\u0625\u0637\u0627\u0631 \u0639\u0645\u0644 \u0627\u0644\u0635\u0646\u0627\u0639\u0629 4.0 \u0627\u0644\u0643\u0648\u0631\u064a ISBM<\/a> \u064a\u0648\u0641\u0631 \u0630\u0644\u0643 \u0625\u0645\u0643\u0627\u0646\u064a\u0629 \u0627\u0644\u062a\u0634\u063a\u064a\u0644 \u0627\u0644\u0622\u0644\u064a.<\/li>\n<\/ul>\n<\/section>\n<\/p>\n\n7. \u0645\u0639\u0627\u064a\u064a\u0631 \u0625\u0646\u062a\u0627\u062c \u063a\u0631\u0641 \u0646\u0638\u064a\u0641\u0629 \u0644\u062a\u063a\u0644\u064a\u0641 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0628\u062a\u0642\u0646\u064a\u0629 ISBM<\/h2>\n
\u0625\u0646\u062a\u0627\u062c \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0641\u064a \u0643\u0648\u0631\u064a\u0627 \u0628\u062a\u0642\u0646\u064a\u0629 ISBM \u0641\u064a \u063a\u0631\u0641 \u0646\u0638\u064a\u0641\u0629 - \u062a\u064f\u0639\u062f\u0651 \u0641\u0626\u0629 ISO 8 (ISO 14644-1\u060c \u2264 3,520,000 \u062c\u0633\u064a\u0645\/\u0645\u00b3 \u2265 0.5 \u0645\u064a\u0643\u0631\u0648\u0645\u062a\u0631) \u0628\u064a\u0626\u0629 \u0627\u0644\u0625\u0646\u062a\u0627\u062c \u0627\u0644\u0642\u064a\u0627\u0633\u064a\u0629 \u0644\u0632\u062c\u0627\u062c\u0627\u062a \u0643\u0648\u0627\u0634\u0641 \u0627\u0644\u062a\u0634\u062e\u064a\u0635 \u0627\u0644\u0645\u062e\u062a\u0628\u0631\u064a \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0646\u064a\u0629 \u0641\u064a \u0643\u0648\u0631\u064a\u0627\u060c \u0648\u062d\u0627\u0648\u064a\u0627\u062a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0645\u0644\u0627\u0645\u0633\u0629 \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0644\u062b\u0629. \u0648\u062a\u062a\u0645\u064a\u0632 \u0639\u0645\u0644\u064a\u0629 ISBM \u0646\u0641\u0633\u0647\u0627 - \u0648\u0647\u064a \u0639\u0645\u0644\u064a\u0629 \u062d\u0642\u0646 \u0648\u0646\u0641\u062e \u0623\u062d\u0627\u062f\u064a\u0629 \u0627\u0644\u062e\u0637\u0648\u0629 \u0641\u064a \u0622\u0644\u0629 \u0645\u063a\u0644\u0642\u0629 - \u0628\u0646\u0638\u0627\u0641\u0629 \u0641\u0627\u0626\u0642\u0629 \u0645\u0642\u0627\u0631\u0646\u0629\u064b \u0628\u0639\u0645\u0644\u064a\u0629 SBM \u062b\u0646\u0627\u0626\u064a\u0629 \u0627\u0644\u0645\u0631\u062d\u0644\u0629 (\u0627\u0644\u062a\u064a \u062a\u0646\u0642\u0644 \u0627\u0644\u0642\u0648\u0627\u0644\u0628 \u0627\u0644\u0623\u0648\u0644\u064a\u0629 \u0639\u0628\u0631 \u0627\u0644\u0647\u0648\u0627\u0621 \u0627\u0644\u0645\u062d\u064a\u0637). \u0648\u062a\u064f\u0639\u062f\u0651 \u0627\u0644\u0645\u0639\u0627\u0644\u062c\u0629 \u0627\u0644\u0645\u063a\u0644\u0642\u0629 \u0641\u064a \u062a\u0642\u0646\u064a\u0629 ISBM \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0645\u064a\u0632\u0629\u064b \u0644\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0645\u0639\u0627\u064a\u064a\u0631: \u062d\u064a\u062b \u064a\u062a\u0634\u0643\u0644 \u0627\u0644\u062c\u0632\u0621 \u0627\u0644\u062f\u0627\u062e\u0644\u064a \u0644\u0644\u0632\u062c\u0627\u062c\u0629 \u062f\u0627\u062e\u0644 \u062a\u062c\u0648\u064a\u0641 \u0627\u0644\u0646\u0641\u062e \u062f\u0648\u0646 \u062a\u0639\u0631\u0636\u0647 \u0644\u0644\u0647\u0648\u0627\u0621 \u0627\u0644\u0645\u062d\u064a\u0637 \u062d\u062a\u0649 \u0644\u062d\u0638\u0629 \u0625\u062e\u0631\u0627\u062c\u0647\u0627\u060c \u0645\u0645\u0627 \u064a\u0639\u0646\u064a \u0623\u0646 \u0628\u064a\u0626\u0629 \u0627\u0644\u0625\u062e\u0631\u0627\u062c \u0627\u0644\u0645\u064f\u062a\u062d\u0643\u0651\u0645 \u0628\u0647\u0627 \u0647\u064a \u0627\u0644\u062a\u064a \u062a\u062d\u062f\u062f \u0645\u0633\u062a\u0648\u0649 \u062e\u0637\u0631 \u0627\u0644\u062a\u0644\u0648\u062b \u0627\u0644\u062f\u0627\u062e\u0644\u064a \u0627\u0644\u0646\u0647\u0627\u0626\u064a.<\/figcaption><\/figure>\n\u062a\u064f\u0644\u0632\u0645 \u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u062a\u0635\u0646\u064a\u0639 \u0627\u0644\u062c\u064a\u062f (GMP) \u0627\u0644\u0635\u0627\u062f\u0631\u0629 \u0639\u0646 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 (KFDA) \u0645\u0635\u0646\u0639\u064a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0628\u0625\u0646\u0634\u0627\u0621 \u0628\u064a\u0626\u0627\u062a \u0625\u0646\u062a\u0627\u062c \u0646\u0638\u064a\u0641\u0629 \u0648\u0627\u0644\u062d\u0641\u0627\u0638 \u0639\u0644\u064a\u0647\u0627\u060c \u0628\u0645\u0627 \u064a\u062a\u0646\u0627\u0633\u0628 \u0645\u0639 \u0645\u0633\u062a\u0648\u0649 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0644\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0645\u064f\u0635\u0646\u0651\u0639. \u0623\u0645\u0627 \u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0625\u0646\u062a\u0627\u062c \u0639\u0628\u0648\u0627\u062a ISBM \u0627\u0644\u0623\u0648\u0644\u064a\u0629 \u0641\u064a \u0643\u0648\u0631\u064a\u0627\u060c \u0641\u0625\u0646 \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0630\u064a \u0627\u0644\u0635\u0644\u0629 \u0647\u0648 ISO 14644-1 (\u063a\u0631\u0641 \u0646\u0638\u064a\u0641\u0629 \u0648\u0628\u064a\u0626\u0627\u062a \u0645\u064f\u0631\u0627\u0642\u0628\u0629 \u0645\u064f\u0631\u062a\u0628\u0637\u0629 \u0628\u0647\u0627). \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0628\u064a\u0626\u0629 \u0625\u0646\u062a\u0627\u062c \u0639\u0628\u0648\u0627\u062a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 ISBM \u0641\u064a \u0643\u0648\u0631\u064a\u0627 \u062d\u0633\u0628 \u0641\u0626\u0629 \u0627\u0644\u062c\u0647\u0627\u0632:<\/p>\n
\n- \u0627\u0644\u062f\u0631\u062c\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0627\u0644\u0623\u0648\u0644\u0649 (\uc2e0\uace0):<\/strong> \u0644\u0627 \u064a\u064f\u0634\u062a\u0631\u0637 \u0648\u062c\u0648\u062f \u0645\u0639\u064a\u0627\u0631 \u0631\u0633\u0645\u064a \u0644\u0644\u063a\u0631\u0641 \u0627\u0644\u0646\u0638\u064a\u0641\u0629\u060c \u0628\u0644 \u064a\u0643\u0641\u064a \u0628\u064a\u0626\u0629 \u0625\u0646\u062a\u0627\u062c \u0635\u0646\u0627\u0639\u064a\u0629 \u0639\u0627\u0645\u0629 \u0645\u0632\u0648\u062f\u0629 \u0628\u0646\u0638\u0627\u0645 \u062a\u0631\u0634\u064a\u062d \u0645\u0648\u062b\u0642 \u0644\u0623\u0646\u0638\u0645\u0629 \u0627\u0644\u062a\u062f\u0641\u0626\u0629 \u0648\u0627\u0644\u062a\u0647\u0648\u064a\u0629 \u0648\u062a\u0643\u064a\u064a\u0641 \u0627\u0644\u0647\u0648\u0627\u0621 (MERV 8 \u0623\u0648 \u0645\u0627 \u064a\u0639\u0627\u062f\u0644\u0647\u060c \u0628\u062f\u0644\u0627\u064b \u0645\u0646 \u0646\u0638\u0627\u0645 \u0633\u062d\u0628 \u0627\u0644\u0647\u0648\u0627\u0621 \u0627\u0644\u0645\u0641\u062a\u0648\u062d \u0627\u0644\u0642\u064a\u0627\u0633\u064a \u0641\u064a \u0627\u0644\u0645\u0635\u0627\u0646\u0639) \u0648\u0625\u062c\u0631\u0627\u0621\u0627\u062a \u062a\u0646\u0638\u064a\u0641 \u0623\u0633\u0627\u0633\u064a\u0629. \u064a\u064f\u0648\u0635\u0649 \u0628\u0645\u0631\u0627\u0642\u0628\u0629 \u0627\u0644\u062c\u0633\u064a\u0645\u0627\u062a \u0627\u0644\u0645\u062d\u0645\u0648\u0644\u0629 \u062c\u0648\u0627\u064b \u0643\u0644 \u062b\u0644\u0627\u062b\u0629 \u0623\u0634\u0647\u0631\u060c \u0648\u0644\u0643\u0646\u0647\u0627 \u0644\u064a\u0633\u062a \u0625\u0644\u0632\u0627\u0645\u064a\u0629.<\/li>\n
- \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0627\u0644\u062b\u0627\u0646\u064a\u0629 (\uc778\uc99d) - \u0639\u0628\u0648\u0627\u062a \u0643\u0648\u0627\u0634\u0641 \u0627\u0644\u062a\u0634\u062e\u064a\u0635 \u0627\u0644\u0645\u062e\u062a\u0628\u0631\u064a:<\/strong> \u0628\u064a\u0626\u0629 \u0625\u0646\u062a\u0627\u062c \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 8 \u0648\u0641\u0642\u064b\u0627 \u0644\u0645\u0639\u064a\u0627\u0631 ISO 14644-1 (\u2264 3,520,000 \u062c\u0633\u064a\u0645\/\u0645\u00b3 \u0628\u062d\u062c\u0645 \u2265 0.5 \u0645\u064a\u0643\u0631\u0648\u0645\u062a\u0631\u060c \u0648\u0647\u0648 \u0645\u0627 \u064a\u0639\u0627\u062f\u0644 \u0645\u0639\u064a\u0627\u0631 \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629 \u0627\u0644\u0641\u064a\u062f\u0631\u0627\u0644\u064a \u0627\u0644\u0642\u062f\u064a\u0645 209E \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 100,000). \u0627\u0644\u062a\u0637\u0628\u064a\u0642 \u0627\u0644\u0639\u0645\u0644\u064a: \u062a\u0632\u0648\u064a\u062f \u0645\u0646\u0637\u0642\u0629 \u0627\u0644\u0625\u0646\u062a\u0627\u062c \u0628\u0647\u0648\u0627\u0621 \u0645\u064f\u0631\u0634\u064e\u0651\u062d \u0628\u0648\u0627\u0633\u0637\u0629 \u0645\u0631\u0634\u062d\u0627\u062a HEPA\u060c \u0648\u0641\u0631\u0642 \u0636\u063a\u0637 \u0625\u064a\u062c\u0627\u0628\u064a (\u2265 +15 \u0628\u0627\u0633\u0643\u0627\u0644) \u0645\u0642\u0627\u0631\u0646\u0629\u064b \u0628\u0627\u0644\u0645\u0646\u0627\u0637\u0642 \u0627\u0644\u0645\u062c\u0627\u0648\u0631\u0629 \u063a\u064a\u0631 \u0627\u0644\u0625\u0646\u062a\u0627\u062c\u064a\u0629\u060c \u0648\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0631\u062a\u062f\u0627\u0621 \u0627\u0644\u0645\u0644\u0627\u0628\u0633 \u0627\u0644\u0648\u0627\u0642\u064a\u0629 (\u0623\u063a\u0637\u064a\u0629 \u0627\u0644\u0634\u0639\u0631\u060c \u0648\u0645\u0639\u0627\u0637\u0641 \u0627\u0644\u063a\u0628\u0627\u0631\u060c \u0648\u0623\u063a\u0637\u064a\u0629 \u0627\u0644\u0623\u062d\u0630\u064a\u0629)\u060c \u0648\u0645\u0631\u0627\u0642\u0628\u0629 \u0639\u062f\u062f \u0627\u0644\u062c\u0633\u064a\u0645\u0627\u062a \u0627\u0644\u0645\u062d\u0645\u0648\u0644\u0629 \u062c\u0648\u064b\u0627 \u0631\u0628\u0639 \u0633\u0646\u0648\u064a\u064b\u0627 \u0648\u0641\u0642\u064b\u0627 \u0644\u0645\u0639\u064a\u0627\u0631 ISO 14644-2.<\/li>\n
- \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0627\u0644\u062b\u0627\u0644\u062b\u0629 (\ud5c8\uac00) - \u062d\u0627\u0648\u064a\u0627\u062a \u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0627\u062a\u0635\u0627\u0644 \u0627\u0644\u0645\u0628\u0627\u0634\u0631:<\/strong> \u0628\u064a\u0626\u0629 \u0625\u0646\u062a\u0627\u062c \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 7 \u0648\u0641\u0642\u064b\u0627 \u0644\u0645\u0639\u064a\u0627\u0631 ISO 14644-1 (\u2264 352,000 \u062c\u0633\u064a\u0645\/\u0645\u00b3 \u0628\u062d\u062c\u0645 \u2265 0.5 \u0645\u064a\u0643\u0631\u0648\u0645\u062a\u0631\u060c \u0645\u0627 \u064a\u0639\u0627\u062f\u0644 \u0627\u0644\u0641\u0626\u0629 10,000) \u0644\u0645\u0627\u0643\u064a\u0646\u0629 ISBM \u0648\u0645\u0646\u0637\u0642\u0629 \u0625\u062e\u0631\u0627\u062c \u0627\u0644\u0632\u062c\u0627\u062c\u0627\u062a. \u062a\u062a\u0636\u0645\u0646 \u0647\u0630\u0647 \u0627\u0644\u0628\u064a\u0626\u0629 \u0645\u0644\u0627\u0628\u0633 \u063a\u0631\u0641 \u0646\u0638\u064a\u0641\u0629 \u0643\u0627\u0645\u0644\u0629 (\u0628\u062f\u0644\u0629 \u0639\u0645\u0644 \u0643\u0627\u0645\u0644\u0629\u060c \u0642\u0641\u0627\u0632\u0627\u062a\u060c \u0643\u0645\u0627\u0645\u0627\u062a)\u060c \u0648\u0646\u0638\u0627\u0645 \u062f\u062e\u0648\u0644 \u0645\u0648\u0627\u062f \u0645\u0639 \u062a\u0639\u0642\u064a\u0645 \u0628\u0627\u0644\u0623\u0634\u0639\u0629 \u0641\u0648\u0642 \u0627\u0644\u0628\u0646\u0641\u0633\u062c\u064a\u0629\u060c \u0648\u0645\u0631\u0627\u0642\u0628\u0629 \u0645\u0633\u062a\u0645\u0631\u0629 \u0644\u0644\u062c\u0633\u064a\u0645\u0627\u062a (\u0625\u0646\u0630\u0627\u0631 \u0641\u0648\u0631\u064a \u0639\u0646\u062f \u062a\u062c\u0627\u0648\u0632 \u062d\u062f\u0648\u062f \u0627\u0644\u0641\u0626\u0629 7)\u060c \u0648\u0634\u0647\u0627\u062f\u0629 \u0623\u062f\u0627\u0621 \u0633\u0646\u0648\u064a\u0629 \u0644\u0644\u063a\u0631\u0641\u0629 \u0627\u0644\u0646\u0638\u064a\u0641\u0629. \u062a\u0633\u062a\u062e\u062f\u0645 \u0639\u0645\u0644\u064a\u0627\u062a ISBM \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0627\u0644\u062a\u064a \u062a\u062d\u0642\u0642 \u0627\u0644\u0641\u0626\u0629 7 \u0641\u064a \u0645\u0646\u0637\u0642\u0629 \u0625\u062e\u0631\u0627\u062c \u0627\u0644\u0632\u062c\u0627\u062c\u0627\u062a \u0639\u0627\u062f\u0629\u064b \u063a\u0637\u0627\u0621 \u062a\u062f\u0641\u0642 \u0635\u0641\u0627\u0626\u062d\u064a \u0645\u0648\u0636\u0639\u064a \u0641\u0648\u0642 \u0646\u0627\u0642\u0644 \u0625\u062e\u0631\u0627\u062c \u0627\u0644\u0632\u062c\u0627\u062c\u0627\u062a \u0645\u0628\u0627\u0634\u0631\u0629\u064b\u060c \u0648\u0647\u0648 \u062d\u0644 \u0623\u0643\u062b\u0631 \u0627\u0642\u062a\u0635\u0627\u062f\u064a\u0629 \u0645\u0646 \u0628\u0646\u0627\u0621 \u063a\u0631\u0641\u0629 \u0643\u0627\u0645\u0644\u0629 \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 7 \u062d\u0648\u0644 \u0645\u0627\u0643\u064a\u0646\u0629 ISBM \u0628\u0623\u0643\u0645\u0644\u0647\u0627.<\/li>\n<\/ul>\n<\/section>\n
<\/p>\n\n8. \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0635\u062d\u0629 \u0645\u0645\u0627\u0631\u0633\u0627\u062a \u0627\u0644\u062a\u0635\u0646\u064a\u0639 \u0627\u0644\u062c\u064a\u062f\u0629: \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u062a\u0631\u0643\u064a\u0628\u060c \u0648\u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u062a\u0634\u063a\u064a\u0644\u060c \u0648\u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0623\u062f\u0627\u0621 \u0644\u062e\u0637\u0648\u0637 \u0625\u0646\u062a\u0627\u062c \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0648\u0641\u0642\u064b\u0627 \u0644\u0645\u0639\u0627\u064a\u064a\u0631 ISBM<\/h2>\n
\n\u0628\u0631\u0648\u062a\u0648\u0643\u0648\u0644 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0635\u062d\u0629 \u0645\u0645\u0627\u0631\u0633\u0627\u062a \u0627\u0644\u062a\u0635\u0646\u064a\u0639 \u0627\u0644\u062c\u064a\u062f\u0629 (GMP) \u0644\u0622\u0644\u0627\u062a ISBM \u0627\u0644\u0643\u0648\u0631\u064a\u0629 - \u062a\u0623\u0647\u064a\u0644 \u0627\u0644\u062a\u0631\u0643\u064a\u0628 (IQ): \u064a\u0624\u0643\u062f \u062a\u0631\u0643\u064a\u0628 \u0627\u0644\u0622\u0644\u0629 \u0648\u0641\u0642\u064b\u0627 \u0644\u0644\u0645\u0648\u0627\u0635\u0641\u0627\u062a\u061b \u062a\u0623\u0647\u064a\u0644 \u0627\u0644\u062a\u0634\u063a\u064a\u0644 (OQ): \u064a\u062d\u062f\u062f \u0646\u0637\u0627\u0642\u0627\u062a \u0645\u0639\u0644\u0645\u0627\u062a \u0627\u0644\u0639\u0645\u0644\u064a\u0629 \u0627\u0644\u0645\u0639\u062a\u0645\u062f\u0629\u061b \u062a\u0623\u0647\u064a\u0644 \u0627\u0644\u0623\u062f\u0627\u0621 (PQ): \u064a\u062b\u0628\u062a \u0625\u0646\u062a\u0627\u062c\u064b\u0627 \u0645\u062a\u0633\u0642\u064b\u0627 \u0641\u064a \u0627\u0644\u0638\u0631\u0648\u0641 \u0627\u0644\u0627\u0633\u0645\u064a\u0629\u060c \u0645\u0633\u062a\u0648\u0641\u064a\u064b\u0627 \u062c\u0645\u064a\u0639 \u0645\u0648\u0627\u0635\u0641\u0627\u062a \u0627\u0644\u062c\u0648\u062f\u0629. \u064a\u062a\u0637\u0644\u0628 \u062a\u0642\u062f\u064a\u0645 \u0627\u0644\u0637\u0644\u0628 \u0625\u0644\u0649 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 (KFDA) \u0625\u0643\u0645\u0627\u0644 \u062c\u0645\u064a\u0639 \u0645\u0631\u0627\u062d\u0644 \u0627\u0644\u062a\u062d\u0642\u0642 \u0627\u0644\u062b\u0644\u0627\u062b \u0648\u062a\u0648\u062b\u064a\u0642\u0647\u0627 \u0642\u0628\u0644 \u0628\u062f\u0621 \u0627\u0644\u0625\u0646\u062a\u0627\u062c \u0627\u0644\u062a\u062c\u0627\u0631\u064a - \u0648\u0647\u0648 \u062c\u062f\u0648\u0644 \u0632\u0645\u0646\u064a \u064a\u062c\u0628 \u0639\u0644\u0649 \u0645\u0646\u062a\u062c\u064a \u0622\u0644\u0627\u062a ISBM \u0627\u0644\u0643\u0648\u0631\u064a\u064a\u0646 \u0627\u0644\u062a\u062e\u0637\u064a\u0637 \u0644\u0647 \u0641\u064a \u0645\u0631\u062d\u0644\u0629 \u0627\u0644\u062a\u0641\u0627\u0648\u0636 \u0639\u0644\u0649 \u0627\u0644\u0639\u0642\u062f\u060c \u0648\u0639\u0627\u062f\u0629\u064b \u0645\u0627 \u064a\u0633\u062a\u063a\u0631\u0642 \u0645\u0646 4 \u0625\u0644\u0649 6 \u0623\u0634\u0647\u0631 \u0645\u0646 \u062a\u0635\u0646\u064a\u0639 \u0627\u0644\u0642\u0627\u0644\u0628 \u0625\u0644\u0649 \u0625\u0643\u0645\u0627\u0644 \u062a\u0623\u0647\u064a\u0644 \u0627\u0644\u0623\u062f\u0627\u0621 (PQ).<\/figcaption><\/figure>\n\u064a\u064f\u0639\u062f \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0635\u062d\u0629 GMP IQ\/OQ\/PQ \u062c\u0648\u0647\u0631 \u062a\u0623\u0647\u064a\u0644 \u062d\u0627\u0648\u064a\u0627\u062a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0644\u062b\u0629 \u0641\u064a \u0643\u0648\u0631\u064a\u0627. \u062a\u062e\u062f\u0645 \u0643\u0644 \u0645\u0631\u062d\u0644\u0629 \u063a\u0631\u0636\u064b\u0627 \u0645\u062d\u062f\u062f\u064b\u0627 \u0648\u062a\u064f\u0646\u062a\u062c \u0648\u062b\u0627\u0626\u0642 \u062e\u0627\u0635\u0629 \u0644\u0645\u0644\u0641 KFDA \ud5c8\uac00.<\/p>\n
\u0645\u0624\u0647\u0644\u0627\u062a \u0627\u0644\u062a\u0631\u0643\u064a\u0628 (IQ):<\/strong> \u064a\u0624\u0643\u062f \u0647\u0630\u0627 \u0627\u0644\u0625\u062c\u0631\u0627\u0621 \u0623\u0646 \u0622\u0644\u0629 ISBM \u0627\u0644\u0643\u0648\u0631\u064a\u0629\u060c \u0648\u0627\u0644\u0642\u0627\u0644\u0628\u060c \u0648\u0627\u0644\u0645\u0639\u062f\u0627\u062a \u0627\u0644\u0645\u0644\u062d\u0642\u0629 (\u0627\u0644\u0645\u062c\u0641\u0641\u060c \u0648\u0627\u0644\u0645\u0628\u0631\u062f\u060c \u0648\u0646\u0638\u0627\u0645 \u0627\u0644\u0647\u0648\u0627\u0621 \u0627\u0644\u0645\u0636\u063a\u0648\u0637) \u0645\u064f\u062b\u0628\u0651\u062a\u0629 \u0648\u0641\u0642\u064b\u0627 \u0644\u0645\u0648\u0627\u0635\u0641\u0627\u062a \u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629. \u062a\u0634\u0645\u0644 \u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u062a\u0631\u0643\u064a\u0628 (IQ) 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(ISBM) \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0644\u062b\u0629 \u0641\u064a \u0643\u0648\u0631\u064a\u0627 \u0627\u0644\u062c\u0646\u0648\u0628\u064a\u0629 \u0627\u0644\u0630\u064a\u0646 \u0644\u0645 \u064a\u0633\u0628\u0642 \u0644\u0647\u0645 \u0627\u0644\u0625\u0646\u062a\u0627\u062c \u0648\u0641\u0642\u064b\u0627 \u0644\u062a\u0641\u0627\u0648\u062a\u0627\u062a \u062f\u0642\u0629 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0644\u062b\u0629.<\/p>\n\u0645\u0624\u0647\u0644\u0627\u062a \u0627\u0644\u0623\u062f\u0627\u0621 (PQ):<\/strong> \u064a\u064f\u062b\u0628\u062a \u0647\u0630\u0627 \u0623\u0646 \u0639\u0645\u0644\u064a\u0629 ISBM \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u062a\u064f\u0646\u062a\u062c \u0645\u0646\u062a\u062c\u064b\u0627 \u0645\u062a\u0648\u0627\u0641\u0642\u064b\u0627 \u0645\u0639 \u0627\u0644\u0645\u0648\u0627\u0635\u0641\u0627\u062a \u0628\u0634\u0643\u0644 \u0645\u062a\u0633\u0642 \u0641\u064a \u0638\u0644 \u0627\u0644\u0638\u0631\u0648\u0641 \u0627\u0644\u0627\u0633\u0645\u064a\u0629 \u0639\u0644\u0649 \u0645\u062f\u0649 \u062b\u0644\u0627\u062b \u062f\u0648\u0631\u0627\u062a \u0625\u0646\u062a\u0627\u062c \u0645\u062a\u062a\u0627\u0644\u064a\u0629 \u0639\u0644\u0649 \u0627\u0644\u0623\u0642\u0644 \u0639\u0644\u0649 \u0646\u0637\u0627\u0642 \u062a\u062c\u0627\u0631\u064a. \u062e\u0637\u0629 \u0623\u062e\u0630 \u0639\u064a\u0646\u0627\u062a PQ: 125 \u0632\u062c\u0627\u062c\u0629 \u0643\u062d\u062f \u0623\u062f\u0646\u0649 \u0644\u0643\u0644 \u062a\u062c\u0648\u064a\u0641 \u0641\u064a \u0643\u0644 \u062f\u0648\u0631\u0629 (\u0625\u062c\u0645\u0627\u0644\u064a 375 \u0632\u062c\u0627\u062c\u0629 \u0644\u0643\u0644 \u062a\u062c\u0648\u064a\u0641 \u0644\u062b\u0644\u0627\u062b \u062f\u0648\u0631\u0627\u062a)\u060c \u062a\u064f\u0642\u0627\u0633 \u0648\u0641\u0642\u064b\u0627 \u0644\u062a\u0633\u0639 \u0633\u0645\u0627\u062a \u062c\u0648\u062f\u0629 \u062a\u0634\u0645\u0644 \u0627\u0644\u0623\u0628\u0639\u0627\u062f\u060c \u0648\u0627\u0644\u0648\u0632\u0646\u060c \u0648\u0627\u0644\u0639\u062a\u0627\u0645\u0629\u060c \u0648\u0627\u0644\u0641\u062d\u0635 \u0627\u0644\u0628\u0635\u0631\u064a \u0648\u0641\u0642\u064b\u0627 \u0644\u0645\u0633\u062a\u0648\u0649 AQL \u0627\u0644\u062b\u0627\u0646\u064a (ANSI\/ASQ Z1.4 \/ ISO 2859-1)\u060c \u0648\u062a\u0623\u0643\u064a\u062f \u0625\u0646\u062a\u0627\u062c \u0639\u064a\u0646\u0629 \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u062d\u064a\u0648\u064a. \u0627\u0644\u062a\u062d\u0644\u064a\u0644 \u0627\u0644\u0625\u062d\u0635\u0627\u0626\u064a PQ: \u0642\u062f\u0631\u0629 \u0627\u0644\u0639\u0645\u0644\u064a\u0629 (Cpk) \u2265 1.33 \u0644\u0643\u0644 \u0633\u0645\u0629 \u062c\u0648\u062f\u0629 \u062d\u0631\u062c\u0629 - \u0645\u0639\u064a\u0627\u0631 KFDA \u0627\u0644\u0643\u0648\u0631\u064a \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0644\u062b\u0629 \u0644\u0642\u062f\u0631\u0629 \u0627\u0644\u062a\u0635\u0646\u064a\u0639 \u0627\u0644\u0645\u0639\u062a\u0645\u062f\u0629. \u062a\u062d\u0642\u0642 \u0645\u0646\u0635\u0627\u062a EV servo ISBM \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0628\u0627\u0633\u062a\u0645\u0631\u0627\u0631 Cpk \u2265 1.50 \u0644\u0648\u0632\u0646 \u0627\u0644\u0632\u062c\u0627\u062c\u0629 \u0648\u0642\u0637\u0631 \u0639\u0646\u0642\u0647\u0627 \u0627\u0644\u062e\u0627\u0631\u062c\u064a \u0641\u064a \u0638\u0644 \u0627\u0644\u0638\u0631\u0648\u0641 \u0627\u0644\u0627\u0633\u0645\u064a\u0629. \u0639\u0627\u062f\u0629\u064b \u0645\u0627 \u062a\u062d\u0642\u0642 \u0627\u0644\u0645\u0646\u0635\u0627\u062a \u0627\u0644\u0647\u064a\u062f\u0631\u0648\u0644\u064a\u0643\u064a\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0642\u064a\u0645\u0629 Cpk \u062a\u062a\u0631\u0627\u0648\u062d \u0628\u064a\u0646 1.00 \u06481.20\u060c \u0648\u0647\u0648 \u0623\u0642\u0644 \u0645\u0646 \u0645\u0639\u064a\u0627\u0631 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0644\u062b\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u060c \u0645\u0645\u0627 \u064a\u0633\u062a\u0644\u0632\u0645 \u062a\u0631\u0642\u064a\u0629 \u0627\u0644\u0646\u0638\u0627\u0645 \u0627\u0644\u0647\u064a\u062f\u0631\u0648\u0644\u064a\u0643\u064a \u0625\u0644\u0649 \u0646\u0638\u0627\u0645 \u0627\u0644\u0645\u0624\u0627\u0632\u0631\u0629 \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u0629 \u0627\u0644\u062a\u064a \u064a\u0648\u0627\u062c\u0647\u0647\u0627 \u0645\u0646\u062a\u062c\u0648 ISBM \u0627\u0644\u0643\u0648\u0631\u064a\u0648\u0646 \u0627\u0644\u0630\u064a\u0646 \u064a\u062f\u062e\u0644\u0648\u0646 \u0641\u064a \u062a\u0648\u0631\u064a\u062f \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0644\u062b\u0629 \u0628\u0627\u0633\u062a\u0645\u0631\u0627\u0631 \u0643\u0634\u0631\u0637 \u0623\u0633\u0627\u0633\u064a \u0644\u0625\u0643\u0645\u0627\u0644 PQ \u0628\u0646\u062c\u0627\u062d.<\/p>\n<\/section>\n<\/p>\n\n\u0627\u0644\u0623\u0633\u0626\u0644\u0629 \u0627\u0644\u0634\u0627\u0626\u0639\u0629<\/h2>\n\n
\n
\n
\u06331 - \u0645\u0627 \u0647\u0648 \u0627\u0644\u062d\u062f \u0627\u0644\u0623\u062f\u0646\u0649 \u0644\u0644\u0627\u0633\u062a\u062b\u0645\u0627\u0631 \u0627\u0644\u0643\u0648\u0631\u064a \u0641\u064a \u0645\u062c\u0627\u0644 \u062a\u063a\u0644\u064a\u0641 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u062a\u0634\u062e\u064a\u0635\u064a\u0629 \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0646\u064a\u0629 \u0641\u064a \u0643\u0648\u0631\u064a\u0627\u061f<\/p>\n<\/div>\n
\n
\u064a\u062a\u0623\u0644\u0641 \u0627\u0644\u062d\u062f \u0627\u0644\u0623\u062f\u0646\u0649 \u0644\u0644\u0627\u0633\u062a\u062b\u0645\u0627\u0631 \u0627\u0644\u0644\u0627\u0632\u0645 \u0644\u0645\u0646\u062a\u062c\u064a \u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u062a\u0634\u062e\u064a\u0635 \u0627\u0644\u0645\u062e\u062a\u0628\u0631\u064a \u0627\u0644\u0645\u062a\u0643\u0627\u0645\u0644\u0629 (ISBM) \u0627\u0644\u0643\u0648\u0631\u064a\u064a\u0646 \u0644\u0644\u062a\u0623\u0647\u0644 \u0643\u0645\u0648\u0631\u062f\u064a\u0646 \u0644\u062d\u0627\u0648\u064a\u0627\u062a \u0643\u0648\u0627\u0634\u0641 \u0627\u0644\u062a\u0634\u062e\u064a\u0635 \u0627\u0644\u0645\u062e\u062a\u0628\u0631\u064a \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0646\u064a\u0629 \u0641\u064a \u0643\u0648\u0631\u064a\u0627\u060c \u0648\u0630\u0644\u0643 \u0644\u0647\u064a\u0626\u0629 \u0645\u0639\u062a\u0645\u062f\u0629 \u0643\u0648\u0631\u064a\u0629 (\uc778\uc99d\uae30\uad00) \u0644\u062a\u0635\u0646\u064a\u0639 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\u060c \u0645\u0646 \u0623\u0631\u0628\u0639\u0629 \u0639\u0646\u0627\u0635\u0631: (1) \u062a\u0631\u0642\u064a\u0629 \u0646\u0638\u0627\u0645 \u0627\u0644\u062c\u0648\u062f\u0629 \u0625\u0644\u0649 \u0645\u0639\u064a\u0627\u0631 ISO 13485:2016: \u064a\u0645\u0643\u0646 \u0644\u0645\u0646\u062a\u062c\u064a \u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u062a\u0634\u062e\u064a\u0635 \u0627\u0644\u0645\u062e\u062a\u0628\u0631\u064a \u0627\u0644\u0645\u062a\u0643\u0627\u0645\u0644\u0629 (ISBM) \u0627\u0644\u0643\u0648\u0631\u064a\u064a\u0646 \u0627\u0644\u0630\u064a\u0646 \u064a\u0639\u0645\u0644\u0648\u0646 \u062d\u0627\u0644\u064a\u064b\u0627 \u0648\u0641\u0642\u064b\u0627 \u0644\u0645\u0639\u064a\u0627\u0631 ISO 9001:2015\u060c \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u062a\u0631\u0642\u064a\u0629 \u0625\u0644\u0649 \u0645\u0639\u064a\u0627\u0631 ISO 13485 \u0641\u064a \u063a\u0636\u0648\u0646 6-9 \u0623\u0634\u0647\u0631 \u0645\u0642\u0627\u0628\u0644 8-15 \u0645\u0644\u064a\u0648\u0646 \u0648\u0648\u0646 \u0643\u0648\u0631\u064a (\u062a\u062d\u0644\u064a\u0644 \u0627\u0644\u0641\u062c\u0648\u0627\u062a\u060c \u0645\u0631\u0627\u062c\u0639\u0629 \u0627\u0644\u0648\u062b\u0627\u0626\u0642\u060c \u0627\u0644\u062a\u062f\u0642\u064a\u0642\u060c \u0627\u0644\u0627\u0639\u062a\u0645\u0627\u062f) \u0645\u0646 \u062e\u0644\u0627\u0644 \u0647\u064a\u0626\u0629 \u0627\u0639\u062a\u0645\u0627\u062f \u0643\u0648\u0631\u064a\u0629 \u0645\u0639\u062a\u0645\u062f\u0629. \u064a\u064f\u0639\u062f \u0645\u0639\u064a\u0627\u0631 ISO 13485 \u0645\u0639\u064a\u0627\u0631 \u0625\u062f\u0627\u0631\u0629 \u062c\u0648\u062f\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0643\u0648\u0631\u064a \u0627\u0644\u0645\u0631\u062c\u0639 \u0641\u064a \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0639\u0645\u0644\u064a\u0629 \u0647\u064a\u0626\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 (KFDA). (2) \u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u0633\u0645\u064a\u0629 \u0627\u0644\u062e\u0644\u0648\u064a\u0629 \u0648\u0641\u0642\u064b\u0627 \u0644\u0645\u0639\u064a\u0627\u0631 ISO 10993-5 \u0639\u0644\u0649 \u0639\u064a\u0646\u0627\u062a \u0627\u0644\u0625\u0646\u062a\u0627\u062c: 1.5-3 \u0645\u0644\u064a\u0648\u0646 \u0648\u0648\u0646 \u0643\u0648\u0631\u064a \u0641\u064a \u0645\u062e\u062a\u0628\u0631\u0627\u062a KTR \u0623\u0648 KCL\u061b \u0648\u064a\u064f\u0635\u062f\u0631 \u0634\u0647\u0627\u062f\u0629 \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u062d\u064a\u0648\u064a \u0627\u0644\u062a\u064a \u062a\u0637\u0644\u0628\u0647\u0627 \u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0627\u0644\u0645\u0639\u062a\u0645\u062f\u0629. (3) \u062a\u0631\u0642\u064a\u0629 \u0628\u064a\u0626\u0629 \u0627\u0644\u0625\u0646\u062a\u0627\u062c \u0625\u0644\u0649 \u0645\u0639\u064a\u0627\u0631 ISO 14644-1 \u0627\u0644\u0641\u0626\u0629 8: \u0644\u0645\u0646\u0637\u0642\u0629 \u0625\u0646\u062a\u0627\u062c ISBM \u0643\u0648\u0631\u064a\u0629 \u0628\u0645\u0633\u0627\u062d\u0629 80-120 \u0645\u062a\u0631\u064b\u0627 \u0645\u0631\u0628\u0639\u064b\u0627\u060c \u0648\u062a\u062d\u062f\u064a\u062b \u0646\u0638\u0627\u0645 \u062a\u0631\u0634\u064a\u062d HEPA \u0648\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0636\u063a\u0637 \u0627\u0644\u0645\u0648\u062c\u0628: 15-30 \u0645\u0644\u064a\u0648\u0646 \u0648\u0648\u0646 \u0643\u0648\u0631\u064a \u0634\u0627\u0645\u0644\u0629 \u0627\u0644\u062a\u062d\u0642\u0642. 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\n
\n
\u06332 - \u0643\u064a\u0641 \u062a\u062e\u062a\u0644\u0641 \u0639\u0645\u0644\u064a\u0629 ISBM \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0630\u0627\u062a \u0627\u0644\u062e\u0637\u0648\u0629 \u0627\u0644\u0648\u0627\u062d\u062f\u0629 \u0639\u0646 \u0639\u0645\u0644\u064a\u0629 SBM \u0630\u0627\u062a \u0627\u0644\u0645\u0631\u062d\u0644\u062a\u064a\u0646 \u0644\u0623\u063a\u0631\u0627\u0636 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629\u061f<\/p>\n<\/div>\n
\n
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\u06334 - \u0643\u064a\u0641 \u064a\u0624\u062b\u0631 \u0627\u0644\u0623\u0633\u064a\u062a\u0627\u0644\u062f\u0647\u064a\u062f \u0627\u0644\u0645\u0648\u062c\u0648\u062f \u0641\u064a \u0645\u0627\u062f\u0629 \u0627\u0644\u0628\u0648\u0644\u064a \u0625\u064a\u062b\u064a\u0644\u064a\u0646 \u062a\u064a\u0631\u064a\u0641\u062b\u0627\u0644\u0627\u062a (PET) \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0627\u0644\u0645\u0633\u062a\u062e\u062f\u0645\u0629 \u0641\u064a \u0635\u0646\u0627\u0639\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0639\u0644\u0649 \u062c\u0648\u062f\u0629 \u0627\u0644\u0643\u0648\u0627\u0634\u0641\u061f<\/p>\n<\/div>\n
\n
\u064a\u064f\u0639\u062f\u0651 \u0627\u0646\u062a\u0642\u0627\u0644 \u0627\u0644\u0623\u0633\u064a\u062a\u0627\u0644\u062f\u0647\u064a\u062f (AA) \u0645\u0646 \u0639\u0628\u0648\u0627\u062a \u0627\u0644\u0628\u0648\u0644\u064a \u0625\u064a\u062b\u064a\u0644\u064a\u0646 \u062a\u064a\u0631\u064a\u0641\u062b\u0627\u0644\u0627\u062a (PET) \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0627\u0644\u0645\u064f\u0635\u0646\u0651\u0639\u0629 \u0648\u0641\u0642\u064b\u0627 \u0644\u0645\u0639\u0627\u064a\u064a\u0631 ISBM \u0625\u0644\u0649 \u0643\u0648\u0627\u0634\u0641 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0645\u0635\u062f\u0631 \u0642\u0644\u0642\u064d \u0628\u0627\u0644\u063a\u064d \u0641\u064a\u0645\u0627 \u064a\u062a\u0639\u0644\u0642 \u0628\u062c\u0648\u062f\u0629 \u0641\u0626\u0627\u062a\u064d \u0645\u064f\u062d\u062f\u0651\u062f\u0629 \u0645\u0646 \u0643\u0648\u0627\u0634\u0641 \u0627\u0644\u062a\u0634\u062e\u064a\u0635 \u0627\u0644\u0645\u062e\u062a\u0628\u0631\u064a (IVD) \u0627\u0644\u0643\u0648\u0631\u064a\u0629\u060c \u0648\u0644\u0627 \u0633\u064a\u0645\u0627 \u0643\u0648\u0627\u0634\u0641 \u0627\u0644\u062a\u0634\u062e\u064a\u0635 \u0627\u0644\u0642\u0627\u0626\u0645\u0629 \u0639\u0644\u0649 \u0627\u0644\u0625\u0646\u0632\u064a\u0645\u0627\u062a \u062d\u064a\u062b \u064a\u064f\u0645\u0643\u0646 \u0623\u0646 \u064a\u062a\u0641\u0627\u0639\u0644 \u0627\u0644\u0623\u0633\u064a\u062a\u0627\u0644\u062f\u0647\u064a\u062f \u0645\u0639 \u0627\u0644\u0645\u0648\u0627\u0642\u0639 \u0627\u0644\u0646\u0634\u0637\u0629 \u0644\u0644\u0625\u0646\u0632\u064a\u0645\u0627\u062a\u060c \u0648\u0643\u0648\u0627\u0634\u0641 \u0627\u0644\u0645\u0642\u0627\u064a\u0633\u0629 \u0627\u0644\u0645\u0646\u0627\u0639\u064a\u0629 \u062d\u064a\u062b \u064a\u064f\u0645\u0643\u0646 \u0623\u0646 \u064a\u062a\u0641\u0627\u0639\u0644 \u0627\u0644\u0623\u0633\u064a\u062a\u0627\u0644\u062f\u0647\u064a\u062f \u0645\u0639 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100 \u0645\u0644 \u0641\u064a \u062f\u0631\u062c\u0629 \u062d\u0631\u0627\u0631\u0629 \u0627\u0644\u063a\u0631\u0641\u0629\u060c \u0628\u0639\u062f \u062a\u062e\u0632\u064a\u0646\u0647\u0627 \u0644\u0645\u062f\u0629 3 \u0623\u0634\u0647\u0631). \u064a\u062c\u0628 \u0639\u0644\u0649 \u0645\u064f\u0635\u0646\u0651\u0639\u064a \u0639\u0628\u0648\u0627\u062a \u0627\u0644\u0623\u062f\u0648\u064a\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 (ISBM) \u0627\u0644\u0630\u064a\u0646 \u064a\u0632\u0648\u0651\u062f\u0648\u0646 \u0634\u0631\u0643\u0627\u062a \u0627\u0644\u062a\u0634\u062e\u064a\u0635 \u0627\u0644\u0645\u062e\u062a\u0628\u0631\u064a (IVD) \u0627\u0644\u0643\u0648\u0631\u064a\u0629\u060c \u0627\u0644\u0625\u0641\u0635\u0627\u062d \u0639\u0646 \u0646\u0633\u0628\u0629 \u0627\u0644\u0627\u0645\u062a\u0635\u0627\u0635 \u0627\u0644\u0636\u0648\u0626\u064a (AA) \u0627\u0644\u0645\u0642\u0627\u0633\u0629 \u0641\u064a \u0639\u0628\u0648\u0627\u062a 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\u0641\u064a\u0645\u0627 \u064a\u0644\u064a: \u062a\u0642\u0644\u064a\u0644 \u062f\u0631\u062c\u0629 \u062d\u0631\u0627\u0631\u0629 \u0627\u0644\u0628\u0631\u0645\u064a\u0644 (\u0627\u0644\u0647\u062f\u0641 265 \u062f\u0631\u062c\u0629 \u0645\u0626\u0648\u064a\u0629 \u0644\u0644\u0645\u0646\u0637\u0642\u0629 1\u060c \u0648\u0644\u064a\u0633 280 \u062f\u0631\u062c\u0629 \u0645\u0626\u0648\u064a\u0629 \u0641\u0623\u0643\u062b\u0631)\u060c \u0648\u062a\u0642\u0644\u064a\u0644 \u0645\u062f\u0629 \u0628\u0642\u0627\u0621 PET \u0641\u064a \u0627\u0644\u0628\u0631\u0645\u064a\u0644 (\u0639\u062f\u0645 \u062a\u0631\u0643 PET \u0641\u064a \u0627\u0644\u0628\u0631\u0645\u064a\u0644 \u0639\u0646\u062f \u062f\u0631\u062c\u0629 \u062d\u0631\u0627\u0631\u0629 \u0639\u0627\u0644\u064a\u0629 \u0623\u062b\u0646\u0627\u0621 \u0641\u062a\u0631\u0627\u062a \u0627\u0644\u062a\u0648\u0642\u0641 \u0627\u0644\u062a\u064a \u062a\u0632\u064a\u062f \u0639\u0646 10 \u062f\u0642\u0627\u0626\u0642)\u060c \u0648\u062a\u0642\u0644\u064a\u0644 \u0645\u062f\u0629 \u0627\u0644\u062a\u0643\u064a\u064a\u0641 (\u0627\u0644\u062d\u062f \u0627\u0644\u0623\u062f\u0646\u0649 \u0627\u0644\u0643\u0627\u0641\u064a \u0644\u0644\u062c\u0648\u062f\u0629\u060c \u0648\u0644\u064a\u0633 \u0627\u0644\u062d\u062f \u0627\u0644\u0623\u0642\u0635\u0649).<\/p>\n<\/div>\n<\/div>\n
\n
\n
\u06335 - \u0645\u0627 \u0647\u064a \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u062a\u062d\u0643\u0645 \u0641\u064a \u062a\u063a\u064a\u064a\u0631 ISBM \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0627\u0644\u062a\u064a \u062a\u0646\u0637\u0628\u0642 \u0628\u0639\u062f \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u062a\u0635\u0646\u064a\u0641 KFDA \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0644\u062b\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629\u061f<\/p>\n<\/div>\n
\n
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\n
\n
\u06336 - \u0643\u064a\u0641 \u062a\u0642\u0627\u0631\u0646 \u062f\u0642\u0629 \u0623\u0628\u0639\u0627\u062f ISBM \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0628\u0627\u0644\u0632\u062c\u0627\u062c \u0641\u064a\u0645\u0627 \u064a\u062a\u0639\u0644\u0642 \u0628\u062a\u0648\u0627\u0641\u0642 \u0642\u0637\u0631 \u0639\u0646\u0642 \u062d\u0627\u0648\u064a\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629\u061f<\/p>\n<\/div>\n
\n
\u062a\u062d\u0642\u0642 \u0639\u0628\u0648\u0627\u062a ISBM \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0627\u0644\u0645\u0635\u0646\u0648\u0639\u0629 \u0645\u0646 \u0627\u0644\u0628\u0648\u0644\u064a \u0625\u064a\u062b\u064a\u0644\u064a\u0646 \u062a\u064a\u0631\u064a\u0641\u062b\u0627\u0644\u0627\u062a (PET) \u0648\u0627\u0644\u0628\u0648\u0644\u064a \u0625\u064a\u062b\u064a\u0644\u064a\u0646 \u062a\u064a\u0631\u064a\u0641\u062b\u0627\u0644\u0627\u062a \u062c\u0644\u064a\u0643\u0648\u0644 (PETG) \u062f\u0642\u0629 \u0623\u0628\u0639\u0627\u062f \u0642\u0637\u0631 \u0639\u0646\u0642\u0647\u0627 \u0627\u0644\u062e\u0627\u0631\u062c\u064a \u062a\u0635\u0644 \u0625\u0644\u0649 \u00b10.04 \u0645\u0645 (4 \u0633\u064a\u062c\u0645\u0627\u060c \u0645\u0646\u0635\u0629 EV \u0627\u0644\u0645\u0624\u0627\u0632\u0631\u0629) \u0641\u064a \u0625\u0646\u062a\u0627\u062c 4 \u062a\u062c\u0627\u0648\u064a\u0641\u060c \u0648\u0647\u064a \u062f\u0642\u0629 \u062a\u0639\u0627\u062f\u0644 \u0623\u0648 \u062a\u0641\u0648\u0642 \u062f\u0642\u0629 \u0642\u0637\u0631 \u0639\u0646\u0642 \u0627\u0644\u0632\u062c\u0627\u062c\u0627\u062a \u0627\u0644\u0645\u0633\u062a\u062e\u062f\u0645\u0629 \u0641\u064a \u0635\u0646\u0627\u0639\u0629 \u0627\u0644\u0623\u062f\u0648\u064a\u0629 (\u0639\u0627\u062f\u0629\u064b \u00b10.05-0.10 \u0645\u0645\u060c \u0627\u0639\u062a\u0645\u0627\u062f\u064b\u0627 \u0639\u0644\u0649 \u0639\u0645\u0644\u064a\u0629 \u062a\u0634\u0643\u064a\u0644 \u0627\u0644\u0632\u062c\u0627\u062c \u0648\u062d\u062c\u0645 \u0627\u0644\u0639\u0646\u0642). \u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u062a\u0637\u0628\u064a\u0642\u0627\u062a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629\u060c \u062d\u064a\u062b \u064a\u0639\u062a\u0645\u062f \u0625\u063a\u0644\u0627\u0642 \u0627\u0644\u0639\u0628\u0648\u0629 (\u063a\u0637\u0627\u0621 \u0643\u0628\u0633\u060c \u0645\u0648\u0635\u0644 \u0644\u0648\u064a\u0631\u060c \u062d\u0627\u062c\u0632) \u0639\u0644\u0649 \u0645\u062f\u0649 \u062a\u062d\u0645\u0644 \u0642\u0637\u0631 \u0639\u0646\u0642\u0647\u0627 \u0627\u0644\u062e\u0627\u0631\u062c\u064a \u0644\u0636\u0645\u0627\u0646 \u0645\u0646\u0639 \u0627\u0644\u062a\u0633\u0631\u0628\u060c \u062a\u0648\u0641\u0631 \u062f\u0642\u0629 ISBM \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0627\u0644\u0628\u0627\u0644\u063a\u0629 \u00b10.04 \u0645\u0645 \u0623\u062f\u0627\u0621\u064b \u0623\u0643\u062b\u0631 \u0627\u062a\u0633\u0627\u0642\u064b\u0627 \u0641\u064a \u0627\u0644\u0625\u063a\u0644\u0627\u0642 \u0645\u0642\u0627\u0631\u0646\u0629\u064b \u0628\u062f\u0642\u0629 \u0627\u0644\u0632\u062c\u0627\u062c (\u00b10.05-0.10 \u0645\u0645)\u060c \u0645\u0639 \u0645\u064a\u0632\u0629 \u0625\u0636\u0627\u0641\u064a\u0629 \u062a\u062a\u0645\u062b\u0644 \u0641\u064a \u0625\u0645\u0643\u0627\u0646\u064a\u0629 \u0627\u0644\u062a\u062d\u0642\u0642 \u0627\u0644\u0643\u0645\u064a \u0645\u0646 \u0647\u0630\u0647 \u0627\u0644\u062f\u0642\u0629 \u0644\u0643\u0644 \u062a\u062c\u0648\u064a\u0641 \u0641\u064a \u0639\u0645\u0644\u064a\u0629 \u0627\u0644\u0625\u0646\u062a\u0627\u062c (\u0628\u064a\u0646\u0645\u0627 \u064a\u0642\u062f\u0645 \u0645\u0635\u0646\u0639\u0648 \u0627\u0644\u0632\u062c\u0627\u062c \u0634\u0647\u0627\u062f\u0627\u062a \u0627\u0644\u0623\u0628\u0639\u0627\u062f \u0639\u0644\u0649 \u0645\u0633\u062a\u0648\u0649 \u0639\u064a\u0646\u0629 \u0625\u062d\u0635\u0627\u0626\u064a\u0629\u060c \u0648\u0644\u064a\u0633 \u0644\u0643\u0644 \u062a\u062c\u0648\u064a\u0641). \u0647\u0646\u0627\u0643 \u0634\u0631\u0637\u0627\u0646 \u0623\u0633\u0627\u0633\u064a\u0627\u0646 \u0644\u062d\u0627\u0648\u064a\u0627\u062a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u062d\u064a\u062b \u064a\u062d\u062a\u0641\u0638 \u0627\u0644\u0632\u062c\u0627\u062c \u0628\u0645\u064a\u0632\u0629 \u0639\u0644\u0649 \u0639\u0628\u0648\u0627\u062a \u0627\u0644\u0628\u0648\u0644\u064a \u0625\u064a\u062b\u064a\u0644\u064a\u0646 \u062a\u064a\u0631\u064a\u0641\u062b\u0627\u0644\u0627\u062a\/\u0627\u0644\u0628\u0648\u0644\u064a \u0625\u064a\u062b\u064a\u0644\u064a\u0646 \u062a\u064a\u0631\u064a\u0641\u062b\u0627\u0644\u0627\u062a (PET\/PETG) \u0627\u0644\u0643\u0648\u0631\u064a\u0629: (1) \u062d\u0627\u062c\u0632 \u0644\u0644\u0623\u0634\u0639\u0629 \u0641\u0648\u0642 \u0627\u0644\u0628\u0646\u0641\u0633\u062c\u064a\u0629 \u0644\u0644\u0645\u0648\u0627\u062f \u0627\u0644\u0643\u064a\u0645\u064a\u0627\u0626\u064a\u0629 \u0634\u062f\u064a\u062f\u0629 \u0627\u0644\u062d\u0633\u0627\u0633\u064a\u0629 \u0644\u0644\u0636\u0648\u0621 - \u064a\u062d\u062c\u0628 \u0627\u0644\u0632\u062c\u0627\u062c \u0627\u0644\u0643\u0647\u0631\u0645\u0627\u0646\u064a \u226599.9% \u0645\u0646 \u0627\u0644\u0623\u0634\u0639\u0629 \u0641\u0648\u0642 \u0627\u0644\u0628\u0646\u0641\u0633\u062c\u064a\u0629 \u0627\u0644\u062a\u064a \u062a\u0642\u0644 \u0639\u0646 450 \u0646\u0627\u0646\u0648\u0645\u062a\u0631\u061b \u0628\u064a\u0646\u0645\u0627 \u064a\u062d\u062c\u0628 \u0627\u0644\u0628\u0648\u0644\u064a \u0625\u064a\u062b\u064a\u0644\u064a\u0646 \u062a\u064a\u0631\u064a\u0641\u062b\u0627\u0644\u0627\u062a (PET) \u0623\u0648 \u0627\u0644\u0628\u0648\u0644\u064a \u0625\u064a\u062b\u064a\u0644\u064a\u0646 \u062a\u064a\u0631\u064a\u0641\u062b\u0627\u0644\u0627\u062a (PETG) \u0627\u0644\u0643\u0647\u0631\u0645\u0627\u0646\u064a 95-99% \u0648\u0644\u0643\u0646\u0647 \u064a\u062a\u0637\u0644\u0628 \u0627\u062e\u062a\u0628\u0627\u0631\u064b\u0627 \u0645\u0639\u062a\u0645\u062f\u064b\u0627 \u0644\u0644\u062e\u0644\u0637\u0629 \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629 \u0648\u0627\u062e\u062a\u0628\u0627\u0631 \u0627\u0644\u0647\u062c\u0631\u0629\u061b (2) \u0645\u0639\u062f\u0644 \u0646\u0641\u0627\u0630\u064a\u0629 \u0628\u062e\u0627\u0631 \u0627\u0644\u0645\u0627\u0621 (WVTR) - \u0627\u0644\u0632\u062c\u0627\u062c \u0644\u0627 \u064a\u0645\u062a\u0635 \u0628\u062e\u0627\u0631 \u0627\u0644\u0645\u0627\u0621\u061b \u0628\u064a\u0646\u0645\u0627 \u064a\u0628\u0644\u063a \u0645\u0639\u062f\u0644 \u0646\u0641\u0627\u0630\u064a\u0629 \u0628\u062e\u0627\u0631 \u0627\u0644\u0645\u0627\u0621 \u0641\u064a \u0627\u0644\u0628\u0648\u0644\u064a \u0625\u064a\u062b\u064a\u0644\u064a\u0646 \u062a\u064a\u0631\u064a\u0641\u062b\u0627\u0644\u0627\u062a (PET) \u062d\u0648\u0627\u0644\u064a 1.5-3.0 \u062c\u0645\u00b7\u0645\u0645\/\u0645\u00b2\u00b7\u064a\u0648\u0645 \u0639\u0646\u062f 38 \u062f\u0631\u062c\u0629 \u0645\u0626\u0648\u064a\u0629\/90% RH - \u0648\u0647\u0648 \u0645\u0642\u0628\u0648\u0644 \u0644\u0645\u0639\u0638\u0645 \u0643\u0648\u0627\u0634\u0641 \u0627\u0644\u062a\u0634\u062e\u064a\u0635 \u0627\u0644\u0645\u062e\u062a\u0628\u0631\u064a \u0627\u0644\u0645\u0627\u0626\u064a\u0629 \u0641\u064a \u0638\u0631\u0648\u0641 \u0627\u0644\u062a\u062e\u0632\u064a\u0646 \u0627\u0644\u0645\u062e\u062a\u0628\u0631\u064a\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0627\u0644\u0642\u064a\u0627\u0633\u064a\u0629 (15-30 \u062f\u0631\u062c\u0629 \u0645\u0626\u0648\u064a\u0629) \u0648\u0644\u0643\u0646\u0647 \u064a\u062a\u0637\u0644\u0628 \u0625\u063a\u0644\u0627\u0642\u064b\u0627 \u0628\u062d\u0627\u062c\u0632 \u0644\u0644\u0631\u0637\u0648\u0628\u0629 \u0644\u0644\u0645\u0648\u0627\u062f \u0627\u0644\u0643\u064a\u0645\u064a\u0627\u0626\u064a\u0629 \u0627\u0644\u062d\u0633\u0627\u0633\u0629 \u0644\u0644\u062a\u062e\u0641\u064a\u0641 \u0627\u0644\u0646\u0627\u062a\u062c \u0639\u0646 \u0627\u0645\u062a\u0635\u0627\u0635 \u0627\u0644\u0631\u0637\u0648\u0628\u0629 \u0627\u0644\u062c\u0648\u064a\u0629 \u0639\u0644\u0649 \u0645\u062f\u0649 \u0641\u062a\u0631\u0629 \u0635\u0644\u0627\u062d\u064a\u0629 \u062a\u0632\u064a\u062f \u0639\u0646 18 \u0634\u0647\u0631\u064b\u0627.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n
<\/p>\n
\n
\u062f\u0639\u0645 \u062a\u0623\u0647\u064a\u0644 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629<\/p>\n
\u0647\u0644 \u062a\u0631\u063a\u0628 \u0641\u064a \u062f\u062e\u0648\u0644 \u0645\u062c\u0627\u0644 \u062a\u063a\u0644\u064a\u0641 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0646\u064a\u0629 \u0623\u0648 \u0627\u0644\u062b\u0627\u0644\u062b\u0629 \u0644\u062f\u0649 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 (KFDA)\u061f \u0647\u0644 \u062a\u062d\u062a\u0627\u062c \u0625\u0644\u0649 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0635\u062d\u0629 \u0645\u0645\u0627\u0631\u0633\u0627\u062a \u0627\u0644\u062a\u0635\u0646\u064a\u0639 \u0627\u0644\u062c\u064a\u062f\u0629 (GMP)\u060c \u0623\u0648 \u0634\u0647\u0627\u062f\u0629 ISO 10993\u060c \u0623\u0648 \u062f\u0639\u0645 IQ\/OQ\/PQ\u061f<\/h2>\n
\u062a\u0648\u0641\u0631 \u0634\u0631\u0643\u0629 Korean Ever-Power \u0642\u0648\u0627\u0644\u0628 \u062a\u0648\u062b\u064a\u0642 \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0646\u064a\u0629\/\u0627\u0644\u062b\u0627\u0644\u062b\u0629 \u0645\u0646 KFDA\u060c \u0648\u062a\u0637\u0648\u064a\u0631 \u0628\u0631\u0648\u062a\u0648\u0643\u0648\u0644\u0627\u062a GMP IQ\/OQ\/PQ\u060c \u0648\u0625\u0646\u062a\u0627\u062c \u0639\u064a\u0646\u0627\u062a \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u062d\u064a\u0648\u064a\u060c \u0648\u062a\u0633\u062c\u064a\u0644 \u0639\u0645\u0644\u064a\u0627\u062a EV \u0627\u0644\u0645\u0624\u0627\u0632\u0631\u0629 \u0644\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0645\u0644\u062d\u0642 11 \u0645\u0646 KFDA\u060c \u0648\u062a\u0634\u063a\u064a\u0644 ISBM \u0641\u064a \u0627\u0644\u063a\u0631\u0641 \u0627\u0644\u0646\u0638\u064a\u0641\u0629 \u0644\u062a\u0623\u0647\u064a\u0644 \u062a\u063a\u0644\u064a\u0641 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629.<\/p>\n
\u0637\u0644\u0628 \u062f\u0639\u0645 \u062a\u0623\u0647\u064a\u0644 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629<\/a><\/p>\n<\/div>\n<\/p>\n\n\u0645\u0648\u0627\u0631\u062f \u0630\u0627\u062a \u0635\u0644\u0629<\/p>\n
\n
\u062f\u0631\u062c\u0629 \u0637\u0628\u064a\u0629 \u0645\u0645\u062a\u0627\u0632\u0629<\/span>
\n\u0645\u0627\u0643\u064a\u0646\u0629 \u0646\u0641\u062e \u0627\u0644\u0642\u0648\u0627\u0644\u0628 \u0628\u0627\u0644\u062d\u0642\u0646 \u0648\u0627\u0644\u062a\u0645\u062f\u064a\u062f HGY150-V4-EV<\/span>
\n\u0645\u062d\u0631\u0643 \u0633\u064a\u0631\u0641\u0648 \u0643\u0647\u0631\u0628\u0627\u0626\u064a \u0628\u0627\u0644\u0643\u0627\u0645\u0644 \u0644\u0644\u0633\u064a\u0627\u0631\u0627\u062a \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u0629 \u00b7 \u062a\u0633\u062c\u064a\u0644 \u0628\u064a\u0627\u0646\u0627\u062a GMP \u0648\u0641\u0642\u064b\u0627 \u0644\u0644\u0645\u0644\u062d\u0642 11 \u0645\u0646 KFDA \u00b7 Cpk \u2265 1.50 \u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a PQ \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0644\u062b\u0629 \u00b7 \u062d\u0632\u0645\u0629 \u0648\u062b\u0627\u0626\u0642 IQ\/OQ\/PQ \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0645\u062a\u0648\u0641\u0631\u0629.<\/span><\/div>\n <\/p>\n
\u0645\u0646\u0635\u0629 \u0627\u0644\u062a\u0634\u062e\u064a\u0635 \u0627\u0644\u0645\u062e\u062a\u0628\u0631\u064a \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0646\u064a\u0629<\/span>
\n\u0645\u0627\u0643\u064a\u0646\u0629 \u0646\u0641\u062e \u0627\u0644\u0642\u0648\u0627\u0644\u0628 \u0628\u0627\u0644\u062d\u0642\u0646 \u0648\u0627\u0644\u062a\u0645\u062f\u064a\u062f HGY200-V4<\/span>
\n\u0645\u062a\u0639\u062f\u062f \u0627\u0644\u0631\u0627\u062a\u0646\u062c\u0627\u062a PET \/ PETG \/ PP \u00b7 \u062f\u0642\u0629 \u0642\u0637\u0631 \u0627\u0644\u0639\u0646\u0642 \u0627\u0644\u062e\u0627\u0631\u062c\u064a \u00b10.04 \u0645\u0645 \u00b7 \u0645\u062a\u0648\u0627\u0641\u0642 \u0645\u0639 \u0645\u0639\u064a\u0627\u0631 ISO 13485 \u0627\u0644\u0643\u0648\u0631\u064a \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0646\u064a\u0629 \u00b7 \u062a\u0645 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u062f\u0631\u062c\u0629 PET \u0627\u0644\u0645\u062b\u0628\u062a\u0629 \u0628\u0627\u0644\u0625\u0634\u0639\u0627\u0639 \u00b7 \u0632\u062c\u0627\u062c\u0629 \u0643\u0627\u0634\u0641 IVD 15-500 \u0645\u0644.<\/span><\/div>\n <\/p>\n
\u0627\u0644\u062e\u062f\u0645\u0627\u062a \u0627\u0644\u0637\u0628\u064a\u0629 \u0630\u0627\u062a \u0627\u0644\u062d\u062c\u0645 \u0627\u0644\u0643\u0628\u064a\u0631<\/span>
\n\u0645\u0627\u0643\u064a\u0646\u0629 \u062d\u0642\u0646 \u0648\u0646\u0641\u062e \u0627\u0644\u0642\u0648\u0627\u0644\u0628 HGY250-V4<\/span>
\n\u0625\u0646\u062a\u0627\u062c \u0639\u0628\u0648\u0627\u062a \u0643\u0628\u064a\u0631\u0629 \u0645\u0646 \u0643\u0648\u0627\u0634\u0641 \u0627\u0644\u062a\u0634\u062e\u064a\u0635 \u0627\u0644\u0645\u062e\u062a\u0628\u0631\u064a \u00b7 \u0645\u062e\u0631\u062c \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0646\u064a\u0629 \u0627\u0644\u0643\u0648\u0631\u064a\u0629 \u0628\u0633\u062a\u0629 \u062a\u062c\u0627\u0648\u064a\u0641 \u00b7 \u0646\u0638\u0627\u0645 \u0637\u0631\u062f \u0645\u062a\u0648\u0627\u0641\u0642 \u0645\u0639 \u063a\u0631\u0641 \u0627\u0644\u0623\u0628\u062d\u0627\u062b \u0627\u0644\u0646\u0638\u064a\u0641\u0629 \u00b7 \u0639\u0646\u0642 \u0648\u0627\u0633\u0639 \u0627\u0644\u0641\u062a\u062d\u0629 86 \u0645\u0645 \u0644\u0639\u0628\u0648\u0627\u062a \u0643\u0648\u0627\u0634\u0641 \u0627\u0644\u062a\u0634\u062e\u064a\u0635 \u0627\u0644\u0643\u0628\u064a\u0631\u0629.<\/span><\/div>\n <\/p>\n<\/div>\n<\/section>\n
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