醫電設備電性安全測試與相關 ... - bmes.org.tw

: : : GMP SGS ISO 13485 T V S D IEC 60601-12nd/3rd TAF IEC 60601-1 Be d / m a ttr e sse s2%Surgucalequipment andconsumables23%infusion/transfusion dialysis16%lifesupport/incuba tor/monitor10%syringe/needle10%drainage/ suction4%disfection/sterilization/monito rs2%implant23%in vitro diagnostics5%Diagnostic imaging5% (dangerous liquids, ) ( X-Ray, ..) / IEC60601 ( ) IEC 61010 ( , ) IEC 10993 ( ) IEC 60529 ( ) IEC 60068 ( ) ISO 13485 ( ) ISO 14971 ( ) IEC 60601-1:1988+A1+A2 IECIEC 601-1:1977 IEC 601-1:1988 IEC 601-1:A1 1991 IEC 601-1:A2 1995 IEC 60601-1:2005 ENEN 60601-1:1990EN 60601-1:A1 1993EN60601-1:A2 1995EN 60601-1:2006 ULUL 544UL 2601-1UL 60601-1 AAMIAAMI/ES 1 ANSI/AAMI 60601-1 IEC 60601 IE

介紹內容 • 醫電設備標準發展介紹 • 醫電設備之標示 • iec 60601-1對電殛保護之基本測試要求與 檢測原理 • 其他重要測試項目

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