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IEC 60601-1-2:2014
Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
📅 Issue date：2014
🔄 Effective date：2014
🌍 Type：国际标准（并列标准）
01 Scope
IEC 60601-1-2 is the EMC collateral standard to IEC 60601-1, specifying emission and immunity for ME equipment and systems. Due to patient safety, immunity criteria are generally stricter than for ordinary products (life-support devices require performance criterion A).
02 Normative references
- IEC 60601-1 General
- CISPR 11 Emission
- IEC 61000-4-x Immunity
- IEC 61000-3-2/-3
03 Terms and definitions
Life-support equipmentME equipment that sustains life; EMC failure can directly endanger life.
Performance criteriaMedical devices usually require maintaining basic performance during/after immunity (criteria A/B).
04 Technical requirements
Conducted/radiated limits per CISPR 11 (ISM) or CISPR 22/32.
ESD, RI, EFT, surge, conducted RF, power-frequency magnetic, dips/interruptions per IEC 61000-4-x with stricter criteria.
Basic performance must be maintained or judged unacceptable risk.
05 Test methods
ME equipment in intended clinical configuration; monitor basic performance.
Measured in anechoic/shielded chamber per CISPR 11.
Disclaimer：This page is a technical summary of the corresponding standard for quick reference. All limits, clauses and methods are subject to the official publication and its latest amendments; formal compliance assessment must refer to the official issued text.