IEC 60601-1-2 EMC Test for Medical Electrical Equipment

Comparison Between IEC 60601-1-2 Edition 4 and Edition 3:

- Regulations and EMC standards for medical devices

- Key changes from Edition 3 to Edition 4

- Equipment labeling and documentation

- emi testing requirements

- Classification of electromagnetic environments

- Immunity testing requirements

EMC Standards for Medical Equipment

1. European Union (EU)

- Medical Devices: Regulated by Directive 93/42/EEC

  Applicable Standards: EN 60601-1-2, EN 60601-2-x

- In Vitro Diagnostic (IVD) Devices: Regulated by Directive 98/79/EC

  Applicable Standards: EN 61326-1, EN 61326-2-6

2. United States

- All Medical Equipment: Subject to fcc part 15 Subpart B or Part 18

  Compliance via Verification, Declaration of Conformity (DoC), or Certification

  Testing Standards: ANSI C63.4-2003 (for Part 15), FCC/OST MP-5 (for Part 18)

3. Canada

- All Medical Equipment: Requires test reports

  Testing Standards: ICES-003, ICES-001

4. International Electrotechnical Commission (IEC)

- Medical Devices: IEC 60601-1-2, IEC 60601-2-x

- IVD Equipment: IEC 61326-1, IEC 61326-2-6

Additional Requirements for Equipment with Radio Functions

1. EU: Regulated by R&TTE Directive 1999/5/EC; self-certification or notified body assessment required.

   Example for Bluetooth (2.4 GHz): EN 300328, EN 301489-1/-17, en 62479

2. USA: RF devices are regulated under FCC Part 15 Subpart C; requires certification.

   Testing Standard: ANSI C63.4-2003

3. Canada: Radio products must be certified by Industry Canada unless exempt.

   Applicable Standards: RSS-GEN, RSS-210, RSS-310 (for Category I low-power devices)

EMC Testing Standards for Medical Equipment

- IEC/EN 60601-1-2:

  Title: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests

  Editions: 3rd (2007), 4th (2014)

- For IVD Equipment:

  IEC/EN 61326-1: General EMC requirements

  IEC/EN 61326-2-6: Specific to IVD medical equipment

  Latest IEC editions: IEC 61326-1:2012, IEC 61326-2-6:2012

  Latest EN editions: EN 61326-1:2013, EN 61326-2-6:2013

Key Changes in Edition 4 of IEC 60601-1-2

- Improved alignment with IEC 60601-1-11: clearer classification of use environments (professional, home healthcare, special environments)

- Introduction of higher RF immunity test levels due to proximity of mobile communications

- Enhanced risk management integration for EMC

- Removed the concept of "life-supporting"

- New methods to determine immunity levels for special environments and performance pass/fail criteria

Change in Title

- Edition 3: "... Electromagnetic compatibility – Requirements and tests"

- Edition 4: "... Electromagnetic disturbances – Requirements and tests"

- Now defined as a safety standard

Standard Objectives

- Emission standards aim to protect:

  - Safety services

  - Other medical devices and systems

  - Non-medical systems such as computers

  - Communication services (radio, TV, navigation)

- Immunity standards ensure:

  - Continued basic safety and essential performance under EMC conditions throughout the equipment’s lifecycle

Key Definitions

- EMC (Electromagnetic Compatibility): Ability of the device/system to function reliably in its electromagnetic environment without causing unacceptable disturbance

- Electromagnetic Disturbance: Any EM phenomenon that could degrade performance

- Electromagnetic Emission: Radiation or conduction of electromagnetic energy

- Immunity: Resistance to performance degradation under EM disturbance

- Large Medical Equipment/System: Cannot fit within a 2m x 2m x 2.5m volume

Chapter 4: General Requirements

- 4.1: Reasonably foreseeable risks due to EM disturbances must be considered in risk management

- 4.2: Non-medical equipment used within systems must also meet relevant standards if they impact safety/performance

- 4.3: General test configuration should reflect worst-case scenarios and follow detailed guidelines (e.g., full cable/load setup, grounded chassis)

Input Voltage and Frequency for Testing

Each EMC test references specific input voltage and frequency guidelines. For example:

- Harmonic Current Emissions (IEC 61000-3-2): AC 230V single-phase, AC 400V three-phase, at 50/60Hz

- Voltage Fluctuations and Flicker (IEC 61000-3-3): Same voltage as above, 50Hz

- Radiated/Conducted Emissions (CISPR 11): Any voltage/frequency

- Immunity Tests (IEC 61000-4-2 to 4-11): Various combinations per test type

Chapter 5: Equipment Labeling and Documentation

- 5.1: Labeling for shielded-use equipment

- 5.2: Instructions for Use (IFU) must include:

  - Environment declarations (including unsuitable environments like MRI rooms)

  - Description of essential performance

  - Warnings against stacked/adjacent equipment use

  - Lists of user-replaceable components affecting EMC

  - RF communications warnings (e.g., portable RF devices must be kept ≥30 cm away)

- 5.2.2: Technical descriptions must include:

  - Compliance details for emissions/immunity

  - Any deviations or relaxations from the standard

  - Information for maintaining basic safety/performance

  - For shielded locations: RF shielding performance, filtering requirements, and usage warnings

  - For RF receiving/transmitting devices: frequencies, bandwidths, ERP, and modulation

  - For large permanently installed systems: statement of exemption from full 80 MHz–6 GHz testing, warning of limited immunity

Chapter 6: Test Documentation

- 6.1: Test documentation must provide all relevant testing and planning information

- 6.2: Test plans must be detailed and submitted before testing

- 6.3: Test reports must comply with Chapter 9 of the standard

EMI Testing Overview

- Continuous Disturbances:

  - Conducted Emissions: CISPR 14-1 / CISPR 11

  - Radiated Emissions: CISPR 14-1 / CISPR 11

  - Harmonics: IEC 61000-3-2

  - Flicker: IEC 61000-3-3

- Discontinuous Disturbances:

  - Clicks: CISPR 14-1 / CISPR 11

EMS Testing Overview

- Transient Phenomena:

  - ESD: IEC 61000-4-2

  - EFT/Burst: IEC 61000-4-4

  - Surge: IEC 61000-4-5

  - Voltage Dips/Interruptions: IEC 61000-4-11

  - Vehicle Transients: ISO 7637-2 (vehicle use only)

- Steady-State Phenomena:

  - Radiated RF: IEC 61000-4-3

  - Conducted RF: IEC 61000-4-6

  - RF Near Field from Wireless: IEC 61000-4-3 (temporary method)