{"id":5340,"date":"2026-03-31T02:38:19","date_gmt":"2026-03-31T02:38:19","guid":{"rendered":"https:\/\/partsmastery.com\/?p=5340"},"modified":"2026-03-31T02:38:19","modified_gmt":"2026-03-31T02:38:19","slug":"medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance","status":"publish","type":"post","link":"https:\/\/partsmastery.com\/ja\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/","title":{"rendered":"\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b\uff1aFDA\u304a\u3088\u3073ISO 13485\u6e96\u62e0\u306e\u305f\u3081\u306e\u6280\u8853\u8981\u4ef6"},"content":{"rendered":"

\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b\uff1aFDA\u304a\u3088\u3073ISO 13485\u6e96\u62e0\u306e\u305f\u3081\u306e\u6280\u8853\u8981\u4ef6<\/p>\n

\n

 <\/p>\n

\"\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b\"
\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/figcaption><\/figure>\n

\u533b\u7642\u6a5f\u5668\u696d\u754c\u306f\u5b8c\u74a7\u3092\u6c42\u3081\u3066\u3044\u308b\u3002\u6d88\u8cbb\u8005\u5411\u3051\u73a9\u5177\u306e\u30e9\u30c3\u30c1\u4e0d\u826f\u306f\u8ff7\u60d1\u306a\u3053\u3068\u3067\u3059\u3002\u624b\u8853\u5668\u5177\u306e\u30e9\u30c3\u30c1\u4e0d\u826f\u306f\u60a3\u8005\u306e\u5b89\u5168\u6027\u306b\u95a2\u308f\u308b\u51fa\u6765\u4e8b\u3067\u3042\u308b\u3002\u3053\u308c\u304c\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>\u00a0\u306f\u3001\u5546\u696d\u7528\u3084\u81ea\u52d5\u8eca\u7528\u306e\u91d1\u578b\u3068\u306f\u6839\u672c\u7684\u306b\u7570\u306a\u308b\u57fa\u6e96\u304c\u9069\u7528\u3055\u308c\u308b\u3002\u5358\u306b\u91d1\u578b\u304c\u304d\u308c\u3044\u306b\u306a\u308b\u3060\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u305d\u308c\u306f\u3001\u3059\u3079\u3066\u306e\u6750\u6599\u3001\u8868\u9762\u4ed5\u4e0a\u3052\u3001\u51b7\u5374\u30c1\u30e3\u30f3\u30cd\u30eb\u304c\u8ffd\u8de1\u53ef\u80fd\u3067\u6587\u66f8\u5316\u3055\u308c\u305f\u3001\u691c\u8a3c\u3055\u308c\u305f\u30b7\u30b9\u30c6\u30e0\u3067\u3059\u3002.<\/p>\n

\u3067\u00a0\u30d1\u30fc\u30c4\u30de\u30b9\u30bf\u30fc<\/strong>, \u3092\u69cb\u7bc9\u3057\u305f\u3002\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>\u00a0\u6ce8\u5c04\u5668\u3001\u70b9\u6ef4\u7528\u90e8\u54c1\u3001\u624b\u8853\u7528\u30cf\u30a6\u30b8\u30f3\u30b0\u3001\u8a3a\u65ad\u7528\u6d88\u8017\u54c1\u306a\u3069\u306e\u30b7\u30b9\u30c6\u30e0\u3067\u3059\u3002FDA 21 CFR Part 820\u3001ISO 13485\u3001EU MDR\u3068\u3044\u3063\u305f\u898f\u5236\u306f\u3001\u92fc\u6750\u306e\u9078\u5b9a\u304b\u3089\u91d1\u578b\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306b\u81f3\u308b\u307e\u3067\u3001\u3042\u3089\u3086\u308b\u6c7a\u5b9a\u3092\u5de6\u53f3\u3057\u307e\u3059\u3002\u3053\u306e\u30ac\u30a4\u30c9\u3067\u306f\u3001\u533b\u7642\u7528\u5de5\u5177\u306e\u91cd\u8981\u306a\u8981\u4ef6\u3068\u3001\u4e00\u822c\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u843d\u3068\u3057\u7a74\u3092\u56de\u907f\u3059\u308b\u65b9\u6cd5\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3059\u3002.<\/p>\n

\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b\u306e\u5b9a\u7fa9\u3068\u306f\uff1f<\/h3>\n

A\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>\u00a0\u3068\u306f\u3001\u7279\u5b9a\u306e\u7a2e\u985e\u306e\u92fc\u3067\u3082\u3001\u7279\u5b9a\u306e\u52a0\u5de5\u6280\u8853\u3067\u3082\u306a\u3044\u3002\u91cd\u306a\u308a\u5408\u30463\u3064\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u5de5\u5177\u306a\u306e\u3060\uff1a<\/p>\n

    \n
  1. \n

    \u6750\u6599\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\uff1a<\/strong>\u00a0\u30b9\u30c1\u30fc\u30eb\u3001\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u3001\u30d5\u30a1\u30b9\u30ca\u30fc\u306b\u306f\u3059\u3079\u3066\u3001\u30ed\u30c3\u30c8\u756a\u53f7\u5165\u308a\u306e\u9069\u5408\u8a3c\u660e\u66f8\uff08COC\uff09\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>\n<\/li>\n

  2. \n

    \u6e05\u6383\u6027\uff1a<\/strong>\u00a0\u91d1\u578b\u306f\u3001\u640d\u50b7\u3059\u308b\u3053\u3068\u306a\u304f\u5b8c\u5168\u306b\u5206\u89e3\u3001\u6d17\u6d44\u3001\u6ec5\u83cc\u3067\u304d\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>\n<\/li>\n

  3. \n

    \u691c\u8a3c\u306e\u6e96\u5099\uff1a<\/strong>\u00a0\u91d1\u578b\u306f\u3001IQ\uff08\u636e\u4ed8\u6642\u9069\u683c\u6027\u78ba\u8a8d\uff09\u3001OQ\uff08\u904b\u7528\u6642\u9069\u683c\u6027\u78ba\u8a8d\uff09\u3001PQ\uff08\u6027\u80fd\u9069\u683c\u6027\u78ba\u8a8d\uff09\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>\n<\/li>\n<\/ol>\n

    \u6a19\u6e96\u7684\u306a\u5e02\u8ca9\u306e\u91d1\u578b\u306f$20,000\u30c9\u30eb\u3059\u308b\u3002\u540c\u7b49\u306e\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>\u00a0\u591a\u304f\u306e\u5834\u5408\u30011TP440,000\u304b\u30891TP480,000\u3067\u3042\u308b\u3002\u3053\u306e\u30d7\u30ec\u30df\u30a2\u30e0\u306f\u3001\u66f8\u985e\u3001\u8868\u9762\u4ed5\u4e0a\u3052\u3001\u8010\u8150\u98df\u6027\u6750\u6599\u306b\u652f\u6255\u308f\u308c\u308b\u3002.<\/p>\n

    \u533b\u7642\u7528\u91d1\u578b\u306e\u898f\u5236\u67a0\u7d44\u307f<\/h3>\n

    \u3092\u6307\u5b9a\u3059\u308b\u524d\u306b\u3001\u898f\u5b9a\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u3002\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>.<\/p>\n

    ISO 13485:2016\uff08\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff09<\/strong>
    \n\u3053\u308c\u306f\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306e\u305f\u3081\u306e\u4e16\u754c\u6a19\u6e96\u3067\u3059\u3002\u91d1\u578b\u88fd\u9020\u696d\u8005\u306b\u3068\u3063\u3066\u3001ISO13485\u306f\u8981\u6c42\u4e8b\u9805\u3067\u3042\u308b\uff1a<\/p>\n

      \n
    • \n

      \u6587\u66f8\u5316\u3055\u308c\u305f\u8a2d\u8a08\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u3002.<\/p>\n<\/li>\n

    • \n

      ISO14971\u306b\u57fa\u3065\u304f\u30ea\u30b9\u30af\u7ba1\u7406\u3002.<\/p>\n<\/li>\n

    • \n

      \u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u627f\u8a8d\u3068\u7d99\u7d9a\u7684\u306a\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0.<\/p>\n<\/li>\n

    • \n

      \u3059\u3079\u3066\u306e\u88fd\u9020\u5de5\u7a0b\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3.<\/p>\n<\/li>\n<\/ul>\n

      FDA 21 CFR Part 820 (\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u898f\u5236)<\/strong>
      \n\u7c73\u56fd\u306b\u51fa\u8377\u3055\u308c\u308b\u91d1\u578b\u306b\u3064\u3044\u3066\u3001FDA\u306f\u4ee5\u4e0b\u3092\u8981\u6c42\u3057\u3066\u3044\u308b\uff1a<\/p>\n

        \n
      • \n

        \u3059\u3079\u3066\u306e\u91d1\u578b\u306e\u30c7\u30d0\u30a4\u30b9\u5c65\u6b74\u30ec\u30b3\u30fc\u30c9\uff08DHR\uff09\u3002.<\/p>\n<\/li>\n

      • \n

        \u3042\u3089\u3086\u308b\u5909\u66f4\u306b\u5bfe\u3059\u308b\u5909\u66f4\u7ba1\u7406\u6587\u66f8\u3002.<\/p>\n<\/li>\n

      • \n

        \u7279\u5b9a\u306e\u5de5\u5177\u306b\u30ea\u30f3\u30af\u3055\u308c\u305f\u82e6\u60c5\u30d5\u30a1\u30a4\u30eb\u3002.<\/p>\n<\/li>\n<\/ul>\n

        EU MDR 2017\/745\uff08\u533b\u7642\u6a5f\u5668\u898f\u5236\uff09<\/strong>
        \n\u6b27\u5dde\u5e02\u5834\u306b\u3064\u3044\u3066\u306f\u3001MDR\u304c\u88dc\u8db3\u3057\u3066\u3044\u308b\uff1a<\/p>\n

          \n
        • \n

          UDI\uff08Unique Device Identification\uff09\u8981\u4ef6\u3002.<\/p>\n<\/li>\n

        • \n

          \u6a5f\u5668\u306e\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u5f37\u5316\u3002.<\/p>\n<\/li>\n

        • \n

          \u88fd\u9020\u5de5\u5177\u306b\u30ea\u30f3\u30af\u3055\u308c\u305f\u5e02\u8ca9\u5f8c\u8abf\u67fb\u30c7\u30fc\u30bf\u3002.<\/p>\n<\/li>\n<\/ul>\n

          A\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>\u00a0\u306f\u3001\u5bfe\u8c61\u3068\u3059\u308b\u5e02\u5834\u306b\u57fa\u3065\u304d\u3001\u3053\u308c\u3089\u306e\u898f\u5236\u306e\u3046\u3061\u6700\u3082\u53b3\u3057\u3044\u3082\u306e\u3092\u6e80\u305f\u3059\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3001\u6587\u66f8\u5316\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>\n

          \u533b\u7642\u7528\u5de5\u5177\u306e\u91cd\u8981\u306a\u92fc\u6750\u9078\u629e<\/h3>\n

          \u3059\u3079\u3066\u306e\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u304c\u3001\u3053\u306e\u3088\u3046\u306a\u7528\u9014\u306b\u9069\u3057\u3066\u3044\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>. .\u3053\u306e\u6750\u6599\u306f\u3001\u6d17\u6d44\u5264\u3001\u4f53\u6db2\u3001\u6ec5\u83cc\u30b5\u30a4\u30af\u30eb\u306b\u3088\u308b\u8150\u98df\u306b\u8010\u3048\u308b\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>\n

          420\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\uff08\u6539\u826f\u578b\uff09<\/strong><\/p>\n

            \n
          • \n

            \u786c\u5ea648-52 HRC<\/p>\n<\/li>\n

          • \n

            \u8010\u98df\u6027\uff1a\u826f\u597d\uff0872\u6642\u9593\u306e\u5869\u6c34\u5674\u9727\u30c6\u30b9\u30c8\u306b\u5408\u683c\uff09<\/p>\n<\/li>\n

          • \n

            \u30b3\u30b9\u30c8\u4e2d\u7a0b\u5ea6<\/p>\n<\/li>\n

          • \n

            \u6700\u9069\u5927\u91cf\u30b7\u30ea\u30f3\u30b8\u3001\u8a3a\u65ad\u30ab\u30bb\u30c3\u30c8\u3001\u624b\u8853\u7528\u30cf\u30f3\u30c9\u30eb<\/p>\n<\/li>\n<\/ul>\n

            S136\uff08\u30a6\u30c9\u30db\u30eb\u30e0\uff09\uff0f2083\uff08\u30dc\u30fc\u30e9\u30fc\uff09<\/strong><\/p>\n

              \n
            • \n

              \u786c\u5ea6: 50-54 HRC<\/p>\n<\/li>\n

            • \n

              \u8010\u98df\u6027\uff1a\u512a\u79c0\uff08240\u6642\u9593\u306e\u5869\u6c34\u5674\u9727\u30c6\u30b9\u30c8\u306b\u5408\u683c\uff09<\/p>\n<\/li>\n

            • \n

              \u30b3\u30b9\u30c8\uff1a\u9ad8\u3044\uff08P-20\u306e2\u500d\u304b\u30893\u500d\uff09<\/p>\n<\/li>\n

            • \n

              \u6700\u9069\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u6a5f\u5668\u90e8\u54c1\u3001\u85ac\u7269\u9001\u9054\u30b7\u30b9\u30c6\u30e0<\/p>\n<\/li>\n<\/ul>\n

              \u7c89\u672b\u51b6\u91d1\u30b9\u30c6\u30f3\u30ec\u30b9\uff08CPM 420V\uff09<\/strong><\/p>\n

                \n
              • \n

                \u786c\u5ea6: 56-60 HRC<\/p>\n<\/li>\n

              • \n

                \u8010\u98df\u6027\uff1a\u8010\u6469\u8017\u6027\u306b\u512a\u308c\u308b<\/p>\n<\/li>\n

              • \n

                \u30b3\u30b9\u30c8\u975e\u5e38\u306b\u9ad8\u3044\uff08P-20\u306e4\u500d\u304b\u30895\u500d\uff09<\/p>\n<\/li>\n

              • \n

                \u6700\u9069\u7814\u78e8\u6027\u306e\u3042\u308b\u533b\u7642\u7528\u30b3\u30f3\u30d1\u30a6\u30f3\u30c9\uff08PEEK\u3001\u786b\u9178\u30d0\u30ea\u30a6\u30e0\u5165\u308aUHMWPE\uff09<\/p>\n<\/li>\n<\/ul>\n

                \u4f55\u3092\u907f\u3051\u308b\u3079\u304d\u304b\uff1a<\/strong>\u00a0P-20\u3001H-13\u3001\u6a19\u6e96\u5de5\u5177\u92fc\u306f\u7d76\u5bfe\u306b\u4f7f\u7528\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>. .\u6700\u521d\u306e\u30aa\u30fc\u30c8\u30af\u30ec\u30fc\u30d6\u30fb\u30b5\u30a4\u30af\u30eb\u3084\u6d88\u6bd2\u5264\u306b\u3055\u3089\u3055\u308c\u308b\u3068\u9306\u3073\u308b\u3002.<\/p>\n

                \u6e05\u6383\u6027\u306e\u305f\u3081\u306e\u8868\u9762\u4ed5\u4e0a\u3052\u8981\u4ef6<\/h3>\n

                \u306e\u8868\u9762\u3067\u3042\u308b\u3002\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>\u00a0\u306f\u3001\u7d30\u83cc\u306e\u4ed8\u7740\u3068\u6d17\u6d44\u52b9\u679c\u306b\u76f4\u63a5\u5f71\u97ff\u3059\u308b\u3002\u7c97\u3044\u8868\u9762\u306f\u751f\u7269\u8ca0\u8377\u3092\u6355\u6349\u3059\u308b\u3002\u6ed1\u3089\u304b\u306a\u8868\u9762\u306f\u7d30\u83cc\u4ed8\u7740\u7269\u3092\u653e\u51fa\u3057\u307e\u3059\u3002.<\/p>\n

                SPI-A1 (\u30c0\u30a4\u30e4\u30e2\u30f3\u30c9\u30fb\u30dd\u30ea\u30c3\u30b7\u30e5)<\/strong><\/p>\n

                  \n
                • \n

                  Ra\uff1a0.005\uff5e0.025\u30df\u30af\u30ed\u30f3<\/p>\n<\/li>\n

                • \n

                  \u8981\u4ef6\u5149\u5b66\u7684\u900f\u660e\u6027\u3001\u6469\u64e6\u306e\u5c11\u306a\u3044\u8868\u9762\u3001\u30b7\u30ea\u30b3\u30fc\u30f3\u30d5\u30ea\u30fc\u306e\u96e2\u578b\u6027<\/p>\n<\/li>\n

                • \n

                  \u30b3\u30b9\u30c8\u975e\u5e38\u306b\u9ad8\u3044\uff08\u866b\u6b6f1\u672c\u306b\u3064\u304d20\uff5e40\u6642\u9593\u306e\u7814\u78e8\u304c\u8ffd\u52a0\u3055\u308c\u308b\uff09<\/p>\n<\/li>\n<\/ul>\n

                  SPI-A2 (\u30cf\u30a4\u30b0\u30ec\u30fc\u30c9\u30fb\u30dd\u30ea\u30c3\u30b7\u30e5)<\/strong><\/p>\n

                    \n
                  • \n

                    Ra\uff1a0.025\uff5e0.05\u30df\u30af\u30ed\u30f3<\/p>\n<\/li>\n

                  • \n

                    \u8981\u4ef6\u307b\u3068\u3093\u3069\u306e\u533b\u7642\u6a5f\u5668\u30cf\u30a6\u30b8\u30f3\u30b0\u304a\u3088\u3073\u30b3\u30cd\u30af\u30bf\u306e\u6a19\u6e96\u898f\u683c<\/p>\n<\/li>\n

                  • \n

                    \u30b3\u30b9\u30c8\uff1a\u9ad8\u3044\u304c\u3001\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b\u3068\u3057\u3066\u306f\u6a19\u6e96\u7684<\/p>\n<\/li>\n<\/ul>\n

                    SPI-B1\uff08\u30da\u30fc\u30d1\u30fc\u30b9\u30c8\u30fc\u30f3\uff09<\/strong><\/p>\n

                      \n
                    • \n

                      Ra\uff1a0.05\uff5e0.10\u30df\u30af\u30ed\u30f3<\/p>\n<\/li>\n

                    • \n

                      \u8981\u4ef6\u5316\u7ca7\u54c1\u4ee5\u5916\u306e\u5185\u90e8\u90e8\u54c1\u306e\u307f<\/p>\n<\/li>\n

                    • \n

                      \u30b3\u30b9\u30c8\u4e2d\u7a0b\u5ea6<\/p>\n<\/li>\n<\/ul>\n

                      \u91cd\u8981\u3060\uff1a<\/strong>\u00a0A\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>\u00a0\u306f\u3001\u30b7\u30ea\u30b3\u30f3\u7cfb\u5316\u5408\u7269\u3092\u4f7f\u7528\u305b\u305a\u306b\u7814\u78e8\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u30b7\u30ea\u30b3\u30fc\u30f3\u6c5a\u67d3\u306f\u90e8\u54c1\u306b\u79fb\u308a\u3001\u60a3\u8005\u306b\u79fb\u308a\u3001\u8a3a\u65ad\u30c6\u30b9\u30c8\u3067\u507d\u9670\u6027\u3092\u5f15\u304d\u8d77\u3053\u3059\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u91d1\u578b\u30e1\u30fc\u30ab\u30fc\u306f \u201c\u30b7\u30ea\u30b3\u30fc\u30f3\u30d5\u30ea\u30fc\u7814\u78e8 \u201d\u3092\u8a3c\u660e\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u201d<\/p>\n

                      \u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u6210\u5f62\u3068\u91d1\u578b\u8a2d\u8a08<\/h3>\n

                      \u307b\u3068\u3093\u3069\u306e\u533b\u7642\u7528\u6210\u5f62\u306fISO\u30af\u30e9\u30b98\uff08\u30af\u30e9\u30b9100,000\uff09\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3067\u884c\u308f\u308c\u308b\u3002\u305d\u306e\u305f\u3081\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>\u00a0\u306f\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306e\u904b\u7528\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>\n

                      \u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u5bfe\u5fdc\u8a2d\u8a08<\/strong><\/p>\n

                        \n
                      • \n

                        \u30d6\u30e9\u30a4\u30f3\u30c9\u30db\u30fc\u30eb\u306f\u306a\u3044\uff1a<\/strong>\u00a0\u3059\u3079\u3066\u306e\u7a74\u3042\u3051\u52a0\u5de5\u306f\u3001\u30b9\u30eb\u30fc\u30db\u30fc\u30eb\u3067\u3042\u308b\u304b\u3001\u6d17\u6d44\u306e\u305f\u3081\u306b\u30a2\u30af\u30bb\u30b9\u53ef\u80fd\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>\n<\/li>\n

                      • \n

                        \u5bc6\u9589\u3055\u308c\u305f\u51b7\u5374\u30c1\u30e3\u30f3\u30cd\u30eb\uff1a<\/strong>\u00a0\u6f0f\u308c\u306f\u8a31\u3055\u308c\u306a\u3044\u3002\u30aa\u30fc\u30c8\u30af\u30ec\u30fc\u30d6\u6e29\u5ea6\uff08180\u2103\u4ee5\u4e0a\uff09\u306b\u5bfe\u5fdc\u3057\u305fO\u30ea\u30f3\u30b0\u3092\u4f7f\u7528\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n<\/li>\n

                      • \n

                        \u5168\u30b9\u30e9\u30a4\u30c9\u306b\u30dd\u30b8\u30c6\u30a3\u30d6\u30b9\u30c8\u30c3\u30d7\u3092\u63a1\u7528\uff1a<\/strong>\u00a0\u30d1\u30fc\u30c6\u30a3\u30af\u30eb\u3092\u767a\u751f\u3055\u305b\u308b\u91d1\u5c5e\u540c\u58eb\u306e\u6469\u8017\u3092\u9632\u3050\u305f\u3081\u3002.<\/p>\n<\/li>\n

                      • \n

                        \u5bc6\u9589\u5f0f\u30a8\u30b8\u30a7\u30af\u30bf\u30fc\u30b7\u30b9\u30c6\u30e0\uff1a<\/strong>\u00a0\u30b9\u30d7\u30ea\u30f3\u30b0\u3068\u30ea\u30bf\u30fc\u30f3\u30d4\u30f3\u306f\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u74b0\u5883\u306b\u3055\u3089\u3055\u306a\u3044\u3053\u3068\u3002.<\/p>\n<\/li>\n<\/ul>\n

                        \u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306b\u304a\u3051\u308b\u6750\u6599\u306e\u5236\u9650\uff1a<\/strong><\/p>\n

                          \n
                        • \n

                          FDA\u8a8d\u53ef\u306e\u30b0\u30ea\u30fc\u30b9\u306e\u307f\u3092\u4f7f\u7528\u3057\u3066\u304f\u3060\u3055\u3044\uff08\u4f8b\u3048\u3070\u3001\u9ad8\u6e29\u7528\u9014\u306b\u306fKrytox PFPE\uff09\u3002.<\/p>\n<\/li>\n

                        • \n

                          \u771f\u936e\u3084\u9285\u306e\u90e8\u54c1\u306f\u4f7f\u308f\u306a\u3044\uff08\u8150\u98df\u3057\u305f\u308a\u5265\u304c\u308c\u305f\u308a\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\uff09\u3002.<\/p>\n<\/li>\n

                        • \n

                          \u30b9\u30c6\u30f3\u30ec\u30b9\u88fd\u30d5\u30a1\u30b9\u30ca\u30fc\u306e\u307f\uff08\u4e9c\u925b\u30e1\u30c3\u30ad\u306e\u91d1\u5177\u306f\u4f7f\u7528\u4e0d\u53ef\uff09\u3002.<\/p>\n<\/li>\n<\/ul>\n

                          \u533b\u7642\u7528\u91d1\u578b\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u30fb\u30d7\u30ed\u30c8\u30b3\u30eb<\/h3>\n

                          \u5e02\u8ca9\u306e\u91d1\u578b\u306f\u3001\u826f\u3044\u90e8\u54c1\u304c\u51fa\u6765\u4e0a\u304c\u308c\u3070\u6e96\u5099\u5b8c\u4e86\u3068\u306a\u308b\u3002A\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>\u00a0\u6b63\u5f0f\u306a\u691c\u8a3c\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u7d42\u3048\u3066\u521d\u3081\u3066\u6e96\u5099\u304c\u6574\u3046\u3002.<\/p>\n

                          IQ\uff08\u30a4\u30f3\u30b9\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3\u30fb\u30af\u30aa\u30ea\u30d5\u30a3\u30b1\u30fc\u30b7\u30e7\u30f3\uff09<\/strong><\/p>\n

                            \n
                          • \n

                            \u91d1\u578b\u306e\u5bf8\u6cd5\u3092CAD\u30d5\u30a1\u30a4\u30eb\u3068\u7167\u5408\u3059\u308b\u3002.<\/p>\n<\/li>\n

                          • \n

                            \u3059\u3079\u3066\u306e\u51b7\u5374\u56de\u8def\u304c\u898f\u5b9a\u306e\u6d41\u91cf\u3067\u6d41\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002.<\/p>\n<\/li>\n

                          • \n

                            \u4ea4\u63db\u53ef\u80fd\u306a\u3059\u3079\u3066\u306e\u90e8\u54c1\u306e\u30b7\u30ea\u30a2\u30eb\u756a\u53f7\u3092\u8a18\u9332\u3059\u308b\u3002.<\/p>\n<\/li>\n

                          • \n

                            \u91d1\u578b\u304c\u627f\u8a8d\u3055\u308c\u305f\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u3042\u308b\u6750\u6599\u304b\u3089\u4f5c\u3089\u308c\u305f\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u3002.<\/p>\n<\/li>\n<\/ul>\n

                            OQ\uff08\u30aa\u30da\u30ec\u30fc\u30b7\u30e7\u30f3\u30fb\u30af\u30aa\u30ea\u30d5\u30a3\u30b1\u30fc\u30b7\u30e7\u30f3\uff09<\/strong><\/p>\n

                              \n
                            • \n

                              \u610f\u56f3\u3057\u305f\u30d7\u30ed\u30bb\u30b9\u30a6\u30a3\u30f3\u30c9\u30a6\uff08\u6eb6\u878d\u6e29\u5ea6\u3001\u5c04\u51fa\u901f\u5ea6\u3001\u4fdd\u5727\uff09\u3067\u91d1\u578b\u3092\u7a3c\u52d5\u3055\u305b\u308b\u3002.<\/p>\n<\/li>\n

                            • \n

                              \u9069\u5408\u90e8\u54c1\u3092\u751f\u7523\u3059\u308b\u300c\u30b4\u30fc\u30eb\u30c7\u30f3\u30e9\u30f3\u300d\u30d1\u30e9\u30e1\u30fc\u30bf\u3092\u7279\u5b9a\u3059\u308b\u3002.<\/p>\n<\/li>\n

                            • \n

                              \u6700\u60aa\u306e\u6761\u4ef6\uff08\u6700\u9ad8\u3068\u6700\u4f4e\u306e\u91d1\u578b\u6e29\u5ea6\uff09\u3092\u30c6\u30b9\u30c8\u3059\u308b\u3002.<\/p>\n<\/li>\n

                            • \n

                              \u3059\u3079\u3066\u306e\u91cd\u8981\u5bf8\u6cd5\u306eCpK\u5024\u3092\u6587\u66f8\u5316\u3059\u308b\uff08\u6700\u4f4e1.33\u304c\u5fc5\u8981\uff09\u3002.<\/p>\n<\/li>\n<\/ul>\n

                              PQ\uff08\u6027\u80fd\u8a8d\u5b9a\uff09<\/strong><\/p>\n

                                \n
                              • \n

                                \u7d71\u8a08\u7684\u306b\u6709\u610f\u306a\u30d0\u30c3\u30c1\uff08\u901a\u5e38\u306f300\uff5e1,000\u56de\u306e\u9023\u7d9a\u30b7\u30e7\u30c3\u30c8\uff09\u3092\u5b9f\u884c\u3057\u307e\u3059\u3002.<\/p>\n<\/li>\n

                              • \n

                                \u751f\u7523\u5de5\u7a0b\u306e\u958b\u59cb\u6642\u3001\u4e2d\u9593\u3001\u7d42\u4e86\u6642\u306b\u90e8\u54c1\u3092\u691c\u67fb\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n<\/li>\n

                              • \n

                                \u5bf8\u6cd5\u516c\u5dee\u306e\u305a\u308c\u3001\u30d0\u30ea\u3001\u8868\u9762\u6b20\u9665\u304c\u306a\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n<\/li>\n

                              • \n

                                \u91d1\u578b\u304c\u30d5\u30eb\u30b7\u30d5\u30c8\u306b\u308f\u305f\u3063\u3066\u751f\u7523\u901f\u5ea6\u3067\u7a3c\u50cd\u3067\u304d\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u3053\u3068\u3002.<\/p>\n<\/li>\n<\/ul>\n

                                \u533b\u7642\u7528\u6210\u5f62\u306b\u4e00\u822c\u7684\u306b\u4f7f\u7528\u3055\u308c\u308b\u6750\u6599<\/h3>\n

                                \u306b\u3064\u3044\u3066\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>\u00a0\u533b\u7642\u5206\u91ce\u3067\u4f7f\u7528\u3055\u308c\u308b\u7279\u5b9a\u306e\u30dd\u30ea\u30de\u30fc\u3068\u4e92\u63db\u6027\u304c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>\n

                                \u5927\u91cf\u306b\u4f7f\u7528\u3055\u308c\u308b\u4f7f\u3044\u6368\u3066\u533b\u7642\u7528\u54c1\uff08\u6ce8\u5c04\u5668\u3001\u8a66\u9a13\u7ba1\u3001\u70b9\u6ef4\u30bb\u30c3\u30c8\uff09<\/strong><\/p>\n

                                  \n
                                • \n

                                  \u30dd\u30ea\u30d7\u30ed\u30d4\u30ec\u30f3\uff08PP\uff09 \u2013 \u91d1\u578b\u306b\u306f\u591a\u30ad\u30e3\u30d3\u30c6\u30a3\uff0816\u300132\u300164\u30ad\u30e3\u30d3\u30c6\u30a3\uff09\u304c\u6c42\u3081\u3089\u308c\u308b\u3002.<\/p>\n<\/li>\n

                                • \n

                                  \u30dd\u30ea\u30a8\u30c1\u30ec\u30f3\uff08PE\uff09 \u2013 PP\u3068\u985e\u4f3c\u3057\u3066\u3044\u308b\u304c\u3001\u53ce\u7e2e\u7387\u304c\u7570\u306a\u308b\uff082.5%\uff09\u3002.<\/p>\n<\/li>\n

                                • \n

                                  \u30dd\u30ea\u30b9\u30c1\u30ec\u30f3\uff08PS\uff09 \u2013 \u8106\u3044\u304c\u900f\u660e\u3067\u3042\u308b\u3002\u93e1\u9762\u4ed5\u4e0a\u3052\u306e\u91d1\u578b\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002.<\/p>\n<\/li>\n<\/ul>\n

                                  \u624b\u8853\u5668\u5177\u304a\u3088\u3073\u518d\u5229\u7528\u53ef\u80fd\u306a\u30cf\u30a6\u30b8\u30f3\u30b0<\/strong><\/p>\n

                                    \n
                                  • \n

                                    ABS\u533b\u7642\u7528\u30b0\u30ec\u30fc\u30c9 \u2013 \u6d17\u6d44\u6027\u3092\u78ba\u4fdd\u3059\u308b\u306b\u306f\u3001SPI-A2\u4ed5\u4e0a\u3052\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>\n<\/li>\n

                                  • \n

                                    \u30dd\u30ea\u30ab\u30fc\u30dc\u30cd\u30fc\u30c8\uff08PC\uff09 \u2013 \u5fdc\u529b\u4e80\u88c2\u3092\u9632\u3050\u305f\u3081\u3001\u5145\u586b\u901f\u5ea6\u3092\u9045\u304f\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n<\/li>\n

                                  • \n

                                    PSU\uff08\u30dd\u30ea\u30b9\u30eb\u30db\u30f3\uff09 \u2013 \u30aa\u30fc\u30c8\u30af\u30ec\u30fc\u30d6\u51e6\u7406\u53ef\u80fd\u3002\u91d1\u578b\u6e29\u5ea6\u306f140\u00b0C\u4ee5\u4e0a\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>\n<\/li>\n<\/ul>\n

                                    \u57cb\u3081\u8fbc\u307f\u578b\u304a\u3088\u3073\u9577\u671f\u63a5\u89e6\u578b\u30c7\u30d0\u30a4\u30b9<\/strong><\/p>\n

                                      \n
                                    • \n

                                      PEEK\uff08\u30dd\u30ea\u30a8\u30fc\u30c6\u30eb\u30a8\u30fc\u30c6\u30eb\u30b1\u30c8\u30f3\uff09 \u2013 \u91d1\u578b\u6e29\u5ea6\u306f200\u00b0C\u4ee5\u4e0a\u304c\u5fc5\u8981\u3067\u3059\u3002\u5c02\u7528\u306e\u52a0\u71b1\u30ab\u30fc\u30c8\u30ea\u30c3\u30b8\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>\n<\/li>\n

                                    • \n

                                      UHMWPE \u2013 \u7814\u78e8\u6027\u304c\u3042\u308b\u3002\u7c89\u672b\u51b6\u91d1\u92fc\u88fd\u306e\u91d1\u578b\u304c\u5fc5\u8981\u3002.<\/p>\n<\/li>\n<\/ul>\n

                                      \u533b\u7642\u7528\u91d1\u578b\u3054\u3068\u306b\u5fc5\u8981\u306a\u66f8\u985e<\/h3>\n

                                      \u5b8c\u5168\u306a\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>\u00a0\u914d\u9001\u30d1\u30c3\u30b1\u30fc\u30b8\u306e\u5185\u5bb9\uff1a<\/p>\n

                                        \n
                                      1. \n

                                        \u6750\u6599\u8a3c\u660e\u66f8<\/strong>\u00a0\u4f7f\u7528\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u92fc\u7a2e\u306b\u3064\u3044\u3066\u3002.<\/p>\n<\/li>\n

                                      2. \n

                                        \u71b1\u51e6\u7406\u30ed\u30b0<\/strong>\u00a0\u6642\u9593-\u6e29\u5ea6\u66f2\u7dda\u3092\u793a\u3057\u3066\u3044\u308b\u3002.<\/p>\n<\/li>\n

                                      3. \n

                                        CMM\u691c\u67fb\u5831\u544a\u66f8<\/strong>\u00a0\u3059\u3079\u3066\u306e\u91cd\u8981\u5bf8\u6cd5\u306b\u3064\u3044\u3066\u3002.<\/p>\n<\/li>\n

                                      4. \n

                                        \u8868\u9762\u4ed5\u4e0a\u3052\u306e\u6e2c\u5b9a<\/strong>\u00a0\u5404\u30ad\u30e3\u30d3\u30c6\u30a3\u306e\uff08Ra\u5024\uff09\u3002.<\/p>\n<\/li>\n

                                      5. \n

                                        \u6d41\u91cf\u8a66\u9a13\u306e\u7d50\u679c<\/strong>\u00a0\u5404\u51b7\u5374\u56de\u8def\u306b\u3064\u3044\u3066\u3002.<\/p>\n<\/li>\n

                                      6. \n

                                        FDA\u6e96\u62e0\u306e\u96e2\u578b\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0<\/strong>\u00a0\u8a8d\u8a3c\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09\u3002.<\/p>\n<\/li>\n

                                      7. \n

                                        \u521d\u56de\u88fd\u54c1\u691c\u67fb\uff08FAI\uff09\u5831\u544a\u66f8<\/strong>\u00a0AS9102 \u307e\u305f\u306f AIAG \u898f\u683c\u306b\u6e96\u62e0\u3057\u3066\u3002.<\/p>\n<\/li>\n

                                      8. \n

                                        \u63a8\u5968\u30b9\u30da\u30a2\u30d1\u30fc\u30c4\u4e00\u89a7<\/strong>\u00a0\uff08\u30a8\u30b8\u30a7\u30af\u30bf\u30d4\u30f3\u3001\u30b9\u30ea\u30fc\u30d6\u3001\u6469\u8017\u30d7\u30ec\u30fc\u30c8\uff09\u3002.<\/p>\n<\/li>\n<\/ol>\n

                                        \u3053\u308c\u3089\u306e\u66f8\u985e\u304c\u306a\u3051\u308c\u3070\u3001\u305d\u306e\u91d1\u578b\u306f\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>. \u3053\u308c\u306f\u5358\u306b\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u304c\u3067\u304d\u306a\u3044\u30b9\u30c6\u30f3\u30ec\u30b9\u88fd\u306e\u91d1\u578b\u306b\u904e\u304e\u306a\u3044\u3002.<\/p>\n

                                        \u7d50\u8ad6\uff1a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306f\u7d76\u5bfe\u6761\u4ef6\u3067\u3042\u308b<\/h3>\n

                                        \u3092\u69cb\u7bc9\u3059\u308b\u3002\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>\u00a0\u5546\u7528\u30c4\u30fc\u30eb\u306b\u6bd4\u3079\u3066\u3001\u51e6\u7406\u901f\u5ea6\u304c\u9045\u304f\u3001\u30b3\u30b9\u30c8\u3082\u9ad8\u304f\u3001\u66f8\u985e\u4f5c\u696d\u3082\u591a\u304f\u306a\u308a\u307e\u3059\u3002\u8fd1\u9053\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u4e0d\u8db3\u3057\u3066\u3044\u308b\u8a3c\u660e\u66f8\u3001\u624b\u76f4\u3057\u3055\u308c\u3066\u3044\u306a\u3044\u90e8\u5206\u3001\u8ffd\u8de1\u4e0d\u53ef\u80fd\u306a\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306e\u3059\u3079\u3066\u304c\u3001\u898f\u5236\u4e0a\u306e\u30ea\u30b9\u30af\u3068\u306a\u308a\u3001\u88fd\u54c1\u306e\u767a\u58f2\u3092\u9045\u3089\u305b\u305f\u308a\u3001FDA\u30d5\u30a9\u30fc\u30e0483\u306e\u767a\u884c\u3092\u62db\u3044\u305f\u308a\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n

                                        \u3053\u306e\u6295\u8cc7\u306f\u5e02\u5834\u306b\u3088\u3063\u3066\u6b63\u5f53\u5316\u3055\u308c\u308b\u3002\u533b\u7642\u6a5f\u5668\u306f\u9ad8\u4fa1\u683c\u5e2f\u3067\u53d6\u5f15\u3055\u308c\u3066\u3044\u308b\u3002\u691c\u8a3c\u6e08\u307f\u306e\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>\u00a0\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306724\u6642\u9593365\u65e5\u7a3c\u50cd\u3059\u308b\u3053\u3068\u3067\u3001\u5e02\u8ca9\u54c1\u3067\u306f\u5b9f\u73fe\u3067\u304d\u306a\u3044\u5229\u76ca\u7387\u3092\u8a87\u308b\u9ad8\u4ed8\u52a0\u4fa1\u5024\u90e8\u54c1\u3092\u751f\u7523\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n

                                        \u30d1\u30fc\u30c4\u30de\u30b9\u30bf\u30fc<\/strong>\u00a0\u69cb\u7bc9\u00a0\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u91d1\u578b<\/strong>\u00a0FDA\u3001ISO 13485\u3001\u304a\u3088\u3073EU MDR\u306e\u76e3\u67fb\u306b\u5408\u683c\u3057\u305f\u30b7\u30b9\u30c6\u30e0\u3002\u304a\u554f\u3044\u5408\u308f\u305b\u306f\u00a0+86 13530838604 (WeChat)<\/strong>\u00a0\u8cb4\u793e\u306e\u533b\u7642\u6a5f\u5668\u306e\u4ed5\u69d8\u3092\u78ba\u8a8d\u3055\u305b\u3066\u3044\u305f\u3060\u304d\u307e\u3059\u3002\u691c\u8a3c\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u542b\u3080\u3001\u8a73\u7d30\u306a\u6587\u66f8\u5316\u304c\u65bd\u3055\u308c\u305f\u91d1\u578b\u88fd\u4f5c\u63d0\u6848\u66f8\u3092\u3054\u63d0\u793a\u3044\u305f\u3057\u307e\u3059\u3002.<\/p>","protected":false},"excerpt":{"rendered":"

                                        Medical Grade Plastic Mold: Engineering Requirements for FDA and ISO 13485 Compliance   The medical device industry demands perfection. A failed latch on a consumer toy is an annoyance. A failed latch on a surgical instrument is a patient safety event. This is why a\u00a0medical grade plastic mold\u00a0is held to fundamentally different standards than commercial or automotive tooling. It is not simply a cleaner mold. It is a validated system where every material, surface finish, and cooling channel is traceable and documented. At\u00a0PartsMastery, we have built\u00a0medical grade plastic mold\u00a0systems for syringes, IV components, surgical housings, and diagnostic consumables. The regulatory landscape\u2014FDA 21 CFR Part 820, ISO 13485, and EU MDR\u2014shapes […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1,13],"tags":[82],"class_list":["post-5340","post","type-post","status-publish","format-standard","hentry","category-blog","category-technical-blog-posts","tag-medical-grade-plastic-mold"],"blocksy_meta":[],"acf":[],"yoast_head":"\nMedical Grade Plastic Mold: Engineering Requirements for FDA and ISO 13485 Compliance -PartsMastery<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/partsmastery.com\/ja\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Grade Plastic Mold: Engineering Requirements for FDA and ISO 13485 Compliance -PartsMastery\" \/>\n<meta property=\"og:description\" content=\"Medical Grade Plastic Mold: Engineering Requirements for FDA and ISO 13485 Compliance   The medical device industry demands perfection. A failed latch on a consumer toy is an annoyance. A failed latch on a surgical instrument is a patient safety event. This is why a\u00a0medical grade plastic mold\u00a0is held to fundamentally different standards than commercial or automotive tooling. It is not simply a cleaner mold. It is a validated system where every material, surface finish, and cooling channel is traceable and documented. At\u00a0PartsMastery, we have built\u00a0medical grade plastic mold\u00a0systems for syringes, IV components, surgical housings, and diagnostic consumables. 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A failed latch on a consumer toy is an annoyance. A failed latch on a surgical instrument is a patient safety event. This is why a\u00a0medical grade plastic mold\u00a0is held to fundamentally different standards than commercial or automotive tooling. It is not simply a cleaner mold. It is a validated system where every material, surface finish, and cooling channel is traceable and documented. At\u00a0PartsMastery, we have built\u00a0medical grade plastic mold\u00a0systems for syringes, IV components, surgical housings, and diagnostic consumables. 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