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Achieving product compliance is hard with evolving technology & expanding markets

The medical industry is rapidly adopting new technology that enables better communication and performance of products & systems to improve the safety of care. Manufacturers today, face a number of compliance challenges, as devices that do not meet the highest quality and safety standards present, a risk of injury, recalls, bans and liability.

IEC 60601-1-2 4th Edition introduced significant technical revisions such as risk management, risk analysis and changes to immunity requirements. These significant changes include specification of immunity test levels according to the environments of intended use, which are categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments. It is imperative for everyone involved with product design to fully understand how the process of risk management and risk analysis incorporates with new requirements to achieve compliance.

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Moving products
to market globally

Why to attend
At a glance

In this Medical EMC Webinar, you'll get an in-depth overview of IEC 60601-1-2 4th Edition with critical insights into emissions and immunity aspects of medical product design, the revamped classification system based on the environments of intended use, and risk management from MET's EMC testing Experts including:

  • Overview of the IEC/EN 60601-1-2
  • What's new in 60601-1-2 4th Edition – Life support, Pass/Fail Criteria, Immunity levels, Voltage/Frequency requirements, and Test Plan from manufacturer.
  • Use environments – Professional Healthcare Facility Environments, Home Healthcare Environments, ans Special Environments.
  • Manufacturer responsibilitiesEssential performance, Test plan requirements, and Markings & Identifications.
Achieving Product Excellence
  • Essential performance, Test plan requirements, and Markings & Identifications – Modes of Operation/Configurations, Conducted Emissions, Radiated Emissions, Radiated Immunity, Conducted Immunity, ESD, Surges, EFT/B, VDI, Harmonics & Flicker, Pass/Fail Criteria & implications.
  • Product Planning – Pre-testing requirements, Testing/Evaluation, Testing sequence, Reports.

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