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Power Supply Corner - Part 3: IECEE CB Scheme Updates

Stay current with medical device power supply testing

Medical Device Regulatory Market Access

November 3, 2020

What you need to know about the CB scheme refresh

This is the third installment in our four-part series on power supply testing and certification. UL experts will summarize updates related to the IECEE CB Scheme for Medical Power Supplies.

Background on the CB Scheme

The IECEE CB Scheme is an international network of product certification organizations in more than 50 countries around the world. The certification establishes an arrangement for mutual acceptance of test reports among participating certification organizations.  The CB Scheme benefits manufacturers and distributors engaged in international trade by providing:

  • A single point of product testing
  • Global acceptance of test reports leading to national certification in member countries
  • Unilateral acceptance of test reports in many developing countries that are not yet participating in the CB Scheme

Changes to the IECEE

Regarding medical power supplies, the IECEE has made some changes. The title of OD-2055 has been updated to “Operational Document on Medical Electrical Equipment in the CB Scheme according to the IEC 60601 and ISO/IEC 80601 Series of Standards” to remove the word, “guidance”. This update was needed to avoid confusion as this document is considered a mandatory read.

The following changes in the operational document relate specifically to medical power supplies:

  • Section 3, “Certification Of Power Supplies According To IEC 60601-1: 2005 and IEC 60601-1:2005 with Am.1:2012” contains important changes related to the application of risk management (RM) and usability for power supplies
  • Updates to the risk management evaluation for power supplies:
    • The evaluation of all of the risk management requirements may be excluded, for both component and standalone power supplies.  When risk management is excluded, the test report should include the following or equivalent wording, “The risk management requirements were not addressed.”
    • This statement shall also be included on the CB certificate
  • What does this mean:
    • All power supplies may be evaluated without risk management.
    • However, a manufacturer cannot use a partial risk management evaluation.
    • Where compliance with a requirement relies entirely on RM, the manufacturer must provide documentation indicating how these clauses were addressed (example clauses: 8.10.1, 8.10.2, 8.10.5 and 8.11.5)
  • Updates to the usability requirements:
    • Component and standalone power supplies evaluation for usability may be excluded using the following or equivalent wording, “The usability evaluation has not been addressed.”
    • This statement shall be included in the TRF and CB certificate

So, what does this mean to medical power supply manufacturers?

Based on this update to the operational document usability and risk management evaluations are not required for power supplies. However, if you choose to use RM and/or usability to modify any requirement in the IEC 60601-1, then you must do a full RM and/or usability evaluation. In other words, you’re either all-in or all-out. 

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