| Safety standards |
CB: IEC 62368-1, IEC 60335-1, IEC 61558-1/-2-16, IEC 61010-1/-2-201, IEC 60601-1 and IEC 62477-1. DEKRA: corresponding BS EN/EN standards, including EN 60601-1 version 3.2. UL: UL 62368-1, ANSI/AAMI ES60601-1 version 3.2 and UL 61010-1/-2-201. CCC GB 4943.1, BSMI CNS 15598-1, EAC TP TC 004 and SEMI F47 are listed. Integration into final equipment remains subject to its applicable requirements. |
| By-request certifications |
KC 62368-1 and BIS IS 13252 (Part 1) certification is by request with no stock; confirm the actual ordered version. A BIS logo may be absent on some factories or models; contact MEAN WELL for details. |
| Medical insulation and leakage |
Primary–secondary: 2 × MOPP; primary–earth: 1 × MOPP; secondary–earth: 1 × MOPP. MOPP applies only at 100–240 V AC input. The series is intended for BF-related medical equipment applications, subject to final-system compliance. Earth leakage is <350 µA rms and touch current <100 µA rms at 277 V AC. |
| Overvoltage category and altitude |
IEC/EN 61558-1/-2-16: OVC III up to 2000 m. IEC/EN/UL 62368-1, IEC/EN 60335-1, IEC/EN/UL 61010-1/-2-201 and IEC/EN 62477-1: OVC II up to 5000 m. IEC/EN/ANSI/AAMI ES60601-1: OVC II up to 4000 m. Do not combine the OVC III rating with the 5000 m limit. |
| SELV scope |
The catalogue SELV/ES1 entries apply to the 5–36 V output models under IEC/EN 61558-2-16, IEC/EN 60335-1 and IEC/EN/UL 62368-1; do not extend them to the 48 V or 60 V models. |
| Dielectric strength |
Input–output 4.2 kV AC; input–FG 2.1 kV AC; output–FG 1.5 kV AC. |
| Insulation resistance |
100 MΩ at 500 V DC, 25°C and 70% RH for input–output, input–FG and output–FG. |
| EMC emissions |
BS EN/EN 55032 (CISPR 32), CNS 15936, GB/T 9254.1, KS C 9832: Class B; BS EN/EN 55011 (CISPR 11): Class B. BS EN/EN 55014-1 (CISPR 14-1) is also listed, without a separate class in that row. |
| Harmonic current and flicker |
EN/IEC 61000-3-2: Class A. Voltage flicker: EN/IEC 61000-3-3. |
| Immunity framework |
BS EN/EN 55035 (CISPR 35), EN/IEC 61000-6-2, EN/IEC 60601-1-2, EN 55014-2 (CISPR 14-2), KS C 9835 and SEMI F47 tested at 200 V AC. |
| Immunity levels |
IEC 61000-4-2 ESD: Level 4, 15 kV air / 8 kV contact. IEC 61000-4-3: Level 3, 10 V/m at 80 MHz–2.7 GHz; Table 9, 9–28 V/m at 385 MHz–5.78 GHz. IEC 61000-4-4 EFT/burst: Level 3, 2 kV. IEC 61000-4-5 surge: Level 4, 2 kV line–line / 4 kV line–earth. IEC 61000-4-6 conducted: Level 3, 10 V. IEC 61000-4-8 magnetic field: Level 4, 30 A/m. |
| Voltage dips and interruptions |
IEC 61000-4-11: >95% dip for 0.5 period, 30% dip for 25 periods, and >95% interruption for 250 periods. |
| Component EMC test arrangement |
The component supply was tested on a 360 × 360 × 1 mm metal plate. Reconfirm the complete equipment against applicable EMC directives; the plate is a test arrangement, not a supplied accessory. |