IEC 60601-1-2 EMC Testing

Comparison Between IEC 60601-1-2 Fourth Edition and Third Edition

• Regulations and EMC Standards for Medical Devices

• Main Changes in IEC 60601-1-2 4th Edition Compared to the 3rd Edition

• Equipment Marking and Documentation

• emi testing Requirements

• Electromagnetic Environment Classification

• Immunity Testing Requirements

EMC Standards for Medical Devices

Other Requirements When Having Radio Functions

emc testing Standards for Medical Devices

• IEC/EN 60601-1-2
  Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

• IEC 60601-1-2
  Third Edition, 3/30/2007
  Fourth Edition, 2/25/2014

• EN 60601-1-2
  Latest 2007 Edition

EMC Testing Standards for In Vitro Diagnostic Medical Devices

• IEC/EN 61326-1
  Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements

• IEC/EN 61326-2-6
  Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

• IEC Versions
  Latest versions (Second Edition): IEC 61326-1:2012, IEC 61326-2-6:2012

• EN Versions
  Latest versions: EN 61326-1:2013, EN 61326-2-6:2013
  Latest Official Journal version: EN 61326-2-6:2006

IEC 60601-1-2 Fourth Edition

• IEC 60601-1-2 Ed4/CDV (62A/801A/CDV), 3/23/2012

• IEC 60601-1-2 Ed4/FDIS (62A/916/FDIS), 11/29/2013

• IEC 60601-1-2 (ed.4), 2/25/2014

Main Changes Compared to the Third Edition

• Main changes content.

• Changes in accompanying documents.

• The classification of equipment use environments is consistent with IEC 60601-1-11: Professional healthcare facility environments, Home healthcare environments, and Special environments. The transportation environment from the previous draft standard is no longer listed as a separate environment.
  
  

• Due to the close-range use of mobile communication devices, higher-level RF radiation immunity testing is added to improve equipment safety.
  
  

• Some testing levels have been increased.
  
  

• Better coordination with the concepts of Basic safety and Essential performance in risk analysis, while simultaneously removing the concept of "life-supporting".
  
  

Added Content

• How to determine immunity testing levels for special environments.

• How to adjust immunity testing levels based on the specific intended use of the equipment or mitigation measures.

• How to consider electromagnetic disturbances in risk management.

• Determining the pass/fail criteria for immunity testing.

Title Changes

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

• Fourth Edition: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

• The new edition defines IEC 60601-1-2 as a safety standard.

Purpose of the Standard

• Electromagnetic emission standards are used to protect the following services:

• Safety services

• Normal operation of other medical equipment and systems

• Normal operation of non-medical devices, such as computers

• Other communication services, such as broadcasting/TV, telephones, and radio navigation

• Electromagnetic immunity standards: Used to ensure the safety of medical devices. Throughout their service life, medical devices must be able to provide Basic safety and Essential performance under their electromagnetic environmental conditions.

Several Definitions

• Electromagnetic Compatibility (EMC)

• The ability of medical equipment or systems to function reliably in their electromagnetic environment without introducing intolerable electromagnetic disturbances to anything in that environment.

• Electromagnetic Disturbance

• Any electromagnetic phenomenon that may degrade the performance of a device, equipment, or system.

• Electromagnetic Emission

• The phenomenon by which electromagnetic energy emanates from a source.

• Immunity

• The ability of a device, equipment, or system to perform without degradation in the presence of an electromagnetic disturbance.

• Large ME Equipment

• Medical equipment that cannot be placed within a 2m x 2m x 2.5m space, excluding cables.

• Large ME System

• A medical system that cannot be placed within a 2m x 2m x 2.5m space, excluding cables, including distributed medical systems.

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