\n\t\t\t\t

\t\t

\n\t\t\t\t\t

ISO 16061<\/h4>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
\u0627\u0628\u0632\u0627\u0631\u0647\u0627\u06cc \u0645\u0648\u0631\u062f \u0627\u0633\u062a\u0641\u0627\u062f\u0647 \u0647\u0645\u0631\u0627\u0647 \u0628\u0627 \u0627\u06cc\u0645\u067e\u0644\u0646\u062a\u200c\u0647\u0627\u06cc \u062c\u0631\u0627\u062d\u06cc \u063a\u06cc\u0631\u0641\u0639\u0627\u0644 \u2013 \u0627\u0644\u0632\u0627\u0645\u0627\u062a \u0639\u0645\u0648\u0645\u06cc\n\n(Instruments for Use in Association with Non-Active Surgical Implants \u2014 General Requirements)<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
\u0645\u0646\u0627\u0628\u0639 \u0645\u0631\u062c\u0639 (Normative References):<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
ISO 16061: Instruments for Use in Association with Non-Active Surgical Implants \u2014 General Requirements
DIN EN ISO 16061: Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden \u2013 Allgemeine Anforderungen<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
\u0634\u0631\u062d \u0627\u0633\u062a\u0627\u0646\u062f\u0627\u0631\u062f:<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\u0627\u0633\u062a\u0627\u0646\u062f\u0627\u0631\u062f \u0628\u06cc\u0646\u200c\u0627\u0644\u0645\u0644\u0644\u06cc ISO 16061<\/strong> \u0628\u0647\u200c\u0639\u0646\u0648\u0627\u0646 \u0645\u0631\u062c\u0639 \u0627\u0635\u0644\u06cc \u0628\u0631\u0627\u06cc \u0627\u0644\u0632\u0627\u0645\u0627\u062a \u0639\u0645\u0648\u0645\u06cc \u0637\u0631\u0627\u062d\u06cc\u060c \u062a\u0648\u0644\u06cc\u062f\u060c \u0648 \u0622\u0632\u0645\u0648\u0646 \u0627\u0628\u0632\u0627\u0631\u0647\u0627\u06cc \u0645\u0648\u0631\u062f \u0627\u0633\u062a\u0641\u0627\u062f\u0647 \u062f\u0631 \u06a9\u0646\u0627\u0631 \u0627\u06cc\u0645\u067e\u0644\u0646\u062a\u200c\u0647\u0627\u06cc \u062c\u0631\u0627\u062d\u06cc \u063a\u06cc\u0631\u0641\u0639\u0627\u0644 (Non-Active Surgical Implants)<\/strong> \u0634\u0646\u0627\u062e\u062a\u0647 \u0645\u06cc\u200c\u0634\u0648\u062f.<\/p>
\u0627\u06cc\u0646 \u0627\u0633\u062a\u0627\u0646\u062f\u0627\u0631\u062f \u062a\u0645\u0627\u0645\u06cc \u0627\u0628\u0632\u0627\u0631\u0647\u0627\u06cc \u0645\u0631\u062a\u0628\u0637 \u0628\u0627 \u06a9\u0627\u0634\u062a \u0648 \u0628\u0631\u062f\u0627\u0634\u062a \u0627\u06cc\u0645\u067e\u0644\u0646\u062a\u200c\u0647\u0627 \u2013 \u0646\u0638\u06cc\u0631 \u062f\u0631\u06cc\u0644\u200c\u0647\u0627\u060c \u0647\u0646\u062f\u0644\u200c\u0647\u0627\u060c \u0622\u0686\u0627\u0631\u0647\u0627\u06cc \u06af\u0634\u062a\u0627\u0648\u0631\u060c \u0627\u0646\u0633\u062a\u0631\u0648\u0645\u0646\u062a\u200c\u0647\u0627\u06cc \u0645\u0648\u0646\u062a\u0627\u0698 \u0648 \u0627\u0628\u0632\u0627\u0631\u0647\u0627\u06cc \u0631\u0627\u0647\u0646\u0645\u0627 \u2013 \u0631\u0627 \u0634\u0627\u0645\u0644 \u0645\u06cc\u200c\u0634\u0648\u062f.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
\u0647\u062f\u0641 \u0627\u0633\u062a\u0627\u0646\u062f\u0627\u0631\u062f:<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\u062a\u0639\u06cc\u06cc\u0646 \u0627\u0644\u0632\u0627\u0645\u0627\u062a \u067e\u0627\u06cc\u0647 \u0628\u0631\u0627\u06cc \u0627\u0637\u0645\u06cc\u0646\u0627\u0646 \u0627\u0632:<\/p>
\u0627\u06cc\u0645\u0646\u06cc \u0645\u06a9\u0627\u0646\u06cc\u06a9\u06cc \u0648 \u0639\u0645\u0644\u06a9\u0631\u062f\u06cc \u0627\u0628\u0632\u0627\u0631\u0647\u0627\u060c<\/strong><\/p>
\u0633\u0627\u0632\u06af\u0627\u0631\u06cc \u0632\u06cc\u0633\u062a\u06cc \u0648 \u0634\u06cc\u0645\u06cc\u0627\u06cc\u06cc \u0645\u0648\u0627\u062f \u062a\u0634\u06a9\u06cc\u0644\u200c\u062f\u0647\u0646\u062f\u0647\u060c<\/strong><\/p>
and \u0642\u0627\u0628\u0644\u06cc\u062a \u0627\u0633\u062a\u0641\u0627\u062f\u0647 \u0645\u06a9\u0631\u0631 \u0648 \u0627\u0633\u062a\u0631\u06cc\u0644\u06cc\u0632\u0627\u0633\u06cc\u0648\u0646 \u0628\u062f\u0648\u0646 \u0627\u0641\u062a \u0639\u0645\u0644\u06a9\u0631\u062f.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
\u0645\u0641\u0627\u062f \u06a9\u0644\u06cc\u062f\u06cc \u0627\u0633\u062a\u0627\u0646\u062f\u0627\u0631\u062f:<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
1-\u0627\u0644\u0632\u0627\u0645\u0627\u062a \u0637\u0631\u0627\u062d\u06cc (Design Requirements):<\/strong><\/p>
\u0637\u0631\u0627\u062d\u06cc \u0628\u0627\u06cc\u062f \u0628\u0631 \u0627\u0633\u0627\u0633 \u0622\u0646\u0627\u0644\u06cc\u0632 \u0631\u06cc\u0633\u06a9 (Risk Analysis)<\/strong> \u0627\u0646\u062c\u0627\u0645 \u0634\u0648\u062f.<\/p>
\u062a\u0645\u0627\u0645 \u0633\u0637\u0648\u062d \u062a\u0645\u0627\u0633 \u0628\u0627 \u0628\u0627\u0641\u062a \u06cc\u0627 \u0627\u06cc\u0645\u067e\u0644\u0646\u062a \u0628\u0627\u06cc\u062f \u0641\u0627\u0642\u062f \u0632\u0628\u0631\u06cc\u060c \u0644\u0628\u0647 \u062a\u06cc\u0632 \u06cc\u0627 \u0646\u0648\u0627\u0642\u0635 \u0633\u0637\u062d\u06cc \u0628\u0627\u0634\u0646\u062f.<\/p>
\u0637\u0631\u0627\u062d\u06cc \u0628\u0627\u06cc\u062f \u0627\u0645\u06a9\u0627\u0646 \u062a\u0645\u06cc\u0632\u06a9\u0627\u0631\u06cc\u060c \u0627\u0633\u062a\u0631\u06cc\u0644\u06cc\u0632\u0627\u0633\u06cc\u0648\u0646 \u0648 \u0645\u0648\u0646\u062a\u0627\u0698 \u0645\u062c\u062f\u062f \u0622\u0633\u0627\u0646<\/strong> \u0631\u0627 \u0641\u0631\u0627\u0647\u0645 \u06a9\u0646\u062f.<\/p>
2-\u0627\u0646\u062a\u062e\u0627\u0628 \u0645\u0648\u0627\u062f (Material Requirements):<\/strong><\/p>
\u0641\u0642\u0637 \u0645\u0648\u0627\u062f\u06cc \u0645\u062c\u0627\u0632 \u0647\u0633\u062a\u0646\u062f \u06a9\u0647 \u0627\u0632 \u0646\u0638\u0631 \u0632\u06cc\u0633\u062a\u200c\u0633\u0627\u0632\u06af\u0627\u0631\u06cc \u0648 \u0645\u0642\u0627\u0648\u0645\u062a \u062f\u0631 \u0628\u0631\u0627\u0628\u0631 \u062e\u0648\u0631\u062f\u06af\u06cc \u0628\u0627 ISO 10993<\/strong> and ISO 13402<\/strong> \u0645\u0637\u0627\u0628\u0642\u062a \u062f\u0627\u0634\u062a\u0647 \u0628\u0627\u0634\u0646\u062f.<\/p>
\u062f\u0631 \u0635\u0648\u0631\u062a \u0627\u0633\u062a\u0641\u0627\u062f\u0647 \u0627\u0632 \u067e\u0648\u0634\u0634 \u06cc\u0627 \u0639\u0645\u0644\u06cc\u0627\u062a \u0633\u0637\u062d\u06cc\u060c \u0628\u0627\u06cc\u062f \u0622\u0632\u0645\u0648\u0646\u200c\u0647\u0627\u06cc \u0686\u0633\u0628\u0646\u062f\u06af\u06cc \u0648 \u062f\u0648\u0627\u0645 \u0627\u0646\u062c\u0627\u0645 \u0634\u0648\u062f.<\/p>
3-\u0627\u0644\u0632\u0627\u0645\u0627\u062a \u0639\u0645\u0644\u06a9\u0631\u062f\u06cc (Functional Requirements):<\/strong><\/p>
\u0627\u0628\u0632\u0627\u0631 \u0628\u0627\u06cc\u062f \u0642\u0627\u062f\u0631 \u0628\u0627\u0634\u062f \u0646\u06cc\u0631\u0648 \u06cc\u0627 \u06af\u0634\u062a\u0627\u0648\u0631 \u0645\u0648\u0631\u062f \u0646\u06cc\u0627\u0632 \u0631\u0627 \u0628\u062f\u0648\u0646 \u0634\u06a9\u0633\u062a \u06cc\u0627 \u062a\u063a\u06cc\u06cc\u0631 \u0634\u06a9\u0644 \u062f\u0627\u0626\u0645 \u062a\u062d\u0645\u0644 \u06a9\u0646\u062f.<\/p>
\u0645\u0642\u0627\u0648\u0645\u062a \u062f\u0631 \u0628\u0631\u0627\u0628\u0631 \u0633\u0627\u06cc\u0634 \u0648 \u062e\u0648\u0631\u062f\u06af\u06cc \u0628\u0627\u06cc\u062f \u0628\u0627 \u0622\u0632\u0645\u0648\u0646\u200c\u0647\u0627\u06cc \u0627\u0633\u062a\u0627\u0646\u062f\u0627\u0631\u062f \u0627\u062b\u0628\u0627\u062a \u0634\u0648\u062f.<\/p>
4-\u0627\u0633\u062a\u0627\u0646\u062f\u0627\u0631\u062f\u0647\u0627\u06cc \u0633\u0637\u0648\u062d \u062f\u0648\u0645 \u0648 \u0633\u0648\u0645 (Level 2 & 3 Standards):<\/strong><\/p>
Level 2:<\/strong> \u0627\u0644\u0632\u0627\u0645\u0627\u062a \u0627\u062e\u062a\u0635\u0627\u0635\u06cc \u0628\u0631\u0627\u06cc \u06af\u0631\u0648\u0647\u200c\u0647\u0627\u06cc \u062e\u0627\u0635 \u0627\u0628\u0632\u0627\u0631 (\u0645\u062b\u0644\u0627\u064b \u062f\u0631\u06cc\u0644\u200c\u0647\u0627 \u06cc\u0627 \u06a9\u0644\u0645\u067e\u200c\u0647\u0627).<\/p>
Level 3:<\/strong> \u0627\u0644\u0632\u0627\u0645\u0627\u062a \u0648\u06cc\u0698\u0647 \u0628\u0631\u0627\u06cc \u0627\u0628\u0632\u0627\u0631\u0647\u0627\u06cc \u0645\u0646\u0641\u0631\u062f \u0628\u0627 \u06a9\u0627\u0631\u0628\u0631\u062f \u062e\u0627\u0635.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
\u06a9\u0627\u0631\u0628\u0631\u062f \u062f\u0631 \u0622\u0632\u0645\u0627\u06cc\u0634\u06af\u0627\u0647 \u067e\u0627\u0631\u0633:<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\u062f\u0631 \u0622\u0632\u0645\u0627\u06cc\u0634\u06af\u0627\u0647 \u067e\u0627\u0631\u0633\u060c<\/strong> \u0622\u0632\u0645\u0648\u0646 \u0627\u0628\u0632\u0627\u0631\u0647\u0627\u06cc \u062c\u0631\u0627\u062d\u06cc \u0645\u0631\u062a\u0628\u0637 \u0628\u0627 \u0627\u06cc\u0645\u067e\u0644\u0646\u062a\u200c\u0647\u0627\u06cc \u063a\u06cc\u0631 \u0641\u0639\u0627\u0644 \u0637\u0628\u0642 \u0627\u0644\u0632\u0627\u0645\u0627\u062a \u0627\u0633\u062a\u0627\u0646\u062f\u0627\u0631\u062f ISO 16061<\/strong> \u0627\u0646\u062c\u0627\u0645 \u0645\u06cc\u200c\u0634\u0648\u062f.
\u0627\u06cc\u0646 \u0622\u0632\u0645\u0648\u0646\u200c\u0647\u0627 \u0634\u0627\u0645\u0644 \u0645\u0648\u0627\u0631\u062f \u0632\u06cc\u0631 \u0647\u0633\u062a\u0646\u062f:<\/p>
\u0622\u0632\u0645\u0648\u0646 \u0627\u0633\u062a\u062d\u06a9\u0627\u0645 \u0645\u06a9\u0627\u0646\u06cc\u06a9\u06cc \u0648 \u062e\u0633\u062a\u06af\u06cc (Mechanical Strength & Fatigue Test)<\/strong><\/p>
\u0622\u0632\u0645\u0648\u0646 \u062e\u0648\u0631\u062f\u06af\u06cc \u0645\u0637\u0627\u0628\u0642 \u0628\u0627 ASTM F1089 \u0648 ISO 13402<\/strong><\/p>
\u0622\u0632\u0645\u0648\u0646 \u062f\u0648\u0627\u0645 \u062f\u0631 \u0628\u0631\u0627\u0628\u0631 \u0627\u0633\u062a\u0631\u06cc\u0644\u06cc\u0632\u0627\u0633\u06cc\u0648\u0646\u200c\u0647\u0627\u06cc \u0645\u06a9\u0631\u0631 (Autoclaving Resistance)<\/strong><\/p>
\u0622\u0632\u0645\u0648\u0646 \u0639\u0645\u0644\u06a9\u0631\u062f \u0645\u0648\u0646\u062a\u0627\u0698 \u0648 \u062c\u062f\u0627\u0633\u0627\u0632\u06cc \u0627\u0628\u0632\u0627\u0631\u0647\u0627 \u0628\u0627 \u0627\u06cc\u0645\u067e\u0644\u0646\u062a \u0645\u0631\u0628\u0648\u0637\u0647 (Fit & Function Testing)<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
\u0648\u06cc\u0698\u06af\u06cc\u200c\u0647\u0627\u06cc \u0622\u0632\u0645\u0648\u0646 \u062f\u0631 \u0622\u0632\u0645\u0627\u06cc\u0634\u06af\u0627\u0647 \u067e\u0627\u0631\u0633:<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\u0627\u0633\u062a\u0641\u0627\u062f\u0647 \u0627\u0632 \u062a\u062c\u0647\u06cc\u0632\u0627\u062a MTS\u00ae \u0648 Zwick\u00ae<\/strong> \u0628\u0631\u0627\u06cc \u0622\u0632\u0645\u0648\u0646\u200c\u0647\u0627\u06cc \u0645\u06a9\u0627\u0646\u06cc\u06a9\u06cc<\/p>
\u0627\u0646\u062c\u0627\u0645 \u062a\u062d\u0644\u06cc\u0644 \u0631\u06cc\u0633\u06a9 \u0637\u0631\u0627\u062d\u06cc (Design FMEA)<\/strong> \u0628\u0631\u0627\u06cc \u0627\u0628\u0632\u0627\u0631\u0647\u0627\u06cc \u062c\u062f\u06cc\u062f<\/p>
\u062b\u0628\u062a \u062f\u06cc\u062c\u06cc\u062a\u0627\u0644 \u062f\u0627\u062f\u0647\u200c\u0647\u0627\u06cc \u0628\u0627\u0631\u2013\u062a\u063a\u06cc\u06cc\u0631\u0634\u06a9\u0644 \u0648 \u062a\u062d\u0644\u06cc\u0644 \u0622\u0645\u0627\u0631\u06cc \u0646\u062a\u0627\u06cc\u062c<\/p>
\u0627\u0631\u0627\u0626\u0647 \u06af\u0632\u0627\u0631\u0634 \u0641\u0646\u06cc \u0645\u0639\u062a\u0628\u0631 \u0628\u0631\u0627\u06cc \u0627\u0631\u0632\u06cc\u0627\u0628\u06cc \u067e\u06cc\u0634\u200c\u0628\u0627\u0644\u06cc\u0646\u06cc (Pre-Clinical Evaluation)<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
\u0647\u062f\u0641 \u0646\u0647\u0627\u06cc\u06cc:<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
\u0627\u0637\u0645\u06cc\u0646\u0627\u0646 \u0627\u0632 \u0622\u0646\u06a9\u0647 \u0627\u0628\u0632\u0627\u0631\u0647\u0627\u06cc \u062c\u0631\u0627\u062d\u06cc \u063a\u06cc\u0631\u0641\u0639\u0627\u0644:<\/p>
\u0639\u0645\u0644\u06a9\u0631\u062f \u0645\u06a9\u0627\u0646\u06cc\u06a9\u06cc \u0648 \u0627\u06cc\u0645\u0646\u06cc \u0645\u0648\u0631\u062f \u0627\u0646\u062a\u0638\u0627\u0631 \u0631\u0627 \u062f\u0631 \u0634\u0631\u0627\u06cc\u0637 \u0628\u0627\u0644\u06cc\u0646\u06cc \u0648\u0627\u0642\u0639\u06cc \u062f\u0627\u0631\u0646\u062f\u060c<\/p>
\u0642\u0627\u0628\u0644\u06cc\u062a \u0627\u0633\u062a\u0631\u06cc\u0644 \u0648 \u0627\u0633\u062a\u0641\u0627\u062f\u0647 \u0645\u062c\u062f\u062f \u0628\u062f\u0648\u0646 \u0627\u0641\u062a \u06a9\u06cc\u0641\u06cc\u062a \u0631\u0627 \u062f\u0627\u0631\u0627 \u0647\u0633\u062a\u0646\u062f\u060c<\/p>
\u0648 \u0628\u0627 \u0627\u0644\u0632\u0627\u0645\u0627\u062a \u0628\u06cc\u0646\u200c\u0627\u0644\u0645\u0644\u0644\u06cc \u0637\u0631\u0627\u062d\u06cc \u0648 \u062a\u0648\u0644\u06cc\u062f \u062a\u062c\u0647\u06cc\u0632\u0627\u062a \u067e\u0632\u0634\u06a9\u06cc \u0645\u0637\u0627\u0628\u0642\u062a \u06a9\u0627\u0645\u0644 \u062f\u0627\u0631\u0646\u062f.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\r\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"
ISO 16061 \u0627\u0628\u0632\u0627\u0631\u0647\u0627\u06cc \u0645\u0648\u0631\u062f \u0627\u0633\u062a\u0641\u0627\u062f\u0647 \u0647\u0645\u0631\u0627\u0647 \u0628\u0627 \u0627\u06cc\u0645\u067e\u0644\u0646\u062a\u200c\u0647\u0627\u06cc \u062c\u0631\u0627\u062d\u06cc \u063a\u06cc\u0631\u0641\u0639\u0627\u0644 \u2013 \u0627\u0644\u0632\u0627\u0645\u0627\u062a \u0639\u0645\u0648\u0645\u06cc (Instruments for Use in Association with Non-Active Surgical Implants \u2014 General Requirements) \u0645\u0646\u0627\u0628\u0639 \u0645\u0631\u062c\u0639 (Normative References): ISO 16061: Instruments for Use in Association with Non-Active Surgical Implants \u2014 General RequirementsDIN EN ISO 16061: Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet […]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-17051","post","type-post","status-publish","format-standard","hentry","category-genetics"],"_links":{"self":[{"href":"https:\/\/parslab.co\/en\/wp-json\/wp\/v2\/posts\/17051","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/parslab.co\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/parslab.co\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/parslab.co\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/parslab.co\/en\/wp-json\/wp\/v2\/comments?post=17051"}],"version-history":[{"count":4,"href":"https:\/\/parslab.co\/en\/wp-json\/wp\/v2\/posts\/17051\/revisions"}],"predecessor-version":[{"id":17055,"href":"https:\/\/parslab.co\/en\/wp-json\/wp\/v2\/posts\/17051\/revisions\/17055"}],"wp:attachment":[{"href":"https:\/\/parslab.co\/en\/wp-json\/wp\/v2\/media?parent=17051"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/parslab.co\/en\/wp-json\/wp\/v2\/categories?post=17051"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/parslab.co\/en\/wp-json\/wp\/v2\/tags?post=17051"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}