Global/Basic:
Core Safety Standard: IEC 60601-1
Core EMC Standard: IEC 60601-1-2
Key regulatory points: Ground leakage current, insulation, and EMC performance
China:
Core safety standard: GB 9706.1 (Compulsory)
Core EMC standard: YY 9706.102 (mandatory)
Key regulatory points: Ground leakage current, insulation, and EMC performance.
North America:
Core safety standards: UL 60601-1 / CSA C22.2 No. 60601-1
Core EMC standards: FCC Part 15 Subpart B, CISPR 1
Key regulatory points: FDA market approval, the filter must have UL/cUL marks.
Europe:
Core safety standard: EN 60601-1
Core EMC standard: EN 60601-1-2
Key regulatory points: CE marking, compliance with MDR regulations, and review by a notified body.