醫電設備電性安全測試與相關 ... - bmes.org.tw

1 : : : 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 IEC 60601-1 IEC 60601-1-1 IEC 60601-1-6 IEC 60601-1-2 IEC 60601-1-8 IEC 60601-1-4 Collateral standardGeneral RequirementsIEC 60601-2-XXParticular RequirementIEC 60601-3-XXIEC 60601-1-9 Requirements for environmentally conscious design ,2007 IEC 60601-1-9 Process requirements for the development of therapeutic closed-loop controllers 2007.

2 IEC 60601-1-10 General requirements and guidelines for the application of alarms in Medical Electrical Equipment .IEC 60601-1-8 Requirements for usability (Analysis, test and validation of human factors compatibility),2007 IEC 60601-1-6 Image quality and dose for X-ray equipment (Project).IEC 60601-1-5 Programmable Electrical Medical Systems, 1996 IEC 60601-1-4 Requirements for Radiation Protection in Diagnostic X-ray Equipment , 60601-1-3 Electromagnetic Compatibility - Requirements and Tests ,2007 IEC 60601-1-2 Safety Requirements for Medical Electrical Systems ,2000 IEC 60601-1-1 IEC60601-1 Collateral StandardsInfant Radiant Warmers (02/94), (10/96)IEC 60601-2-21 Transport Incubators (12/90), (10/96). IEC 60601-2-20 Baby Incubators (12/90), (10/96).IEC 60601-2-19 Transcutaneous Partial Pressure Monitoring Equipment (09/93), Including essential performance Ed. 2 (12/99).IEC 60601-2-23 Electrically Operated Hospital Beds (10/96), (12/99), (Next Ed.)

3 Will be IEC 60601-2-52). IEC 60601-2-38 Diagnostic and Therapeutic Laser Equipment Ed. 2 (11/95), Ed. 3 (Project).IEC 60601-2-22 Nerve and Muscle Stimulators (12/87), (09/01), Corrigendum (02/02). IEC 60601-2-10:Microwave Therapy Equipment (01/84).IEC 60601-2-6 Ultrasonic Therapy Equipment (01/84), (07/00)IEC 60601-2-5 Cardiac Defibrillators and Cardiac Defibrillator-Monitors (01/83), (08/02),IEC 60601-2-4 Short-Wave Therapy Equipment Ed. 2 (06/91), (09/98) (Project).IEC 60601-2-3 High Frequency Surgical Equipment Ed. 3 (09/98) (Project). [AAMI HF18-331].IEC 60601-2-2 Particular Standards IEC60601-1 2012 ( 2009 9 ) IEC 60601-1 2nd+A1,+A2 (ME Equipment) applied part , IEC 60601-1 Basic safety Essential performance =Total safety situation (SFC) Annex A of IEC 60601-1 ?

4 AP, APG IPX(0-6)X(0-8) IPType B, BF, CFApplied partClass I, II, internal power Class I Class II 3. 2. (Air clearance ) (Creepage) insulation (MOP)Applied parts B, BF CF . Type CF applied part . Type BF Type CF . Type B Type B Type BF and CF floating Applied Part B,BF or CF BF or CF (from or to patient) CF Applied Part Applied part( ) Type BF ( ) CE NB ~ II - MEDIUM PRIORITY - HIGH PRIORITY IEC60601-1-8 100% on or Low Priority20% to 60% Priority20% to 60% priority Threshold of Reception: min.

5 Let go:6mA min. Respiratory paralysis, pain and fatigue:18~22mA Ventricular fibrillation:35mA~400mA Sustained Myocardial Contraction:1~6A Burn and Physical Injury:>10A~60Hz 1~3 secFrom Medical Instrumentation Application and DesignJohn G. Webster 35mA (15-100Hz) (50/60Hz ) 10mA (15-100Hz)Let (50/60Hz) From:IEC60479-1 1. 2. 3. 5. 6. IEC 60601-1 1. 2. 3. 4. Type B BF (NC), (SFC) (NC),. (SFC) (NC) 5mAfor (SFC) 10mAfor 3rd (NC), (SFC) Type CF 10uA(NC),50uA(SFC) 10uA(NC),50uA(SFC) (NC) 5mA for 3rd (SFC) 10mA for 3rd (NC), (SFC) : : : F applied part : 1kHz1kHz IEC 60601-1 AAMIES1 IEC 60601-1 TN-C TN-S TN-C-S 1.

6 2. 3. 4. :100m ( )200m ( non-DETACHABLE POWER SUPPLY CORD) IVR/=VI:25AR=V/IEUTG round Bond Tester ( ) Plugs and sockets L N : (93% RH) : 50Hz/60Hz 4000V1500V230V3000V1500V115V2 MOPP1 MOPP U MOPP Mean of patient protection 2 MOPP :UL 2008 6 Hi-pot TesterEUT 250N 10N 5s Push Test70 C (or 10 C+Tnc), 7hr Mould Stress test40mm Rough Handling Test :1m m 10kg 5 cm10kg<m 50kg 3cm50kg<m 2cm Drop test500g , Impact Test EMI (150kHz~30 MHz) (30 MHz~ )EMS (ESD) 8kV air/ 6kV contact (10V/m) (EFT) RF RF * : ext 512