088\u3063\u3066\u6b63\u5f0f\u306b\u627f\u8a8d\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n\n\n\n

FDA\u3067\u88fd\u9020\u3055\u308c\u305f\u88fd\u54c1\u306f\u3059\u3079\u3066\u3001\u8a8d\u5b9a\u3055\u308c\u305f\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u74b0\u5883\u3067\u53d6\u308a\u6271\u308f\u308c\u3001\u5305\u88c5\u3055\u308c\u3001\u6700\u3082\u56f0\u96e3\u306a\u98df\u54c1\u52a0\u5de5\u7523\u696d\u3084\u98f2\u6599\u7528\u9014\u306e\u30cb\u30fc\u30ba\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u53b3\u3057\u304f\u30c6\u30b9\u30c8\u3055\u308c\u3066\u304a\u308a\u3001\u3053\u308c\u3089\u306e\u30b4\u30e0\u6750\u6599\u306f\u305d\u306e\u4ee3\u8868\u7684\u306a\u3082\u306e\u3067\u3042\u308b\u3002<\/p>\n\n\n\n

1.\u98df\u54c1\u3001\u98f2\u6599\u3001\u98df\u8089\u3001\u725b\u4e73\u3001\u307e\u305f\u306f\u98df\u54c1\u306b\u9069\u5408\u3059\u308b\u5316\u5b66\u85ac\u54c1\u306b\u4f7f\u7528\u3055\u308c\u308b\u3002<\/p>\n\n\n\n

2.\u7121\u5473\u7121\u81ed\u3067\u3001\u7d30\u83cc\u304c\u7e41\u6b96\u3057\u306b\u304f\u3044\u3002<\/p>\n\n\n\n

3.\u5e83\u3044\u6e29\u5ea6\u7bc4\u56f2\u3067\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b<\/p>\n\n\n\n

4.\u975e\u6bd2\u6027\u3001\u975e\u30de\u30fc\u30ad\u30f3\u30b0\u3001\u975e\u30a2\u30ec\u30eb\u30ae\u30fc\u306e\u7d20\u6750\u3002<\/p>\n\n\n\n

\n
\n
\"\"<\/figure>\n<\/div><\/div>\n<\/div>\n\n\n\n

\u30b4\u30e0FDA\u8a8d\u8a3c\u898f\u5b9a<\/mark><\/h2>\n\n\n\n

FDA\u8a8d\u53ef\u30b4\u30e0\u306e\u4f7f\u7528\u306b\u95a2\u3059\u308bFDA\u306e\u4ed5\u69d8\u66f8\u306b\u306f\u3001\u6b21\u306e\u3088\u3046\u306b\u8a18\u3055\u308c\u3066\u3044\u308b\u3002\u30b4\u30e0\u88fd\u54c1<\/a> \u518d\u5229\u7528\u3092\u76ee\u7684\u3068\u3057\u305f\u98df\u54c1\u306f\u3001\u672c\u9805\u306b\u5f93\u3046\u3053\u3068\u3092\u6761\u4ef6\u3068\u3057\u3066\u3001\u98df\u54c1\u306e\u88fd\u9020\u3001\u88fd\u9020\u3001\u5305\u88c5\u3001\u52a0\u5de5\u3001\u8abf\u88fd\u3001\u53d6\u6271\u3044\u3001\u5305\u88c5\u3001\u8f38\u9001\u3001\u307e\u305f\u306f\u4fdd\u5b58\u306b\u5b89\u5168\u306b\u4f7f\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/p>\n\n\n\n

\u7565\u3057\u3066FDA\u30b4\u30e0\u306f\u3001\u98df\u54c1\u3084\u98f2\u6599\u306a\u3069\u306e\u6d88\u8017\u54c1\u306b\u4f7f\u7528\u3055\u308c\u308b\u6750\u6599\u3092\u5bfe\u8c61\u3068\u3059\u308b\u9023\u90a6\u898f\u5236\uff08FDA 21 CFR 177.2600\uff09\u306e\u4e0b\u3001FDA\u898f\u5236\u306b\u6e96\u62e0\u3057\u3066\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u98df\u54c1\u5b89\u5168\u30b7\u30ea\u30b3\u30fc\u30f3\u306f\u5316\u7ca7\u54c1\u3084\u88fd\u85ac\u7523\u696d\u306b\u3082\u4f7f\u7528\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n

FDA\u8a8d\u53ef\u306e\u30b4\u30e0\u306f\u3001\u5546\u696d\u30b0\u30ec\u30fc\u30c9\u3084\u533b\u7642\u30fb\u88fd\u85ac\u30b0\u30ec\u30fc\u30c9\u306e\u30b4\u30e0\u3068\u6df7\u540c\u3055\u308c\u308b\u3079\u304d\u3067\u306f\u306a\u3044\u3053\u3068\u306b\u7559\u610f\u3059\u3079\u304d\u3067\u3042\u308b\u3002<\/p>\n\n\n\n

\n
\n
\"\"<\/figure>\n<\/div><\/div>\n<\/div>\n\n\n\n

\u30b4\u30e0FDA\u98df\u54c1\u63a5\u89e6\u6750\u6599\u8a66\u9a13<\/mark><\/h2>\n\n\n\n

\u98df\u54c1\u7528\u30b4\u30e0\u306f\u3001\u30b7\u30ea\u30b3\u30fc\u30f3\u3001\u5929\u7136\u30b4\u30e0\u3001\u30cb\u30c8\u30ea\u30eb\u30b4\u30e0\u3001\u30cd\u30aa\u30d7\u30ec\u30f3\u3001\u30dd\u30ea\u30a6\u30ec\u30bf\u30f3\u30b4\u30e0\u3092\u4f7f\u7528\u3057\u3001\u98df\u54c1\u88fd\u9020\u304a\u3088\u3073\u5305\u88c5\u7528\u306b\u8a8d\u53ef\u3055\u308c\u305f\u7279\u5225\u306b\u8a8d\u5b9a\u3055\u308c\u305f\u30b0\u30ec\u30fc\u30c9\u306e\u30b4\u30e0\u3067\u3042\u308b\u3002 \u98df\u54c1\u7528\u30b4\u30e0\u88fd\u54c1<\/a> \u98df\u54c1\u3060\u3051\u3067\u306a\u304f\u3001\u6db2\u4f53\u3084\u533b\u85ac\u54c1\u306e\u88fd\u9020\u306b\u3082\u4f7f\u7528\u3067\u304d\u308b\u3002<\/p>\n\n\n\n

FDA\u30b4\u30e0\u306f\u901a\u5e38\u3001\u98df\u54c1\u3001\u98f2\u6599\u3001\u6d88\u8017\u54c1\u306e\u88fd\u9020\u3001\u5305\u88c5\u3001\u52a0\u5de5\u3001\u8abf\u88fd\u3001\u4fdd\u5b58\u306b\u95a2\u308f\u308b\u7528\u9014\u3067\u4f7f\u7528\u3055\u308c\u3001\u3053\u308c\u3089\u306e\u88fd\u54c1\u306e\u54c1\u8cea\u3092\u7dad\u6301\u3057\u3001\u7570\u7269\u306b\u3055\u3089\u3055\u308c\u308b\u3053\u3068\u306b\u3088\u308b\u6c5a\u67d3\u3092\u9632\u6b62\u3057\u307e\u3059\u3002 FDA\u30b7\u30ea\u30b3\u30fc\u30f3\u30b4\u30e0<\/a>R\u306f\u6709\u5bb3\u306a\u6c5a\u67d3\u7269\u8cea\u3092\u5bc4\u305b\u4ed8\u3051\u306a\u3044\u3002<\/p>\n\n\n\n

FDA 21 CFR 177.2600\uff09\u306e\u8a8d\u5b9a\u3092\u53d7\u3051\u305f\u30b4\u30e0\u3092\u4f7f\u7528\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n\n\n\n

\u7279\u5b9a\u306e\u98df\u54c1\u3084\u6db2\u4f53\u3068\u983b\u7e41\u306b\u63a5\u89e6\u3059\u308b\u3068\u3001\u98df\u54c1\u306e\u54c1\u8cea\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u9178\u3084\u5316\u5b66\u7269\u8cea\u304c\u751f\u6210\u3055\u308c\u3001\u98df\u4e2d\u6bd2\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002FDA\u8a8d\u53ef\u306e\u30b4\u30e0\u306f\u7121\u6bd2\u3067\u30de\u30fc\u30ad\u30f3\u30b0\u306e\u306a\u3044\u7d20\u6750\u3068\u3055\u308c\u3066\u3044\u308b\u305f\u3081\u3001\u98df\u54c1\u95a2\u9023\u306e\u7528\u9014\u306b\u6700\u9069\u306a\u30a8\u30e9\u30b9\u30c8\u30de\u30fc\u3067\u3042\u308b\u3002<\/p>\n\n\n\n

\n
\n
\"\"<\/figure>\n<\/div><\/div>\n<\/div>\n\n\n\n

\u98df\u54c1FDA\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9<\/mark><\/h2>\n\n\n\n

\u98df\u54c1\u304a\u3088\u3073FDA\u8a8d\u53ef\u6750\u6599\u306e\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u306f\u4ee5\u4e0b\u306e\u901a\u308a\uff1a<\/p>\n\n\n\n

1.\u76f8\u8ac7\uff1a\u7533\u8acb\u8005\u306fFDA\u7533\u8acb\u306b\u5fc5\u8981\u306a\u88fd\u54c1\u60c5\u5831\u5199\u771f\u3084\u88fd\u54c1\u30fb\u6750\u6599\u306e\u8aac\u660e\u3092\u63d0\u4f9b\u3059\u308b\u3002<\/p>\n\n\n\n

2.\u898b\u7a4d\u3082\u308a\uff1a\u7533\u8acb\u8005\u304b\u3089\u63d0\u4f9b\u3055\u308c\u305f\u60c5\u5831\u306b\u57fa\u3065\u304d\u3001\u30c6\u30af\u30cb\u30ab\u30eb\u30a8\u30f3\u30b8\u30cb\u30a2\u304c\u8a55\u4fa1\u3092\u884c\u3044\u3001\u8a66\u9a13\u9805\u76ee\u3092\u6c7a\u5b9a\u3057\u3001\u7533\u8acb\u8005\u306b\u898b\u7a4d\u66f8\u3092\u63d0\u51fa\u3059\u308b\u3002<\/p>\n\n\n\n

3.\u7533\u8fbc\u8005\u306f\u898b\u7a4d\u66f8\u3092\u78ba\u8a8d\u3057\u3001\u8a66\u9a13\u7533\u8fbc\u66f8\u3068\u8a66\u9a13\u30b5\u30f3\u30d7\u30eb\u306b\u5fc5\u8981\u4e8b\u9805\u3092\u8a18\u5165\u3059\u308b\u3002<\/p>\n\n\n\n

4.\u691c\u4f53\u691c\u67fb\u306f\u3001\u9069\u7528\u3055\u308c\u308bFDA\u57fa\u6e96\u306b\u3088\u308a\u5b9f\u65bd\u3055\u308c\u308b\u3002<\/p>\n\n\n\n

5.\u8a66\u9a13\u7d42\u4e86\u5f8c\u3001FDA\u8a8d\u8a3c\u5831\u544a\u66f8\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u3002<\/p>\n\n\n\n

\n
\n
\"\"<\/figure>\n<\/div><\/div>\n<\/div>\n\n\n\n

\u98df\u54c1\u7528\u30b4\u30e0<\/mark><\/h2>\n\n\n\n

1.EPDM<\/mark><\/h3>\n\n\n\n

EPDM\u30b4\u30e0\u306f\u3001\u30b4\u30e0\u304c\u74b0\u5883\u52a3\u5316\u3084\u30aa\u30be\u30f3\u66b4\u9732\u306b\u8010\u3048\u308b\u5fc5\u8981\u304c\u3042\u308b\u5834\u5408\u306b\u4f7f\u7528\u3055\u308c\u308b\u3002<\/p>\n\n\n\n

2.\u5929\u7136\u30b4\u30e0<\/mark><\/h3>\n\n\n\n

\u5929\u7136\u30b4\u30e0\u306f\u3001\u4e7e\u6e7f\u4e21\u7528\u306e\u6709\u6a5f\u9178\u3084\u30a2\u30eb\u30b3\u30fc\u30eb\u3001\u4e2d\u7a0b\u5ea6\u306epH\u306e\u5316\u5b66\u85ac\u54c1\u306b\u3055\u3089\u3055\u308c\u308b\u88fd\u54c1\u306b\u9069\u3057\u3066\u3044\u308b\u3002<\/p>\n\n\n\n

3.\u30cd\u30aa\u30d7\u30ec\u30f3<\/mark><\/h3>\n\n\n\n

\u30cd\u30aa\u30d7\u30ec\u30f3\u306f\u3001\u5f37\u3044\u6469\u8017\u306b\u3055\u3089\u3055\u308c\u305f\u308a\u3001\u30b0\u30ea\u30fc\u30b9\u306a\u3069\u306e\u6b8b\u7559\u7269\u3092\u6b8b\u3059\u5316\u5b66\u85ac\u54c1\u3092\u7740\u7528\u3057\u305f\u308a\u3059\u308b\u306e\u306b\u9069\u3057\u3066\u3044\u308b\u3002<\/p>\n\n\n\n

4.\u30cb\u30c8\u30ea\u30eb\u30b4\u30e0<\/mark><\/h3>\n\n\n\n

\u30cb\u30c8\u30ea\u30eb\u30b4\u30e0\u306f\u5408\u6210\u30b4\u30e0\u3067\u3001\u30b0\u30ea\u30fc\u30b9\u88fd\u54c1\u3068\u306e\u76f4\u63a5\u6df7\u5408\u306b\u9069\u3057\u3066\u3044\u308b\u3002<\/p>\n\n\n\n

5.\u30b7\u30ea\u30b3\u30fc\u30f3\u30b4\u30e0<\/mark><\/h3>\n\n\n\n

\u8010\u71b1\u6027\u3001\u76f4\u706b\u6027\u3001\u96fb\u6c17\u7d76\u7e01\u6027\u304c\u3042\u308a\u3001\u98df\u54c1\u3084\u533b\u85ac\u54c1\u306e\u88fd\u9020\u306b\u5e83\u304f\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u30b4\u30e0\u3002<\/p>","protected":false},"excerpt":{"rendered":"

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