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ISO 14971-2007 中文版 医疗器械 风险管理对医疗器械的应用-.pdf

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ISO14971( )2007-03-01 Medical devices –Application of risk management to medical devicesMedical devices –Application of risk management to medical devicesMedical devices –Application of risk management to medical devices 1 1. 2. 3. 3.1 3.2 3.3 3.4 3.5 4. 4.1 4.2 4.3 4.4 5. 6. 6.1 6.2 6.3 6.4 6.5 / 6.6 6.7 7. 8. 9. A (A (A ( ) B (B (B ( ) C (C ( ) D ( ) E ( ) , F ( ) G ( ) H ( ) J ( ) 2 ISO 14971-2007 ISO( ) (ISO ) ISO , , . ISO ( ) ,ISO (IEC) ISO/IEC 2 , 75% , ISOISO ISO 14971 ISO/TC210(
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