{"id":8182,"date":"2025-10-11T12:05:34","date_gmt":"2025-10-11T12:05:34","guid":{"rendered":"https:\/\/kmslaser.com\/?p=8182"},"modified":"2025-10-19T13:03:04","modified_gmt":"2025-10-19T13:03:04","slug":"%d9%85%d8%a7-%d8%a7%d9%84%d8%b0%d9%8a-%d9%8a%d8%ac%d8%a8-%d8%aa%d8%b6%d9%85%d9%8a%d9%86%d9%87-%d9%81%d9%8a-%d8%aa%d9%82%d8%b1%d9%8a%d8%b1-%d9%81%d8%ad%d8%b5-%d8%a7%d9%84%d8%ac%d9%88%d8%af%d8%a9-%d9%84","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/ar\/what-should-be-included-in-the-quality-inspection-report-for-imported-shockwave-therapy-machines\/","title":{"rendered":"\u0645\u0627 \u0627\u0644\u0630\u064a \u064a\u062c\u0628 \u062a\u0636\u0645\u064a\u0646\u0647 \u0641\u064a \u062a\u0642\u0631\u064a\u0631 \u0641\u062d\u0635 \u0627\u0644\u062c\u0648\u062f\u0629 \u0644\u0622\u0644\u0627\u062a \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u0629\u061f"},"content":{"rendered":"<p><iframe data-testid=\"embed-iframe\" style=\"border-radius:12px\" src=\"https:\/\/open.spotify.com\/embed\/episode\/5n093mFAwRbsjg03ZgfOIu?utm_source=generator&amp;theme=0\" width=\"100%\" height=\"152\" frameborder=\"0\" allowfullscreen=\"\" allow=\"autoplay; clipboard-write; encrypted-media; fullscreen; picture-in-picture\" loading=\"lazy\"><\/iframe><\/p>\n<p style=\"float: right; margin-left: 15px; margin-bottom: 15px;\">\n  <img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/1a-professional-report-cover-labeled-shockwave-the.jpg\" alt=\"\u062a\u0642\u0631\u064a\u0631 \u0641\u062d\u0635 \u062c\u0648\u062f\u0629 \u062c\u0647\u0627\u0632 \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0639\u0644\u0649 \u0627\u0644\u0645\u0643\u062a\u0628 (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>\u0628\u0635\u0641\u062a\u064a \u0645\u064f\u0635\u0646\u0650\u0651\u0639\u064b\u0627 \u064a\u0635\u062f\u0631 \u0639\u0627\u0644\u0645\u064a\u064b\u0627\u060c \u0623\u0642\u0648\u0645 \u0628\u0645\u0631\u0627\u062c\u0639\u0629 \u062a\u0642\u0627\u0631\u064a\u0631 \u0627\u0644\u0641\u062d\u0635 \u0623\u0633\u0628\u0648\u0639\u064a\u064b\u0627. \u0623\u0631\u064a\u062f\u0647\u0627 \u0648\u0627\u0636\u062d\u0629\u060c \u0645\u062f\u0641\u0648\u0639\u0629 \u0628\u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631\u060c \u0648\u0642\u0627\u0628\u0644\u0629 \u0644\u0644\u062f\u0641\u0627\u0639 \u0639\u0646\u0647\u0627 \u0623\u0645\u0627\u0645 \u0627\u0644\u062c\u0647\u0627\u062a \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629 \u0648\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u062a\u0623\u0645\u064a\u0646.<\/p>\n<p><strong>\u064a\u062c\u0628 \u0623\u0646 \u064a\u0648\u062b\u0642 \u062a\u0642\u0631\u064a\u0631 \u0627\u0644\u0641\u062d\u0635 \u0627\u0644\u0643\u0627\u0645\u0644 \u0644\u0622\u0644\u0627\u062a \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u0629 \u0627\u0644\u062a\u0639\u0631\u064a\u0641\u060c \u0648\u0641\u062d\u0648\u0635\u0627\u062a \u0627\u0644\u0648\u062b\u0627\u0626\u0642\u060c \u0648\u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0633\u0644\u0627\u0645\u0629\u060c \u0648\u0628\u064a\u0627\u0646\u0627\u062a \u0627\u0644\u0623\u062f\u0627\u0621\u060c \u0648\u0623\u062f\u0644\u0629 \u0627\u0644\u0645\u062a\u0627\u0646\u0629\u060c \u0648\u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0628\u0631\u0627\u0645\u062c \u0648\u0627\u0644\u062a\u0633\u0645\u064a\u0627\u062a\u060c \u0648\u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u062a\u0639\u0628\u0626\u0629 \u0648\u0627\u0644\u062a\u063a\u0644\u064a\u0641\u060c \u0648\u064a\u0646\u062a\u0647\u064a \u0628\u062a\u0648\u0635\u064a\u0629 \u0648\u0627\u0636\u062d\u0629 \u0628\u0627\u0644\u0646\u062c\u0627\u062d\/\u0627\u0644\u0642\u0628\u0648\u0644 \u0627\u0644\u0645\u0634\u0631\u0648\u0637\/\u0627\u0644\u0631\u0641\u0636 \u0648\u0627\u0644\u0628\u064a\u0627\u0646\u0627\u062a \u0627\u0644\u0623\u0648\u0644\u064a\u0629 \u0627\u0644\u0642\u0627\u0628\u0644\u0629 \u0644\u0644\u062a\u062a\u0628\u0639.<\/strong><\/p>\n<p>\u0647\u0630\u0627 \u0627\u0644\u0645\u0633\u062a\u0648\u0649 \u0645\u0646 \u0627\u0644\u0647\u064a\u0643\u0644\u0629 \u064a\u062d\u0645\u064a \u0647\u0648\u0627\u0645\u0634\u0643\u060c \u0648\u064a\u0642\u0644\u0644 \u0645\u0646 \u0625\u0639\u0627\u062f\u0629 \u0627\u0644\u0639\u0645\u0644\u060c \u0648\u064a\u0633\u0631\u0639 \u0645\u0646 \u0627\u0644\u062a\u062e\u0644\u064a\u0635 \u0627\u0644\u062c\u0645\u0631\u0643\u064a. \u0623\u062f\u0646\u0627\u0647 \u0623\u0642\u0648\u0645 \u0628\u062a\u0641\u0635\u064a\u0644 \u0645\u0627 \u064a\u062c\u0628 \u062a\u0636\u0645\u064a\u0646\u0647 \u0648\u0643\u064a\u0641\u064a\u0629 \u062a\u0642\u062f\u064a\u0645\u0647 \u062d\u062a\u0649 \u064a\u062a\u0645\u0643\u0646 \u0627\u0644\u0645\u0634\u062a\u0631\u064a\u0627\u062a \u0648\u0636\u0645\u0627\u0646 \u0627\u0644\u062c\u0648\u062f\u0629 \u0648\u0627\u0644\u062c\u0647\u0627\u062a \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629 \u0645\u0646 \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0628\u0633\u0631\u0639\u0629.<\/p>\n<hr \/>\n<h2>\u0645\u0627 \u0627\u0644\u0630\u064a \u064a\u062c\u0628 \u062a\u0636\u0645\u064a\u0646\u0647 \u0641\u064a \u062a\u0642\u0631\u064a\u0631 \u0641\u062d\u0635 \u0627\u0644\u062c\u0648\u062f\u0629\u061f<\/h2>\n<p>\u0639\u0646\u062f\u0645\u0627 \u0623\u0642\u0648\u0645 \u0628\u062a\u062f\u0642\u064a\u0642 \u0645\u0641\u062a\u0634\u064a \u0627\u0644\u0637\u0631\u0641 \u0627\u0644\u062b\u0627\u0644\u062b\u060c \u062a\u0638\u0647\u0631 \u0639\u0627\u062f\u0629\u064b \u0641\u062c\u0648\u0627\u062a \u0641\u064a \u0627\u0644\u062a\u062a\u0628\u0639 \u0648\u0623\u062f\u0644\u0629 \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631. \u062a\u0624\u062f\u064a \u0627\u0644\u0631\u0648\u0627\u0628\u0637 \u0627\u0644\u062a\u0633\u0644\u0633\u0644\u064a\u0629 \u0627\u0644\u0645\u0641\u0642\u0648\u062f\u0629 \u0623\u0648 \u062c\u062f\u0627\u0648\u0644 \u0627\u0644\u0628\u064a\u0627\u0646\u0627\u062a \u0627\u0644\u0623\u0648\u0644\u064a\u0629 \u0625\u0644\u0649 \u062a\u0623\u062e\u064a\u0631\u0627\u062a \u0648\u0646\u0632\u0627\u0639\u0627\u062a.<\/p>\n<p><strong>\u064a\u062c\u0628 \u0623\u0646 \u064a\u062a\u0636\u0645\u0646 \u062a\u0642\u0631\u064a\u0631\u0643 \u0627\u0644\u062a\u062a\u0628\u0639 (\u0623\u0645\u0631 \u0627\u0644\u0634\u0631\u0627\u0621\u060c \u0627\u0644\u062f\u0641\u0639\u0629\u060c \u0627\u0644\u0623\u0631\u0642\u0627\u0645 \u0627\u0644\u062a\u0633\u0644\u0633\u0644\u064a\u0629)\u060c \u0648\u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0648\u062b\u0627\u0626\u0642\u060c \u0648\u0627\u0644\u0641\u062d\u0648\u0635\u0627\u062a \u0627\u0644\u0628\u0635\u0631\u064a\u0629\/\u0627\u0644\u0645\u064a\u0643\u0627\u0646\u064a\u0643\u064a\u0629\u060c \u0648\u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u0629\u060c \u0648\u0623\u062f\u0644\u0629 \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u0643\u0647\u0631\u0648\u0645\u063a\u0646\u0627\u0637\u064a\u0633\u064a\u060c \u0648\u062a\u0641\u0627\u0635\u064a\u0644 \u0627\u0644\u0628\u0631\u0627\u0645\u062c\/\u0627\u0644\u0628\u0631\u0627\u0645\u062c \u0627\u0644\u062b\u0627\u0628\u062a\u0629\u060c \u0648\u0646\u062a\u0627\u0626\u062c \u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u0623\u062f\u0627\u0621\u060c \u0648\u0639\u062f\u0645 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629 \u0645\u0639 \u0627\u0644\u0635\u0648\u0631\u060c \u0648\u0627\u0644\u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0627\u0644\u062a\u0635\u062d\u064a\u062d\u064a\u0629\u060c \u0648\u0642\u0631\u0627\u0631 \u0645\u0644\u062e\u0635 \u0645\u0648\u0642\u0639.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/2technician-conducts-electrical-safety-testing-on-a.jpg\" alt=\"\u0645\u0647\u0646\u062f\u0633 \u064a\u062e\u062a\u0628\u0631 \u062c\u0647\u0627\u0632\u064b\u0627 \u0625\u0644\u0643\u062a\u0631\u0648\u0646\u064a\u064b\u0627 \u0628\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0645\u062c\u0645\u0648\u0639\u0629 \u0645\u0639\u0627\u064a\u0631\u0629 (ID#2)\" title=\"\u0645\u0639\u0627\u064a\u0631\u0629 \u0627\u0644\u062c\u0647\u0627\u0632\" \/><\/p>\n<p>\u0644\u062a\u0644\u0628\u064a\u0629 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u0629\u060c \u0627\u0631\u062c\u0639 \u0625\u0644\u0649 <strong><a href=\"https:\/\/webstore.iec.ch\/publication\/2612\">\u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u0633\u0644\u0627\u0645\u0629 IEC 60601-1<\/a><\/strong> <sup><a href=\"#footnote-1\" id=\"ref-1\">1<\/a><\/sup> \u0648 <strong><a href=\"https:\/\/webstore.iec.ch\/publication\/29275\">\u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u0643\u0647\u0631\u0648\u0645\u063a\u0646\u0627\u0637\u064a\u0633\u064a IEC 60601-1-2<\/a><\/strong> <sup><a href=\"#footnote-2\" id=\"ref-2\">2<\/a><\/sup> \u062d\u064a\u062b\u0645\u0627 \u064a\u0646\u0637\u0628\u0642 \u0630\u0644\u0643. \u0644\u0645\u0648\u0627\u0621\u0645\u0629 \u0646\u0638\u0627\u0645 \u0627\u0644\u062c\u0648\u062f\u0629\u060c \u0627\u0633\u062a\u0634\u0647\u062f \u0628\u0640 <strong><a href=\"https:\/\/www.iso.org\/standard\/59752.html\">ISO 13485<\/a><\/strong> <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup>. \u0625\u0630\u0627 \u0643\u0646\u062a \u062a\u0633\u062a\u062e\u062f\u0645 \u0645\u062e\u062a\u0628\u0631\u0627\u062a \u062e\u0627\u0631\u062c\u064a\u0629\u060c \u0641\u062a\u0623\u0643\u062f \u0645\u0646 \u0623\u0646\u0647\u0627 <strong><a href=\"https:\/\/www.iso.org\/standard\/66912.html\">\u0645\u0639\u062a\u0645\u062f \u0648\u0641\u0642\u064b\u0627 \u0644\u0645\u0639\u064a\u0627\u0631 ISO\/IEC 17025<\/a><\/strong> <sup><a href=\"#footnote-4\" id=\"ref-4\">4<\/a><\/sup>.<\/p>\n<h3>\u0627\u0644\u0645\u062e\u0637\u0637 \u0627\u0644\u0623\u0633\u0627\u0633\u064a \u0627\u0644\u0630\u064a \u064a\u0645\u0643\u0646 \u0644\u0644\u062c\u0645\u064a\u0639 \u0627\u062a\u0628\u0627\u0639\u0647<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0627\u0644\u0642\u0633\u0645<\/th>\n<th>\u0645\u0627 \u062a\u062b\u0628\u062a\u0647<\/th>\n<th>\u0627\u0644\u0623\u062f\u0644\u0629 \u0627\u0644\u0646\u0645\u0648\u0630\u062c\u064a\u0629<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u0627\u0644\u0645\u0639\u0631\u0641\u0627\u062a \u0648\u062a\u0641\u0627\u0635\u064a\u0644 \u0627\u0644\u0634\u062d\u0646<\/td>\n<td>\u0627\u0644\u062a\u062a\u0628\u0639 \u0648\u0633\u0644\u0633\u0644\u0629 \u0627\u0644\u0639\u0647\u062f\u0629<\/td>\n<td>\u0623\u0645\u0631 \u0627\u0644\u0634\u0631\u0627\u0621\u060c \u0627\u0644\u0641\u0627\u062a\u0648\u0631\u0629\u060c \u0642\u0627\u0626\u0645\u0629 \u0627\u0644\u062f\u0641\u0639\u0627\u062a\/\u0627\u0644\u0623\u0631\u0642\u0627\u0645 \u0627\u0644\u062a\u0633\u0644\u0633\u0644\u064a\u0629\u060c \u0645\u0639\u0631\u0641 \u0627\u0644\u0645\u0641\u062a\u0634\u060c \u0627\u0644\u062a\u0627\u0631\u064a\u062e \u0648\u0627\u0644\u0645\u0648\u0642\u0639<\/td>\n<\/tr>\n<tr>\n<td>\u0645\u0631\u0627\u062c\u0639\u0629 \u0627\u0644\u0648\u062b\u0627\u0626\u0642<\/td>\n<td>\u0627\u0644\u062c\u0627\u0647\u0632\u064a\u0629 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629 \u0648\u0627\u0644\u062a\u0639\u0627\u0642\u062f\u064a\u0629<\/td>\n<td>\u0625\u0639\u0644\u0627\u0646 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629 CE\u060c 510(k) \u0623\u0648 \u0645\u0644\u0641\u060c ISO 13485\u060c \u0623\u062f\u0644\u0629\u060c \u0634\u0647\u0627\u062f\u0627\u062a \u0627\u0644\u0645\u0639\u0627\u064a\u0631\u0629<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0641\u062d\u0635 \u0627\u0644\u0628\u0635\u0631\u064a \u0648\u0627\u0644\u0645\u064a\u0643\u0627\u0646\u064a\u0643\u064a<\/td>\n<td>\u062c\u0648\u062f\u0629 \u0627\u0644\u0639\u0645\u0644 \u0648\u0627\u0644\u0627\u0643\u062a\u0645\u0627\u0644<\/td>\n<td>\u0645\u062c\u0645\u0648\u0639\u0629 \u0635\u0648\u0631\u060c \u0642\u0627\u0626\u0645\u0629 \u0627\u0644\u0645\u0644\u062d\u0642\u0627\u062a\u060c \u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a \u0648\u0627\u0644\u0639\u0644\u0627\u0645\u0627\u062a<\/td>\n<\/tr>\n<tr>\n<td>Electrical Safety (IEC 60601-1)<\/td>\n<td>\u062d\u0645\u0627\u064a\u0629 \u0627\u0644\u0645\u0631\u064a\u0636\/\u0627\u0644\u0645\u0633\u062a\u062e\u062f\u0645<\/td>\n<td>\u0646\u062a\u0627\u0626\u062c \u0627\u0633\u062a\u0645\u0631\u0627\u0631\u064a\u0629 \u0627\u0644\u062a\u0623\u0631\u064a\u0636\u060c \u0627\u0644\u062a\u0633\u0631\u0628\u060c \u0642\u0648\u0629 \u0627\u0644\u0639\u0632\u0644 \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a<\/td>\n<\/tr>\n<tr>\n<td>EMC (IEC 60601-1-2)<\/td>\n<td>\u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u062d\u0635\u0627\u0646\u0629\/\u0627\u0644\u0627\u0646\u0628\u0639\u0627\u062b\u0627\u062a<\/td>\n<td>\u0645\u0631\u0627\u062c\u0639 \u062a\u0642\u0627\u0631\u064a\u0631 \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631 \u0623\u0648 \u0646\u062a\u0627\u0626\u062c \u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u0641\u062d\u0635<\/td>\n<\/tr>\n<tr>\n<td>\u0648\u0638\u064a\u0641\u064a \u0648\u0623\u062f\u0627\u0626\u064a<\/td>\n<td>\u0627\u0644\u0645\u062e\u0631\u062c\u0627\u062a \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u062a\u0644\u0628\u064a \u0627\u0644\u0645\u0648\u0627\u0635\u0641\u0627\u062a<\/td>\n<td>\u0627\u0644\u0637\u0627\u0642\u0629\u060c \u0627\u0644\u062a\u0631\u062f\u062f\u060c \u062f\u0642\u0629 \u0639\u062f\u062f \u0627\u0644\u0646\u0628\u0636\u0627\u062a\u060c \u0641\u062d\u0648\u0635\u0627\u062a \u0648\u0627\u062c\u0647\u0629 \u0627\u0644\u0645\u0633\u062a\u062e\u062f\u0645<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0628\u0631\u0645\u062c\u064a\u0627\u062a \u0648\u0627\u0644\u0623\u0645\u0646 \u0627\u0644\u0633\u064a\u0628\u0631\u0627\u0646\u064a<\/td>\n<td>\u0627\u0644\u0625\u0635\u062f\u0627\u0631 \u0627\u0644\u0635\u062d\u064a\u062d \u0648\u0627\u0644\u0633\u0644\u0627\u0645\u0629<\/td>\n<td>\u0625\u0635\u062f\u0627\u0631 \u0627\u0644\u0628\u0631\u0646\u0627\u0645\u062c \u0627\u0644\u062b\u0627\u0628\u062a\u060c \u0627\u0644\u0645\u062c\u0645\u0648\u0639 \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631\u064a\u060c \u0636\u0648\u0627\u0628\u0637 \u0627\u0644\u0648\u0635\u0648\u0644\u060c \u0627\u0644\u0633\u062c\u0644\u0627\u062a<\/td>\n<\/tr>\n<tr>\n<td>\u062c\u0627\u0647\u0632\u064a\u0629 \u0627\u0644\u062a\u0639\u0628\u0626\u0629 \u0648\u0627\u0644\u0646\u0642\u0644<\/td>\n<td>\u0642\u0627\u0628\u0644\u064a\u0629 \u0627\u0644\u0628\u0642\u0627\u0621 \u0623\u062b\u0646\u0627\u0621 \u0627\u0644\u0634\u062d\u0646<\/td>\n<td>\u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u0633\u0642\u0648\u0637 \u0648\u0627\u0644\u0627\u0647\u062a\u0632\u0627\u0632 \u0648\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u062e\u062a\u0645 \u0648\u0641\u0642\u064b\u0627 \u0644\u0640 ISTA\/ASTM<\/td>\n<\/tr>\n<tr>\n<td>\u062d\u0627\u0644\u0627\u062a \u0639\u062f\u0645 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629 \u0648\u0627\u0644\u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0627\u0644\u062a\u0635\u062d\u064a\u062d\u064a\u0629 \u0648\u0627\u0644\u0648\u0642\u0627\u0626\u064a\u0629 (CAPA)<\/td>\n<td>\u0627\u0644\u0634\u0641\u0627\u0641\u064a\u0629 \u0648\u062e\u0637\u0629 \u0627\u0644\u0625\u063a\u0644\u0627\u0642<\/td>\n<td>\u0642\u0627\u0626\u0645\u0629 \u062d\u0627\u0644\u0627\u062a \u0639\u062f\u0645 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629\u060c \u0627\u0644\u0634\u062f\u0629\u060c \u0627\u0644\u0633\u0628\u0628 \u0627\u0644\u062c\u0630\u0631\u064a\u060c \u0627\u0644\u0625\u062c\u0631\u0627\u0621 \u0627\u0644\u062a\u0635\u062d\u064a\u062d\u064a \u0648\u062e\u0637\u0629 \u0625\u0639\u0627\u062f\u0629 \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u062a\u0648\u0642\u064a\u0639 \u0648\u0627\u0644\u062a\u0648\u0635\u064a\u0629<\/td>\n<td>\u0627\u0644\u0645\u0633\u0627\u0621\u0644\u0629<\/td>\n<td>\u0627\u062c\u062a\u064a\u0627\u0632\/\u0645\u0634\u0631\u0648\u0637\/\u0631\u0641\u0636\u060c \u0627\u0644\u062a\u0648\u0642\u064a\u0639\u0627\u062a\u060c \u0627\u0644\u0637\u0648\u0627\u0628\u0639 \u0627\u0644\u0632\u0645\u0646\u064a\u0629<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u0647\u0644 \u064a\u062c\u0628 \u0623\u0646 \u062a\u063a\u0637\u064a \u0627\u0644\u062a\u0642\u0627\u0631\u064a\u0631 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0633\u0644\u0627\u0645\u0629\u061f<\/h2>\n<p><strong>\u0646\u0639\u0645. \u064a\u062c\u0628 \u0623\u0646 \u062a\u063a\u0637\u064a \u0627\u0644\u062a\u0642\u0627\u0631\u064a\u0631 \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u0629 \u0648\u0641\u0642\u064b\u0627 \u0644\u0640 IEC 60601-1 \u0648\u062a\u0638\u0647\u0631 \u062f\u0644\u064a\u0644 \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u0643\u0647\u0631\u0648\u0645\u063a\u0646\u0627\u0637\u064a\u0633\u064a (EMC) \u0648\u0641\u0642\u064b\u0627 \u0644\u0640 IEC 60601-1-2. \u0642\u0645 \u0628\u062a\u0636\u0645\u064a\u0646 \u062a\u064a\u0627\u0631 \u0627\u0644\u062a\u0633\u0631\u0628 \u0627\u0644\u0645\u0642\u0627\u0633\u060c \u0648\u0645\u0642\u0627\u0648\u0645\u0629 \u0627\u0644\u0639\u0632\u0644\u060c \u0648\u0627\u0633\u062a\u0645\u0631\u0627\u0631\u064a\u0629 \u0627\u0644\u0623\u0631\u0636\u064a\u060c \u0648\u0642\u0648\u0629 \u0627\u0644\u0639\u0632\u0644 \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u060c \u0648\u0627\u0644\u0625\u0634\u0627\u0631\u0627\u062a \u0625\u0644\u0649 \u062a\u0642\u0627\u0631\u064a\u0631 \u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u0643\u0647\u0631\u0648\u0645\u063a\u0646\u0627\u0637\u064a\u0633\u064a \u0623\u0648 \u0646\u062a\u0627\u0626\u062c \u0627\u0644\u0641\u062d\u0635.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/3a-technician-measures-shockwave-energy-output-usin.jpg\" alt=\"\u0641\u0646\u064a \u064a\u062a\u062d\u0642\u0642 \u0645\u0646 \u062e\u0631\u062c \u0625\u0634\u0627\u0631\u0629 \u0642\u0637\u0639\u0629 \u0627\u0644\u064a\u062f \u0628\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0631\u0627\u0633\u0645 \u0627\u0644\u0630\u0628\u0630\u0628\u0627\u062a (ID#3)\" title=\"\u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0625\u0634\u0627\u0631\u0629\" \/><\/p>\n<p>\u062a\u062d\u0642\u0642 \u0623\u064a\u0636\u064b\u0627 \u0645\u0646 \u0631\u0645\u0648\u0632 \u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a \u0648\u0641\u0642\u064b\u0627 \u0644\u0640 <strong><a href=\"https:\/\/www.iso.org\/standard\/83482.html\">\u0627\u0644\u0623\u064a\u0632\u0648 15223-1 ISO 15223-1<\/a><\/strong> <sup><a href=\"#footnote-5\" id=\"ref-5\">5<\/a><\/sup> \u0648\u062a\u0633\u062c\u064a\u0644 \u0623\u064a \u0645\u0639\u0631\u0641\u0627\u062a \u062e\u0627\u0635\u0629 \u0628\u0627\u0644\u0633\u0648\u0642 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a \u0645\u062b\u0644 <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/device-labeling\/universal-device-identification-udi-system\">\u0645\u0644\u0635\u0642\u0627\u062a \u062c\u0647\u0627\u0632 UDI<\/a><\/strong> <sup><a href=\"#footnote-6\" id=\"ref-6\">6<\/a><\/sup> \u0639\u0646\u062f \u0627\u0644\u0627\u0642\u062a\u0636\u0627\u0621.<\/p>\n<p><strong>\u0643\u062a\u0644\u0629 \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u0629<\/strong><\/p>\n<ul>\n<li><strong>\u0627\u0633\u062a\u0645\u0631\u0627\u0631\u064a\u0629 \u0627\u0644\u0623\u0631\u0636\u064a \u0627\u0644\u0648\u0627\u0642\u064a (PE):<\/strong> \u0633\u062c\u0644 \u0627\u0644\u0645\u0642\u0627\u0648\u0645\u0629 \u0645\u0646 \u062f\u0628\u0648\u0633 PE \u0625\u0644\u0649 \u0627\u0644\u0647\u064a\u0643\u0644 \u0641\u064a \u0646\u0642\u0627\u0637 \u0645\u062a\u0639\u062f\u062f\u0629.<\/li>\n<li><strong>\u0645\u0642\u0627\u0648\u0645\u0629 \u0627\u0644\u0639\u0632\u0644:<\/strong> \u0627\u0644\u062a\u064a\u0627\u0631 \u0627\u0644\u0631\u0626\u064a\u0633\u064a \u0625\u0644\u0649 \u0627\u0644\u0623\u062c\u0632\u0627\u0621 \u0627\u0644\u062a\u064a \u064a\u0645\u0643\u0646 \u0627\u0644\u0648\u0635\u0648\u0644 \u0625\u0644\u064a\u0647\u0627 \u0639\u0646\u062f \u0627\u0644\u062c\u0647\u062f \u0648\u0627\u0644\u0645\u062f\u0629 \u0627\u0644\u0645\u062d\u062f\u062f\u064a\u0646.<\/li>\n<li><strong>\u062a\u064a\u0627\u0631\u0627\u062a \u0627\u0644\u062a\u0633\u0631\u0628:<\/strong> \u062a\u0633\u0631\u0628 \u0627\u0644\u0623\u0631\u0636\u064a\u060c \u0648\u0627\u0644\u0644\u0645\u0633\u060c \u0648\u0627\u0644\u0645\u0631\u064a\u0636 \u0641\u064a \u0627\u0644\u0638\u0631\u0648\u0641 \u0627\u0644\u0639\u0627\u062f\u064a\u0629 \u0648\u0638\u0631\u0648\u0641 \u0627\u0644\u062e\u0637\u0623 \u0627\u0644\u0645\u0641\u0631\u062f.<\/li>\n<li><strong>\u062a\u062d\u0645\u0644 \u0627\u0644\u0639\u0632\u0644 \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a (HiPot):<\/strong> \u0627\u0644\u062a\u064a\u0627\u0631 \u0627\u0644\u0631\u0626\u064a\u0633\u064a \u0625\u0644\u0649 \u0627\u0644\u063a\u0644\u0627\u0641 \u0648\u062f\u0627\u0626\u0631\u0629 \u0627\u0644\u0645\u0631\u064a\u0636 \u062d\u0633\u0628 \u0627\u0644\u062a\u0635\u0646\u064a\u0641.<\/li>\n<\/ul>\n<p><strong>\u0643\u062a\u0644\u0629 \u062f\u0644\u064a\u0644 \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u0643\u0647\u0631\u0648\u0645\u063a\u0646\u0627\u0637\u064a\u0633\u064a (EMC)<\/strong><\/p>\n<ul>\n<li><strong>\u0628\u064a\u0627\u0646 \u0627\u0644\u0627\u0646\u0628\u0639\u0627\u062b\u0627\u062a\/\u0627\u0644\u062d\u0635\u0627\u0646\u0629:<\/strong> \u0623\u0631\u0641\u0642 \u0634\u0647\u0627\u062f\u0629 \u0645\u062e\u062a\u0628\u0631 \u0645\u0639\u062a\u0645\u062f \u0623\u0648 \u0631\u0642\u0645 \u0645\u0631\u062c\u0639 \u0627\u0644\u062a\u0642\u0631\u064a\u0631 \u0627\u0644\u0643\u0627\u0645\u0644.<\/li>\n<li><strong>\u0627\u0644\u0641\u062d\u0635 \u0627\u0644\u0645\u064a\u062f\u0627\u0646\u064a (\u0639\u0646\u062f \u0648\u062c\u0648\u062f \u062a\u0642\u0631\u064a\u0631 \u0645\u062e\u062a\u0628\u0631 \u0643\u0627\u0645\u0644 \u0645\u0633\u0628\u0642\u064b\u0627):<\/strong> \u0633\u062c\u0644 \u0627\u0644\u0641\u062d\u0648\u0635\u0627\u062a \u0627\u0644\u0633\u0631\u064a\u0639\u0629 \u0644\u0644\u062d\u0635\u0627\u0646\u0629 \u0627\u0644\u0643\u0647\u0631\u0648\u0645\u063a\u0646\u0627\u0637\u064a\u0633\u064a\u0629 \u0648\u0627\u0644\u0625\u0634\u0639\u0627\u0639\u064a\u0629 \u0625\u0630\u0627 \u0643\u0627\u0646 \u0628\u0644\u062f\u0643 \u0627\u0644\u0645\u0633\u062a\u0644\u0645 \u064a\u0637\u0644\u0628 \u0627\u0644\u062a\u062d\u0642\u0642 \u0627\u0644\u0648\u0627\u0631\u062f.<\/li>\n<\/ul>\n<p><strong>\u0642\u0627\u0628\u0644\u064a\u0629 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0648\u0627\u0644\u0625\u0646\u0630\u0627\u0631\u0627\u062a<\/strong><\/p>\n<ul>\n<li><strong>\u0627\u062e\u062a\u0628\u0627\u0631 \u0625\u064a\u0642\u0627\u0641 \u0627\u0644\u0637\u0648\u0627\u0631\u0626:<\/strong> \u062a\u0623\u0643\u064a\u062f \u0627\u0644\u0625\u063a\u0644\u0627\u0642 \u0627\u0644\u0641\u0648\u0631\u064a \u0648\u062a\u0633\u062c\u064a\u0644 \u0627\u0644\u062e\u0637\u0623.<\/li>\n<li><strong>\u0623\u0642\u0641\u0627\u0644 \u0627\u0644\u062d\u0645\u0627\u064a\u0629 \u0645\u0646 \u0627\u0644\u062d\u0631\u0627\u0631\u0629 \u0627\u0644\u0632\u0627\u0626\u062f\u0629\/\u0627\u0644\u0636\u063a\u0637 \u0627\u0644\u0632\u0627\u0626\u062f:<\/strong> \u0641\u0631\u0636 \u0648\u062a\u0633\u062c\u064a\u0644 \u0646\u0642\u0627\u0637 \u0627\u0644\u062a\u0639\u062b\u0631 \u0648\u0633\u0644\u0648\u0643 \u0627\u0644\u0627\u0633\u062a\u0639\u0627\u062f\u0629.<\/li>\n<\/ul>\n<hr \/>\n<h2>\u0647\u0644 \u062a\u062a\u0636\u0645\u0646 \u0627\u0644\u062a\u0642\u0627\u0631\u064a\u0631 \u0646\u062a\u0627\u0626\u062c \u0627\u0644\u0623\u062f\u0627\u0621\u061f<\/h2>\n<p><strong>\u0646\u0639\u0645. \u064a\u062c\u0628 \u0623\u0646 \u064a\u062a\u0636\u0645\u0646 \u0627\u0644\u062a\u0642\u0631\u064a\u0631 \u0627\u0644\u0642\u064a\u0627\u0633\u0627\u062a \u0639\u0628\u0631 \u0646\u0637\u0627\u0642 \u0627\u0644\u062a\u0634\u063a\u064a\u0644 \u0627\u0644\u0645\u0639\u0644\u0646: \u0627\u0644\u0637\u0627\u0642\u0629\/\u0627\u0644\u0636\u063a\u0637\u060c \u062f\u0642\u0629 \u0627\u0644\u062a\u0631\u062f\u062f\u060c \u062f\u0642\u0629 \u0639\u062f\u062f \u0627\u0644\u0646\u0628\u0636\u0627\u062a\u060c \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0639\u0645\u0642 \u0627\u0644\u062a\u0631\u0643\u064a\u0632 (\u0644\u0644\u0623\u0646\u0638\u0645\u0629 \u0627\u0644\u0645\u0631\u0643\u0632\u0629)\u060c \u0648\u0627\u0644\u062a\u0643\u0631\u0627\u0631\/\u0627\u0644\u0627\u0633\u062a\u0642\u0631\u0627\u0631 \u0628\u0645\u0631\u0648\u0631 \u0627\u0644\u0648\u0642\u062a.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/4lab-setup-showing-a-shockwave-handpiece-running-en.jpg\" alt=\"\u062c\u0647\u0627\u0632 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0639\u0644\u0649 \u0637\u0627\u0648\u0644\u0629 \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631 \u0645\u062a\u0635\u0644 \u0628\u0627\u0644\u0628\u0631\u0646\u0627\u0645\u062c \u0648\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0627\u0633\u062a\u0634\u0639\u0627\u0631 (ID#4)\" title=\"\u0625\u0639\u062f\u0627\u062f \u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u0645\u0639\u0645\u0644\" \/><\/p>\n<p>\u062d\u064a\u062b \u062a\u062a\u0637\u0644\u0628 \u0645\u0639\u0627\u064a\u0631\u0629 \u0627\u0644\u0637\u0627\u0642\u0629 \u0627\u0644\u062a\u062d\u0642\u0642 \u0627\u0644\u0635\u0648\u062a\u064a\u060c \u0642\u0645 \u0628\u062a\u0648\u062b\u064a\u0642 \u0627\u0644\u0637\u0631\u064a\u0642\u0629 \u0648\u0634\u0647\u0627\u062f\u0627\u062a \u0627\u0644\u0645\u062e\u062a\u0628\u0631 (\u064a\u0641\u0636\u0644 \u0623\u0646 \u062a\u0643\u0648\u0646 \u0645\u0639\u062a\u0645\u062f\u0629) <strong><a href=\"https:\/\/ilac.org\/ilac-mra-and-signatories\/\">ILAC MRA<\/a><\/strong>-\u0645\u0639\u062a\u0631\u0641 \u0628\u0647\u0627) <sup><a href=\"#footnote-7\" id=\"ref-7\">7<\/a><\/sup>.<\/p>\n<h3>\u0645\u0635\u0641\u0648\u0641\u0629 \u0627\u0644\u0623\u062f\u0627\u0621 \u0627\u0644\u062c\u0627\u0647\u0632\u0629 \u0644\u0644\u0645\u064a\u062f\u0627\u0646 (\u0645\u0627\u0630\u0627 \u062a\u0642\u064a\u0633)<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0627\u0644\u0645\u0639\u0644\u0645\u0629<\/th>\n<th>\u0627\u0644\u0637\u0631\u064a\u0642\u0629 \/ \u0627\u0644\u0623\u062f\u0627\u0629<\/th>\n<th>\u0645\u062b\u0627\u0644 \u0627\u0644\u0642\u0628\u0648\u0644<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u0623\u0642\u0635\u0649 \u0636\u063a\u0637 \/ EFD<\/td>\n<td>\u062e\u0632\u0627\u0646 \u0647\u064a\u062f\u0631\u0648\u0641\u0648\u0646 \u0623\u0648 \u0645\u0633\u062a\u0634\u0639\u0631 \u0636\u063a\u0637 \u0645\u0639\u0627\u064a\u0631<\/td>\n<td>\u0636\u0645\u0646 \u00b110% \u0645\u0646 \u0627\u0644\u0645\u0648\u0627\u0635\u0641\u0627\u062a \u0639\u0628\u0631 \u0646\u0642\u0627\u0637 \u0627\u0644\u0636\u0628\u0637<\/td>\n<\/tr>\n<tr>\n<td>\u062f\u0642\u0629 \u0627\u0644\u062a\u0631\u062f\u062f<\/td>\n<td>\u0645\u0633\u062a\u0634\u0639\u0631 \u0628\u0635\u0631\u064a\/\u0635\u0648\u062a\u064a + \u0627\u0644\u062a\u0642\u0627\u0637 \u0627\u0644\u0645\u0624\u0642\u062a<\/td>\n<td>\u00b10.2 \u0647\u0631\u062a\u0632 \u0623\u0648 \u062d\u0633\u0628 \u0627\u0644\u0645\u0648\u0627\u0635\u0641\u0627\u062a<\/td>\n<\/tr>\n<tr>\n<td>\u062f\u0642\u0629 \u0639\u062f \u0627\u0644\u0646\u0628\u0636\u0627\u062a<\/td>\n<td>\u0642\u0627\u0631\u0646 \u0639\u062f\u0627\u062f \u0627\u0644\u062c\u0647\u0627\u0632 \u0645\u0642\u0627\u0628\u0644 \u0627\u0644\u0639\u062f\u0627\u062f \u0627\u0644\u062e\u0627\u0631\u062c\u064a<\/td>\n<td>\u00b11% \u0639\u0644\u0649 \u0645\u062f\u0649 10,000 \u0646\u0628\u0636\u0629<\/td>\n<\/tr>\n<tr>\n<td>\u0639\u0645\u0642 \u0627\u0644\u0628\u0624\u0631\u0629 \/ \u0634\u0643\u0644 \u0627\u0644\u062d\u0632\u0645\u0629<\/td>\n<td>\u0634\u0628\u064a\u0647 \u0627\u0644\u0623\u0646\u0633\u062c\u0629 \u0623\u0648 \u0623\u062f\u0627\u0629 \u062a\u062d\u062f\u064a\u062f \u0627\u0644\u0645\u0648\u0636\u0639<\/td>\n<td>\u0636\u0645\u0646 \u062a\u062d\u0645\u0644 \u0627\u0644\u0639\u0645\u0642 \u0627\u0644\u0645\u062d\u062f\u062f<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0633\u062a\u0642\u0631\u0627\u0631 \u0627\u0644\u062e\u0631\u062c (\u0627\u0644\u0627\u0646\u062c\u0631\u0627\u0641)<\/td>\n<td>\u0645\u0633\u062d \u062a\u062d\u0645\u0644 \u0644\u0645\u062f\u0629 30-60 \u062f\u0642\u064a\u0642\u0629 \u0628\u0625\u0639\u062f\u0627\u062f\u0627\u062a \u062b\u0627\u0628\u062a\u0629<\/td>\n<td>\u0627\u0644\u0627\u0646\u062c\u0631\u0627\u0641 \u22645% \u0645\u0646 \u062e\u0637 \u0627\u0644\u0623\u0633\u0627\u0633<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u0647\u0644 \u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u0645\u062a\u0627\u0646\u0629 \u062c\u0632\u0621 \u0645\u0646 \u0627\u0644\u062a\u0642\u0627\u0631\u064a\u0631\u061f<\/h2>\n<p><strong>\u0646\u0639\u0645. \u0642\u0645 \u0628\u062a\u0636\u0645\u064a\u0646 \u0623\u062f\u0644\u0629 \u0627\u0644\u0645\u062a\u0627\u0646\u0629 \u0627\u0644\u0645\u0646\u0627\u0633\u0628\u0629 \u0644\u0641\u0626\u0629 \u0627\u0644\u062c\u0647\u0627\u0632: \u0641\u062d\u0648\u0635\u0627\u062a \u0639\u0645\u0631 \u0627\u0644\u0646\u0628\u0636\u0627\u062a \u0639\u0644\u0649 \u0642\u0637\u0639 \u0627\u0644\u064a\u062f\u060c \u0648\u062f\u0648\u0631\u0627\u062a \u062d\u0631\u0627\u0631\u064a\u0629\u060c \u0648\u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0625\u062c\u0647\u0627\u062f \u0627\u0644\u0645\u0648\u0635\u0644\u0627\u062a\u060c \u0648\u062c\u0648\u0644\u0627\u062a \u062a\u062d\u0645\u0644 \u0645\u062d\u062f\u0648\u062f\u0629. \u0644\u0627 \u062a\u062d\u062a\u0627\u062c \u0625\u0644\u0649 \u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u0639\u0645\u0631 \u0639\u0646\u062f \u0627\u0644\u0627\u0633\u062a\u0644\u0627\u0645\u060c \u0648\u0644\u0643\u0646 \u064a\u062c\u0628 \u0639\u0644\u064a\u0643 \u062a\u0642\u062f\u064a\u0645 \u0646\u062a\u0627\u0626\u062c \u0625\u062c\u0647\u0627\u062f \u062a\u0645\u062b\u064a\u0644\u064a\u0629 \u0648\u0641\u062d\u0635 \u0627\u0644\u0623\u062c\u0632\u0627\u0621 \u0627\u0644\u0628\u0627\u0644\u064a\u0629.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/5technician-performs-carton-drop-test-with-shock-in.jpg\" alt=\"\u0639\u0627\u0645\u0644 \u064a\u062e\u062a\u0628\u0631 \u0642\u0648\u0629 \u0627\u0644\u062a\u0639\u0628\u0626\u0629 \u0648\u0627\u0644\u062a\u063a\u0644\u064a\u0641 \u0639\u0644\u0649 \u0622\u0644\u0629 \u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u0633\u0642\u0648\u0637 (ID#5)\" title=\"\u0627\u062e\u062a\u0628\u0627\u0631 \u0645\u0631\u0627\u0642\u0628\u0629 \u062c\u0648\u062f\u0629 \u0627\u0644\u062a\u0639\u0628\u0626\u0629 \u0648\u0627\u0644\u062a\u063a\u0644\u064a\u0641\" \/><\/p>\n<p>\u0642\u0645 \u0628\u062a\u0636\u0645\u064a\u0646 \u0627\u0644\u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0627\u0644\u062a\u0635\u062d\u064a\u062d\u064a\u0629 \u0636\u0645\u0646 <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/postmarket-requirements-devices\/corrective-and-preventive-actions-capa\">\u0639\u0645\u0644\u064a\u0629 CAPA \u0627\u0644\u0631\u0633\u0645\u064a\u0629<\/a><\/strong> <sup><a href=\"#footnote-8\" id=\"ref-8\">8<\/a><\/sup> \u0648\u0627\u0631\u0628\u0637 \u0627\u0644\u0646\u062a\u0627\u0626\u062c \u0628\u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 \u0627\u0644\u062e\u0627\u0635 \u0628\u0643.<\/p>\n<p><strong>\u0627\u0644\u062a\u062d\u0645\u0644 \u0628\u0646\u0627\u0621\u064b \u0639\u0644\u0649 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645<\/strong><\/p>\n<ul>\n<li><strong>\u0623\u062e\u0630 \u0639\u064a\u0646\u0627\u062a \u0645\u0646 \u0639\u0645\u0631 \u0627\u0644\u0646\u0628\u0636\u0627\u062a:<\/strong> \u0637\u0628\u0642 100 \u0623\u0644\u0641 - 200 \u0623\u0644\u0641 \u0646\u0628\u0636\u0629 \u0628\u0625\u0639\u062f\u0627\u062f\u0627\u062a \u0633\u0631\u064a\u0631\u064a\u0629 \u0639\u0644\u0649 \u0648\u062d\u062f\u0627\u062a \u0627\u0644\u0639\u064a\u0646\u0629\u061b \u0633\u062c\u0644 \u0627\u0644\u0627\u0646\u062c\u0631\u0627\u0641 \u0648\u0627\u0644\u0636\u0648\u0636\u0627\u0621.<\/li>\n<li><strong>\u0641\u062d\u0635 \u0627\u0644\u0623\u062c\u0632\u0627\u0621 \u0627\u0644\u0642\u0627\u0628\u0644\u0629 \u0644\u0644\u062a\u0622\u0643\u0644:<\/strong> \u0627\u0641\u062d\u0635 \u0627\u0644\u0631\u0635\u0627\u0635\u0629\u060c \u0623\u0646\u0628\u0648\u0628 \u0627\u0644\u062a\u0648\u062c\u064a\u0647\u060c \u062d\u0644\u0642\u0627\u062a O\u060c \u0648\u0648\u062c\u0648\u0647 \u0627\u0644\u0645\u0637\u0628\u0642 \u062a\u062d\u062a \u0627\u0644\u062a\u0643\u0628\u064a\u0631\u061b \u0635\u0648\u0631 \u0639\u0644\u0627\u0645\u0627\u062a \u0627\u0644\u062a\u0622\u0643\u0644.<\/li>\n<\/ul>\n<p><strong>\u0627\u0644\u062d\u0631\u0627\u0631\u0629 \u0648\u062f\u0648\u0631\u0629 \u0627\u0644\u062a\u0634\u063a\u064a\u0644<\/strong><\/p>\n<ul>\n<li><strong>\u0645\u062d\u0627\u0643\u0627\u0629 \u062f\u0648\u0631\u0629 \u0627\u0644\u062a\u0634\u063a\u064a\u0644:<\/strong> 10 \u062f\u0642\u0627\u0626\u0642 \u062a\u0634\u063a\u064a\u0644 \/ 5 \u062f\u0642\u0627\u0626\u0642 \u0625\u064a\u0642\u0627\u0641 \u0644\u0645\u062f\u0629 20 \u062f\u0648\u0631\u0629\u061b \u0633\u062c\u0644 \u0623\u0642\u0635\u0649 \u062f\u0631\u062c\u0629 \u062d\u0631\u0627\u0631\u0629 \u0644\u0644\u0647\u064a\u0643\u0644 \u0648\u0623\u064a \u0623\u062d\u062f\u0627\u062b \u0627\u062e\u062a\u0646\u0627\u0642.<\/li>\n<li><strong>\u0641\u062d\u0635 \u0646\u0638\u0627\u0641\u0629 \u0627\u0644\u0645\u0631\u0648\u062d\u0629\/\u0627\u0644\u0645\u0634\u062a\u062a \u0627\u0644\u062d\u0631\u0627\u0631\u064a:<\/strong> \u062a\u062d\u0642\u0642 \u0645\u0646 \u062a\u062f\u0641\u0642 \u0627\u0644\u0647\u0648\u0627\u0621 \u0648\u0627\u0631\u062a\u0641\u0627\u0639 \u062f\u0631\u062c\u0629 \u0627\u0644\u062d\u0631\u0627\u0631\u0629 \u0645\u0642\u0627\u0628\u0644 \u0627\u0644\u0645\u0648\u0627\u0635\u0641\u0627\u062a.<\/li>\n<\/ul>\n<p><strong>\u0625\u062c\u0647\u0627\u062f \u0627\u0644\u0643\u0627\u0628\u0644 \u0648\u0627\u0644\u0645\u0648\u0635\u0644<\/strong><\/p>\n<ul>\n<li><strong>\u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u0627\u0646\u062d\u0646\u0627\u0621\/\u0627\u0644\u0625\u062c\u0647\u0627\u062f:<\/strong> 200 \u062f\u0648\u0631\u0629 \u0628\u0646\u0635\u0641 \u0627\u0644\u0642\u0637\u0631 \u0627\u0644\u0645\u062d\u062f\u062f\u061b \u0641\u062d\u0635 \u0628\u0635\u0631\u064a \u0644\u0644\u0634\u0642\u0648\u0642 \u0648\u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u0627\u0633\u062a\u0645\u0631\u0627\u0631\u064a\u0629.<\/li>\n<li><strong>\u0625\u062f\u062e\u0627\u0644\u0627\u062a \u0627\u0644\u0645\u0648\u0635\u0644:<\/strong> 200 \u062f\u0648\u0631\u0629 \u062a\u0648\u0635\u064a\u0644\/\u0641\u0635\u0644\u061b \u062a\u062d\u0642\u0642 \u0645\u0646 \u0648\u0638\u064a\u0641\u0629 \u0627\u0644\u0645\u0632\u0644\u0627\u062c \u0648\u062a\u0622\u0643\u0644 \u0627\u0644\u062a\u0644\u0627\u0645\u0633.<\/li>\n<\/ul>\n<hr \/>\n<h2>\u0647\u0644 \u064a\u062c\u0628 \u062a\u0636\u0645\u064a\u0646 \u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u062a\u0639\u0628\u0626\u0629 \u0648\u0627\u0644\u062a\u063a\u0644\u064a\u0641\u061f<\/h2>\n<p><strong>\u0646\u0639\u0645. \u0642\u0645 \u0628\u062a\u0636\u0645\u064a\u0646 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u062a\u0639\u0628\u0626\u0629 \u0645\u0639 \u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u0633\u0642\u0648\u0637\u060c \u0627\u0644\u0627\u0647\u062a\u0632\u0627\u0632\u060c \u0627\u0644\u0636\u063a\u0637\u060c \u0648\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u062e\u062a\u0645. \u0627\u0631\u062c\u0639 \u0625\u0644\u0649 \u0637\u0631\u0642 ISTA \u0623\u0648 ASTM \u062d\u064a\u062b\u0645\u0627 \u0623\u0645\u0643\u0646\u060c \u0648\u0633\u062c\u0644 \u0627\u0644\u0646\u062a\u0627\u0626\u062c \u0645\u0639 \u0635\u0648\u0631 \u0627\u0644\u0623\u0636\u0631\u0627\u0631 \u0648\u0642\u0631\u0627\u0621\u0627\u062a \u0645\u0624\u0634\u0631 \u0627\u0644\u0635\u062f\u0645\u0629\/\u0627\u0644\u0645\u064a\u0644.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/5technician-performs-carton-drop-test-with-shock-in.jpg\" alt=\"\u0639\u0627\u0645\u0644 \u064a\u062e\u062a\u0628\u0631 \u0642\u0648\u0629 \u0627\u0644\u062a\u0639\u0628\u0626\u0629 \u0648\u0627\u0644\u062a\u063a\u0644\u064a\u0641 \u0639\u0644\u0649 \u0622\u0644\u0629 \u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u0633\u0642\u0648\u0637 (ID#5)\" title=\"\u0627\u062e\u062a\u0628\u0627\u0631 \u0645\u0631\u0627\u0642\u0628\u0629 \u062c\u0648\u062f\u0629 \u0627\u0644\u062a\u0639\u0628\u0626\u0629 \u0648\u0627\u0644\u062a\u063a\u0644\u064a\u0641\" \/><\/p>\n<p>\u0644\u0645\u062a\u0627\u0646\u0629 \u0627\u0644\u0646\u0642\u0644\u060c \u062a\u0648\u0627\u0641\u0642 \u0645\u0639 <strong><a href=\"https:\/\/ista.org\/pages\/standards\/ista-3-series.php\">ISTA 3A<\/a><\/strong> <sup><a href=\"#footnote-9\" id=\"ref-9\">9<\/a><\/sup> \u0644\u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u0645\u0646\u062a\u062c \u0627\u0644\u0645\u0639\u0628\u0623\u060c \u0648\u0627\u0633\u062a\u062e\u062f\u0645 <strong><a href=\"https:\/\/www.astm.org\/d0642-15.html\">\u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u0636\u063a\u0637 ASTM D642<\/a><\/strong> <sup><a href=\"#footnote-10\" id=\"ref-10\">10<\/a><\/sup> \u0644\u0645\u0642\u0627\u0648\u0645\u0629 \u0627\u0644\u062a\u0643\u062f\u064a\u0633.<\/p>\n<h3>\u0644\u0642\u0637\u0629 \u062a\u0623\u0647\u064a\u0644 \u0627\u0644\u062a\u0639\u0628\u0626\u0629 \u0648\u0627\u0644\u062a\u063a\u0644\u064a\u0641<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0646\u0648\u0639 \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631<\/th>\n<th>\u0627\u0644\u063a\u0631\u0636<\/th>\n<th>\u0627\u0644\u0637\u0631\u064a\u0642\u0629 \/ \u0627\u0644\u0645\u0633\u062a\u0648\u0649 \u0627\u0644\u0646\u0645\u0648\u0630\u062c\u064a<\/th>\n<th>\u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u0646\u062c\u0627\u062d<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u0625\u0633\u0642\u0627\u0637 (\u0637\u0631\u062f\/\u0645\u0646\u0635\u0629 \u0646\u0642\u0627\u0644\u0629)<\/td>\n<td>\u0642\u062f\u0631\u0629 \u062a\u062d\u0645\u0644 \u0627\u0644\u0635\u062f\u0645\u0627\u062a<\/td>\n<td>ISTA 3A\/2A\u061b \u0625\u0633\u0642\u0627\u0637\u0627\u062a \u0627\u0644\u062d\u0627\u0641\u0629\/\u0627\u0644\u0632\u0627\u0648\u064a\u0629\/\u0627\u0644\u0648\u062c\u0647<\/td>\n<td>\u0644\u0627 \u064a\u0648\u062c\u062f \u062a\u0644\u0641 \u0648\u0638\u064a\u0641\u064a\u061b \u062e\u062f\u0648\u0634 \u0637\u0641\u064a\u0641\u0629 \u0645\u0642\u0628\u0648\u0644\u0629<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0647\u062a\u0632\u0627\u0632 \u0639\u0634\u0648\u0627\u0626\u064a<\/td>\n<td>\u062a\u062d\u0645\u0644 \u0627\u0647\u062a\u0632\u0627\u0632 \u0627\u0644\u0646\u0642\u0644<\/td>\n<td>\u0645\u0644\u0641 \u062a\u0639\u0631\u064a\u0641 ISTA 3A \u0639\u0644\u0649 \u0633\u0637\u062d \u0637\u0627\u0648\u0644\u0629 \u0623\u0648 \u0645\u0646\u0635\u0629 \u0646\u0642\u0627\u0644\u0629<\/td>\n<td>\u0644\u0627 \u062a\u0648\u062c\u062f \u0623\u062c\u0632\u0627\u0621 \u0645\u0641\u0643\u0648\u0643\u0629\u061b \u0644\u0627 \u064a\u0648\u062c\u062f \u0627\u0646\u062d\u0631\u0627\u0641 \u0641\u064a \u0627\u0644\u0645\u0639\u0627\u064a\u0631\u0629<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0636\u063a\u0637<\/td>\n<td>\u0645\u0642\u0627\u0648\u0645\u0629 \u0627\u0644\u062a\u0643\u062f\u064a\u0633<\/td>\n<td>\u0645\u0627 \u064a\u0639\u0627\u062f\u0644 ASTM D642<\/td>\n<td>\u062a\u0645\u0631 \u0627\u0644\u0643\u0631\u062a\u0648\u0646\u0629 \u0628\u0627\u0644\u062d\u0645\u0644 \u0627\u0644\u0645\u062d\u062f\u062f \u062f\u0648\u0646 \u0627\u0646\u0647\u064a\u0627\u0631<\/td>\n<\/tr>\n<tr>\n<td>\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u062e\u062a\u0645<\/td>\n<td>\u062d\u0645\u0627\u064a\u0629 \u0645\u0646 \u062f\u062e\u0648\u0644 \u0627\u0644\u0631\u0637\u0648\u0628\u0629\/\u0627\u0644\u063a\u0628\u0627\u0631<\/td>\n<td>\u0633\u062d\u0642 \u0627\u0644\u062d\u0627\u0641\u0629 (ECT)\u060c \u062e\u062a\u0645 \u0627\u0644\u0634\u0631\u064a\u0637\u060c \u0641\u062d\u0635 \u0627\u0644\u0645\u062c\u0641\u0641<\/td>\n<td>\u0627\u0644\u0623\u062e\u062a\u0627\u0645 \u0633\u0644\u064a\u0645\u0629\u061b \u0644\u0648\u0646 \u0628\u0637\u0627\u0642\u0629 \u0627\u0644\u0645\u0624\u0634\u0631 \u0636\u0645\u0646 \u0627\u0644\u0646\u0637\u0627\u0642<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u0639\u0646\u0627\u0635\u0631 \u0625\u0636\u0627\u0641\u064a\u0629 \u062a\u0639\u0632\u0632 \u0623\u064a \u062a\u0642\u0631\u064a\u0631<\/h2>\n<p><strong>\u0627\u0644\u0628\u0631\u0627\u0645\u062c \u0648\u0627\u0644\u0635\u062d\u0629 \u0627\u0644\u0633\u064a\u0628\u0631\u0627\u0646\u064a\u0629:<\/strong> \u0644\u0627\u062d\u0638 \u0625\u0635\u062f\u0627\u0631 \u0627\u0644\u0628\u0631\u0646\u0627\u0645\u062c \u0627\u0644\u062b\u0627\u0628\u062a\u060c \u0648\u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0645\u062c\u0645\u0648\u0639 \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631\u064a\u060c \u0648\u0645\u0631\u062c\u0639 \u0633\u062c\u0644 \u0627\u0644\u062a\u063a\u064a\u064a\u0631\u060c \u0648\u0633\u064a\u0627\u0633\u0629 \u0643\u0644\u0645\u0629 \u0627\u0644\u0645\u0631\u0648\u0631\u060c \u0648\u0645\u0627 \u0625\u0630\u0627 \u0643\u0627\u0646 \u0648\u0636\u0639 \u0627\u0644\u062a\u0634\u062e\u064a\u0635 \u0645\u0642\u0641\u0644\u0627\u064b.<br \/>\n<strong>\u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a \u0648\u062a\u062d\u062f\u064a\u062f \u0627\u0644\u0647\u0648\u064a\u0629 \u0627\u0644\u0641\u0631\u064a\u062f (UDI):<\/strong> \u062a\u0623\u0643\u064a\u062f \u0645\u0644\u0635\u0642\u0627\u062a \u0627\u0644\u062c\u0647\u0627\u0632\u060c \u0648\u062a\u062d\u062f\u064a\u062f \u0627\u0644\u0647\u0648\u064a\u0629 \u0627\u0644\u0641\u0631\u064a\u062f\/\u0627\u0644\u0623\u0631\u0642\u0627\u0645 \u0627\u0644\u062a\u0633\u0644\u0633\u0644\u064a\u0629\u060c \u0648\u062a\u0627\u0631\u064a\u062e \u0627\u0644\u062a\u0635\u0646\u064a\u0639\u060c \u0648\u0627\u0644\u062a\u062d\u0630\u064a\u0631\u0627\u062a\u060c \u0648\u0627\u0644\u0631\u0645\u0648\u0632 \u0648\u0641\u0642\u064b\u0627 \u0644\u0644\u0645\u0639\u064a\u0627\u0631 ISO 15223-1.<br \/>\n<strong>\u0643\u062a\u064a\u0628\u0627\u062a \u0645\u062a\u0639\u062f\u062f\u0629 \u0627\u0644\u0644\u063a\u0627\u062a:<\/strong> \u062a\u062d\u0642\u0642 \u0645\u0646 \u062a\u0637\u0627\u0628\u0642 \u0627\u0644\u0644\u063a\u0629 \u0645\u0639 \u0639\u0642\u062f \u0627\u0644\u0634\u0631\u0627\u0621\u061b \u062a\u0623\u0643\u064a\u062f \u0627\u0644\u0627\u062a\u0633\u0627\u0642 \u0628\u064a\u0646 \u0644\u063a\u0629 \u0648\u0627\u062c\u0647\u0629 \u0627\u0644\u0645\u0633\u062a\u062e\u062f\u0645 \u0648\u0644\u0642\u0637\u0627\u062a \u0634\u0627\u0634\u0629 \u0627\u0644\u0643\u062a\u064a\u0628.<br \/>\n<strong>\u0627\u0644\u0645\u0634\u0643\u0644\u0627\u062a \u0627\u0644\u0645\u0641\u062a\u0648\u062d\u0629 \u0648\u0627\u0644\u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0627\u0644\u062a\u0635\u062d\u064a\u062d\u064a\u0629 \u0648\u0627\u0644\u0648\u0642\u0627\u0626\u064a\u0629 (CAPA):<\/strong> \u0633\u0631\u062f \u062a\u0642\u0627\u0631\u064a\u0631 \u0639\u062f\u0645 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629 (NCRs) \u0645\u0639 \u0634\u062f\u062a\u0647\u0627 (\u062d\u0631\u062c\u0629\/\u0631\u0626\u064a\u0633\u064a\u0629\/\u062b\u0627\u0646\u0648\u064a\u0629)\u060c \u0648\u0627\u0644\u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0627\u0644\u062a\u0635\u062d\u064a\u062d\u064a\u0629 \u0627\u0644\u0645\u0642\u062a\u0631\u062d\u0629\u060c \u0648\u0627\u0644\u0645\u0633\u0624\u0648\u0644\u064a\u0646\u060c \u0648\u062a\u0648\u0627\u0631\u064a\u062e \u0625\u0639\u0627\u062f\u0629 \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631.<br \/>\n<strong>\u0627\u0644\u062a\u0648\u0642\u064a\u0639\u0627\u062a:<\/strong> \u0627\u0644\u0645\u0641\u062a\u0634\u060c \u0648\u0645\u0648\u0627\u0641\u0642 \u0627\u0644\u062c\u0648\u062f\u0629\u060c \u0648\u0645\u0645\u062b\u0644 \u0627\u0644\u0645\u0648\u0631\u062f. \u0645\u062e\u062a\u0648\u0645\u0629 \u0628\u0627\u0644\u0648\u0642\u062a.<\/p>\n<hr \/>\n<h2>\u0627\u0644\u062e\u0627\u062a\u0645\u0629<\/h2>\n<p>\u0627\u0644\u062a\u0642\u0627\u0631\u064a\u0631 \u0627\u0644\u0642\u0648\u064a\u0629 \u062a\u062b\u0628\u062a \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0648\u0627\u0644\u0623\u062f\u0627\u0621 \u0648\u0627\u0644\u0645\u062a\u0627\u0646\u0629 \u0648\u0645\u0631\u0648\u0646\u0629 \u0627\u0644\u062a\u0639\u0628\u0626\u0629 \u0648\u0627\u0644\u062a\u063a\u0644\u064a\u0641\u060c \u0644\u0630\u0627 \u062a\u0642\u0628\u0644 \u0628\u062b\u0642\u0629 - \u0623\u0648 \u0627\u0631\u0641\u0636 \u0628\u0627\u0644\u0623\u062f\u0644\u0629. \u0642\u0645 \u0628\u0628\u0646\u0627\u0626\u0647\u0627 \u0645\u0631\u0629 \u0648\u0627\u062d\u062f\u0629\u060c \u0648\u0627\u0633\u062a\u062e\u062f\u0645\u0647\u0627 \u0639\u0628\u0631 \u0627\u0644\u0639\u0644\u0627\u0645\u0627\u062a \u0627\u0644\u062a\u062c\u0627\u0631\u064a\u0629\u060c \u0648\u062d\u0627\u0641\u0638 \u0639\u0644\u0649 \u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0645\u0631\u0636\u0649 \u0648\u0627\u0644\u0623\u0631\u0628\u0627\u062d.<\/p>\n<hr \/>\n<h2>\u0627\u0644\u062d\u0648\u0627\u0634\u064a<\/h2>\n<p><span id=\"footnote-1\">1. \u064a\u062d\u062f\u062f \u0627\u0644\u0645\u0639\u064a\u0627\u0631 IEC 60601-1 \u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u0629 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u0629. <a href=\"#ref-1\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-2\">2. \u064a\u063a\u0637\u064a \u0627\u0644\u0645\u0639\u064a\u0627\u0631 IEC 60601-1-2 \u0623\u062f\u0644\u0629 \u0627\u0644\u0627\u0646\u0628\u0639\u0627\u062b\u0627\u062a \u0627\u0644\u0643\u0647\u0631\u0648\u0645\u063a\u0646\u0627\u0637\u064a\u0633\u064a\u0629 \u0648\u0627\u0644\u0645\u0646\u0627\u0639\u0629. <a href=\"#ref-2\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-3\">3. \u064a\u062d\u062f\u062f \u0627\u0644\u0645\u0639\u064a\u0627\u0631 ISO 13485 \u062a\u0648\u0642\u0639\u0627\u062a \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 (QMS) \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629. <a href=\"#ref-3\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-4\">4. \u064a\u0636\u0645\u0646 \u0627\u0644\u0627\u0639\u062a\u0645\u0627\u062f ISO\/IEC 17025 \u0645\u062e\u062a\u0628\u0631\u0627\u062a \u0627\u062e\u062a\u0628\u0627\u0631 \u0645\u062e\u062a\u0635\u0629. <a href=\"#ref-4\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-5\">5. \u064a\u0648\u062d\u062f \u0645\u0639\u064a\u0627\u0631 ISO 15223-1 \u0627\u0644\u0631\u0645\u0648\u0632 \u0627\u0644\u0645\u0633\u062a\u062e\u062f\u0645\u0629 \u0641\u064a \u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a \u0627\u0644\u062e\u0627\u0635\u0629 \u0628\u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629. <a href=\"#ref-5\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-6\">6. \u064a\u062d\u0633\u0646 \u0646\u0638\u0627\u0645 UDI \u0627\u0644\u062e\u0627\u0635 \u0628\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 (FDA) \u0625\u0645\u0643\u0627\u0646\u064a\u0629 \u0627\u0644\u062a\u062a\u0628\u0639 \u0648\u0639\u0645\u0644\u064a\u0627\u062a \u0627\u0644\u0627\u0633\u062a\u062f\u0639\u0627\u0621. <a href=\"#ref-6\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-7\">7. \u064a\u0639\u0632\u0632 \u0627\u0639\u062a\u0631\u0627\u0641 ILAC MRA \u0642\u0628\u0648\u0644 \u0627\u0644\u062a\u0642\u0627\u0631\u064a\u0631 \u0639\u0627\u0644\u0645\u064a\u064b\u0627. <a href=\"#ref-7\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-8\">8. \u064a\u0624\u0637\u0631 \u0625\u0637\u0627\u0631 \u0639\u0645\u0644 CAPA \u0627\u0644\u062e\u0627\u0635 \u0628\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 (FDA) \u0627\u0644\u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0627\u0644\u062a\u0635\u062d\u064a\u062d\u064a\u0629. <a href=\"#ref-8\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-9\">9. \u064a\u0648\u0641\u0631 ISTA 3A \u0637\u0631\u0642 \u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u0633\u0642\u0648\u0637 \u0648\u0627\u0644\u0627\u0647\u062a\u0632\u0627\u0632 \u0644\u0644\u0637\u0631\u062f. <a href=\"#ref-9\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-10\">10. \u064a\u0642\u064a\u0633 ASTM D642 \u0645\u0642\u0627\u0648\u0645\u0629 \u0627\u0644\u0639\u0628\u0648\u0627\u062a \u0644\u0644\u0636\u063a\u0637. <a href=\"#ref-10\">\ufe0e<\/a><\/span>  <\/p>","protected":false},"excerpt":{"rendered":"<p>As a manufacturer exporting globally, I review inspection reports weekly. I want them clear, test-driven, and defensible for regulators and insurers. A complete inspection report for imported shockwave therapy machines should document identification, documentation checks, safety compliance, performance data, durability evidence, software and labeling verification, and packaging tests, ending with a clear pass\/conditional accept\/reject recommendation [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":8185,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[60],"tags":[],"class_list":["post-8182","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-shockwave-therapy-machine"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>What Should Be Included in the Quality Inspection Report for Imported Shockwave Therapy Machines? - KMSLaser<\/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:\/\/kmslaser.com\/ar\/\u0645\u0627-\u0627\u0644\u0630\u064a-\u064a\u062c\u0628-\u062a\u0636\u0645\u064a\u0646\u0647-\u0641\u064a-\u062a\u0642\u0631\u064a\u0631-\u0641\u062d\u0635-\u0627\u0644\u062c\u0648\u062f\u0629-\u0644\/\" \/>\n<meta property=\"og:locale\" content=\"ar_AR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What Should Be Included in the Quality Inspection Report for Imported Shockwave Therapy Machines?\" \/>\n<meta property=\"og:description\" content=\"As a manufacturer exporting globally, I review inspection reports weekly. 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I want them clear, test-driven, and defensible for regulators and insurers. A complete inspection report for imported shockwave therapy machines should document identification, documentation checks, safety compliance, performance data, durability evidence, software and labeling verification, and packaging tests, ending with a clear pass\/conditional accept\/reject recommendation [&hellip;]","og_url":"https:\/\/kmslaser.com\/ar\/\u0645\u0627-\u0627\u0644\u0630\u064a-\u064a\u062c\u0628-\u062a\u0636\u0645\u064a\u0646\u0647-\u0641\u064a-\u062a\u0642\u0631\u064a\u0631-\u0641\u062d\u0635-\u0627\u0644\u062c\u0648\u062f\u0629-\u0644\/","og_site_name":"KMSLaser","article_published_time":"2025-10-11T12:05:34+00:00","article_modified_time":"2025-10-19T13:03:04+00:00","og_image":[{"width":682,"height":455,"url":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/4lab-setup-showing-a-shockwave-handpiece-running-en.jpg","type":"image\/jpeg"}],"author":"Sophia Wu","twitter_card":"summary_large_image","twitter_misc":{"\u0643\u064f\u062a\u0628 \u0628\u0648\u0627\u0633\u0637\u0629":"Sophia Wu","\u0648\u0642\u062a \u0627\u0644\u0642\u0631\u0627\u0621\u0629 \u0627\u0644\u0645\u064f\u0642\u062f\u0651\u0631":"7 \u062f\u0642\u0627\u0626\u0642"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/kmslaser.com\/what-should-be-included-in-the-quality-inspection-report-for-imported-shockwave-therapy-machines\/#article","isPartOf":{"@id":"https:\/\/kmslaser.com\/what-should-be-included-in-the-quality-inspection-report-for-imported-shockwave-therapy-machines\/"},"author":{"name":"Sophia Wu","@id":"https:\/\/kmslaser.com\/#\/schema\/person\/c37fe1d989e6bd9dbe4f1f7b6cfa9588"},"headline":"What Should Be Included in the Quality Inspection Report for Imported Shockwave Therapy Machines?","datePublished":"2025-10-11T12:05:34+00:00","dateModified":"2025-10-19T13:03:04+00:00","mainEntityOfPage":{"@id":"https:\/\/kmslaser.com\/what-should-be-included-in-the-quality-inspection-report-for-imported-shockwave-therapy-machines\/"},"wordCount":1128,"commentCount":0,"publisher":{"@id":"https:\/\/kmslaser.com\/#organization"},"image":{"@id":"https:\/\/kmslaser.com\/what-should-be-included-in-the-quality-inspection-report-for-imported-shockwave-therapy-machines\/#primaryimage"},"thumbnailUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/4lab-setup-showing-a-shockwave-handpiece-running-en.jpg","articleSection":["Shockwave Therapy Machine"],"inLanguage":"ar","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/kmslaser.com\/what-should-be-included-in-the-quality-inspection-report-for-imported-shockwave-therapy-machines\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/kmslaser.com\/what-should-be-included-in-the-quality-inspection-report-for-imported-shockwave-therapy-machines\/","url":"https:\/\/kmslaser.com\/what-should-be-included-in-the-quality-inspection-report-for-imported-shockwave-therapy-machines\/","name":"\u0645\u0627 \u0627\u0644\u0630\u064a \u064a\u062c\u0628 \u062a\u0636\u0645\u064a\u0646\u0647 \u0641\u064a \u062a\u0642\u0631\u064a\u0631 \u0641\u062d\u0635 \u062c\u0648\u062f\u0629 \u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u0629\u061f - 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