TECHNICAL NOTE IEC 60601-1 3rd Edition + AM1 Guidelines for MOOP and MOPP Prepared by: Ross Sacolles 12/17/2013 AMERICAS | EUROPE | ASIA I SL Power Electronics I TECHNICAL NOTE Class I: Working Voltage ≤250 Vrms ≤354 Vpk Means of Operator Protection (MOOP) Operator Accessible Part <240 VA or Non-Accessible Part Primary to Ground 1 MOOP 1 MOPP 1 MOPP 1 - Y2 Capacitors or 1 - Y1 Clause 8.5.1.3 1 – Y2 or Y1 Capacitor Clause 8.5.1.2 1 – Y2 or Y1 Capacitor Clause 8.5.1.2 Primary to Plastic Enclosure Means of Patient Protection (MOPP) Applied Part - Type B Means of Patient Protection (MOPP) Applied Parts - Type BF, CF 4/2.5 mm Creepage/Clearance 2.5/2.0 mm Creepage/ Clearance Pollution Degree 2, Material Group IIIa or IIIb (Clearance required increases if measured Vpk exceed 420 Vpk) 4/2.5 mm Creepage/Clearance 1 layer insulation - Basic 1 layer insulation - Basic 1 layer insulation - Basic Dielectric = 1500 Vac Note: Test voltage increases if measured Vpk exceed 354 Vpk – See Table 7 Dielectric = 1500 Vac Note: Test voltage increases if measured Vpk exceed 354 Vpk – See Table 6 Dielectric = 1500 Vac Note: Test voltage increases if measured Vpk exceed 354 Vpk – See Table 6 2 MOOP 2 MOPP 2 MOPP Any thickness needed to comply Any thickness needed to comply Any thickness needed to comply with enclosure tests. with enclosure tests. with enclosure tests. Primary to Secondary Dielectric = 3000 Vac (copper foil wrapped around enclosure) Dielectric = 4000 Vac (copper foil wrapped around enclosure) Dielectric = 4000 Vac (copper foil wrapped around enclosure) 2 MOOP 2 MOPP 2 MOPP 2 - Y2 or Y1 Capacitors or 1 - Y1 2 - Y1 Capacitors (No Y2s allowed) 2 - Y1 Capacitors (No Y2s allowed) 5/4 mm Creepage/Clearance 8/5 mm Creepage/Clearance 8/5 mm Creepage/Clearance Pollution Degree 2, (Clause 8.9.4 - Enamel coatings (Clause 8.9.4 - Enamel coatings Material Group IIIa or IIIb on magnet wires are ignored) on magnet wires are ignored) (Clearance required increases if measured Vpk exceed 420 Vpk) Dielectric = 3000 Vac Secondary to Ground Dielectric = 4000 Vac Dielectric = 4000 Vac Note: Test voltage increases if measured Vpk exceed 354 Vpk – See Table 6 Note: Test voltage increases if measured Vpk exceed 354 Vpk – See Table 6 1 layer, 0.4 mm thick or 2 layers, with 1 layer passing 3000 Vac dielectric test or 3 layers, with 2 layers passing 3000 Vac dielectric test. 1 layer, 0.4 mm thick or 2 layers, with 1 layer passing 4000 Vac dielectric test or 3 layers, with 2 layers passing 4000 Vac dielectric test. 1 layer, 0.4 mm thick or 2 layers, with 1 layer passing 4000 Vac dielectric test or 3 layers, with 2 layers passing 4000 Vac dielectric test. Output may be floating (Functional), isolated by MOP (1 MOOP), connected to earth, or protectively earthed. Output may be floating 1 MOPP (Functional), isolated by MOP (1 MOOP), connected to earth, or protectively earthed. Non-approved capacitor okay if used for Functional or 1-Y2 capacitor for 1 MOOP. Non-approved capacitor okay if used for Functional or 1-Y2 capacitor for 1 MOOP. 1 – Y2 or Y1 Capacitor Page 2 I SL Power Electronics I TECHNICAL NOTE Class I: Working Voltage ≤250 Vrms ≤354 Vpk Means of Operator Protection (MOOP) Operator Accessible Part <240 VA or Non-Accessible Part Means of Patient Protection (MOPP) Applied Part - Type B Means of Patient Protection (MOPP) Applied Parts - Type BF, CF Functional Insulation – if output is floating or 1 MOOP for isolated output. Functional Insulation – if output is floating or 1 MOOP for isolated output. Working Voltage: Equal to maximum rated mains voltage (240 V) 4/2.5 mm Creepage/Clearance Touch Current: (Applies to Operator Accessible Part only) Measure Patient Leakage: Measure Patient Leakage: Limits per Table 3 & 4 Limits per Table 3 & 4 Dielectric = No Test Dielectric = 1500 Vac 100 µA NC 500 µA SFC Dielectric = No Test NOTES: 1. Interpolation is permitted for creepage requirements per Clause 8.9.1.6 for MOOP and MOPP. Also, refer to Table 14 (MOOP only) for additional clearances for insulation in mains part with peak working voltages exceeding the peak value of the nominal mains voltage. 2. Refer to Table 8 in the IEC standard document for multiplication factors for air clearances for altitudes up to 5000 m for altitudes >2000 m (MOOP), and >3000 m (MOPP). NOTE: If 10,000 ft (3048 m) is declared in the Product Specs the multiplication factor for 3000 to 4000 m should be used. Page 3 I SL Power Electronics I TECHNICAL NOTE Class II with FE: Working Voltage ≤250 Vrms ≤354 Vpk Means of Operator Protection (MOOP) Operator Accessible Part <240 VA or Non-Accessible Part Primary to Functional Earth: 2 MOOP 2 MOPP 2 MOPP 2 - Y2 Capacitors or 1 - Y1 2 - Y1 Capacitor (No Y2s allowed) 2 - Y1 Capacitor (No Y2s allowed) Primary to Plastic Enclosure: Means of Patient Protection (MOPP) Applied Part - Type B Means of Patient Protection (MOPP) Applied Parts - Type BF, CF 8/5 mm Creepage/Clearance 5/4 mm Creepage/Clearance Pollution Degree 2, Material Group IIIa or IIIb (Clearance required increases if measured Vpk exceed 420 Vpk) 8/5 mm Creepage/Clearance Dielectric = 3000 Vac Dielectric = 4000 Vac Dielectric = 4000 Vac Note: Test voltage increases if measured Vpk exceed 354 Vpk – See Table 6 Note: Test voltage increases if measured Vpk exceed 354 Vpk – See Table 6 1 layer, 0.4 mm thick or 2 layers, with 1 layer passing 3000 Vac dielectric test or 3 layers, with 2 layers passing 3000 Vac dielectric test. 1 layer, 0.4 mm thick or 2 layers, with 1 layer passing 4000 Vac dielectric test or 3 layers, with 2 layers passing 4000 Vac dielectric test. 1 layer, 0.4 mm thick or 2 layers, with 1 layer passing 4000 Vac dielectric test or 3 layers, with 2 layers passing 4000 Vac dielectric test. 2 MOOP 2 MOPP 2 MOPP Any thickness needed to comply Any thickness needed to comply Any thickness needed to comply with enclosure tests. with enclosure tests. with enclosure tests. Primary to Secondary: Dielectric = 3000 Vac (copper foil wrapped around enclosure) Dielectric = 4000 Vac (copper foil wrapped around enclosure) Dielectric = 4000 Vac (copper foil wrapped around enclosure) 2 MOOP 2 MOPP 2 MOPP 2 - Y2 or Y1 Capacitors or 1 - Y1 2 - Y1 Capacitors (No Y2s allowed) 2 - Y1 Capacitors (No Y2s allowed) 5/4 mm Creepage/Clearance 8/5 mm Creepage/Clearance 8/5 mm Creepage/Clearance Pollution Degree 2, (Clause 8.9.4 - Enamel coatings (Clause 8.9.4 - Enamel coatings Material Group IIIa or IIIb on magnet wires are ignored) on magnet wires are ignored) (Clearance required increases if measured Vpk exceed 420 Vpk) Dielectric = 3000 Vac Secondary to Functional Earth: Dielectric = 4000 Vac Dielectric = 4000 Vac Note: Test voltage increases if measured Vpk exceed 354 Vpk – See Table 6 Note: Test voltage increases if measured Vpk exceed 354 Vpk – See Table 6 1 layer, 0.4 mm thick or 2 layers, with 1 layer passing 3000 Vac dielectric test or 3 layers, with 2 layers passing 3000 Vac dielectric test. 1 layer, 0.4 mm thick or 2 layers, with 1 layer passing 4000 Vac dielectric test or 3 layers, with 2 layers passing 4000 Vac dielectric test. 1 layer, 0.4 mm thick or 2 layers, with 1 layer passing 4000 Vac dielectric test or 3 layers, with 2 layers passing 4000 Vac dielectric test. Output may be floating (Functional), isolated by MOP (1 MOOP), connected to earth, or protectively earthed. Output may be floating 1 MOPP (Functional), isolated by MOP (1 MOOP), connected to earth, or protectively earthed. Page 4 I SL Power Electronics I TECHNICAL NOTE Class II with FE: Working Voltage ≤250 Vrms ≤354 Vpk Means of Operator Protection (MOOP) Operator Accessible Part <240 VA or Non-Accessible Part Means of Patient Protection (MOPP) Applied Part - Type B Means of Patient Protection (MOPP) Applied Parts - Type BF, CF Non-approved capacitor okay if used for Functional or 1-Y2 capacitor for 1 MOOP. Non-approved capacitor okay if used for Functional or 1-Y2 capacitor for 1 MOOP. 1 – Y2 or Y1 Capacitor Functional Insulation – if output is floating or 1 MOOP for isolated output. Functional Insulation – if output is floating or 1 MOOP for isolated output. Working Voltage: Equal to maximum rated mains voltage (240 V) 4/2.5 mm Creepage/Clearance Touch Current: (Applies to Operator Accessible Part only) Measure Patient Leakage: Measure Patient Leakage: Limits per Table 3 & 4 Limits per Table 3 & 4 Dielectric = No Test Dielectric = 1500 Vac 100 uA NC 500 uA SFC NOTES: Dielectric = No Test 1. Interpolation is permitted for creepage requirements per Clause 8.9.1.6 for MOOP and MOPP. Also, refer to Table 14 in the IEC standard document (MOOP only) for additional clearances for insulation in mains part with peak working voltages exceeding the peak value of the nominal mains voltage. 2. Refer to Table 8 in the IEC standard document for multiplication factors for air clearances for altitudes up to 5000 m for altitudes >2000 m (MOOP), and >3000 m (MOPP). NOTE: If 10,000 ft (3048 m) is declared in the Product Specs the multiplication factor for 3000 to 4000 m should be used. Page 5 I SL Power Electronics I TECHNICAL NOTE Class II: Working Voltage ≤250 Vrms ≤354 Vpk Means of Operator Protection (MOOP) Operator Accessible Part <240 VA or Non-Accessible Part Primary to Plastic Enclosure 2 MOOP Means of Patient Protection (MOPP) Applied Part - Type B 2 MOPP Means of Patient Protection (MOPP) Applied Parts - Type BF, CF 2 MOPP Any thickness needed to comply Any thickness needed to comply Any thickness needed to comply with enclosure tests. with enclosure tests. with enclosure tests. Primary to Secondary Dielectric = 3000 Vac (copper foil wrapped around enclosure) Dielectric = 4000 Vac (copper foil wrapped around enclosure) Dielectric = 4000 Vac (copper foil wrapped around enclosure) 2 MOOP 2 MOPP 2 MOPP 2 - Y2 or Y1 Capacitors or 1 - Y1 2 - Y1 Capacitors (No Y2s allowed) 2 - Y1 Capacitors (No Y2s allowed) 5/4 mm Creepage/Clearance 8/5 mm Creepage/Clearance 8/5 mm Creepage/Clearance Pollution Degree 2, (Clause 8.9.4 - Enamel coatings (Clause 8.9.4 - Enamel coatings Material Group IIIa or IIIb on magnet wires are ignored) on magnet wires are ignored) (Clearance required increases if measured Vpk exceed 420 Vpk) Dielectric = 3000 Vac Dielectric = 4000 Vac Dielectric = 4000 Vac Note: Test voltage increases if measured Vpk exceed 354 Vpk – See Table 6 Note: Test voltage increases if measured Vpk exceed 354 Vpk – See Table 6 1 layer, 0.4 mm thick or 2 layers, with 1 layer passing 3000 Vac dielectric test or 3 layers, with 2 layers passing 3000 Vac dielectric test. 1 layer, 0.4 mm thick or 2 layers, with 1 layer passing 4000 Vac dielectric test or 3 layers, with 2 layers passing 4000 Vac dielectric test. 1 layer, 0.4 mm thick or 2 layers, with 1 layer passing 4000 Vac dielectric test or 3 layers, with 2 layers passing 4000 Vac dielectric test. Touch Current: (Applies to Operator Accessible Part only) Measure Patient Leakage: Measure Patient Leakage: Limits per Table 3 & 4 Limits per Table 3 & 4 100 µA NC 500 µA SFC AN-G-003/16 | Page 6 I SL Power Electronics I TECHNICAL NOTE Questions to Ask End-Product Customer to Determine Requirements and Proper Approval for Power Supply: MOOP requirements: 1. Is isolation required from Output to Ground? 2. Functional or connected to Ground? 3. Is output operator accessible? 4. If operator accessible, output voltage must be ≤60 Vdc or ≤42.4 Vpk and <240VA. In addition, leakage current limit from output to neutral/ground must be 100 µA NC and 500 µA SFC. MOPP requirements: 1. Is isolation required from Output to Ground? 2. Functional or connected to Ground (Type B), or Floating (Type BF or CF)? 3. Type B may be provided with Functional insulation from output to ground or connected to ground. In addition, requirements for Operator Accessible output (item 4 above) applies if the output is accessible. If the output is not accessible in the end product, compliance with (item 4 above) is not required. 4. Type BF: Power Supply Y1 or Y2 cap must be used from output to ground. 4.0/2.5 mm min creepage/clearance from output to ground. 1500 Vac dielectric strength test required from output to ground. 100 µA NC/500 µA SFC leakage current limit from output to neutral/ground. 5. Type CF: Power Supply Y1 or Y2 cap must be used from output to ground. 4.0/2.5 mm min creepage/clearance from output to ground. 1500 Vac dielectric strength test required from output to ground. 10 µA NC/50 µA SFC leakage current limit from output to neutral/ground. 6. Type BF and CF: End Product Patient leakage, 1500 Vac dielectric test, Floating output isolation and Y1 or Y2 type Secondary to Ground capacitors are not required if the output is not accessible in the end product and the Type BF and/or Type CF Applied Parts are isolated from the output and ground with 1-MOPP based on the AC Mains voltage or 2-MOPP based on the Secondary voltage. 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