{"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\/zh\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/","title":{"rendered":"\u533b\u7528\u7ea7\u5851\u6599\u6a21\u5177\uff1a\u7b26\u5408 FDA \u548c ISO 13485 \u7684\u5de5\u7a0b\u8981\u6c42"},"content":{"rendered":"<p class=\"ds-markdown-paragraph\" style=\"text-align: center;\">\u533b\u7528\u7ea7\u5851\u6599\u6a21\u5177\uff1a\u7b26\u5408 FDA \u548c ISO 13485 \u7684\u5de5\u7a0b\u8981\u6c42<\/p>\n<p class=\"ds-markdown-paragraph\">\n<p>&nbsp;<\/p>\n<figure id=\"attachment_5341\" aria-describedby=\"caption-attachment-5341\" style=\"width: 900px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"wp-image-5341\" src=\"https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015.jpg\" alt=\"Medical grade plastic mold\" width=\"900\" height=\"533\" srcset=\"https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015.jpg 1566w, https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015-300x178.jpg 300w, https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015-1024x607.jpg 1024w, https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015-768x455.jpg 768w, https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015-1536x910.jpg 1536w, https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015-18x12.jpg 18w\" sizes=\"(max-width: 900px) 100vw, 900px\" \/><figcaption id=\"caption-attachment-5341\" class=\"wp-caption-text\">\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/figcaption><\/figure>\n<p class=\"ds-markdown-paragraph\">\u533b\u7597\u5668\u68b0\u884c\u4e1a\u8981\u6c42\u5c3d\u5584\u5c3d\u7f8e\u3002\u6d88\u8d39\u8005\u73a9\u5177\u4e0a\u7684\u95e9\u9501\u5931\u7075\u662f\u4e00\u79cd\u70e6\u607c\u3002\u800c\u624b\u672f\u5668\u68b0\u7684\u95e9\u9501\u5931\u7075\u5219\u662f\u4e00\u4e2a\u75c5\u4eba\u5b89\u5168\u4e8b\u4ef6\u3002\u8fd9\u5c31\u662f\u4e3a\u4ec0\u4e48\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>\u00a0\u4e0e\u5546\u4e1a\u6216\u6c7d\u8f66\u6a21\u5177\u7684\u6807\u51c6\u6839\u672c\u4e0d\u540c\u3002\u5b83\u4e0d\u4ec5\u4ec5\u662f\u4e00\u4e2a\u66f4\u6e05\u6d01\u7684\u6a21\u5177\u3002\u5b83\u662f\u4e00\u4e2a\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u7cfb\u7edf\uff0c\u6bcf\u79cd\u6750\u6599\u3001\u8868\u9762\u5904\u7406\u548c\u51b7\u5374\u901a\u9053\u90fd\u662f\u53ef\u8ffd\u6eaf\u548c\u6709\u8bb0\u5f55\u7684\u3002.<\/p>\n<p class=\"ds-markdown-paragraph\">\u5728\u00a0<strong>PartsMastery<\/strong>, \u6211\u4eec\u5efa\u7acb\u4e86\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>\u00a0\u7cfb\u7edf\uff0c\u7528\u4e8e\u6ce8\u5c04\u5668\u3001\u9759\u8109\u6ce8\u5c04\u5668\u7ec4\u4ef6\u3001\u624b\u672f\u5916\u58f3\u548c\u8bca\u65ad\u8017\u6750\u3002\u4ece\u94a2\u6750\u9009\u62e9\u5230\u6a21\u5177\u9a8c\u8bc1\uff0c\u4ece 21 CFR Part 820\u3001ISO 13485 \u5230\u6b27\u76df MDR\uff0c\u6bcf\u4e00\u4e2a\u51b3\u7b56\u90fd\u53d7\u5230\u76d1\u7ba1\u73af\u5883\u7684\u5f71\u54cd\u3002\u672c\u6307\u5357\u89e3\u91ca\u4e86\u533b\u7597\u6a21\u5177\u7684\u5173\u952e\u8981\u6c42\u4ee5\u53ca\u5982\u4f55\u907f\u514d\u5e38\u89c1\u7684\u5408\u89c4\u9677\u9631\u3002.<\/p>\n<h3>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177\u7684\u5b9a\u4e49\u662f\u4ec0\u4e48\uff1f<\/h3>\n<p class=\"ds-markdown-paragraph\">A\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>\u00a0\u4e0d\u662f\u4e00\u79cd\u7279\u5b9a\u7684\u94a2\u6750\u6216\u7279\u5b9a\u7684\u52a0\u5de5\u6280\u672f\u3002\u5b83\u662f\u4e00\u79cd\u6ee1\u8db3\u4e09\u4e2a\u91cd\u53e0\u8981\u6c42\u7684\u5de5\u5177\uff1a<\/p>\n<ol start=\"1\">\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u6750\u6599\u53ef\u8ffd\u6eaf\u6027\uff1a<\/strong>\u00a0\u6bcf\u5757\u94a2\u6750\u3001\u6d82\u5c42\u548c\u7d27\u56fa\u4ef6\u90fd\u5fc5\u987b\u6709\u9644\u6709\u6279\u53f7\u7684\u5408\u683c\u8bc1\u4e66 (COC)\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u6e05\u6d01\u6027<\/strong>\u00a0\u6a21\u5177\u7684\u8bbe\u8ba1\u5fc5\u987b\u80fd\u591f\u5b8c\u5168\u62c6\u5378\u3001\u6e05\u6d17\u548c\u6d88\u6bd2\u800c\u4e0d\u4f1a\u9020\u6210\u635f\u574f\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u9a8c\u8bc1\u51c6\u5907\u5c31\u7eea\uff1a<\/strong>\u00a0\u6a21\u5177\u5fc5\u987b\u652f\u6301 IQ\uff08\u5b89\u88c5\u9274\u5b9a\uff09\u3001OQ\uff08\u8fd0\u884c\u9274\u5b9a\uff09\u548c PQ\uff08\u6027\u80fd\u9274\u5b9a\uff09\u534f\u8bae\u3002.<\/p>\n<\/li>\n<\/ol>\n<p class=\"ds-markdown-paragraph\">\u4e00\u4e2a\u6807\u51c6\u7684\u5546\u7528\u6a21\u5177\u53ef\u80fd\u9700\u8981 $20,000 \u7f8e\u5143\u3002\u540c\u6837\u7684\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>\u00a0\u901a\u5e38\u8d39\u7528\u4e3a $40,000 \u81f3 $80,000 \u7f8e\u5143\u3002\u6ea2\u4ef7\u7528\u4e8e\u652f\u4ed8\u6587\u4ef6\u3001\u8868\u9762\u5904\u7406\u548c\u8010\u8150\u8680\u6750\u6599\u7684\u8d39\u7528\u3002.<\/p>\n<h3>\u533b\u7528\u6a21\u5177\u76d1\u7ba1\u6846\u67b6<\/h3>\n<p class=\"ds-markdown-paragraph\">\u5728\u6307\u5b9a\u8bbe\u5907\u4e4b\u524d\uff0c\u4e86\u89e3\u76f8\u5173\u6cd5\u89c4\u81f3\u5173\u91cd\u8981\u3002\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>.<\/p>\n<p class=\"ds-markdown-paragraph\"><strong>ISO 13485:2016\uff08\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff09<\/strong><br \/>\n\u8fd9\u662f\u533b\u7597\u8bbe\u5907\u5236\u9020\u7684\u5168\u7403\u6807\u51c6\u3002\u5bf9\u4e8e\u6a21\u5177\u5236\u9020\u5546\uff0cISO 13485 \u8981\u6c42\uff1a<\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">\u6709\u636e\u53ef\u67e5\u7684\u8bbe\u8ba1\u63a7\u5236\u6d41\u7a0b\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u6839\u636e ISO 14971 \u8fdb\u884c\u98ce\u9669\u7ba1\u7406\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u4f9b\u5e94\u5546\u5ba1\u6279\u548c\u6301\u7eed\u76d1\u63a7\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u9a8c\u8bc1\u6240\u6709\u751f\u4ea7\u6d41\u7a0b\u3002.<\/p>\n<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 21 CFR \u7b2c 820 \u90e8\u5206\uff08\u8d28\u91cf\u4f53\u7cfb\u6cd5\u89c4\uff09<\/strong><br \/>\n\u5bf9\u4e8e\u8fd0\u5f80\u7f8e\u56fd\u7684\u6a21\u5177\uff0cFDA \u8981\u6c42\uff1a<\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">\u6bcf\u4e2a\u6a21\u5177\u7684\u8bbe\u5907\u5386\u53f2\u8bb0\u5f55 (DHR)\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u4efb\u4f55\u4fee\u6539\u7684\u53d8\u66f4\u63a7\u5236\u6587\u4ef6\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u4e0e\u7279\u5b9a\u5de5\u5177\u76f8\u5173\u8054\u7684\u6295\u8bc9\u6587\u4ef6\u3002.<\/p>\n<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>\u6b27\u76df MDR 2017\/745\uff08\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff09<\/strong><br \/>\n\u5bf9\u4e8e\u6b27\u6d32\u5e02\u573a\uff0cMDR \u8865\u5145\u9053\uff1a<\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">\u552f\u4e00\u8bbe\u5907\u6807\u8bc6 (UDI) \u8981\u6c42\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u589e\u5f3a\u8bbe\u5907\u7684\u4e34\u5e8a\u8bc1\u636e\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u4e0e\u751f\u4ea7\u5de5\u5177\u76f8\u5173\u8054\u7684\u4e0a\u5e02\u540e\u76d1\u63a7\u6570\u636e\u3002.<\/p>\n<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\">A\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>\u00a0\u5fc5\u987b\u6839\u636e\u60a8\u7684\u76ee\u6807\u5e02\u573a\u8bbe\u8ba1\u548c\u8bb0\u5f55\u8fd9\u4e9b\u6700\u4e25\u683c\u7684\u89c4\u5b9a\u3002.<\/p>\n<h3>\u533b\u7597\u5de5\u5177\u7684\u5173\u952e\u94a2\u6750\u9009\u62e9<\/h3>\n<p class=\"ds-markdown-paragraph\">\u5e76\u4e0d\u662f\u6240\u6709\u7684\u4e0d\u9508\u94a2\u90fd\u9002\u7528\u4e8e\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>. .\u6750\u6599\u5fc5\u987b\u80fd\u62b5\u5fa1\u6e05\u6d01\u5242\u3001\u4f53\u6db2\u548c\u706d\u83cc\u5468\u671f\u7684\u8150\u8680\u3002.<\/p>\n<p class=\"ds-markdown-paragraph\"><strong>420 \u4e0d\u9508\u94a2\uff08\u6539\u826f\u578b\uff09<\/strong><\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">\u786c\u5ea6\u786c\u5ea6\uff1a 48-52 HRC<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u8010\u8150\u8680\u6027\uff1a\u826f\u597d\uff08\u901a\u8fc7 72 \u5c0f\u65f6\u76d0\u96fe\u6d4b\u8bd5\uff09<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u8d39\u7528\u4e2d\u7b49<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u6700\u9002\u7528\u4e8e\u5927\u5bb9\u91cf\u6ce8\u5c04\u5668\u3001\u8bca\u65ad\u76d2\u3001\u624b\u672f\u624b\u67c4<\/p>\n<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>S136 (Uddeholm) \/ 2083 (Bohler)<\/strong><\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">\u786c\u5ea6\uff1a50-54 HRC<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u8010\u8150\u8680\u6027\uff1a\u4f18\u5f02\uff08\u901a\u8fc7 240 \u5c0f\u65f6\u76d0\u96fe\u6d4b\u8bd5\uff09<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u6210\u672c\uff1a\u9ad8\uff082 \u500d\u81f3 3 \u500d P-20\uff09<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u6700\u9002\u7528\u4e8e\u690d\u5165\u5f0f\u8bbe\u5907\u90e8\u4ef6\u3001\u7ed9\u836f\u7cfb\u7edf<\/p>\n<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>\u7c89\u672b\u51b6\u91d1\u4e0d\u9508\u94a2\uff08CPM 420V\uff09<\/strong><\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">\u786c\u5ea6\uff1a56-60 HRC<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u8010\u8150\u8680\u6027\uff1a\u5353\u8d8a\u7684\u9ad8\u8010\u78e8\u6027<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u6210\u672c\uff1a\u975e\u5e38\u9ad8\uff084 \u81f3 5 \u500d P-20\uff09<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u6700\u9002\u7528\u4e8e\u78e8\u8680\u6027\u533b\u7528\u5316\u5408\u7269\uff08\u542b\u786b\u9178\u94a1\u7684 PEEK\u3001UHMWPE\uff09<\/p>\n<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>\u5e94\u907f\u514d\u7684\u4e8b\u9879<\/strong>\u00a0\u5207\u52ff\u5c06 P-20\u3001H-13 \u6216\u6807\u51c6\u5de5\u5177\u94a2\u7528\u4e8e\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>. .\u7b2c\u4e00\u6b21\u9ad8\u538b\u706d\u83cc\u6216\u63a5\u89e6\u6d88\u6bd2\u5242\u540e\uff0c\u5b83\u4eec\u5c31\u4f1a\u751f\u9508\u3002.<\/p>\n<h3>\u8868\u9762\u6e05\u6d01\u5ea6\u8981\u6c42<\/h3>\n<p class=\"ds-markdown-paragraph\">\u7684\u8868\u9762\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>\u00a0\u76f4\u63a5\u5f71\u54cd\u7ec6\u83cc\u9644\u7740\u548c\u6e05\u6d01\u6548\u679c\u3002\u7c97\u7cd9\u7684\u8868\u9762\u4f1a\u5438\u9644\u751f\u7269\u8d1f\u8f7d\u3002\u5149\u6ed1\u7684\u8868\u9762\u5219\u4f1a\u91ca\u653e\u7ec6\u83cc\u3002.<\/p>\n<p class=\"ds-markdown-paragraph\"><strong>SPI-A1\uff08\u94bb\u77f3\u629b\u5149\uff09<\/strong><\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">Ra: 0.005 \u81f3 0.025 \u5fae\u7c73<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u8981\u6c42\u5149\u5b66\u6e05\u6670\u5ea6\u3001\u4f4e\u6469\u64e6\u8868\u9762\u3001\u65e0\u7845\u91ca\u653e<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u6210\u672c\uff1a\u975e\u5e38\u9ad8\uff08\u6bcf\u4e2a\u7a91\u6d1e\u9700\u8981\u589e\u52a0 20-40 \u4e2a\u5c0f\u65f6\u7684\u629b\u5149\u65f6\u95f4\uff09<\/p>\n<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>SPI-A2\uff08\u9ad8\u7ea7\u629b\u5149\u5242\uff09<\/strong><\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">Ra: 0.025 \u81f3 0.05 \u5fae\u7c73<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u8981\u6c42\uff1a\u5927\u591a\u6570\u533b\u7597\u8bbe\u5907\u5916\u58f3\u548c\u8fde\u63a5\u5668\u7684\u6807\u51c6\u914d\u7f6e<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u6210\u672c\uff1a\u8f83\u9ad8\uff0c\u4f46\u7b26\u5408\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177\u5de5\u4f5c\u7684\u6807\u51c6<\/p>\n<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>SPI-B1\uff08\u7eb8\u77f3\uff09<\/strong><\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">Ra\uff1a 0.05 \u81f3 0.10 \u5fae\u7c73<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u8981\u6c42\uff1a\u4ec5\u9650\u975e\u5916\u89c2\u5185\u90e8\u7ec4\u4ef6<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u8d39\u7528\u4e2d\u7b49<\/p>\n<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>\u91cd\u8981\uff1a<\/strong>\u00a0A\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>\u00a0\u5fc5\u987b\u5728\u4e0d\u4f7f\u7528\u7845\u57fa\u5316\u5408\u7269\u7684\u60c5\u51b5\u4e0b\u8fdb\u884c\u629b\u5149\u3002\u7845\u6c61\u67d3\u4f1a\u8f6c\u79fb\u5230\u96f6\u4ef6\u4e0a\uff0c\u7136\u540e\u8f6c\u79fb\u5230\u60a3\u8005\u8eab\u4e0a\uff0c\u5e76\u53ef\u80fd\u5728\u8bca\u65ad\u6d4b\u8bd5\u4e2d\u9020\u6210\u5047\u9634\u6027\u3002\u60a8\u7684\u6a21\u5177\u5236\u9020\u5546\u5fc5\u987b\u8ba4\u8bc1 \u201c\u65e0\u7845\u629b\u5149\u201d\u3002\u201d<\/p>\n<h3>\u6d01\u51c0\u5ba4\u6210\u578b\u548c\u6a21\u5177\u8bbe\u8ba1<\/h3>\n<p class=\"ds-markdown-paragraph\">\u5927\u591a\u6570\u533b\u7597\u6a21\u5851\u90fd\u5728 ISO 8 \u7ea7\uff08100,000 \u7ea7\uff09\u6d01\u51c0\u5ba4\u4e2d\u8fdb\u884c\u3002\u6d01\u51c0\u5ba4\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>\u00a0\u5fc5\u987b\u652f\u6301\u6d01\u51c0\u5ba4\u64cd\u4f5c\u3002.<\/p>\n<p class=\"ds-markdown-paragraph\"><strong>\u65e0\u5c18\u5ba4\u517c\u5bb9\u6027\u8bbe\u8ba1<\/strong><\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u6ca1\u6709\u76f2\u5b54\uff1a<\/strong>\u00a0\u6bcf\u4e2a\u94bb\u5b54\u90fd\u5fc5\u987b\u662f\u901a\u5b54\u6216\u4fbf\u4e8e\u6e05\u6d01\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u5bc6\u5c01\u51b7\u5374\u901a\u9053<\/strong>\u00a0\u4e0d\u5141\u8bb8\u6cc4\u6f0f\u3002\u4f7f\u7528\u9002\u7528\u4e8e\u9ad8\u538b\u706d\u83cc\u5668\u6e29\u5ea6\uff08180\u00b0C \u4ee5\u4e0a\uff09\u7684 O \u5f62\u5708\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u6240\u6709\u6ed1\u5757\u4e0a\u90fd\u6709\u6b63\u5411\u6b62\u52a8\u88c5\u7f6e\uff1a<\/strong>\u00a0\u9632\u6b62\u4ea7\u751f\u9897\u7c92\u7684\u91d1\u5c5e\u5bf9\u91d1\u5c5e\u78e8\u635f\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u5c01\u95ed\u5f0f\u55b7\u5c04\u7cfb\u7edf\uff1a<\/strong>\u00a0\u5f39\u7c27\u548c\u56de\u4f4d\u9500\u4e0d\u5e94\u66b4\u9732\u5728\u6d01\u51c0\u5ba4\u73af\u5883\u4e2d\u3002.<\/p>\n<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>\u6d01\u51c0\u5ba4\u4e2d\u7684\u6750\u6599\u9650\u5236\uff1a<\/strong><\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">\u53ea\u80fd\u4f7f\u7528\u7ecf FDA \u6279\u51c6\u7684\u6da6\u6ed1\u8102\uff08\u5982\u7528\u4e8e\u9ad8\u6e29\u5e94\u7528\u7684 Krytox PFPE\uff09\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u65e0\u9ec4\u94dc\u6216\u94dc\u90e8\u4ef6\uff08\u5b83\u4eec\u4f1a\u8150\u8680\u548c\u5265\u843d\uff09\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u4ec5\u9650\u4e0d\u9508\u94a2\u7d27\u56fa\u4ef6\uff08\u65e0\u9540\u950c\u786c\u4ef6\uff09\u3002.<\/p>\n<\/li>\n<\/ul>\n<h3>\u533b\u7528\u7ea7\u6a21\u5177\u9a8c\u8bc1\u534f\u8bae<\/h3>\n<p class=\"ds-markdown-paragraph\">\u5f53\u5546\u7528\u6a21\u5177\u80fd\u751f\u4ea7\u51fa\u826f\u597d\u7684\u96f6\u4ef6\u65f6\uff0c\u5b83\u5c31\u51c6\u5907\u5c31\u7eea\u4e86\u3002A\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>\u00a0\u53ea\u6709\u5728\u5b8c\u6210\u6b63\u5f0f\u7684\u9a8c\u8bc1\u534f\u8bae\u540e\uff0c\u624d\u80fd\u4f7f\u7528\u3002.<\/p>\n<p class=\"ds-markdown-paragraph\"><strong>IQ\uff08\u5b89\u88c5\u8d44\u683c\uff09<\/strong><\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">\u6839\u636e CAD \u6587\u4ef6\u9a8c\u8bc1\u6a21\u5177\u5c3a\u5bf8\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u786e\u8ba4\u6240\u6709\u51b7\u5374\u56de\u8def\u7684\u6d41\u901f\u7b26\u5408\u89c4\u5b9a\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u8bb0\u5f55\u6bcf\u4e2a\u53ef\u66f4\u6362\u90e8\u4ef6\u7684\u5e8f\u5217\u53f7\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u8bc1\u660e\u6a21\u5177\u662f\u7528\u7ecf\u6279\u51c6\u7684\u53ef\u8ffd\u6eaf\u6750\u6599\u5236\u9020\u7684\u3002.<\/p>\n<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>OQ\uff08\u8fd0\u884c\u8d44\u683c\uff09<\/strong><\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">\u5728\u9884\u5b9a\u7684\u5de5\u827a\u7a97\u53e3\uff08\u7194\u4f53\u6e29\u5ea6\u3001\u6ce8\u5851\u901f\u5ea6\u548c\u4fdd\u538b\u538b\u529b\uff09\u5185\u8fd0\u884c\u6a21\u5177\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u786e\u5b9a\u751f\u4ea7\u5408\u683c\u96f6\u4ef6\u7684 \u201c\u9ec4\u91d1\u8fd0\u884c \u201d\u53c2\u6570\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u6d4b\u8bd5\u6700\u574f\u60c5\u51b5\uff08\u6700\u9ad8\u548c\u6700\u4f4e\u6a21\u5177\u6e29\u5ea6\uff09\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u8bb0\u5f55\u6240\u6709\u5173\u952e\u5c3a\u5bf8\u7684 CpK \u503c\uff08\u6700\u4f4e\u8981\u6c42 1.33\uff09\u3002.<\/p>\n<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>PQ\uff08\u6027\u80fd\u9274\u5b9a\uff09<\/strong><\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">\u8fd0\u884c\u4e00\u6279\u5177\u6709\u7edf\u8ba1\u610f\u4e49\u7684\u6570\u636e\uff08\u901a\u5e38\u4e3a 300 \u81f3 1,000 \u6b21\u8fde\u7eed\u62cd\u6444\uff09\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u5728\u8fd0\u884c\u5f00\u59cb\u3001\u4e2d\u95f4\u548c\u7ed3\u675f\u65f6\u68c0\u67e5\u90e8\u4ef6\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u786e\u8ba4\u65e0\u5c3a\u5bf8\u504f\u5dee\u3001\u98de\u8fb9\u6216\u8868\u9762\u7f3a\u9677\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u8bc1\u660e\u6a21\u5177\u53ef\u4ee5\u6309\u751f\u4ea7\u7387\u6574\u73ed\u8fd0\u884c\u3002.<\/p>\n<\/li>\n<\/ul>\n<h3>\u5e38\u7528\u533b\u7528\u6210\u578b\u6750\u6599<\/h3>\n<p class=\"ds-markdown-paragraph\">\"(\u300a\u4e16\u754c\u4eba\u6743\u5ba3\u8a00\u300b)\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>\u00a0\u5fc5\u987b\u4e0e\u533b\u7597\u4fdd\u5065\u4e2d\u4f7f\u7528\u7684\u7279\u5b9a\u805a\u5408\u7269\u517c\u5bb9\u3002.<\/p>\n<p class=\"ds-markdown-paragraph\"><strong>\u5927\u6279\u91cf\u4e00\u6b21\u6027\u7528\u54c1\uff08\u6ce8\u5c04\u5668\u3001\u8bd5\u7ba1\u3001\u9759\u8109\u6ce8\u5c04\u5668\uff09<\/strong><\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">\u805a\u4e19\u70ef (PP) - \u6a21\u5177\u8981\u6c42\u9ad8\u7a7a\u5316\uff0816\u300132\u300164 \u578b\u8154\uff09\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u805a\u4e59\u70ef (PE) - \u4e0e\u805a\u4e19\u70ef\u76f8\u4f3c\uff0c\u4f46\u6536\u7f29\u7387\u4e0d\u540c\uff082.5%\uff09\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u805a\u82ef\u4e59\u70ef\uff08PS\uff09--\u6613\u788e\u4f46\u900f\u660e\u3002\u9700\u8981\u955c\u9762\u629b\u5149\u7684\u7a7a\u8154\u3002.<\/p>\n<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>\u624b\u672f\u5668\u68b0\u548c\u53ef\u91cd\u590d\u4f7f\u7528\u7684\u5916\u58f3<\/strong><\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">ABS \u533b\u7528\u7ea7 - \u9700\u8981 SPI-A2 \u8868\u9762\u5904\u7406\uff0c\u4ee5\u4fbf\u6e05\u6d01\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u805a\u78b3\u9178\u916f (PC) - \u9700\u8981\u7f13\u6162\u586b\u5145\uff0c\u4ee5\u907f\u514d\u5e94\u529b\u5f00\u88c2\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">PSU\uff08\u805a\u781c\uff09--\u53ef\u9ad8\u538b\u706d\u83cc\u3002\u9700\u8981 140\u00b0C \u4ee5\u4e0a\u7684\u6a21\u5177\u6e29\u5ea6\u3002.<\/p>\n<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>\u690d\u5165\u5f0f\u548c\u957f\u671f\u63a5\u89e6\u5f0f\u8bbe\u5907<\/strong><\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">PEEK\uff08\u805a\u919a\u919a\u916e\uff09- \u9700\u8981 200\u00b0C \u4ee5\u4e0a\u7684\u6a21\u5177\u6e29\u5ea6\u3002\u9700\u8981\u7279\u6b8a\u7684\u52a0\u70ed\u7b52\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u8d85\u9ad8\u5206\u5b50\u91cf\u805a\u4e59\u70ef - \u78e8\u6599\u3002\u9700\u8981\u7c89\u672b\u51b6\u91d1\u94a2\u8154\u3002.<\/p>\n<\/li>\n<\/ul>\n<h3>\u6bcf\u79cd\u533b\u7528\u7ea7\u6a21\u5177\u6240\u9700\u7684\u6587\u4ef6<\/h3>\n<p class=\"ds-markdown-paragraph\">\u4e00\u4e2a\u5b8c\u6574\u7684\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>\u00a0\u4ea4\u8d27\u5305\u5305\u62ec<\/p>\n<ol start=\"1\">\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u6750\u6599\u8bc1\u4e66<\/strong>\u00a0\u6240\u4f7f\u7528\u7684\u6bcf\u79cd\u94a2\u6750.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u70ed\u5904\u7406\u65e5\u5fd7<\/strong>\u00a0\u663e\u793a\u65f6\u95f4-\u6e29\u5ea6\u66f2\u7ebf\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u5750\u6807\u6d4b\u91cf\u673a\u68c0\u6d4b\u62a5\u544a<\/strong>\u00a0\u4e3a\u6240\u6709\u5173\u952e\u5c3a\u5bf8\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u8868\u9762\u7c97\u7cd9\u5ea6\u6d4b\u91cf<\/strong>\u00a0(Ra \u503c\uff09\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u6d41\u901f\u6d4b\u8bd5\u7ed3\u679c<\/strong>\u00a0\u6bcf\u4e2a\u51b7\u5374\u56de\u8def.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u7b26\u5408 FDA \u6807\u51c6\u7684\u8131\u6a21\u6d82\u5c42<\/strong>\u00a0\u8ba4\u8bc1\uff08\u5982\u9002\u7528\uff09\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u9996\u4ef6\u68c0\u9a8c (FAI) \u62a5\u544a<\/strong>\u00a0\u7b26\u5408 AS9102 \u6216 AIAG \u6807\u51c6\u3002.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u5efa\u8bae\u5907\u4ef6\u6e05\u5355<\/strong>\u00a0(\u9876\u9488\u3001\u5957\u7b52\u3001\u8010\u78e8\u677f\uff09\u3002.<\/p>\n<\/li>\n<\/ol>\n<p class=\"ds-markdown-paragraph\">\u6ca1\u6709\u8fd9\u4e9b\u6587\u4ef6\uff0c\u6a21\u5177\u5c31\u4e0d\u662f\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>. .\u5b83\u53ea\u662f\u4e00\u4e2a\u65e0\u6cd5\u9a8c\u8bc1\u7684\u4e0d\u9508\u94a2\u6a21\u5177\u3002.<\/p>\n<h3>\u7ed3\u8bba\uff1a\u5408\u89c4\u4e0d\u5bb9\u5546\u91cf<\/h3>\n<p class=\"ds-markdown-paragraph\">\u5efa\u7acb\u4e00\u4e2a\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>\u00a0\u6bd4\u5546\u4e1a\u5de5\u5177\u66f4\u6162\u3001\u66f4\u8d35\u3001\u6587\u4ef6\u66f4\u5bc6\u96c6\u3002\u6ca1\u6709\u6377\u5f84\u53ef\u8d70\u3002\u6bcf\u4e00\u4efd\u8bc1\u4e66\u7684\u7f3a\u5931\u3001\u6bcf\u4e00\u4e2a\u672a\u6253\u78e8\u7684\u89d2\u843d\u3001\u6bcf\u4e00\u4e2a\u4e0d\u53ef\u8ffd\u6eaf\u7684\u90e8\u4ef6\u90fd\u4f1a\u5e26\u6765\u76d1\u7ba1\u98ce\u9669\uff0c\u53ef\u80fd\u4f1a\u5ef6\u8bef\u4ea7\u54c1\u4e0a\u5e02\u6216\u89e6\u53d1 FDA 483 \u8868\u3002.<\/p>\n<p class=\"ds-markdown-paragraph\">\u5e02\u573a\u8bc1\u660e\u6295\u8d44\u662f\u5408\u7406\u7684\u3002\u533b\u7597\u5668\u68b0\u7684\u5b9a\u4ef7\u8f83\u9ad8\u3002\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>\u00a0\u5728\u6d01\u51c0\u5ba4\u4e2d\u5168\u5929\u5019\u8fd0\u884c\u53ef\u751f\u4ea7\u9ad8\u4ef7\u503c\u90e8\u4ef6\uff0c\u5176\u5229\u6da6\u7387\u662f\u5546\u4e1a\u4ea7\u54c1\u65e0\u6cd5\u6bd4\u62df\u7684\u3002.<\/p>\n<p class=\"ds-markdown-paragraph\"><strong>PartsMastery<\/strong>\u00a0\u5efa\u7b51\u00a0<strong>\u533b\u7597\u7ea7\u5851\u6599\u6a21\u5177<\/strong>\u00a0\u901a\u8fc7 FDA\u3001ISO 13485 \u548c\u6b27\u76df MDR \u5ba1\u6838\u7684\u7cfb\u7edf\u3002\u8054\u7cfb\u6211\u4eec\u00a0<strong>+86 13530838604\uff08\u5fae\u4fe1\uff09<\/strong>\u00a0\u5ba1\u67e5\u60a8\u7684\u533b\u7597\u8bbe\u5907\u89c4\u683c\u3002\u6211\u4eec\u5c06\u63d0\u4f9b\u4e00\u4efd\u5305\u542b\u9a8c\u8bc1\u534f\u8bae\u7684\u6587\u4ef6\u9f50\u5168\u7684\u5de5\u5177\u63d0\u6848\u3002.<\/p>","protected":false},"excerpt":{"rendered":"<p>Medical Grade Plastic Mold: Engineering Requirements for FDA and ISO 13485 Compliance &nbsp; 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 [&hellip;]<\/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-cnc-machining-articles","tag-medical-grade-plastic-mold"],"blocksy_meta":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.9 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Medical 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\/zh\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\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\" \/>\n<meta property=\"og:description\" content=\"Medical Grade Plastic Mold: Engineering Requirements for FDA and ISO 13485 Compliance &nbsp; 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 [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/partsmastery.com\/zh\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/\" \/>\n<meta property=\"og:site_name\" content=\"PartsMastery\" \/>\n<meta property=\"article:published_time\" content=\"2026-03-31T02:38:19+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1566\" \/>\n\t<meta property=\"og:image:height\" content=\"928\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"PartsMastery\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"PartsMastery\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 \u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/\"},\"author\":{\"name\":\"PartsMastery\",\"@id\":\"https:\/\/partsmastery.com\/#\/schema\/person\/968ef55191b1dc083f65c31b027658b1\"},\"headline\":\"Medical Grade Plastic Mold: Engineering Requirements for FDA and ISO 13485 Compliance\",\"datePublished\":\"2026-03-31T02:38:19+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/\"},\"wordCount\":1264,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/partsmastery.com\/#organization\"},\"image\":{\"@id\":\"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015.jpg\",\"keywords\":[\"Medical Grade Plastic Mold\"],\"articleSection\":[\"Blog\",\"CNC Machining Articles\"],\"inLanguage\":\"zh-Hans\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/\",\"url\":\"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/\",\"name\":\"Medical Grade Plastic Mold: Engineering Requirements for FDA and ISO 13485 Compliance -PartsMastery\",\"isPartOf\":{\"@id\":\"https:\/\/partsmastery.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015.jpg\",\"datePublished\":\"2026-03-31T02:38:19+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#breadcrumb\"},\"inLanguage\":\"zh-Hans\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#primaryimage\",\"url\":\"https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015.jpg\",\"contentUrl\":\"https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015.jpg\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"\u9996\u9875\",\"item\":\"https:\/\/partsmastery.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Medical Grade Plastic Mold: Engineering Requirements for FDA and ISO 13485 Compliance\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/partsmastery.com\/#website\",\"url\":\"https:\/\/partsmastery.com\/\",\"name\":\"PartsMastery\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\/\/partsmastery.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/partsmastery.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/partsmastery.com\/#organization\",\"name\":\"PartsMastery\",\"url\":\"https:\/\/partsmastery.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\/\/partsmastery.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/partsmastery.com\/wp-content\/uploads\/2025\/09\/\u672a\u6807\u9898-2_\u753b\u677f-11-scaled.png\",\"contentUrl\":\"https:\/\/partsmastery.com\/wp-content\/uploads\/2025\/09\/\u672a\u6807\u9898-2_\u753b\u677f-11-scaled.png\",\"width\":2560,\"height\":1075,\"caption\":\"PartsMastery\"},\"image\":{\"@id\":\"https:\/\/partsmastery.com\/#\/schema\/logo\/image\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/partsmastery.com\/#\/schema\/person\/968ef55191b1dc083f65c31b027658b1\",\"name\":\"PartsMastery\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\/\/secure.gravatar.com\/avatar\/03c7b423981b9409e241380ff49992aac5686905da54aa2ad2239d7ed9133c0f?s=96&d=mm&r=g\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/03c7b423981b9409e241380ff49992aac5686905da54aa2ad2239d7ed9133c0f?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/03c7b423981b9409e241380ff49992aac5686905da54aa2ad2239d7ed9133c0f?s=96&d=mm&r=g\",\"caption\":\"PartsMastery\"},\"sameAs\":[\"https:\/\/partsmastery.com\"],\"url\":\"https:\/\/partsmastery.com\/zh\/author\/1203181089qq-com\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Medical Grade Plastic Mold: Engineering Requirements for FDA and ISO 13485 Compliance -PartsMastery","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/partsmastery.com\/zh\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/","og_locale":"zh_CN","og_type":"article","og_title":"Medical Grade Plastic Mold: Engineering Requirements for FDA and ISO 13485 Compliance","og_description":"Medical Grade Plastic Mold: Engineering Requirements for FDA and ISO 13485 Compliance &nbsp; 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 [&hellip;]","og_url":"https:\/\/partsmastery.com\/zh\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/","og_site_name":"PartsMastery","article_published_time":"2026-03-31T02:38:19+00:00","og_image":[{"width":1566,"height":928,"url":"https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015.jpg","type":"image\/jpeg"}],"author":"PartsMastery","twitter_card":"summary_large_image","twitter_misc":{"\u4f5c\u8005":"PartsMastery","\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4":"6 \u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#article","isPartOf":{"@id":"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/"},"author":{"name":"PartsMastery","@id":"https:\/\/partsmastery.com\/#\/schema\/person\/968ef55191b1dc083f65c31b027658b1"},"headline":"Medical Grade Plastic Mold: Engineering Requirements for FDA and ISO 13485 Compliance","datePublished":"2026-03-31T02:38:19+00:00","mainEntityOfPage":{"@id":"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/"},"wordCount":1264,"commentCount":0,"publisher":{"@id":"https:\/\/partsmastery.com\/#organization"},"image":{"@id":"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#primaryimage"},"thumbnailUrl":"https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015.jpg","keywords":["Medical Grade Plastic Mold"],"articleSection":["Blog","CNC Machining Articles"],"inLanguage":"zh-Hans","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/","url":"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/","name":"Medical Grade Plastic Mold: Engineering Requirements for FDA and ISO 13485 Compliance -PartsMastery","isPartOf":{"@id":"https:\/\/partsmastery.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#primaryimage"},"image":{"@id":"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#primaryimage"},"thumbnailUrl":"https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015.jpg","datePublished":"2026-03-31T02:38:19+00:00","breadcrumb":{"@id":"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#breadcrumb"},"inLanguage":"zh-Hans","potentialAction":[{"@type":"ReadAction","target":["https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/"]}]},{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#primaryimage","url":"https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015.jpg","contentUrl":"https:\/\/partsmastery.com\/wp-content\/uploads\/2026\/03\/015.jpg"},{"@type":"BreadcrumbList","@id":"https:\/\/partsmastery.com\/medical-grade-plastic-mold-engineering-requirements-for-fda-and-iso-13485-compliance\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"\u9996\u9875","item":"https:\/\/partsmastery.com\/"},{"@type":"ListItem","position":2,"name":"Medical Grade Plastic Mold: Engineering Requirements for FDA and ISO 13485 Compliance"}]},{"@type":"WebSite","@id":"https:\/\/partsmastery.com\/#website","url":"https:\/\/partsmastery.com\/","name":"PartsMastery","description":"","publisher":{"@id":"https:\/\/partsmastery.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/partsmastery.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"zh-Hans"},{"@type":"Organization","@id":"https:\/\/partsmastery.com\/#organization","name":"PartsMastery","url":"https:\/\/partsmastery.com\/","logo":{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/partsmastery.com\/#\/schema\/logo\/image\/","url":"https:\/\/partsmastery.com\/wp-content\/uploads\/2025\/09\/\u672a\u6807\u9898-2_\u753b\u677f-11-scaled.png","contentUrl":"https:\/\/partsmastery.com\/wp-content\/uploads\/2025\/09\/\u672a\u6807\u9898-2_\u753b\u677f-11-scaled.png","width":2560,"height":1075,"caption":"PartsMastery"},"image":{"@id":"https:\/\/partsmastery.com\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/partsmastery.com\/#\/schema\/person\/968ef55191b1dc083f65c31b027658b1","name":"PartsMastery","image":{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/secure.gravatar.com\/avatar\/03c7b423981b9409e241380ff49992aac5686905da54aa2ad2239d7ed9133c0f?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/03c7b423981b9409e241380ff49992aac5686905da54aa2ad2239d7ed9133c0f?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/03c7b423981b9409e241380ff49992aac5686905da54aa2ad2239d7ed9133c0f?s=96&d=mm&r=g","caption":"PartsMastery"},"sameAs":["https:\/\/partsmastery.com"],"url":"https:\/\/partsmastery.com\/zh\/author\/1203181089qq-com\/"}]}},"_links":{"self":[{"href":"https:\/\/partsmastery.com\/zh\/wp-json\/wp\/v2\/posts\/5340","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/partsmastery.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/partsmastery.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/partsmastery.com\/zh\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/partsmastery.com\/zh\/wp-json\/wp\/v2\/comments?post=5340"}],"version-history":[{"count":2,"href":"https:\/\/partsmastery.com\/zh\/wp-json\/wp\/v2\/posts\/5340\/revisions"}],"predecessor-version":[{"id":5343,"href":"https:\/\/partsmastery.com\/zh\/wp-json\/wp\/v2\/posts\/5340\/revisions\/5343"}],"wp:attachment":[{"href":"https:\/\/partsmastery.com\/zh\/wp-json\/wp\/v2\/media?parent=5340"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/partsmastery.com\/zh\/wp-json\/wp\/v2\/categories?post=5340"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/partsmastery.com\/zh\/wp-json\/wp\/v2\/tags?post=5340"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}