{"id":15443,"date":"2023-02-26T12:59:36","date_gmt":"2023-02-26T12:59:36","guid":{"rendered":"https:\/\/blog.gts-translation.com\/?p=15443"},"modified":"2023-02-27T06:10:45","modified_gmt":"2023-02-27T06:10:45","slug":"%d7%a9%d7%99%d7%95%d7%95%d7%a7-%d7%9e%d7%9b%d7%a9%d7%99%d7%a8%d7%99%d7%9d-%d7%a8%d7%a4%d7%95%d7%90%d7%99%d7%99%d7%9d-%d7%91%d7%90%d7%99%d7%a8%d7%95%d7%a4%d7%94-%d7%93%d7%a8%d7%99%d7%a9%d7%95%d7%aa","status":"publish","type":"post","link":"https:\/\/blog.gts-translation.com\/he\/2023\/02\/26\/%d7%a9%d7%99%d7%95%d7%95%d7%a7-%d7%9e%d7%9b%d7%a9%d7%99%d7%a8%d7%99%d7%9d-%d7%a8%d7%a4%d7%95%d7%90%d7%99%d7%99%d7%9d-%d7%91%d7%90%d7%99%d7%a8%d7%95%d7%a4%d7%94-%d7%93%d7%a8%d7%99%d7%a9%d7%95%d7%aa\/","title":{"rendered":"\u05e9\u05d9\u05d5\u05d5\u05e7 \u05de\u05db\u05e9\u05d9\u05e8\u05d9\u05dd \u05e8\u05e4\u05d5\u05d0\u05d9\u05d9\u05dd \u05d1\u05d0\u05d9\u05e8\u05d5\u05e4\u05d4-\u05d3\u05e8\u05d9\u05e9\u05d5\u05ea \u05dc\u05e9\u05d5\u05e0\u05d9\u05d5\u05ea"},"content":{"rendered":"<p style=\"direction: rtl;\">\u05d1\u05e9\u05e0\u05ea 2023, \u05d9\u05d5\u05ea\u05e8 \u05de-500,000 \u05e1\u05d5\u05d2\u05d9\u05dd \u05e9\u05dc \u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9 \u05e0\u05de\u05db\u05e8\u05d9\u05dd \u05d1\u05e9\u05d5\u05e7 \u05d4\u05d0\u05d9\u05e8\u05d5\u05e4\u05d9-\u05d4\u05d7\u05dc \u05de\u05de\u05db\u05e9\u05d9\u05e8\u05d9\u05dd \u05e4\u05e9\u05d5\u05d8\u05d9\u05dd \u05db\u05de\u05d5 \u05e2\u05e8\u05db\u05d5\u05ea \u05d1\u05d3\u05d9\u05e7\u05d4 \u05d1\u05d9\u05ea\u05d9\u05d5\u05ea \u05dc\u05d6\u05d9\u05d4\u05d5\u05d9 COVID-19 \u05d5\u05e2\u05d3 \u05de\u05db\u05e9\u05d9\u05e8\u05d9\u05dd \u05de\u05d5\u05e8\u05db\u05d1\u05d9\u05dd \u05d9\u05d5\u05ea\u05e8 \u05db\u05de\u05d5 \u05e7\u05d5\u05e6\u05d1\u05d9 \u05dc\u05d1 \u05d5\u05e9\u05ea\u05dc\u05d9\u05dd \u05dc\u05d7\u05d6\u05d4. \u05db\u05e6\u05e4\u05d5\u05d9, \u05de\u05db\u05d9\u05e8\u05ea \u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9 \u05d1\u05d0\u05d9\u05e8\u05d5\u05e4\u05d4 \u05de\u05d5\u05e1\u05d3\u05e8\u05ea \u05de\u05d0\u05d5\u05d3 \u05d1\u05e8\u05d2\u05d5\u05dc\u05e6\u05d9\u05d5\u05ea \u05e7\u05e4\u05d3\u05e0\u05d9\u05d5\u05ea. \u05d7\u05d1\u05e8\u05d5\u05ea \u05e9\u05e8\u05d5\u05e6\u05d5\u05ea \u05dc\u05e9\u05d5\u05d5\u05e7 \u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9 \u05d1\u05d0\u05d9\u05e8\u05d5\u05e4\u05d4 \u05d7\u05d9\u05d9\u05d1\u05d5\u05ea \u05dc\u05e2\u05de\u05d5\u05d3 \u05d1\u05ea\u05e7\u05e0\u05d5\u05ea \u05d4-<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/medical-devices#:~:text=Medical%20devices%20legislation,-The%20Regulations%20on&amp;text=The%20Medical%20Devices%20Regulation%20applies,on%20active%20implantable%20medical%20devices.\">European Union Medical Device Regulation<\/a> \u05d5\u05e2\u05dc\u05d9\u05d4\u05df \u05d2\u05dd \u05dc\u05e7\u05d1\u05dc \u05e1\u05d9\u05de\u05d5\u05df CE \u05e2\u05d1\u05d5\u05e8 \u05d4\u05de\u05d5\u05e6\u05e8 \u05de\u05d2\u05d5\u05e3 \u05de\u05d5\u05e1\u05de\u05da.<\/p>\n<p style=\"direction: rtl;\">\u05e0\u05d9\u05d5\u05d5\u05d8 \u05d1\u05ea\u05d4\u05dc\u05d9\u05db\u05d9 \u05d4\u05d0\u05d9\u05e9\u05d5\u05e8 \u05d5\u05d4\u05ea\u05d0\u05d9\u05de\u05d5\u05ea \u05dc\u05de\u05db\u05d9\u05e8\u05ea \u05de\u05db\u05e9\u05d9\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9 \u05d1\u05d0\u05d9\u05e8\u05d5\u05e4\u05d4 \u05d9\u05db\u05d5\u05dc \u05dc\u05d4\u05d9\u05d5\u05ea \u05de\u05d0\u05ea\u05d2\u05e8. \u05d5\u05d9\u05e9\u05e0\u05df \u05d7\u05d1\u05e8\u05d5\u05ea \u05d4\u05de\u05ea\u05de\u05d7\u05d5\u05ea \u05d1\u05e1\u05d9\u05de\u05d5\u05df CE \u05d5\u05d1\u05ea\u05d0\u05d9\u05de\u05d5\u05ea \u05dc-EU MDR.<\/p>\n<h2 style=\"direction: rtl;\">\u05ea\u05e4\u05e7\u05d9\u05d3\u05dd \u05e9\u05dc \u05e9\u05d9\u05e8\u05d5\u05ea\u05d9 \u05ea\u05e8\u05d2\u05d5\u05dd \u05d1\u05e9\u05d9\u05d5\u05d5\u05e7 \u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9<\/h2>\n<p style=\"direction: rtl;\">\u05d7\u05d1\u05e8\u05d5\u05ea \u05e9\u05de\u05d5\u05db\u05e8\u05d5\u05ea \u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9 \u05dc\u05e9\u05d5\u05d5\u05e7\u05d9\u05dd \u05d1\u05d0\u05d9\u05e8\u05d5\u05e4\u05d4 \u05d9\u05e6\u05d8\u05e8\u05db\u05d5 \u05d1\u05d3\u05e8\u05da \u05db\u05dc\u05dc \u05dc\u05ea\u05e8\u05d2\u05dd \u05de\u05d2\u05d5\u05d5\u05df \u05e8\u05d7\u05d1 \u05e9\u05dc \u05d7\u05d5\u05de\u05e8\u05d9\u05dd \u05dc\u05e9\u05e4\u05d5\u05ea \u05e9\u05d5\u05e0\u05d5\u05ea. \u05d7\u05dc\u05e7 \u05de\u05d4\u05de\u05e1\u05de\u05db\u05d9\u05dd \u05d9\u05e6\u05d8\u05e8\u05db\u05d5 \u05dc\u05d4\u05d9\u05d5\u05ea \u05de\u05ea\u05d5\u05e8\u05d2\u05de\u05d9\u05dd \u05dc\u05de\u05d8\u05e8\u05d5\u05ea \u05d0\u05d9\u05e9\u05d5\u05e8 \u05d4\u05de\u05d5\u05e6\u05e8 \u05d1\u05e9\u05d5\u05e7 \u05d4\u05d0\u05d9\u05e8\u05d5\u05e4\u05d9. \u05d7\u05d5\u05de\u05e8\u05d9\u05dd \u05d0\u05d7\u05e8\u05d9\u05dd \u05d9\u05ea\u05d5\u05e8\u05d2\u05de\u05d5 \u05dc\u05e9\u05d9\u05de\u05d5\u05e9 \u05dc\u05e4\u05e0\u05d9 \u05d5\u05d0\u05d7\u05e8\u05d9 \u05d4\u05de\u05db\u05d9\u05e8\u05d4. \u05d6\u05d4 \u05db\u05d5\u05dc\u05dc \u05d7\u05d5\u05d1\u05e8\u05d5\u05ea \u05e9\u05d9\u05d5\u05d5\u05e7, \u05ea\u05d9\u05d5\u05d2 \u05de\u05d5\u05e6\u05e8\u05d9\u05dd, \u05d0\u05e8\u05d9\u05d6\u05d4, \u05de\u05d9\u05d3\u05e2 \u05dc\u05de\u05e9\u05ea\u05de\u05e9 (IFU), \u05ea\u05d5\u05db\u05df \u05de\u05e7\u05d5\u05d5\u05df \u05d5\u05de\u05de\u05e9\u05e7 \u05de\u05e9\u05ea\u05de\u05e9 \u05e9\u05dc \u05ea\u05d5\u05db\u05e0\u05d4 (UI). \u05ea\u05e8\u05d2\u05d5\u05dd \u05e9\u05dc \u05d7\u05dc\u05e7 \u05de\u05d4\u05d7\u05d5\u05de\u05e8\u05d9\u05dd \u05d4\u05d9\u05d0 \u05d7\u05d5\u05d1\u05d4 (\u05e2\u05d5\u05d3 \u05e2\u05dc \u05db\u05da \u05d1\u05d4\u05de\u05e9\u05da) \u05d5\u05ea\u05e8\u05d2\u05d5\u05dd \u05e9\u05dc \u05d7\u05d5\u05de\u05e8\u05d9\u05dd \u05d0\u05d7\u05e8\u05d9\u05dd \u05d4\u05d9\u05d0 \u05d0\u05d5\u05e4\u05e6\u05d9\u05d4 \u05d0\u05da \u05d9\u05d5\u05e2\u05d9\u05dc \u05dc\u05d4\u05e6\u05dc\u05d7\u05ea \u05d4\u05de\u05d5\u05e6\u05e8 \u05de\u05d1\u05d7\u05d9\u05e0\u05d4 \u05de\u05e1\u05d7\u05e8\u05d9\u05ea.<\/p>\n<p style=\"direction: rtl;\">\u05d1\u05d0\u05d5\u05e4\u05df \u05db\u05dc\u05dc\u05d9, \u05d3\u05e8\u05d9\u05e9\u05d5\u05ea \u05d4\u05e9\u05e4\u05d5\u05ea \u05e2\u05d1\u05d5\u05e8 \u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9 \u05ea\u05dc\u05d5\u05d9\u05d5\u05ea \u05d1\u05db\u05dc \u05de\u05d3\u05d9\u05e0\u05d4 \u05d4\u05d7\u05d1\u05e8\u05d4 \u05d1\u05d0\u05d9\u05d7\u05d5\u05d3 \u05d4\u05d0\u05d9\u05e8\u05d5\u05e4\u05d9. \u05d1\u05d6\u05de\u05df \u05db\u05ea\u05d9\u05d1\u05ea \u05e9\u05d5\u05e8\u05d5\u05ea \u05d0\u05dc\u05d4, \u05d9\u05e9\u05e0\u05df 27 \u05de\u05d3\u05d9\u05e0\u05d5\u05ea \u05d7\u05d1\u05e8\u05d5\u05ea \u05d1\u05d0\u05d9\u05d7\u05d5\u05d3 \u05d4\u05d0\u05d9\u05e8\u05d5\u05e4\u05d9 \u05d5-24 \u05e9\u05e4\u05d5\u05ea \u05e8\u05e9\u05de\u05d9\u05d5\u05ea \u05e9\u05dc \u05d4\u05d0\u05d9\u05d7\u05d5\u05d3. \u05d2\u05dd \u05db\u05d0\u05df, \u05d9\u05d5\u05e2\u05e5 \u05d4\u05e8\u05d2\u05d5\u05dc\u05e6\u05d9\u05d4 \u05e9\u05dc\u05db\u05dd \u05d9\u05d5\u05db\u05dc \u05dc\u05d5\u05de\u05e8 \u05dc\u05db\u05dd \u05d0\u05d9\u05dc\u05d5 \u05de\u05e1\u05de\u05db\u05d9\u05dd \u05d9\u05e9 \u05dc\u05ea\u05e8\u05d2\u05dd \u05e2\u05dc \u05e1\u05de\u05da \u05d4\u05de\u05d3\u05d9\u05e0\u05d5\u05ea \u05d1\u05d4\u05df \u05d0\u05ea\u05dd \u05de\u05ea\u05db\u05e0\u05e0\u05d9\u05dd \u05dc\u05e9\u05d5\u05d5\u05e7 \u05d0\u05ea \u05d4\u05de\u05db\u05e9\u05d9\u05e8 \u05d4\u05e8\u05e4\u05d5\u05d0\u05d9.<\/p>\n<h2 style=\"direction: rtl;\">\u05ea\u05e7\u05df (EU) 2021\/2226<\/h2>\n<p style=\"direction: rtl;\">\u05ea\u05e7\u05df \u05d7\u05d3\u05e9 \u05d9\u05d7\u05e1\u05d9\u05ea, <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg_impl\/2021\/2226\/oj\">EU 2021\/2226<\/a> \u05de\u05d0\u05e4\u05e9\u05e8 \u05dc\u05d9\u05e6\u05e8\u05e0\u05d9\u05dd \u05dc\u05e1\u05e4\u05e7 \u05d4\u05d5\u05e8\u05d0\u05d5\u05ea \u05e9\u05d9\u05de\u05d5\u05e9 \u05d0\u05dc\u05e7\u05d8\u05e8\u05d5\u05e0\u05d9\u05d5\u05ea (eIFUs) \u05e2\u05d1\u05d5\u05e8 \u05de\u05db\u05e9\u05d9\u05e8\u05d9\u05dd \u05e8\u05e4\u05d5\u05d0\u05d9\u05d9\u05dd. \u05d6\u05d4 \u05d0\u05de\u05e0\u05dd \u05de\u05e6\u05de\u05e6\u05dd \u05d0\u05ea \u05d4\u05e2\u05d1\u05d5\u05d3\u05d4 \u05d4\u05db\u05e8\u05d5\u05db\u05d4 \u05d1\u05d4\u05d3\u05e4\u05e1\u05d4 \u05d5\u05d4\u05e4\u05e6\u05ea \u05d4\u05d5\u05e8\u05d0\u05d5\u05ea \u05e0\u05d9\u05d9\u05e8, \u05d0\u05d1\u05dc \u05d6\u05d4 \u05dc\u05d0 \u05de\u05e7\u05d8\u05d9\u05df \u05d0\u05ea \u05d4\u05d3\u05e8\u05d9\u05e9\u05d5\u05ea \u05dc\u05ea\u05e8\u05d2\u05d5\u05dd.<\/p>\n<blockquote>\n<p style=\"direction: rtl;\">\u05db\u05d3\u05d9 \u05dc\u05d4\u05d1\u05d8\u05d9\u05d7 \u05d2\u05d9\u05e9\u05d4 \u05d1\u05dc\u05ea\u05d9 \u05de\u05d5\u05ea\u05e0\u05d9\u05ea \u05dc\u05d4\u05d5\u05e8\u05d0\u05d5\u05ea \u05d4\u05e9\u05d9\u05de\u05d5\u05e9 \u05d1\u05e6\u05d5\u05e8\u05d4 \u05d0\u05dc\u05e7\u05d8\u05e8\u05d5\u05e0\u05d9\u05ea \u05d5\u05db\u05d3\u05d9 \u05dc\u05d4\u05e7\u05dc \u05e2\u05dc \u05d4\u05e2\u05d1\u05e8\u05ea \u05e2\u05d3\u05db\u05d5\u05e0\u05d9\u05dd, \u05d4\u05d5\u05e8\u05d0\u05d5\u05ea \u05d0\u05dc\u05d4 \u05e6\u05e8\u05d9\u05db\u05d5\u05ea \u05dc\u05d4\u05d9\u05d5\u05ea \u05d6\u05de\u05d9\u05e0\u05d5\u05ea \u05d1\u05d0\u05ea\u05e8 \u05d4\u05d0\u05d9\u05e0\u05d8\u05e8\u05e0\u05d8 \u05e9\u05dc \u05d4\u05d9\u05e6\u05e8\u05df \u05d1\u05e9\u05e4\u05d4\/\u05e9\u05e4\u05d5\u05ea \u05e8\u05e9\u05de\u05d9\u05d5\u05ea \u05e9\u05dc \u05d4\u05d0\u05d9\u05d7\u05d5\u05d3 \u05e9\u05e0\u05e7\u05d1\u05e2\u05d5 \u05e2\u05dc \u05d9\u05d3\u05d9 \u05d4\u05de\u05d3\u05d9\u05e0\u05d4 \u05d4\u05d7\u05d1\u05e8\u05d9\u05ea \u05e9\u05d1\u05d4 \u05d4\u05de\u05db\u05e9\u05d9\u05e8 \u05d6\u05de\u05d9\u05df \u05dc\u05de\u05e9\u05ea\u05de\u05e9 \u05d0\u05d5 \u05dc\u05de\u05d8\u05d5\u05e4\u05dc.<br \/>\n(\u05de\u05ea\u05d5\u05da \u05d3\u05e8\u05d9\u05e9\u05ea \u05d4\u05ea\u05e7\u05df)<\/p>\n<\/blockquote>\n<h2 style=\"direction: rtl;\">\u05de\u05d9\u05d3\u05e2 \u05dc\u05de\u05e9\u05ea\u05de\u05e9 (IFU)<\/h2>\n<p style=\"direction: rtl;\">\u05d4-IFU \u05d4\u05d5\u05d0 \u05d4\u05de\u05e1\u05de\u05da \u05d4\u05e2\u05d9\u05e7\u05e8\u05d9 \u05d0\u05e9\u05e8 \u05d1\u05d3\u05e8\u05da \u05db\u05dc\u05dc \u05e6\u05e8\u05d9\u05da \u05dc\u05d4\u05d9\u05d5\u05ea \u05de\u05ea\u05d5\u05e8\u05d2\u05dd \u05d1\u05e9\u05e4\u05d5\u05ea \u05d4\u05d0\u05d9\u05d7\u05d5\u05d3 \u05d4\u05d0\u05d9\u05e8\u05d5\u05e4\u05d9 \u05d4\u05e9\u05d5\u05e0\u05d5\u05ea. \u05d6\u05d4 \u05d2\u05dd \u05d4\u05de\u05e1\u05de\u05da \u05d4\u05d2\u05d3\u05d5\u05dc \u05d1\u05d9\u05d5\u05ea\u05e8. \u05e2\u05d1\u05d5\u05e8 \u05de\u05db\u05e9\u05d9\u05e8 \u05e4\u05e9\u05d5\u05d8 (\u05db\u05de\u05d5 \u05e2\u05e8\u05db\u05ea \u05d0\u05e0\u05d8\u05d9\u05d2\u05df \u05d1\u05d9\u05ea\u05d9\u05ea \u05e9\u05dc COVID-19), \u05d4-IFU \u05e2\u05e9\u05d5\u05d9 \u05dc\u05d4\u05d9\u05d5\u05ea \u05e2\u05de\u05d5\u05d3 \u05d0\u05d7\u05d3 \u05d1\u05dc\u05d1\u05d3. \u05d0\u05d1\u05dc \u05e2\u05d1\u05d5\u05e8 \u05de\u05db\u05e9\u05d9\u05e8 \u05de\u05d5\u05e8\u05db\u05d1 \u05d9\u05d5\u05ea\u05e8 \u05db\u05de\u05d5 \u05e1\u05d5\u05e8\u05e7 MRI, \u05d4 IFU \u05d9\u05db\u05d5\u05dc \u05dc\u05d4\u05db\u05d9\u05dc \u05db\u05de\u05d4 \u05de\u05d0\u05d5\u05ea \u05e2\u05de\u05d5\u05d3\u05d9\u05dd.<\/p>\n<p style=\"direction: rtl;\">\u05de\u05db\u05e9\u05d9\u05e8\u05d9\u05dd \u05e8\u05e4\u05d5\u05d0\u05d9\u05d9\u05dd \u05de\u05ea\u05e7\u05d3\u05de\u05d9\u05dd \u05d9\u05d4\u05d9\u05d5 \u05d1\u05d3\u05e8\u05da \u05db\u05dc\u05dc \u05de\u05d1\u05d5\u05e1\u05e1\u05d9 \u05ea\u05d5\u05db\u05e0\u05d4, \u05de\u05d4 \u05e9\u05d0\u05d5\u05de\u05e8 \u05e9\u05d9\u05d4\u05d9\u05d4 \u05dc\u05d4\u05dd \u05de\u05de\u05e9\u05e7 \u05de\u05e9\u05ea\u05de\u05e9 (UI). \u05d9\u05e6\u05e8\u05e0\u05d9\u05dd \u05d9\u05e6\u05d8\u05e8\u05db\u05d5 \u05d1\u05d3\u05e8\u05da \u05db\u05dc\u05dc \u05dc\u05ea\u05e8\u05d2\u05dd \u05d0\u05ea \u05d4-IFU \u05dc\u05e9\u05e4\u05ea \u05db\u05dc \u05de\u05d3\u05d9\u05e0\u05ea EU \u05e9\u05d1\u05d4 \u05d9\u05d9\u05de\u05db\u05e8 \u05d4\u05de\u05db\u05e9\u05d9\u05e8 \u05d4\u05e8\u05e4\u05d5\u05d0\u05d9. \u05ea\u05e8\u05d2\u05d5\u05dd \u05de\u05de\u05e9\u05e7 \u05d4\u05de\u05e9\u05ea\u05de\u05e9 \u05d0\u05d9\u05e0\u05d5 \u05d7\u05d5\u05d1\u05d4 \u05d0\u05dd \u05d4-IFU \u05de\u05ea\u05d5\u05e8\u05d2\u05dd. \u05d0\u05d1\u05dc \u05d9\u05e6\u05e8\u05e0\u05d9\u05dd \u05e8\u05d1\u05d9\u05dd \u05d9\u05ea\u05e8\u05d2\u05de\u05d5 \u05d0\u05ea \u05de\u05de\u05e9\u05e7 \u05d4\u05de\u05e9\u05ea\u05de\u05e9 \u05d1\u05db\u05dc \u05d6\u05d0\u05ea, \u05d0\u05dd \u05dc\u05e6\u05d5\u05e8\u05da \u05e8\u05d2\u05d5\u05dc\u05d8\u05d5\u05e8\u05d9 \u05d5\u05d0\u05dd \u05dc\u05e6\u05d5\u05e8\u05da \u05de\u05e1\u05d7\u05e8\u05d9.<\/p>\n<h2 style=\"direction: rtl;\">\u05e1\u05de\u05dc\u05d9\u05dd \u05d1 IFU<\/h2>\n<p style=\"direction: rtl;\"><a href=\"https:\/\/www.iso.org\/standard\/77326.html\"> ISO 15223-1<\/a> \u05d4\u05d5\u05d0 \u05d4\u05ea\u05e7\u05df \u05d4\u05de\u05e4\u05e8\u05d8 \u05d0\u05ea \u05d4\u05e1\u05de\u05dc\u05d9\u05dd \u05e9\u05d9\u05e9 \u05dc\u05d4\u05db\u05e0\u05d9\u05e1 \u05dc-IFU. \u05e1\u05de\u05dc\u05d9\u05dd \u05d0\u05dc\u05d4 \u05d4\u05dd \u05d0\u05d9\u05e0\u05d3\u05d9\u05e7\u05e6\u05d9\u05d5\u05ea \u05e6\u05d9\u05d5\u05e8\u05d9\u05d5\u05ea \u05e9\u05dc \u05d4\u05e1\u05d9\u05db\u05d5\u05e0\u05d9\u05dd \u05d5\u05d4\u05d0\u05d6\u05d4\u05e8\u05d5\u05ea \u05d4\u05e7\u05e9\u05d5\u05e8\u05d9\u05dd \u05dc\u05e9\u05d9\u05de\u05d5\u05e9 \u05d1\u05de\u05db\u05e9\u05d9\u05e8 \u05d4\u05e8\u05e4\u05d5\u05d0\u05d9. \u05db\u05dc \u05e1\u05de\u05dc \u05de\u05e1\u05d5\u05de\u05df \u05d1\u05d8\u05e7\u05e1\u05d8 \u05db\u05dc\u05e9\u05d4\u05d5 \u05db\u05d3\u05d9 \u05dc\u05e6\u05d9\u05d9\u05df \u05de\u05d4 \u05d4\u05e1\u05de\u05dc \u05de\u05d9\u05d9\u05e6\u05d2. \u05dc\u05e1\u05e4\u05e7 \u05d4\u05ea\u05e8\u05d2\u05d5\u05dd \u05e9\u05dc\u05da \u05d9\u05d4\u05d9\u05d5 <a href=\"https:\/\/www.gts-translation.com\/wp-content\/uploads\/2022\/12\/medical-device-symbols.pdf\">\u05ea\u05e8\u05d2\u05d5\u05de\u05d9\u05dd \u05e9\u05dc \u05d4\u05d8\u05e7\u05e1\u05d8\u05d9\u05dd \u05d4\u05e1\u05d8\u05e0\u05d3\u05e8\u05d8\u05d9\u05d9\u05dd \u05e9\u05dc \u05e1\u05de\u05dc\u05d9 \u05d4 IFU<\/a> \u05dc\u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9 \u05d1\u05db\u05dc \u05d0\u05d7\u05ea \u05de\u05d4\u05e9\u05e4\u05d5\u05ea \u05e9\u05dc \u05d4\u05d0\u05d9\u05d7\u05d5\u05d3 \u05d4\u05d0\u05d9\u05e8\u05d5\u05e4\u05d9.<\/p>\n<h2 style=\"direction: rtl;\">\u05d0\u05ea\u05d2\u05e8\u05d9\u05dd \u05d1\u05ea\u05d4\u05dc\u05d9\u05da \u05d4\u05ea\u05e8\u05d2\u05d5\u05dd \u05e9\u05dc \u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9<\/h2>\n<p style=\"direction: rtl;\">\u05d9\u05e6\u05e8\u05e0\u05d9\u05dd \u05d4\u05de\u05e9\u05d5\u05d5\u05e7\u05d9\u05dd \u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9 \u05dc\u05d0\u05d9\u05e8\u05d5\u05e4\u05d4 \u05de\u05ea\u05de\u05d5\u05d3\u05d3\u05d9\u05dd \u05e2\u05dd \u05d0\u05ea\u05d2\u05e8\u05d9\u05dd \u05e8\u05d1\u05d9\u05dd \u05d1\u05de\u05ea\u05df \u05ea\u05e8\u05d2\u05d5\u05de\u05d9\u05dd \u05d1\u05d0\u05d9\u05db\u05d5\u05ea \u05d2\u05d1\u05d5\u05d4\u05d4 \u05d1\u05d0\u05d5\u05e4\u05df \u05e2\u05e7\u05d1\u05d9. \u05e7\u05d5\u05d3\u05dd \u05db\u05dc, \u05d9\u05e6\u05e8\u05e0\u05d9\u05dd \u05e8\u05d1\u05d9\u05dd \u05e6\u05e8\u05d9\u05db\u05d9\u05dd \u05dc\u05ea\u05e8\u05d2\u05dd \u05d7\u05d5\u05de\u05e8\u05d9\u05dd \u05d1\u05dc\u05de\u05e2\u05dc\u05d4 \u05de-20 \u05e9\u05e4\u05d5\u05ea \u05d1\u05d5-\u05d6\u05de\u05e0\u05d9\u05ea, \u05de\u05e9\u05d9\u05de\u05d4 \u05e9\u05dc\u05e2\u05e6\u05de\u05d4 \u05d0\u05d9\u05e0\u05d4 \u05e4\u05e9\u05d5\u05d8\u05d4. \u05d1\u05e0\u05d5\u05e1\u05e3, \u05d4\u05d8\u05e7\u05e1\u05d8\u05d9\u05dd \u05de\u05d2\u05d9\u05e2\u05d9\u05dd \u05de\u05de\u05e1\u05e4\u05e8 \u05de\u05e1\u05de\u05db\u05d9\u05dd (\u05d4-IFU, \u05de\u05de\u05e9\u05e7 \u05d4\u05de\u05e9\u05ea\u05de\u05e9, \u05d4\u05ea\u05d9\u05d5\u05d2 \u05d5\u05d4\u05d0\u05e8\u05d9\u05d6\u05d4) \u05d5\u05d4\u05ea\u05e8\u05d2\u05d5\u05de\u05d9\u05dd \u05d7\u05d9\u05d9\u05d1\u05d9\u05dd \u05dc\u05d4\u05d9\u05d5\u05ea \u05e2\u05e7\u05d1\u05d9\u05d9\u05dd \u05d1\u05db\u05dc \u05de\u05e1\u05de\u05da\/\u05ea\u05d5\u05d5\u05d9\u05ea. \u05db\u05d3\u05d9 \u05dc\u05d8\u05e4\u05dc \u05d1\u05e4\u05e8\u05d5\u05d9\u05e7\u05d8 \u05db\u05d6\u05d4, \u05ea\u05d6\u05d3\u05e7\u05e7\u05d5 <a href=\"https:\/\/www.gts-translation.com\/he\/services\/medical_translation_services\/\">\u05dc\u05d7\u05d1\u05e8\u05ea \u05ea\u05e8\u05d2\u05d5\u05dd \u05e8\u05e4\u05d5\u05d0\u05d9<\/a> \u05e2\u05dd \u05de\u05ea\u05e8\u05d2\u05de\u05d9\u05dd \u05e8\u05e4\u05d5\u05d0\u05d9\u05d9\u05dd \u05d4\u05de\u05ea\u05de\u05d7\u05d9\u05dd \u05d1\u05e2\u05e9\u05e8\u05d5\u05ea \u05e9\u05e4\u05d5\u05ea. \u05d1\u05e0\u05d9\u05d9\u05ea \u05e6\u05d5\u05d5\u05ea \u05ea\u05e8\u05d2\u05d5\u05dd \u05ea\u05e2\u05d6\u05d5\u05e8 \u05dc\u05da \u05dc\u05d4\u05d1\u05d9\u05d0 \u05d0\u05ea \u05d4\u05de\u05d5\u05e6\u05e8\u05d9\u05dd \u05e9\u05dc\u05da \u05dc\u05e9\u05d5\u05e7 \u05d1\u05de\u05d4\u05d9\u05e8\u05d5\u05ea \u05d5\u05d1\u05d9\u05e2\u05d9\u05dc\u05d5\u05ea \u05d4\u05d0\u05e4\u05e9\u05e8\u05d9\u05d9\u05dd.<\/p>\n<h2 style=\"direction: rtl;\">\u05ea\u05e4\u05e7\u05d9\u05d3\u05dd \u05e9\u05dc \u05de\u05d9\u05dc\u05d5\u05e0\u05d9\u05dd \u05de\u05d5\u05e0\u05d7\u05d9\u05dd \u05d5\u05d6\u05d9\u05db\u05e8\u05d5\u05e0\u05d5\u05ea \u05ea\u05e8\u05d2\u05d5\u05dd \u05d1\u05ea\u05d4\u05dc\u05d9\u05da<\/h2>\n<p style=\"direction: rtl;\">\u05e2\u05dc \u05de\u05e0\u05ea \u05dc\u05d9\u05d9\u05e6\u05e8 \u05ea\u05e8\u05d2\u05d5\u05de\u05d9\u05dd \u05e2\u05e7\u05d1\u05d9\u05d9\u05dd \u05d5\u05d0\u05d9\u05db\u05d5\u05ea\u05d9\u05d9\u05dd \u05e2\u05d1\u05d5\u05e8 \u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9, \u05d7\u05d1\u05e8\u05d5\u05ea \u05ea\u05e8\u05d2\u05d5\u05dd \u05de\u05d9\u05d9\u05e9\u05de\u05d5\u05ea \u05db\u05dc\u05d9 \u05ea\u05d5\u05db\u05e0\u05d4 \u05e9\u05e0\u05d5\u05e2\u05d3\u05d5 \u05dc\u05d4\u05e4\u05d5\u05da \u05d0\u05ea \u05d4\u05e2\u05d1\u05d5\u05d3\u05d4 \u05dc\u05d9\u05e2\u05d9\u05dc\u05d4 \u05d5\u05d6\u05d5\u05dc\u05d4 \u05d9\u05d5\u05ea\u05e8. \u05db\u05dc\u05d9 \u05e0\u05d9\u05d4\u05d5\u05dc \u05d8\u05e8\u05de\u05d9\u05e0\u05d5\u05dc\u05d5\u05d2\u05d9\u05d4 \u05de\u05d0\u05d7\u05e1\u05e0\u05d9\u05dd \u05ea\u05e8\u05d2\u05d5\u05de\u05d9\u05dd \u05e9\u05dc \u05de\u05d5\u05e0\u05d7\u05d9\u05dd \u05e1\u05e4\u05e6\u05d9\u05e4\u05d9\u05d9\u05dd \u05dc\u05ea\u05e2\u05e9\u05d9\u05d9\u05d4 \u05d5\u05d8\u05db\u05e0\u05d9\u05d9\u05dd\/\u05e8\u05e4\u05d5\u05d0\u05d9\u05d9\u05dd \u05d4\u05e8\u05dc\u05d5\u05d5\u05e0\u05d8\u05d9\u05d9\u05dd \u05dc\u05db\u05dc \u05de\u05db\u05e9\u05d9\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9. \u05e9\u05d9\u05de\u05d5\u05e9 \u05d9\u05e2\u05d9\u05dc \u05d1\u05de\u05d0\u05d2\u05e8\u05d9 \u05de\u05d5\u05e0\u05d7\u05d9\u05dd \u05d9\u05d1\u05d8\u05d9\u05d7 \u05e9\u05d4\u05de\u05ea\u05e8\u05d2\u05de\u05d9\u05dd \u05d9\u05e9\u05ea\u05de\u05e9\u05d5 \u05d1\u05de\u05d5\u05e0\u05d7\u05d9\u05dd \u05d4\u05e0\u05db\u05d5\u05e0\u05d9\u05dd \u05d1\u05d0\u05d5\u05e4\u05df \u05e2\u05e7\u05d1\u05d9 \u05d1\u05db\u05dc \u05e4\u05e2\u05dd.<\/p>\n<p style=\"direction: rtl;\">\u05d6\u05d9\u05db\u05e8\u05d5\u05e0\u05d5\u05ea \u05ea\u05e8\u05d2\u05d5\u05dd (TM) \u05de\u05d0\u05d7\u05e1\u05e0\u05d9\u05dd \u05e8\u05e9\u05d5\u05de\u05d5\u05ea \u05e9\u05dc \u05ea\u05e8\u05d2\u05d5\u05de\u05d9\u05dd \u05de\u05d3\u05d5\u05e8 \u05e7\u05d5\u05d3\u05dd. \u05d6\u05d4 \u05d4\u05de\u05e4\u05ea\u05d7, \u05d1\u05de\u05d9\u05d5\u05d7\u05d3 \u05de\u05db\u05d9\u05d5\u05d5\u05df \u05e9\u05d0\u05d5\u05ea\u05d5 \u05ea\u05d9\u05e2\u05d5\u05d3 \u05e6\u05e8\u05d9\u05da \u05dc\u05d4\u05ea\u05e2\u05d3\u05db\u05df \u05dc\u05e2\u05ea\u05d9\u05dd \u05e7\u05e8\u05d5\u05d1\u05d5\u05ea. \u05d6\u05d9\u05db\u05e8\u05d5\u05df \u05ea\u05e8\u05d2\u05d5\u05dd \u05d9\u05d1\u05d9\u05d0 \u05dc\u05d7\u05d9\u05e1\u05db\u05d5\u05df \u05de\u05e9\u05de\u05e2\u05d5\u05ea\u05d9 \u05d1\u05e2\u05dc\u05d5\u05d9\u05d5\u05ea.<\/p>\n<p style=\"direction: rtl;\">\u05d0\u05dd \u05d9\u05e9 \u05dc\u05db\u05dd \u05e6\u05d5\u05e8\u05da \u05d1<a href=\"https:\/\/www.gts-translation.com\/he\/services\/medical_translation_services\/%d7%aa%d7%a8%d7%92%d7%95%d7%9e%d7%99%d7%9d-%d7%9c%d7%9e%d7%9b%d7%a9%d7%95%d7%a8-%d7%a8%d7%a4%d7%95%d7%90%d7%99\/\">\u05e9\u05d9\u05e8\u05d5\u05ea\u05d9 \u05ea\u05e8\u05d2\u05d5\u05dd \u05dc\u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9<\/a>, \u05ea\u05e4\u05e0\u05d5 \u05dc GTS. \u05d9\u05e9 \u05dc\u05e0\u05d5 \u05e0\u05d9\u05e1\u05d9\u05d5\u05df \u05de\u05d5\u05db\u05d7 \u05e9\u05dc 20 \u05e9\u05e0\u05d4 \u05d1\u05ea\u05d7\u05d5\u05dd. \u05de\u05e2\u05e8\u05db\u05ea \u05d4\u05d0\u05d9\u05db\u05d5\u05ea \u05e9\u05dc\u05e0\u05d5 \u05de\u05d0\u05d5\u05e9\u05e8\u05ea \u05dc\u05ea\u05e7\u05df ISO 17100:2015.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u05d1\u05e9\u05e0\u05ea 2023, \u05d9\u05d5\u05ea\u05e8 \u05de-500,000 \u05e1\u05d5\u05d2\u05d9\u05dd \u05e9\u05dc \u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9 \u05e0\u05de\u05db\u05e8\u05d9\u05dd \u05d1\u05e9\u05d5\u05e7 \u05d4\u05d0\u05d9\u05e8\u05d5\u05e4\u05d9-\u05d4\u05d7\u05dc \u05de\u05de\u05db\u05e9\u05d9\u05e8\u05d9\u05dd \u05e4\u05e9\u05d5\u05d8\u05d9\u05dd \u05db\u05de\u05d5 \u05e2\u05e8\u05db\u05d5\u05ea \u05d1\u05d3\u05d9\u05e7\u05d4 \u05d1\u05d9\u05ea\u05d9\u05d5\u05ea \u05dc\u05d6\u05d9\u05d4\u05d5\u05d9 COVID-19 \u05d5\u05e2\u05d3 \u05de\u05db\u05e9\u05d9\u05e8\u05d9\u05dd \u05de\u05d5\u05e8\u05db\u05d1\u05d9\u05dd \u05d9\u05d5\u05ea\u05e8 \u05db\u05de\u05d5 \u05e7\u05d5\u05e6\u05d1\u05d9 \u05dc\u05d1 \u05d5\u05e9\u05ea\u05dc\u05d9\u05dd \u05dc\u05d7\u05d6\u05d4. \u05db\u05e6\u05e4\u05d5\u05d9, \u05de\u05db\u05d9\u05e8\u05ea \u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9 \u05d1\u05d0\u05d9\u05e8\u05d5\u05e4\u05d4 \u05de\u05d5\u05e1\u05d3\u05e8\u05ea \u05de\u05d0\u05d5\u05d3 \u05d1\u05e8\u05d2\u05d5\u05dc\u05e6\u05d9\u05d5\u05ea \u05e7\u05e4\u05d3\u05e0\u05d9\u05d5\u05ea. \u05d7\u05d1\u05e8\u05d5\u05ea \u05e9\u05e8\u05d5\u05e6\u05d5\u05ea \u05dc\u05e9\u05d5\u05d5\u05e7 \u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9 \u05d1\u05d0\u05d9\u05e8\u05d5\u05e4\u05d4 \u05d7\u05d9\u05d9\u05d1\u05d5\u05ea \u05dc\u05e2\u05de\u05d5\u05d3 \u05d1\u05ea\u05e7\u05e0\u05d5\u05ea \u05d4-European Union Medical Device Regulation \u05d5\u05e2\u05dc\u05d9\u05d4\u05df \u05d2\u05dd \u05dc\u05e7\u05d1\u05dc \u05e1\u05d9\u05de\u05d5\u05df &hellip; <\/p>\n","protected":false},"author":2,"featured_media":15452,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"sfsi_plus_gutenberg_text_before_share":"","sfsi_plus_gutenberg_show_text_before_share":"","sfsi_plus_gutenberg_icon_type":"","sfsi_plus_gutenberg_icon_alignemt":"","sfsi_plus_gutenburg_max_per_row":"","footnotes":""},"categories":[143],"tags":[],"class_list":["post-15443","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-143"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u05e9\u05d9\u05d5\u05d5\u05e7 \u05de\u05db\u05e9\u05d9\u05e8\u05d9\u05dd \u05e8\u05e4\u05d5\u05d0\u05d9\u05d9\u05dd \u05d1\u05d0\u05d9\u05e8\u05d5\u05e4\u05d4-\u05d3\u05e8\u05d9\u05e9\u05d5\u05ea \u05dc\u05e9\u05d5\u05e0\u05d9\u05d5\u05ea - \u05d4\u05d1\u05dc\u05d5\u05d2 \u05e9\u05dc GTS<\/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:\/\/blog.gts-translation.com\/he\/2023\/02\/26\/%d7%a9%d7%99%d7%95%d7%95%d7%a7-%d7%9e%d7%9b%d7%a9%d7%99%d7%a8%d7%99%d7%9d-%d7%a8%d7%a4%d7%95%d7%90%d7%99%d7%99%d7%9d-%d7%91%d7%90%d7%99%d7%a8%d7%95%d7%a4%d7%94-%d7%93%d7%a8%d7%99%d7%a9%d7%95%d7%aa\/\" \/>\n<meta property=\"og:locale\" content=\"he_IL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u05e9\u05d9\u05d5\u05d5\u05e7 \u05de\u05db\u05e9\u05d9\u05e8\u05d9\u05dd \u05e8\u05e4\u05d5\u05d0\u05d9\u05d9\u05dd \u05d1\u05d0\u05d9\u05e8\u05d5\u05e4\u05d4-\u05d3\u05e8\u05d9\u05e9\u05d5\u05ea \u05dc\u05e9\u05d5\u05e0\u05d9\u05d5\u05ea - \u05d4\u05d1\u05dc\u05d5\u05d2 \u05e9\u05dc GTS\" \/>\n<meta property=\"og:description\" content=\"\u05d1\u05e9\u05e0\u05ea 2023, \u05d9\u05d5\u05ea\u05e8 \u05de-500,000 \u05e1\u05d5\u05d2\u05d9\u05dd \u05e9\u05dc \u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9 \u05e0\u05de\u05db\u05e8\u05d9\u05dd \u05d1\u05e9\u05d5\u05e7 \u05d4\u05d0\u05d9\u05e8\u05d5\u05e4\u05d9-\u05d4\u05d7\u05dc \u05de\u05de\u05db\u05e9\u05d9\u05e8\u05d9\u05dd \u05e4\u05e9\u05d5\u05d8\u05d9\u05dd \u05db\u05de\u05d5 \u05e2\u05e8\u05db\u05d5\u05ea \u05d1\u05d3\u05d9\u05e7\u05d4 \u05d1\u05d9\u05ea\u05d9\u05d5\u05ea \u05dc\u05d6\u05d9\u05d4\u05d5\u05d9 COVID-19 \u05d5\u05e2\u05d3 \u05de\u05db\u05e9\u05d9\u05e8\u05d9\u05dd \u05de\u05d5\u05e8\u05db\u05d1\u05d9\u05dd \u05d9\u05d5\u05ea\u05e8 \u05db\u05de\u05d5 \u05e7\u05d5\u05e6\u05d1\u05d9 \u05dc\u05d1 \u05d5\u05e9\u05ea\u05dc\u05d9\u05dd \u05dc\u05d7\u05d6\u05d4. \u05db\u05e6\u05e4\u05d5\u05d9, \u05de\u05db\u05d9\u05e8\u05ea \u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9 \u05d1\u05d0\u05d9\u05e8\u05d5\u05e4\u05d4 \u05de\u05d5\u05e1\u05d3\u05e8\u05ea \u05de\u05d0\u05d5\u05d3 \u05d1\u05e8\u05d2\u05d5\u05dc\u05e6\u05d9\u05d5\u05ea \u05e7\u05e4\u05d3\u05e0\u05d9\u05d5\u05ea. \u05d7\u05d1\u05e8\u05d5\u05ea \u05e9\u05e8\u05d5\u05e6\u05d5\u05ea \u05dc\u05e9\u05d5\u05d5\u05e7 \u05de\u05db\u05e9\u05d5\u05e8 \u05e8\u05e4\u05d5\u05d0\u05d9 \u05d1\u05d0\u05d9\u05e8\u05d5\u05e4\u05d4 \u05d7\u05d9\u05d9\u05d1\u05d5\u05ea \u05dc\u05e2\u05de\u05d5\u05d3 \u05d1\u05ea\u05e7\u05e0\u05d5\u05ea \u05d4-European Union Medical Device Regulation \u05d5\u05e2\u05dc\u05d9\u05d4\u05df \u05d2\u05dd \u05dc\u05e7\u05d1\u05dc \u05e1\u05d9\u05de\u05d5\u05df &hellip;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/blog.gts-translation.com\/he\/2023\/02\/26\/%d7%a9%d7%99%d7%95%d7%95%d7%a7-%d7%9e%d7%9b%d7%a9%d7%99%d7%a8%d7%99%d7%9d-%d7%a8%d7%a4%d7%95%d7%90%d7%99%d7%99%d7%9d-%d7%91%d7%90%d7%99%d7%a8%d7%95%d7%a4%d7%94-%d7%93%d7%a8%d7%99%d7%a9%d7%95%d7%aa\/\" \/>\n<meta property=\"og:site_name\" content=\"\u05d4\u05d1\u05dc\u05d5\u05d2 \u05e9\u05dc GTS\" \/>\n<meta property=\"article:published_time\" content=\"2023-02-26T12:59:36+00:00\" 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