{"id":8025,"date":"2025-09-18T16:18:11","date_gmt":"2025-09-18T16:18:11","guid":{"rendered":"https:\/\/kmslaser.com\/?p=8025"},"modified":"2025-09-18T16:28:20","modified_gmt":"2025-09-18T16:28:20","slug":"%d9%83%d9%8a%d9%81%d9%8a%d8%a9-%d8%aa%d9%82%d9%8a%d9%8a%d9%85-%d8%ac%d9%87%d8%a7%d8%b2-%d8%a7%d9%84%d8%b9%d9%84%d8%a7%d8%ac-%d8%a8%d8%a7%d9%84%d9%85%d9%88%d8%ac%d8%a7%d8%aa-%d8%a7%d9%84%d8%b5%d8%af","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/ar\/how-to-assess-a-shockwave-therapy-machine-for-international-safety-compliance\/","title":{"rendered":"\u0643\u064a\u0641 \u062a\u0642\u064a\u0651\u0645 \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 \u0644\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0627\u0644\u062f\u0648\u0644\u064a \u0644\u0644\u0633\u0644\u0627\u0645\u0629\u061f"},"content":{"rendered":"<p><iframe data-testid=\"embed-iframe\" style=\"border-radius:12px\" src=\"https:\/\/open.spotify.com\/embed\/episode\/4o7evsmNCUvqqRcI0mKJTk?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\/09\/1-Gemini_Generated_Image_lboyoslboyoslboy.png\" alt=\"\u0642\u0627\u0626\u0645\u0629 \u0645\u0631\u062c\u0639\u064a\u0629 \u0628\u0627\u0644\u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u062f\u0648\u0644\u064a\u0629 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0645\u0639 \u0633\u0645\u0627\u0639\u0629 \u0637\u0628\u064a\u0629\" class=\"top-image-square\">\n<\/p>\n<p>\u0644\u0642\u062f \u0631\u0623\u064a\u062a \u0645\u0634\u062a\u0631\u064a\u0646 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\u0648\u0641\u0642\u064b\u0627 \u0644\u0640 ISO 10993\u060c \u0648\u0645\u0644\u0641 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0648\u0641\u0642\u064b\u0627 \u0644\u0640 ISO 14971. \u062b\u0645 \u062a\u062d\u0642\u0642 \u0645\u0646 \u062d\u0627\u0644\u0629 FDA \u0623\u0648 CE\u060c \u0628\u0627\u0644\u0625\u0636\u0627\u0641\u0629 \u0625\u0644\u0649 \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 ISO 13485.<\/strong><\/p>\n<p>\u0623\u0633\u062a\u062e\u062f\u0645 \u0645\u0633\u0627\u0631\u064b\u0627 \u0628\u0633\u064a\u0637\u064b\u0627. \u0623\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u0645\u0637\u0628\u0642\u0629\u060c \u062b\u0645 \u0623\u0637\u0644\u0628 \u0627\u0644\u0625\u062b\u0628\u0627\u062a\u0627\u062a. \u0623\u062a\u062d\u0642\u0642 \u0645\u0646 \u0623\u0631\u0642\u0627\u0645 \u0627\u0644\u0637\u0631\u0627\u0632\u0627\u062a\u060c \u0648\u062a\u0648\u0627\u0631\u064a\u062e \u0627\u0644\u062a\u0642\u0627\u0631\u064a\u0631\u060c \u0648\u0627\u0639\u062a\u0645\u0627\u062f \u0627\u0644\u0645\u062e\u062a\u0628\u0631. \u0644\u0627 \u0623\u062a\u0627\u0628\u0639 \u0625\u0644\u0627 \u0639\u0646\u062f\u0645\u0627 \u062a\u062a\u0637\u0627\u0628\u0642 \u0627\u0644\u0623\u0648\u0631\u0627\u0642 \u0648\u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a \u0645\u0639 \u0627\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0645\u0648\u062c\u0648\u062f \u0641\u064a \u0627\u0644\u064a\u062f.<\/p>\n<h2>\u0645\u0627 \u0647\u064a \u0623\u062c\u0632\u0627\u0621 IEC 60601 \u0627\u0644\u062a\u064a \u062a\u0646\u0637\u0628\u0642 \u0639\u0644\u0649 \u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629\u061f<\/h2>\n<p>\u063a\u0627\u0644\u0628\u064b\u0627 \u0645\u0627 \u0623\u062d\u0635\u0644 \u0639\u0644\u0649 \u0625\u062c\u0627\u0628\u0627\u062a \u062c\u0632\u0626\u064a\u0629 \u0645\u062b\u0644 \u201c\u0644\u0642\u062f \u0627\u062c\u062a\u0632\u0646\u0627 60601\u201d. \u0647\u0630\u0627 \u063a\u064a\u0631 \u0643\u0627\u0641\u064d. \u0623\u062d\u062a\u0627\u062c \u0625\u0644\u0649 \u0627\u0644\u0623\u062c\u0632\u0627\u0621 \u0648\u0627\u0644\u0625\u0635\u062f\u0627\u0631\u0627\u062a \u0627\u0644\u062f\u0642\u064a\u0642\u0629\u060c \u0648\u0625\u0644\u0627 \u0633\u0623\u0646\u0633\u062d\u0628.<\/p>\n<p><strong>\u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629\u060c \u0627\u0628\u062f\u0623 \u0628\u0640 IEC 60601-1 \u0644\u0644\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u0629 \u0648\u0627\u0644\u0623\u062f\u0627\u0621 \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u060c \u0648\u0623\u0636\u0641 IEC 60601-1-2 \u0644\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u0643\u0647\u0631\u0648\u0645\u063a\u0646\u0627\u0637\u064a\u0633\u064a\u060c \u0648\u0642\u0645 \u0628\u062a\u0636\u0645\u064a\u0646 \u0627\u0644\u062c\u0632\u0621 \u0627\u0644\u0645\u062d\u062f\u062f \u0630\u064a \u0627\u0644\u0635\u0644\u0629 (\u0645\u062b\u0644 IEC 60601-2-36 \u0644\u0623\u062c\u0647\u0632\u0629 \u062a\u0641\u062a\u064a\u062a \u0627\u0644\u062d\u0635\u0648\u0627\u062a \u0623\u0648 \u0627\u0644\u062c\u0632\u0621 \u0627\u0644\u062e\u0627\u0635 \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0627\u0644\u0645\u0637\u0628\u0642)\u060c \u0648\u0642\u0645 \u0628\u062a\u0639\u064a\u064a\u0646 \u0627\u0644\u0628\u0631\u0645\u062c\u064a\u0627\u062a \u0625\u0644\u0649 IEC 62304 \u0645\u0639 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0628\u0645\u0648\u062c\u0628 ISO 14971.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/09\/2-a-professional-lab-environment-where-a-shockwave-t.jpg\" alt=\"\u0645\u0647\u0646\u062f\u0633\u0648\u0646 \u064a\u062e\u062a\u0628\u0631\u0648\u0646 \u0627\u0645\u062a\u062b\u0627\u0644 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0641\u064a \u0627\u0644\u0645\u062e\u062a\u0628\u0631\" title=\"\u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u062c\u0647\u0627\u0632\" \/><\/p>\n<p>\u0623\u062d\u0627\u0641\u0638 \u0639\u0644\u0649 \u062e\u0631\u064a\u0637\u062a\u064a IEC \u0628\u0633\u064a\u0637\u0629 \u0648\u0635\u0627\u0631\u0645\u0629. \u0623\u0628\u062f\u0623 \u0645\u0646 \u0642\u0627\u0639\u062f\u0629 \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0639\u0627\u0645\u0629\u060c, <a href=\"https:\/\/webstore.iec.ch\/publication\/2612\">IEC 60601-1 \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0639\u0627\u0645\u0629 \u0648\u0627\u0644\u0623\u062f\u0627\u0621 \u0627\u0644\u0623\u0633\u0627\u0633\u064a<\/a> <sup><a href=\"#footnote-1\" id=\"ref-1\">1<\/a><\/sup>. \u064a\u063a\u0637\u064a \u0627\u0644\u0635\u062f\u0645\u0627\u062a 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\u0627\u0644\u0628\u0646\u0648\u062f \u0644\u0644\u0639\u0646\u0627\u0635\u0631 \u0627\u0644\u0641\u0627\u0634\u0644\u0629 \u0648\u0636\u0648\u0627\u0628\u0637 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0627\u0644\u0645\u0637\u0628\u0642\u0629. \u0628\u0639\u062f \u0630\u0644\u0643\u060c \u0623\u0624\u0643\u062f \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u0643\u0647\u0631\u0648\u0645\u063a\u0646\u0627\u0637\u064a\u0633\u064a \u0628\u0645\u0648\u062c\u0628 <a href=\"https:\/\/webstore.iec.ch\/publication\/2613\">IEC 60601-1-2 \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u0643\u0647\u0631\u0648\u0645\u063a\u0646\u0627\u0637\u064a\u0633\u064a<\/a> <sup><a href=\"#footnote-2\" id=\"ref-2\">2<\/a><\/sup>. \u0623\u0628\u062d\u062b \u0639\u0646 \u0627\u0644\u0627\u0646\u0628\u0639\u0627\u062b\u0627\u062a\u060c \u0648\u0627\u0644\u0645\u0646\u0627\u0639\u0629\u060c \u0648\u0645\u0633\u062a\u0648\u064a\u0627\u062a ESD\u060c \u0648\u0627\u0644\u0645\u0646\u0627\u0639\u0629 \u0627\u0644\u0645\u0634\u0639\u0629\u060c \u0648\u0627\u0644\u0645\u0646\u0627\u0639\u0629 \u0627\u0644\u0645\u0648\u0635\u0644\u0629\u060c \u0648\u0627\u0644\u0627\u0646\u062f\u0641\u0627\u0639\u060c \u0648\u0627\u0646\u062e\u0641\u0627\u0636 \u0627\u0644\u062c\u0647\u062f\u060c \u0648\u0627\u0644\u062a\u0648\u0627\u0641\u0642\u064a\u0627\u062a. \u064a\u062a\u0636\u0645\u0646 \u0627\u0644\u062a\u0642\u0631\u064a\u0631 \u0627\u0644\u062d\u0642\u064a\u0642\u064a \u0645\u0633\u062a\u0648\u064a\u0627\u062a \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631\u060c \u0648\u0627\u0644\u0623\u0648\u0636\u0627\u0639\u060c \u0648\u0635\u0648\u0631 \u0627\u0644\u0625\u0639\u062f\u0627\u062f\u060c \u0648\u0645\u0644\u0627\u062d\u0638\u0627\u062a \u0627\u0644\u0646\u062c\u0627\u062d\/\u0627\u0644\u0641\u0634\u0644.<\/p>\n<p>\u062b\u0645 \u0623\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u201c\u0627\u0644\u062e\u0627\u0635\u201d \u0628\u0627\u0644\u062c\u0647\u0627\u0632. \u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u062e\u0627\u0631\u062c \u0627\u0644\u062c\u0633\u0645 \u0627\u0644\u062a\u064a \u062a\u0633\u062a\u0647\u062f\u0641 \u0627\u0644\u0623\u0646\u0633\u062c\u0629 \u0623\u0648 \u0627\u0644\u062d\u0635\u0648\u0627\u062a\u060c \u064a\u0639\u0627\u0644\u062c \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0627\u0644\u062e\u0627\u0635 \u0627\u0644\u0645\u062e\u0631\u062c\u0627\u062a \u0627\u0644\u0635\u0648\u062a\u064a\u0629\u060c \u0648\u0636\u0648\u0627\u0628\u0637 \u0627\u0644\u0637\u0627\u0642\u0629\u060c \u0648\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0645\u0644\u062d\u0642\u0627\u062a\u060c \u0648\u0627\u0644\u0645\u0644\u062d\u0642\u0627\u062a. \u0623\u0624\u0643\u062f \u0627\u0644\u062c\u0632\u0621 \u0648\u0627\u0644\u0625\u0635\u062f\u0627\u0631 \u0627\u0644\u062f\u0642\u064a\u0642 \u0627\u0644\u0630\u064a \u0627\u0633\u062a\u062e\u062f\u0645\u0647 \u0627\u0644\u0645\u062e\u062a\u0628\u0631\u060c \u0645\u062b\u0644 <a href=\"https:\/\/webstore.iec.ch\/publication\/5257\">IEC 60601-2-36 \u0644\u062a\u0641\u062a\u064a\u062a \u0627\u0644\u062d\u0635\u0648\u0627\u062a \u062e\u0627\u0631\u062c \u0627\u0644\u062c\u0633\u0645<\/a> <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup>. \u0642\u062f \u062a\u0646\u062f\u0631\u062c \u0623\u0646\u0648\u0627\u0639 \u0645\u062e\u062a\u0644\u0641\u0629 \u0645\u0646 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629\u060c \u0645\u062b\u0644 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0645\u0631\u0643\u0632\u0629 \u0623\u0648 \u0627\u0644\u0634\u0639\u0627\u0639\u064a\u0629 \u0623\u0648 \u0627\u0644\u0643\u0647\u0631\u0636\u063a\u0637\u064a\u0629\u060c \u062a\u062d\u062a \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0623\u0648 \u0625\u0631\u0634\u0627\u062f\u0627\u062a \u0645\u062d\u062f\u062f\u0629 \u0645\u062e\u062a\u0644\u0641\u0629\u060c \u0644\u0630\u0644\u0643 \u0623\u0637\u0644\u0628 \u0645\u0646 \u0627\u0644\u0645\u0648\u0631\u062f \u062a\u062d\u062f\u064a\u062f \u0641\u0626\u0629 \u0627\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u062f\u0642\u064a\u0642\u0629 \u0648\u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0645\u0642\u0635\u0648\u062f. \u0625\u0630\u0627 \u0643\u0627\u0646 \u0627\u0644\u062c\u0647\u0627\u0632 \u064a\u062d\u062a\u0648\u064a \u0639\u0644\u0649 \u0623\u064a \u062a\u062d\u0643\u0645 \u0628\u0631\u0645\u062c\u064a\u060c \u0641\u0623\u0646\u0627 \u0623\u0631\u0628\u0637\u0647 \u0628\u0640 <a href=\"https:\/\/webstore.iec.ch\/publication\/22795\">\u0639\u0645\u0644\u064a\u0627\u062a \u062f\u0648\u0631\u0629 \u062d\u064a\u0627\u0629 \u0627\u0644\u0628\u0631\u0645\u062c\u064a\u0627\u062a IEC 62304<\/a> <sup><a href=\"#footnote-4\" id=\"ref-4\">4<\/a><\/sup>. \u0648\u0623\u062a\u062d\u0642\u0642 \u0623\u064a\u0636\u064b\u0627 \u0645\u0646 \u0645\u0644\u0641 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0648\u0641\u0642\u064b\u0627 \u0644\u0640 <a href=\"https:\/\/www.iso.org\/standard\/72704.html\">\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 ISO 14971<\/a> <sup><a href=\"#footnote-5\" id=\"ref-5\">5<\/a><\/sup>. \u064a\u062c\u0628 \u0623\u0646 \u064a\u0631\u0628\u0637 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 (\u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u0629\u060c \u0627\u0644\u0645\u064a\u0643\u0627\u0646\u064a\u0643\u064a\u0629\u060c \u0627\u0644\u062c\u0631\u0639\u0629 \u0627\u0644\u0632\u0627\u0626\u062f\u0629 \u0627\u0644\u0635\u0648\u062a\u064a\u0629\u060c \u0627\u0644\u0641\u0634\u0644 \u0641\u064a \u0627\u0644\u0625\u0637\u0644\u0627\u0642\u060c \u062e\u0637\u0623 \u0648\u0627\u062c\u0647\u0629 \u0627\u0644\u0645\u0633\u062a\u062e\u062f\u0645) \u0628\u0627\u0644\u0636\u0648\u0627\u0628\u0637\u060c \u0648\u064a\u0638\u0647\u0631 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0643\u0644 \u0636\u0627\u0628\u0637.<\/p>\n<h3>\u062e\u0631\u064a\u0637\u0629 \u0645\u0639\u0627\u064a\u064a\u0631 IEC \u0627\u0644\u062a\u064a \u0623\u0637\u0644\u0628\u0647\u0627<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0645\u0646\u0637\u0642\u0629 \u0627\u0644\u0633\u0644\u0627\u0645\u0629<\/th>\n<th>\u0627\u0644\u0645\u0639\u064a\u0627\u0631 \/ \u0627\u0644\u062c\u0632\u0621<\/th>\n<th>\u0645\u0627 \u0623\u062a\u062d\u0642\u0642 \u0645\u0646\u0647<\/th>\n<th>\u0627\u0644\u0623\u062f\u0644\u0629 \u0627\u0644\u0645\u0637\u0644\u0648\u0628\u0629<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u0629 \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u0629<\/td>\n<td>IEC 60601-1<\/td>\n<td>\u0627\u0644\u0625\u0635\u062f\u0627\u0631 \u0648\u0627\u0644\u062a\u0639\u062f\u064a\u0644\u0627\u062a\u061b \u062a\u064a\u0627\u0631 \u0627\u0644\u062a\u0633\u0631\u0628\u061b \u0627\u0644\u0639\u0632\u0644 \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u061b \u0627\u0644\u0623\u062f\u0627\u0621 \u0627\u0644\u0623\u0633\u0627\u0633\u064a<\/td>\n<td>\u062a\u0642\u0631\u064a\u0631 \u0627\u062e\u062a\u0628\u0627\u0631 \u0643\u0627\u0645\u0644 + \u0634\u0647\u0627\u062f\u0629 CB<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u0643\u0647\u0631\u0648\u0645\u063a\u0646\u0627\u0637\u064a\u0633\u064a (EMC)<\/td>\n<td>IEC 60601-1-2<\/td>\n<td>\u0645\u0633\u062a\u0648\u064a\u0627\u062a \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631\u061b \u0635\u0648\u0631 \u0627\u0644\u0625\u0639\u062f\u0627\u062f\u061b \u0627\u062c\u062a\u064a\u0627\u0632\/\u0641\u0634\u0644<\/td>\n<td>\u062a\u0642\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 (EMC) \u0645\u0646 \u0645\u062e\u062a\u0628\u0631 \u0645\u0639\u062a\u0645\u062f<\/td>\n<\/tr>\n<tr>\n<td>\u062e\u0627\u0635 (\u0645\u0648\u062c\u0629 \u0635\u0627\u062f\u0645\u0629)<\/td>\n<td>IEC 60601-2-36 \u0623\u0648 \u062e\u0627\u0635\u064a\u0629 \u0642\u0627\u0628\u0644\u0629 \u0644\u0644\u062a\u0637\u0628\u064a\u0642<\/td>\n<td>\u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0635\u0648\u062a\u064a\u0629\u061b \u0627\u0644\u0636\u0648\u0627\u0628\u0637\u061b \u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a<\/td>\n<td>\u062a\u0642\u0631\u064a\u0631 \u0627\u062e\u062a\u0628\u0627\u0631 \u062e\u0627\u0635 \u0645\u0639 \u0639\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u0646\u062c\u0627\u062d<\/td>\n<\/tr>\n<tr>\n<td>\u062f\u0648\u0631\u0629 \u062d\u064a\u0627\u0629 \u0627\u0644\u0628\u0631\u0646\u0627\u0645\u062c<\/td>\n<td>IEC 62304<\/td>\n<td>\u0627\u0644\u0641\u0626\u0629 A\/B\/C\u061b \u0627\u0644\u062a\u062d\u0642\u0642\u061b \u0627\u0644\u062a\u062d\u0643\u0645 \u0641\u064a \u0627\u0644\u062a\u063a\u064a\u064a\u0631<\/td>\n<td>\u0645\u0644\u0641 \u0627\u0644\u0628\u0631\u0646\u0627\u0645\u062c \u0645\u0639 \u0645\u0635\u0641\u0648\u0641\u0629 \u0627\u0644\u062a\u062a\u0628\u0639<\/td>\n<\/tr>\n<tr>\n<td>\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631<\/td>\n<td>ISO 14971<\/td>\n<td>\u062a\u062d\u0644\u064a\u0644 \u0627\u0644\u0645\u062e\u0627\u0637\u0631\u061b \u0636\u0648\u0627\u0628\u0637 \u0627\u0644\u0645\u062e\u0627\u0637\u0631\u061b \u0627\u0644\u062a\u062d\u0642\u0642<\/td>\n<td>\u062a\u0642\u0631\u064a\u0631 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0627\u0644\u0645\u0631\u062a\u0628\u0637 \u0628\u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u0644\u0627 \u0623\u0642\u0628\u0644 \u201c\u0634\u0647\u0627\u062f\u0629\u201d \u0645\u0646 \u0635\u0641\u062d\u0629 \u0648\u0627\u062d\u062f\u0629. \u0623\u0646\u0627 \u0623\u062b\u0642 \u0641\u0642\u0637 \u0641\u064a \u062a\u0642\u0631\u064a\u0631 \u0643\u0627\u0645\u0644\u060c \u0648\u0639\u0646\u062f \u0627\u0644\u0625\u0645\u0643\u0627\u0646\u060c \u0634\u0647\u0627\u062f\u0629 \u0627\u062e\u062a\u0628\u0627\u0631 CB \u0645\u0639 \u062a\u0642\u0631\u064a\u0631 \u0627\u062e\u062a\u0628\u0627\u0631 CB. \u0623\u0646\u0627 \u0623\u064a\u0636\u064b\u0627 \u0623\u062a\u062d\u0642\u0642 \u0645\u0646 \u0623\u0646 \u0627\u0644\u0645\u062e\u062a\u0628\u0631 \u0647\u0648 <a href=\"https:\/\/ilac.org\/ilac-mra-and-signatories\/\">\u0645\u062e\u062a\u0628\u0631 \u0645\u0639\u062a\u0645\u062f \u0648\u0641\u0642\u064b\u0627 \u0644\u0645\u0639\u064a\u0627\u0631 ISO\/IEC 17025<\/a> <sup><a href=\"#footnote-6\" id=\"ref-6\">6<\/a><\/sup>. \u0625\u0630\u0627 \u0643\u0627\u0646 \u0645\u0644\u0635\u0642 \u0627\u0644\u0645\u0646\u062a\u062c \u0623\u0648 \u0644\u0648\u062d\u0629 \u0627\u0644\u062a\u0642\u064a\u064a\u0645 \u0644\u0627 \u062a\u062a\u0637\u0627\u0628\u0642 \u0645\u0639 \u0646\u0645\u0648\u0630\u062c \u0627\u0644\u062a\u0642\u0631\u064a\u0631\u060c \u0623\u062a\u0648\u0642\u0641 \u0639\u0646 \u0627\u0644\u0634\u0631\u0627\u0621.<\/p>\n<h2>\u0647\u0644 \u0627\u0644\u062c\u0647\u0627\u0632 \u0645\u0639\u062a\u0645\u062f \u0645\u0646 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 (FDA) \u0623\u0648 \u064a\u062d\u0645\u0644 \u0639\u0644\u0627\u0645\u0629 CE\u061f<\/h2>\n<p>\u0644\u0627 \u0623\u0639\u062a\u0645\u062f \u0639\u0644\u0649 \u0627\u062f\u0639\u0627\u0621\u0627\u062a \u0627\u0644\u0645\u0628\u064a\u0639\u0627\u062a \u0644\u0640 \u201c\u0645\u0648\u0627\u0641\u0642\u0629 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629\u201d. \u0623\u0646\u0627 \u0623\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0645\u0633\u0627\u0631 \u0627\u0644\u062f\u0642\u064a\u0642\u060c \u0648\u0631\u0645\u0632 \u0627\u0644\u0645\u0646\u062a\u062c\u060c \u0648\u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0645\u0642\u0635\u0648\u062f.<\/p>\n<p><strong>\u0641\u064a \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629\u060c \u0623\u0628\u062d\u062b \u0639\u0646 \u062a\u0635\u0631\u064a\u062d 510(k) \u0627\u0644\u0630\u064a \u064a\u062a\u0637\u0627\u0628\u0642 \u0645\u0639 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0645\u0642\u0635\u0648\u062f \u0648\u0646\u0648\u0639 \u0627\u0644\u062c\u0647\u0627\u0632. \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u060c \u0623\u0624\u0643\u062f \u0639\u0644\u0627\u0645\u0629 CE \u0628\u0645\u0648\u062c\u0628 MDR \u0645\u0639 \u0625\u0639\u0644\u0627\u0646 \u0645\u0637\u0627\u0628\u0642\u0629 \u0635\u0627\u0644\u062d\u060c \u0648\u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0630\u0627\u062a \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u0623\u0639\u0644\u0649\u060c \u0634\u0647\u0627\u062f\u0629 \u0647\u064a\u0626\u0629 \u0645\u0639\u062a\u0645\u062f\u0629 \u062a\u0634\u064a\u0631 \u0625\u0644\u0649 \u0627\u0644\u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u0635\u062d\u064a\u062d\u0629 \u0648\u0627\u0644\u0646\u0645\u0648\u0630\u062c \u0627\u0644\u062f\u0642\u064a\u0642.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/09\/33-a-close-up-shot-of-a-computer-screen-displaying-an.jpg\" alt=\"\u0645\u0631\u0627\u062c\u0639\u0629 \u0648\u062b\u064a\u0642\u0629 \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 FDA 510k \u0639\u0644\u0649 \u0645\u0643\u062a\u0628 \u0627\u0644\u0645\u0643\u062a\u0628\" title=\"\u0645\u0648\u0627\u0641\u0642\u0629 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629\" \/><\/p>\n<p>\u0623\u0628\u062f\u0623 \u0628\u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629. \u0645\u0639\u0638\u0645 \u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u0627\u062f\u0645\u0629 \u063a\u064a\u0631 \u0627\u0644\u063a\u0627\u0632\u064a\u0629 \u062a\u0646\u062f\u0631\u062c \u062a\u062d\u062a \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0646\u064a\u0629 \u0645\u0639 \u062a\u0635\u0631\u064a\u062d 510(k)\u060c \u0648\u0644\u0643\u0646\u0646\u064a \u0623\u0642\u0631\u0623 \u0645\u0644\u062e\u0635 510(k) \u0644\u0631\u0624\u064a\u0629 \u0627\u0644\u0645\u0624\u0634\u0631\u0627\u062a \u0627\u0644\u062f\u0642\u064a\u0642\u0629 \u0648\u0627\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0633\u0627\u0628\u0642. \u0623\u062a\u062d\u0642\u0642 \u0645\u0646 \u0631\u0645\u0632 \u0627\u0644\u0645\u0646\u062a\u062c\u060c \u0648\u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u0623\u062f\u0627\u0621\u060c \u0648\u0645\u0627 \u0625\u0630\u0627 \u0643\u0627\u0646\u062a \u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a \u062a\u062a\u0637\u0627\u0628\u0642 \u0645\u0639 \u0627\u0644\u0646\u0645\u0648\u0630\u062c \u0627\u0644\u0630\u064a \u0633\u0623\u0634\u062a\u0631\u064a\u0647. \u0625\u0630\u0627 \u0642\u0627\u0644 \u0627\u0644\u0645\u0648\u0631\u062f \u201c\u0645\u0633\u062c\u0644 \u0641\u0642\u0637\u201d\u060c \u0641\u0647\u0630\u0627 \u0644\u064a\u0633 \u062a\u0635\u0631\u064a\u062d\u064b\u0627. \u0623\u0646\u0627 \u0623\u0637\u0644\u0628 \u0631\u0642\u0645 510(k) \u0648\u0627\u0644\u0645\u0644\u062e\u0635 \u0645\u0646 <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPMN\/pmn.cfm\">\u0642\u0627\u0639\u062f\u0629 \u0628\u064a\u0627\u0646\u0627\u062a FDA 510(k)<\/a> <sup><a href=\"#footnote-7\" id=\"ref-7\">7<\/a><\/sup> \u0627\u0644\u0630\u064a \u064a\u0633\u0631\u062f \u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u0629 \u0648\u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u0643\u0647\u0631\u0648\u0645\u063a\u0646\u0627\u0637\u064a\u0633\u064a \u0648\u0641\u0642\u064b\u0627 \u0644\u0623\u062c\u0632\u0627\u0621 IEC 60601. \u0625\u0630\u0627 \u0643\u0627\u0646 \u0627\u0644\u062c\u0647\u0627\u0632 \u201c\u0645\u062f\u0631\u062c\u064b\u0627\u201d \u0641\u0642\u0637 \u0628\u062f\u0648\u0646 \u0645\u0624\u0634\u0631 \u0645\u0639\u062a\u0645\u062f\u060c \u0641\u0623\u0646\u0627 \u0623\u062a\u0639\u0627\u0645\u0644 \u0645\u0639\u0647 \u0643\u0645\u062e\u0627\u0637\u0631\u0629 \u0648\u0644\u0627 \u0623\u0642\u0648\u0645 \u0628\u0627\u0633\u062a\u064a\u0631\u0627\u062f\u0647 \u0644\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0633\u0631\u064a\u0631\u064a.<\/p>\n<p>\u0641\u064a \u0623\u0648\u0631\u0648\u0628\u0627\u060c \u0623\u062a\u062d\u0642\u0642 \u0645\u0646 \u0639\u0644\u0627\u0645\u0629 CE \u0628\u0645\u0648\u062c\u0628 <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations_en\">\u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0644\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a (MDR) 2017\/745<\/a> <sup><a href=\"#footnote-8\" id=\"ref-8\">8<\/a><\/sup>. \u0623\u0637\u0644\u0628 \u0625\u0639\u0644\u0627\u0646 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629 \u0648\u0634\u0647\u0627\u062f\u0629 \u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0645\u064f\u062e\u0637\u0631 \u0628\u0647\u0627 \u0625\u0630\u0627 \u0643\u0627\u0646\u062a \u0641\u0626\u0629 \u0627\u0644\u062c\u0647\u0627\u0632 \u062a\u062a\u0637\u0644\u0628 \u0630\u0644\u0643. \u0623\u062a\u0623\u0643\u062f \u0645\u0646 \u0623\u0646 \u0627\u0644\u0646\u0637\u0627\u0642 \u064a\u063a\u0637\u064a \u0646\u0648\u0639 \u0627\u0644\u062c\u0647\u0627\u0632 \u0648\u0646\u0637\u0627\u0642 \u0627\u0644\u0637\u0631\u0627\u0632 \u0627\u0644\u062f\u0642\u064a\u0642. \u0623\u0624\u0643\u062f \u0623\u0646 \u0631\u0642\u0645 \u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0645\u064f\u062e\u0637\u0631 \u0628\u0647\u0627 \u0639\u0644\u0649 \u0627\u0644\u0645\u0644\u0635\u0642 \u064a\u062a\u0637\u0627\u0628\u0642 \u0645\u0639 \u0627\u0644\u0634\u0647\u0627\u062f\u0629. \u0623\u0642\u0631\u0623 <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\">\u0642\u0627\u0626\u0645\u0629 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0648\u0627\u0644\u0623\u062f\u0627\u0621 \u0627\u0644\u0639\u0627\u0645\u0629 (GSPR)<\/a> <sup><a href=\"#footnote-9\" id=\"ref-9\">9<\/a><\/sup>. \u064a\u062c\u0628 \u0623\u0646 \u064a\u0631\u0628\u0637 \u0643\u0644 \u0645\u062a\u0637\u0644\u0628 \u0628\u062f\u0644\u064a\u0644\u060c \u0645\u062b\u0644 \u062a\u0642\u0627\u0631\u064a\u0631 IEC\u060c \u0648\u0627\u0644\u062a\u0642\u064a\u064a\u0645 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u060c \u0648\u0645\u0644\u0641 \u0627\u0644\u0645\u062e\u0627\u0637\u0631. \u0625\u0630\u0627 \u0643\u0627\u0646\u062a \u0639\u0644\u0627\u0645\u0629 CE \u0628\u0645\u0648\u062c\u0628 MDD \u0627\u0644\u0642\u062f\u064a\u0645\u0629 \u0645\u0639 \u0627\u0646\u062a\u0642\u0627\u0644 \u0635\u0627\u0644\u062d\u060c \u0623\u0624\u0643\u062f \u0627\u0644\u062c\u062f\u0648\u0644 \u0627\u0644\u0632\u0645\u0646\u064a \u0648\u0623\u064a \u0634\u0631\u0648\u0637. \u0625\u0630\u0627 \u0643\u0627\u0646 \u0627\u0644\u0645\u0648\u0631\u062f \u064a\u0628\u064a\u0639 \u0641\u064a \u0627\u0644\u0645\u0645\u0644\u0643\u0629 \u0627\u0644\u0645\u062a\u062d\u062f\u0629\u060c \u0623\u0633\u0623\u0644 \u0623\u064a\u0636\u064b\u0627 \u0639\u0646 UKCA\u060c \u0644\u0643\u0646\u0646\u064a \u0623\u0628\u0642\u064a \u062a\u0631\u0643\u064a\u0632\u064a \u0627\u0644\u0631\u0626\u064a\u0633\u064a \u0639\u0644\u0649 CE \u0648 FDA \u0644\u0623\u0646 \u0647\u0630\u0647 \u0647\u064a \u0645\u0627 \u064a\u0637\u0644\u0628\u0647 \u0627\u0644\u0645\u0634\u062a\u0631\u0648\u0646 \u0645\u0646\u064a.<\/p>\n<h3>\u062a\u062f\u0642\u064a\u0642 \u062a\u0646\u0638\u064a\u0645\u064a \u0633\u0631\u064a\u0639<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0627\u0644\u0645\u0646\u0637\u0642\u0629<\/th>\n<th>\u0627\u0644\u0623\u062f\u0644\u0629 \u0627\u0644\u062a\u064a \u0623\u0637\u0644\u0628\u0647\u0627<\/th>\n<th>\u0645\u0627 \u064a\u062c\u0628 \u0623\u0646 \u064a\u062a\u0637\u0627\u0628\u0642<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 (FDA)<\/td>\n<td>\u0631\u0642\u0645 \u0648\u0645\u0644\u062e\u0635 510(k)<\/td>\n<td>\u0627\u0644\u0637\u0631\u0627\u0632\u060c \u0627\u0644\u062f\u0648\u0627\u0639\u064a\u060c \u0645\u0631\u0627\u062c\u0639 \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a (CE)<\/td>\n<td>\u0625\u0639\u0644\u0627\u0646 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629\u061b \u0634\u0647\u0627\u062f\u0629 \u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0645\u064f\u062e\u0637\u0631 \u0628\u0647\u0627 (\u0625\u0630\u0627 \u0643\u0627\u0646 \u0630\u0644\u0643 \u0645\u0646\u0637\u0628\u0642\u064b\u0627)<\/td>\n<td>\u0627\u0644\u0637\u0631\u0627\u0632\u060c \u0641\u0626\u0629 MDR\u060c \u0627\u0644\u0645\u0639\u0627\u064a\u064a\u0631\u060c \u0631\u0642\u0645 \u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0645\u064f\u062e\u0637\u0631 \u0628\u0647\u0627<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a<\/td>\n<td>\u0635\u0648\u0631 \u0644\u0648\u062d\u0629 \u0627\u0644\u062a\u0635\u0646\u064a\u0641<\/td>\n<td>\u0631\u0645\u0632 \u0627\u0644\u0637\u0631\u0627\u0632\u060c \u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u0637\u0627\u0642\u0629\u060c \u0645\u0639\u0631\u0641\u0627\u062a CE\/FDA<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u0625\u0630\u0627 \u0623\u062f\u0631\u062c \u0623\u064a \u0645\u0633\u062a\u0646\u062f \u0631\u0645\u0632 \u0637\u0631\u0627\u0632 \u0645\u062e\u062a\u0644\u0641 \u0639\u0646 \u0627\u0644\u0645\u0644\u0635\u0642\u060c \u0623\u062a\u0648\u0642\u0641 \u0639\u0646 \u0627\u0644\u0635\u0641\u0642\u0629 \u0648\u0623\u0637\u0644\u0628 \u0645\u0644\u0641\u064b\u0627 \u0645\u0635\u062d\u062d\u064b\u0627 \u0623\u0648 \u0627\u062e\u062a\u0628\u0627\u0631\u064b\u0627 \u062c\u062f\u064a\u062f\u064b\u0627.<\/p>\n<h2>\u0645\u0627 \u0647\u064a \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0648\u0627\u0644\u062a\u0642\u0627\u0631\u064a\u0631 \u0627\u0644\u062a\u064a \u064a\u062c\u0628 \u0623\u0646 \u064a\u0642\u062f\u0645\u0647\u0627 \u0627\u0644\u0645\u0648\u0631\u062f\u0648\u0646\u061f<\/h2>\n<p>\u0644\u0627 \u0623\u0642\u0628\u0644 \u0627\u062f\u0639\u0627\u0621\u0627\u062a \u063a\u0627\u0645\u0636\u0629 \u0645\u062b\u0644 \u201c\u0627\u062c\u062a\u0627\u0632 \u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u0645\u0639\u0645\u0644\u201d. \u0623\u0637\u0644\u0628 \u0645\u062c\u0645\u0648\u0639\u0629 \u0645\u0633\u062a\u0646\u062f\u0627\u062a\u060c \u0645\u0639 \u062a\u0648\u0627\u0631\u064a\u062e \u0648\u062a\u0648\u0642\u064a\u0639\u0627\u062a \u0648\u0639\u062f\u062f \u0635\u0641\u062d\u0627\u062a.<\/p>\n<p><strong>\u0627\u0637\u0644\u0628 \u062a\u0642\u0631\u064a\u0631 \u0627\u0644\u0633\u0644\u0627\u0645\u0629 CB\/IEC 60601-1\u060c \u0648\u062a\u0642\u0631\u064a\u0631 \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\u060c \u0648\u0627\u0644\u062a\u0642\u0631\u064a\u0631 \u0627\u0644\u062e\u0627\u0635 \u0628\u0627\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0645\u062d\u062f\u062f\u060c \u0648\u0642\u064a\u0627\u0633\u0627\u062a \u0627\u0644\u0645\u062e\u0631\u062c\u0627\u062a \u0627\u0644\u0635\u0648\u062a\u064a\u0629\u060c \u0648\u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u062d\u064a\u0648\u064a \u0644\u0644\u0623\u062c\u0632\u0627\u0621 \u0627\u0644\u0645\u0644\u0627\u0645\u0633\u0629 \u0644\u0644\u0645\u0631\u064a\u0636 (ISO 10993)\u060c \u0648\u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0635\u062d\u0629 \u0627\u0644\u0628\u0631\u0627\u0645\u062c (IEC 62304)\u060c \u0648\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 (ISO 14971)\u060c \u0648\u0623\u062f\u0644\u0629 \u0633\u0647\u0648\u0644\u0629 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0625\u0630\u0627 \u0643\u0627\u0646 \u0630\u0644\u0643 \u0645\u0646\u0637\u0628\u0642\u064b\u0627.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/09\/4-a-detailed-desktop-scene-showing-a-complete-set-of.jpg\" alt=\"\u062a\u0642\u0631\u064a\u0631 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0645\u0639 \u0645\u0639\u0627\u064a\u064a\u0631 ISO \u0648 IEC\" title=\"\u062a\u0642\u0631\u064a\u0631 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644\" \/><\/p>\n<p>\u0623\u0642\u0648\u0645 \u0628\u0625\u0646\u0634\u0627\u0621 \u0642\u0627\u0626\u0645\u0629 \u062a\u062f\u0642\u064a\u0642 \u0646\u0638\u064a\u0641\u0629 \u0648\u0644\u0627 \u0623\u062a\u062e\u0637\u0649 \u0623\u064a \u062e\u0637\u0648\u0627\u062a. \u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0644\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u0629\u060c \u0623\u0637\u0644\u0628 \u062a\u0642\u0631\u064a\u0631 IEC 60601-1 \u0627\u0644\u0643\u0627\u0645\u0644 \u0648\u0634\u0647\u0627\u062f\u0629 CB. \u064a\u062c\u0628 \u0623\u0646 \u064a\u0648\u0636\u062d \u0627\u0644\u062a\u0642\u0631\u064a\u0631 \u0646\u062a\u0627\u0626\u062c \u0628\u0646\u062f\u064b\u0627 \u0628\u0628\u0646\u062f\u060c \u0648\u0642\u0648\u0627\u0626\u0645 \u0645\u0639\u062f\u0627\u062a \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631\u060c \u0648\u0635\u0648\u0631\u064b\u0627. \u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u0643\u0647\u0631\u0648\u0645\u063a\u0646\u0627\u0637\u064a\u0633\u064a\u060c \u0623\u0631\u064a\u062f \u062a\u0642\u0631\u064a\u0631 IEC 60601-1-2 \u0645\u0639 \u0623\u0642\u0633\u0627\u0645 \u0627\u0644\u0627\u0646\u0628\u0639\u0627\u062b\u0627\u062a \u0648\u0627\u0644\u062d\u0635\u0627\u0646\u0629. \u064a\u062c\u0628 \u0623\u0646 \u064a\u0634\u0645\u0644 ESD\u060c \u0648\u0627\u0644\u0625\u0634\u0639\u0627\u0639\u060c \u0648\u0627\u0644\u062a\u0648\u0635\u064a\u0644\u060c \u0648 EFT\u060c \u0648\u0627\u0644\u0627\u0631\u062a\u0641\u0627\u0639 \u0627\u0644\u0645\u0641\u0627\u062c\u0626\u060c \u0648\u0627\u0644\u0627\u0646\u062e\u0641\u0627\u0636\u0627\u062a\u060c \u0648\u0627\u0644\u062a\u0648\u0627\u0641\u0642\u064a\u0627\u062a\u060c \u0648\u0627\u0644\u0648\u0645\u064a\u0636. \u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0644\u0645\u0639\u064a\u0627\u0631 \u0627\u0644\u062e\u0627\u0635\u060c \u0623\u062a\u062d\u0642\u0642 \u0645\u0646 \u062d\u062f\u0648\u062f \u0627\u0644\u0637\u0627\u0642\u0629 \u0627\u0644\u0635\u0648\u062a\u064a\u0629\u060c \u0648\u062f\u0642\u0629 \u0627\u0644\u062a\u062d\u0643\u0645 \u0641\u064a \u0627\u0644\u0645\u062e\u0631\u062c\u0627\u062a\u060c \u0648\u062a\u062d\u062f\u064a\u062f \u0627\u0644\u0645\u0644\u062d\u0642\u0627\u062a\u060c \u0648\u0622\u0644\u064a\u0627\u062a \u0627\u0644\u0642\u0641\u0644. \u0623\u0637\u0644\u0628 \u062a\u0642\u0631\u064a\u0631\u064b\u0627 \u0645\u062e\u0635\u0635\u064b\u0627 \u0644\u0644\u0645\u062e\u0631\u062c\u0627\u062a \u0627\u0644\u0635\u0648\u062a\u064a\u0629 \u064a\u0633\u0631\u062f \u0643\u062b\u0627\u0641\u0629 \u062a\u062f\u0641\u0642 \u0627\u0644\u0637\u0627\u0642\u0629\u060c \u0648\u0627\u0644\u0636\u063a\u0637 \u0627\u0644\u0623\u0642\u0635\u0649\u060c \u0648\u0639\u062f\u062f \u0627\u0644\u0646\u0628\u0636\u0627\u062a\u060c \u0648\u062d\u062c\u0645 \u0627\u0644\u0628\u0624\u0631\u0629\u060c \u0648\u0642\u0627\u0628\u0644\u064a\u0629 \u0627\u0644\u062a\u0643\u0631\u0627\u0631. \u0623\u0642\u0627\u0631\u0646 \u0647\u0630\u0647 \u0627\u0644\u0623\u0631\u0642\u0627\u0645 \u0628\u0625\u0639\u062f\u0627\u062f\u0627\u062a \u062f\u0644\u064a\u0644 \u0627\u0644\u0645\u0633\u062a\u062e\u062f\u0645 \u0644\u0645\u0639\u0631\u0641\u0629 \u0645\u0627 \u0625\u0630\u0627 \u0643\u0627\u0646\u062a \u0646\u0637\u0627\u0642\u0627\u062a \u0648\u0627\u062c\u0647\u0629 \u0627\u0644\u0645\u0633\u062a\u062e\u062f\u0645 \u062a\u062a\u0637\u0627\u0628\u0642 \u0645\u0639 \u0642\u064a\u0645 \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631.<\/p>\n<p>\u0625\u0630\u0627 \u0643\u0627\u0646 \u0627\u0644\u062c\u0647\u0627\u0632 \u064a\u062d\u062a\u0648\u064a \u0639\u0644\u0649 \u0623\u062c\u0632\u0627\u0621 \u0645\u0644\u0627\u0645\u0633\u0629 \u0644\u0644\u062c\u0644\u062f\u060c \u0623\u0648 \u0645\u0648\u0627\u062f \u0647\u0644\u0627\u0645\u064a\u0629\u060c \u0623\u0648 \u0623\u063a\u0637\u064a\u0629 \u0644\u0644\u0645\u0644\u062d\u0642\u0627\u062a\u060c \u0641\u0623\u0646\u0627 \u0623\u0637\u0644\u0628 <a href=\"https:\/\/www.iso.org\/standard\/68936.html\">\u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u062d\u064a\u0648\u064a ISO 10993<\/a> <sup><a href=\"#footnote-10\" id=\"ref-10\">10<\/a><\/sup> \u0644\u0644\u062e\u0644\u0627\u064a\u0627 \u0627\u0644\u0633\u0627\u0645\u0629\u060c \u0648\u0627\u0644\u062a\u0647\u064a\u062c\u060c \u0648\u0627\u0644\u062d\u0633\u0627\u0633\u064a\u0629. \u0625\u0630\u0627 \u0643\u0627\u0646 \u0627\u0644\u062a\u0644\u0627\u0645\u0633 \u0623\u0637\u0648\u0644 \u0623\u0648 \u063a\u0627\u0632\u064a\u064b\u0627\u060c \u0623\u0637\u0644\u0628 \u0623\u062c\u0632\u0627\u0621 \u0623\u062e\u0631\u0649 \u0645\u0646 10993 \u062d\u0633\u0628 \u0645\u0627 \u062a\u0642\u062a\u0636\u064a\u0647 \u0627\u0644\u0645\u062e\u0627\u0637\u0631. \u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0644\u0628\u0631\u0627\u0645\u062c\u060c \u0623\u0631\u064a\u062f \u062e\u0637\u0629 \u062a\u0637\u0648\u064a\u0631 \u0627\u0644\u0628\u0631\u0627\u0645\u062c\u060c \u0648\u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u0645\u062e\u0627\u0637\u0631\u060c \u0648\u0627\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a\u060c \u0648\u062d\u0627\u0644\u0627\u062a \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631\u060c \u0648\u0645\u0644\u062e\u0635 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0635\u062d\u0629 \u0648\u0641\u0642\u064b\u0627 \u0644\u0640 IEC 62304. \u0623\u0637\u0644\u0628 \u0623\u064a\u0636\u064b\u0627 \u0645\u0644\u0627\u062d\u0638\u0629 \u062d\u0648\u0644 \u0627\u0644\u0623\u0645\u0646 \u0627\u0644\u0633\u064a\u0628\u0631\u0627\u0646\u064a \u0625\u0630\u0627 \u0643\u0627\u0646 \u0627\u0644\u062c\u0647\u0627\u0632 \u064a\u062d\u062a\u0648\u064a \u0639\u0644\u0649 \u0623\u064a \u0645\u064a\u0632\u0629 \u0634\u0628\u0643\u0629. \u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631\u060c \u0623\u0628\u062d\u062b \u0639\u0646 \u0645\u0644\u0641 ISO 14971 \u0643\u0627\u0645\u0644 \u0645\u0639 \u062a\u062d\u0644\u064a\u0644 \u0627\u0644\u0645\u062e\u0627\u0637\u0631\u060c \u0648 FMEA \u0623\u0648 \u0645\u0627 \u0634\u0627\u0628\u0647\u060c \u0648\u0636\u0648\u0627\u0628\u0637 \u0627\u0644\u0645\u062e\u0627\u0637\u0631\u060c \u0648\u062f\u0644\u064a\u0644 \u0627\u0644\u062a\u062d\u0642\u0642.<\/p>\n<p>\u0623\u0637\u0644\u0628 \u0623\u064a\u0636\u064b\u0627 \u0647\u0646\u062f\u0633\u0629 \u0633\u0647\u0648\u0644\u0629 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0625\u0630\u0627 \u0643\u0627\u0646\u062a \u0648\u0627\u062c\u0647\u0629 \u0627\u0644\u0645\u0633\u062a\u062e\u062f\u0645 \u064a\u0645\u0643\u0646 \u0623\u0646 \u062a\u0633\u0628\u0628 \u0633\u0648\u0621 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645. <a href=\"https:\/\/webstore.iec.ch\/publication\/25919\">\u0647\u0646\u062f\u0633\u0629 \u0633\u0647\u0648\u0644\u0629 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 IEC 62366-1<\/a> <sup><a href=\"#footnote-11\" id=\"ref-11\">11<\/a><\/sup> \u062a\u0633\u0627\u0639\u062f \u0645\u0644\u0641\u0627\u062a \u0627\u0644\u0623\u0646\u0645\u0627\u0637 \u0641\u064a \u062a\u0642\u0644\u064a\u0644 \u0623\u062e\u0637\u0627\u0621 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645. \u0623\u062e\u064a\u0631\u064b\u0627\u060c \u0623\u062a\u062d\u0642\u0642 \u0645\u0646 \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\u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u0646\u0642\u0644\u060c \u0648\u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0635\u062d\u0629 \u0627\u0644\u062a\u0639\u0642\u064a\u0645 \u0625\u0630\u0627 \u0643\u0627\u0646\u062a \u0647\u0646\u0627\u0643 \u0623\u064a \u0645\u0644\u062d\u0642\u0627\u062a \u0645\u0639\u0642\u0645\u0629.<\/p>\n<h3>\u0642\u0627\u0626\u0645\u0629 \u062a\u062f\u0642\u064a\u0642 \u0645\u0633\u062a\u0646\u062f\u0627\u062a \u0627\u0644\u0645\u0648\u0631\u062f (\u0645\u0627 \u0623\u0637\u0644\u0628\u0647)<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0648\u062b\u064a\u0642\u0629<\/th>\n<th>\u0644\u0645\u0627\u0630\u0627 \u0623\u062d\u062a\u0627\u062c\u0647<\/th>\n<th>\u0645\u0627 \u0623\u062a\u062d\u0642\u0642 \u0645\u0646\u0647<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u062a\u0642\u0631\u064a\u0631 CB + \u0634\u0647\u0627\u062f\u0629 IEC 60601-1<\/td>\n<td>\u064a\u062b\u0628\u062a \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u0629<\/td>\n<td>\u0627\u0644\u0625\u0635\u062f\u0627\u0631\u060c \u0627\u0644\u0637\u0631\u0627\u0632\u060c \u0627\u0644\u0635\u0648\u0631\u060c \u0645\u0639\u0627\u0644\u062c\u0629 \u062d\u0627\u0644\u0627\u062a \u0627\u0644\u0641\u0634\u0644<\/td>\n<\/tr>\n<tr>\n<td>\u062a\u0642\u0631\u064a\u0631 \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<\/td>\n<td>\u064a\u062b\u0628\u062a \u0633\u0644\u0627\u0645\u0629 EMC<\/td>\n<td>\u0627\u0644\u0645\u0633\u062a\u0648\u064a\u0627\u062a\u060c \u0635\u0648\u0631 \u0627\u0644\u0625\u0639\u062f\u0627\u062f\u060c \u0627\u062c\u062a\u064a\u0627\u0632\/\u0641\u0634\u0644<\/td>\n<\/tr>\n<tr>\n<td>\u062a\u0642\u0631\u064a\u0631 \u0642\u064a\u0627\u0633\u064a \u0645\u0639\u064a\u0646<\/td>\n<td>\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0645\u062d\u062f\u062f<\/td>\n<td>\u062d\u062f\u0648\u062f \u0627\u0644\u0635\u0648\u062a\/\u0627\u0644\u0637\u0627\u0642\u0629\u060c \u0623\u0642\u0641\u0627\u0644 \u0627\u0644\u0623\u0645\u0627\u0646<\/td>\n<\/tr>\n<tr>\n<td>\u062a\u0642\u0631\u064a\u0631 \u062e\u0631\u062c \u0627\u0644\u0635\u0648\u062a<\/td>\n<td>\u0627\u0644\u0623\u062f\u0627\u0621 \u0627\u0644\u062d\u0642\u064a\u0642\u064a<\/td>\n<td>\u0630\u0631\u0648\u0629 \u0627\u0644\u0636\u063a\u0637\u060c EFD\u060c \u062d\u062c\u0645 \u0627\u0644\u062a\u0631\u0643\u064a\u0632<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a ISO 10993<\/td>\n<td>\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0645\u0631\u064a\u0636<\/td>\n<td>\u0646\u0648\u0639 \u0627\u0644\u0627\u062a\u0635\u0627\u0644 \u0645\u0642\u0627\u0628\u0644 \u0646\u0637\u0627\u0642 \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631<\/td>\n<\/tr>\n<tr>\n<td>\u0645\u0644\u0641 \u0628\u0631\u0646\u0627\u0645\u062c IEC 62304<\/td>\n<td>\u0645\u0648\u062b\u0648\u0642\u064a\u0629 \u0627\u0644\u0628\u0631\u0646\u0627\u0645\u062c<\/td>\n<td>\u0627\u0644\u0641\u0626\u0629\u060c \u0627\u0644\u062a\u062d\u0642\u0642\u060c \u0627\u0644\u062a\u062a\u0628\u0639<\/td>\n<\/tr>\n<tr>\n<td>\u0645\u0644\u0641 \u0645\u062e\u0627\u0637\u0631 ISO 14971<\/td>\n<td>\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0646\u0638\u0627\u0645<\/td>\n<td>\u0627\u0644\u0645\u062e\u0627\u0637\u0631\u060c \u0627\u0644\u0636\u0648\u0627\u0628\u0637\u060c \u0627\u0644\u062a\u062d\u0642\u0642<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a + \u062a\u0639\u0644\u064a\u0645\u0627\u062a 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\u0627\u0644\u0645\u064a\u062f\u0627\u0646\u064a\u0629\u060c \u0625\u0646 \u0648\u062c\u062f\u062a. \u0623\u062a\u062d\u0642\u0642 \u0645\u0646 \u0625\u0645\u0643\u0627\u0646\u064a\u0629 \u0627\u0644\u062a\u062a\u0628\u0639 \u0625\u0644\u0649 \u0627\u0644\u062f\u0641\u0639\u0627\u062a \u0648\u0627\u0644\u0623\u0631\u0642\u0627\u0645 \u0627\u0644\u062a\u0633\u0644\u0633\u0644\u064a\u0629. \u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0644\u062a\u062d\u0643\u0645 \u0641\u064a \u0627\u0644\u0625\u0646\u062a\u0627\u062c\u060c \u0623\u0646\u0638\u0631 \u0625\u0644\u0649 \u0625\u0639\u062f\u0627\u062f\u0627\u062a \u0639\u0632\u0645 \u0627\u0644\u062f\u0648\u0631\u0627\u0646 \u0648\u0639\u0645\u0644\u064a\u0627\u062a \u0627\u0644\u062a\u063a\u0644\u064a\u0641 \u0648\u062d\u0645\u0627\u064a\u0629 ESD \u0648\u0623\u0648\u0631\u0627\u0642 \u0627\u0644\u0641\u062d\u0635 \u0627\u0644\u0646\u0647\u0627\u0626\u064a\u0629. \u0623\u0631\u0627\u062c\u0639 \u0623\u064a\u0636\u064b\u0627 \u0633\u062c\u0644\u0627\u062a \u0627\u0644\u062a\u062f\u0631\u064a\u0628 \u0644\u0644\u0645\u0634\u063a\u0644\u064a\u0646 \u0627\u0644\u0630\u064a\u0646 \u064a\u0642\u0648\u0645\u0648\u0646 \u0628\u062a\u062c\u0645\u064a\u0639 \u0648\u062d\u062f\u0627\u062a \u0627\u0644\u062c\u0647\u062f \u0627\u0644\u0639\u0627\u0644\u064a.<\/p>\n<p>\u0645\u0627 \u0628\u0639\u062f \u0627\u0644\u062a\u0633\u0648\u064a\u0642 \u0647\u0648 \u0645\u062c\u0627\u0644 \u0631\u0626\u064a\u0633\u064a \u0622\u062e\u0631. \u0623\u0633\u0623\u0644 \u0643\u064a\u0641 \u064a\u062c\u0645\u0639\u0648\u0646 \u0627\u0644\u0645\u0644\u0627\u062d\u0638\u0627\u062a \u0648\u0643\u064a\u0641 \u064a\u062a\u062a\u0628\u0639\u0648\u0646 \u0645\u0639\u062f\u0644\u0627\u062a \u0627\u0644\u0641\u0634\u0644. \u0623\u0637\u0644\u0628 \u062a\u0642\u0627\u0631\u064a\u0631 \u062e\u062f\u0645\u0629 \u0646\u0645\u0648\u0630\u062c\u064a\u0629. \u0625\u0630\u0627 \u0644\u0645 \u064a\u062a\u0645\u0643\u0646\u0648\u0627 \u0645\u0646 \u0625\u0638\u0647\u0627\u0631 \u062e\u0637\u0629 \u0625\u062f\u0627\u0631\u0629 \u0645\u0627 \u0628\u0639\u062f \u0627\u0644\u062a\u0633\u0648\u064a\u0642\u060c \u0623\u0639\u062a\u0628\u0631 \u0630\u0644\u0643 \u0639\u0644\u0627\u0645\u0629 \u062d\u0645\u0631\u0627\u0621. \u0623\u062a\u062d\u0642\u0642 \u0623\u064a\u0636\u064b\u0627 \u0645\u0646 \u0623\u0646\u0647\u0645 \u064a\u0645\u0643\u0646\u0647\u0645 \u062f\u0639\u0645 \u0627\u0644\u062e\u062f\u0645\u0627\u062a \u0627\u0644\u0644\u0648\u062c\u0633\u062a\u064a\u0629 \u0645\u0646 \u0627\u0644\u0628\u0627\u0628 \u0625\u0644\u0649 \u0627\u0644\u0628\u0627\u0628 \u0648\u064a\u0645\u0643\u0646\u0647\u0645 \u062a\u0639\u0628\u0626\u0629 \u0627\u0644\u0648\u062d\u062f\u0627\u062a \u0644\u062a\u062d\u0645\u0644 \u0627\u0644\u0645\u0633\u0627\u0631\u0627\u062a \u0627\u0644\u0637\u0648\u064a\u0644\u0629. \u0645\u0645\u0627\u0631\u0633\u0627\u062a \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 \u0627\u0644\u062c\u064a\u062f\u0629 \u062a\u0642\u0644\u0644 \u0645\u0646 \u0645\u062e\u0627\u0637\u0631 \u0648\u0642\u062a \u0627\u0644\u062a\u0633\u0644\u064a\u0645 \u0648\u0627\u0646\u062d\u0631\u0627\u0641 \u0627\u0644\u062c\u0648\u062f\u0629. \u0643\u0645\u0627 \u0623\u0646\u0647\u0627 \u062a\u062c\u0639\u0644 \u0627\u0644\u062a\u063a\u064a\u064a\u0631\u0627\u062a \u062e\u0627\u0636\u0639\u0629 \u0644\u0644\u0631\u0642\u0627\u0628\u0629 \u0639\u0646\u062f\u0645\u0627 \u0623\u062d\u062a\u0627\u062c \u0625\u0644\u0649 \u062a\u062e\u0637\u064a\u0637 \u0648\u0627\u062c\u0647\u0629 \u0645\u0633\u062a\u062e\u062f\u0645 \u062c\u062f\u064a\u062f \u0623\u0648 \u0645\u0627\u062f\u0629 \u0645\u064f\u0637\u0628\u0642\u0629 \u062c\u062f\u064a\u062f\u0629.<\/p>\n<h3>\u0623\u062f\u0644\u0629 \u062a\u062f\u0642\u064a\u0642 \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 \u0627\u0644\u062a\u064a \u0623\u062d\u0628 \u0631\u0624\u064a\u062a\u0647\u0627<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0627\u0644\u0639\u0645\u0644\u064a\u0629<\/th>\n<th>\u062f\u0644\u064a\u0644<\/th>\n<th>\u0645\u0627 \u0623\u0628\u062d\u062b \u0639\u0646\u0647<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u0627\u0644\u062a\u062d\u0643\u0645 \u0641\u064a \u0627\u0644\u062a\u0635\u0645\u064a\u0645<\/td>\n<td>\u062e\u0637\u0629 \u0627\u0644\u062a\u0635\u0645\u064a\u0645\u060c \u0627\u0644\u0645\u0631\u0627\u062c\u0639\u0627\u062a\u060c \u0627\u0644\u062a\u062d\u0642\u0642 \u0648\u0627\u0644\u062a\u062d\u0642\u0642 (V\\&amp;V)<\/td>\n<td>\u0645\u062f\u062e\u0644\u0627\u062a\/\u0645\u062e\u0631\u062c\u0627\u062a \u0648\u0627\u0636\u062d\u0629\u060c \u0633\u062c\u0644\u0627\u062a \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0645\u0634\u062a\u0631\u064a\u0627\u062a<\/td>\n<td>\u0642\u0627\u0626\u0645\u0629 \u0627\u0644\u0645\u0648\u0631\u062f\u064a\u0646 \u0627\u0644\u0645\u0639\u062a\u0645\u062f\u064a\u0646\u060c \u0633\u062c\u0644\u0627\u062a \u0641\u062d\u0635 \u0627\u0644\u062c\u0648\u062f\u0629 \u0627\u0644\u0648\u0627\u0631\u062f\u0629 (IQC)<\/td>\n<td>\u0641\u062d\u0648\u0635\u0627\u062a \u0627\u0644\u0623\u062c\u0632\u0627\u0621 \u0627\u0644\u062d\u0631\u062c\u0629\u060c \u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u0642\u0628\u0648\u0644<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0625\u0646\u062a\u0627\u062c<\/td>\n<td>\u062a\u0639\u0644\u064a\u0645\u0627\u062a \u0627\u0644\u0639\u0645\u0644\u060c \u0623\u0648\u0631\u0627\u0642 \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u0646\u0647\u0627\u0626\u064a\u0629<\/td>\n<td>\u0627\u0644\u062a\u062a\u0628\u0639\u060c \u0627\u0644\u0623\u062f\u0648\u0627\u062a \u0627\u0644\u0645\u0639\u0627\u064a\u0631\u0629<\/td>\n<\/tr>\n<tr>\n<td>\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>\u0646\u0645\u0627\u0630\u062c \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 \u0645\u0639 \u0627\u0644\u0633\u0628\u0628 \u0627\u0644\u062c\u0630\u0631\u064a<\/td>\n<td>\u0627\u0644\u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0627\u0644\u062a\u0635\u062d\u064a\u062d\u064a\u0629 \u0627\u0644\u062d\u0642\u064a\u0642\u064a\u0629\u060c \u062a\u0648\u0627\u0631\u064a\u062e \u0627\u0644\u0625\u063a\u0644\u0627\u0642<\/td>\n<\/tr>\n<tr>\n<td>\u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0623\u062f\u0627\u0621 (PMS)<\/td>\n<td>\u0633\u062c\u0644\u0627\u062a \u0627\u0644\u0634\u0643\u0627\u0648\u0649\u060c \u0627\u0644\u0627\u062a\u062c\u0627\u0647\u0627\u062a<\/td>\n<td>\u0627\u0644\u0645\u0634\u0643\u0644\u0627\u062a \u0627\u0644\u0645\u062a\u0643\u0631\u0631\u0629 \u0627\u0644\u0645\u0646\u062e\u0641\u0636\u0629\u060c \u0639\u0645\u0644\u064a\u0629 \u0627\u0644\u0625\u062c\u0631\u0627\u0621 \u0627\u0644\u0645\u064a\u062f\u0627\u0646\u064a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u062c\u0648\u062f\u0629 \u0642\u0648\u064a \u0644\u0627 \u064a\u062d\u0644 \u0645\u062d\u0644 \u062a\u0642\u0627\u0631\u064a\u0631 IEC\u060c \u0648\u0644\u0643\u0646\u0647 \u064a\u062d\u0627\u0641\u0638 \u0639\u0644\u0649 \u0627\u0633\u062a\u0642\u0631\u0627\u0631 \u0627\u0644\u062c\u0648\u062f\u0629. \u064a\u0642\u0644\u0644 \u0645\u0646 \u0627\u0644\u062a\u0623\u062e\u064a\u0631 \u0648\u064a\u0642\u0644\u0644 \u0645\u0646 \u0641\u0631\u0635\u0629 \u0625\u0639\u0627\u062f\u0629 \u0627\u0644\u0639\u0645\u0644 \u0628\u0639\u062f \u0627\u0644\u0634\u062d\u0646. \u0643\u0645\u0627 \u0623\u0646\u0647 \u064a\u0645\u0646\u062d\u0646\u064a \u0627\u0644\u062b\u0642\u0629 \u0623\u062b\u0646\u0627\u0621 \u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a \u0627\u0644\u062e\u0627\u0635\u0629 \u0648\u0627\u0644\u062a\u0637\u0648\u064a\u0631 \u0627\u0644\u0645\u062e\u0635\u0635.<\/p>\n<h2>\u0627\u0644\u062e\u0627\u062a\u0645\u0629<\/h2>\n<p>\u062a\u062d\u0642\u0642 \u0645\u0646 \u0623\u062c\u0632\u0627\u0621 IEC \u0627\u0644\u0635\u062d\u064a\u062d\u0629\u060c \u0623\u0643\u062f \u0639\u0644\u0649 \u0645\u0648\u0627\u0641\u0642\u0629 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 (FDA) \u0623\u0648 CE\u060c \u0627\u0637\u0644\u0628 \u0627\u0644\u062a\u0642\u0627\u0631\u064a\u0631 \u0627\u0644\u0643\u0627\u0645\u0644\u0629\u060c \u0648\u0631\u0627\u062c\u0639 \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 ISO 13485. \u0639\u0646\u062f\u0647\u0627 \u0641\u0642\u0637 \u0642\u0645 \u0628\u062a\u0642\u062f\u064a\u0645 \u0627\u0644\u0637\u0644\u0628.<\/p>\n<hr \/>\n<h2>\u0627\u0644\u062d\u0648\u0627\u0634\u064a<\/h2>\n<p><span id=\"footnote-1\">1. IEC 60601-1 \u0627\u0644\u0631\u0633\u0645\u064a \u064a\u062d\u062f\u062f \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u0629 \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u0629. <a href=\"#ref-1\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-2\">2. \u064a\u062d\u062f\u062f IEC 60601-1-2 \u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u0627\u0646\u0628\u0639\u0627\u062b\u0627\u062a \u0648\u0627\u0644\u0645\u0646\u0627\u0639\u0629 \u0627\u0644\u0643\u0647\u0631\u0648\u0645\u063a\u0646\u0627\u0637\u064a\u0633\u064a\u0629. <a href=\"#ref-2\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-3\">3. \u0645\u0639\u064a\u0627\u0631 \u062e\u0627\u0635 \u0644\u0633\u0644\u0627\u0645\u0629 \u062a\u0641\u062a\u064a\u062a \u0627\u0644\u062d\u0635\u0648\u0627\u062a \u062e\u0627\u0631\u062c \u0627\u0644\u062c\u0633\u0645. <a href=\"#ref-3\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-4\">4. \u064a\u062d\u062f\u062f IEC 62304 \u0639\u0645\u0644\u064a\u0627\u062a \u062f\u0648\u0631\u0629 \u062d\u064a\u0627\u0629 \u0627\u0644\u0628\u0631\u0627\u0645\u062c \u0644\u0644\u0623\u062c\u0647\u0632\u0629. <a href=\"#ref-4\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-5\">5. \u0625\u0637\u0627\u0631 \u0639\u0645\u0644 ISO 14971 \u0644\u0625\u062f\u0627\u0631\u0629 \u0645\u062e\u0627\u0637\u0631 \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. \u0642\u0627\u0626\u0645\u0629 ILAC \u062a\u062a\u062d\u0642\u0642 \u0645\u0646 \u0645\u062e\u062a\u0628\u0631\u0627\u062a \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u0645\u0639\u062a\u0645\u062f\u0629 \u0648\u0641\u0642\u064b\u0627 \u0644\u0640 ISO\/IEC 17025. <a href=\"#ref-6\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-7\">7. \u0642\u0627\u0639\u062f\u0629 \u0628\u064a\u0627\u0646\u0627\u062a FDA 510(k) \u0644\u062a\u0623\u0643\u064a\u062f \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0627\u062a \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629. <a href=\"#ref-7\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-8\">8. \u0628\u0648\u0627\u0628\u0629 \u0646\u0638\u0631\u0629 \u0639\u0627\u0645\u0629 \u0648\u0625\u0631\u0634\u0627\u062f\u0627\u062a \u0644\u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 (EU MDR) 2017\/745. <a href=\"#ref-8\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-9\">9. \u0627\u0644\u0645\u0644\u062d\u0642 \u0627\u0644\u0623\u0648\u0644 \u0644\u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (MDR) \u0647\u0648 \u0645\u0635\u062f\u0631 \u0642\u0627\u0626\u0645\u0629 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0639\u0627\u0645\u0629 \u0644\u0644\u0633\u0644\u0627\u0645\u0629 \u0648\u0627\u0644\u0623\u062f\u0627\u0621 (GSPR). <a href=\"#ref-9\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-10\">10. \u0625\u0631\u0634\u0627\u062f\u0627\u062a ISO 10993 \u062d\u0648\u0644 \u0627\u062e\u062a\u064a\u0627\u0631 \u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u062d\u064a\u0648\u064a. <a href=\"#ref-10\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-11\">11. \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0647\u0646\u062f\u0633\u0629 \u0642\u0627\u0628\u0644\u064a\u0629 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0641\u064a IEC 62366-1 \u0644\u062a\u0642\u0644\u064a\u0644 \u0623\u062e\u0637\u0627\u0621 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645. <a href=\"#ref-11\">\ufe0e<\/a><\/span>  <\/p>","protected":false},"excerpt":{"rendered":"<p>I have seen buyers lose money from missed standards. I do not want you to repeat that mistake. To assess compliance fast, confirm IEC 60601 safety parts, EMC per IEC 60601-1-2, device-specific IEC part, software per IEC 62304, biocompatibility per ISO 10993, and risk file per ISO 14971. Then verify FDA or CE status, plus [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":8026,"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-8025","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 v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>How to Assess a Shockwave Therapy Machine for International Safety Compliance? - 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\/\u0643\u064a\u0641\u064a\u0629-\u062a\u0642\u064a\u064a\u0645-\u062c\u0647\u0627\u0632-\u0627\u0644\u0639\u0644\u0627\u062c-\u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a-\u0627\u0644\u0635\u062f\/\" \/>\n<meta property=\"og:locale\" content=\"ar_AR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How to Assess a Shockwave Therapy Machine for International Safety Compliance?\" \/>\n<meta property=\"og:description\" content=\"I have seen buyers lose money from missed standards. 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