IEC 60601 3rd Edition Regulatory Requirements

The 3rd edition of IEC 60601-1 — expected to be implemented June 1, 2012 — represents a shift in philosophy from the 2nd edition, including a greater emphasis on risk management and essential performance.

The motivation for the change in the standard was to establish a uniform basis to allow manufacturers the flexibility to assess new designs incorporating new technology while still providing a level of safety acceptible to the user community.

As with any other standard change, a failure to implement these new requirements in a timely manner could cause costly delays in getting customers' device to market.

BENEFITS of using GlobTek Power Supplies which are Already Compliant:

  • Simplified Risk Management File development supporting 3rd edition certifications
  • May have less up front overhead needed to develop the certification
  • Reduced effort required for component characteristics identification that may impact safety and/or performance
  • Clear identification of features / characteristics for supplier control
  • Less detail needed to complete the end product Certification Report (TRF)
  • Simplified process for certification of overall system

IMPLICATIONS of using NON-Compliant Power Supplies:

  • Risk Management relevant information may be requested by each OEM using the power supply involved
  • Design information may need to be shared with each end-product manufacturer
  • End product manufacturer may consider other vendors due to the lack of Risk Management assessment
  • OEM may require tighter supplier controls power supplies as determined neccessary to their Risk Management plan
  • Potential for duplicate risk management assessment by each certification agency and/or each OEM

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As always, GlobTek offers one of the largest offerings of power supplies and related products / services: (Power Cords, Battery packs, LED Drivers, PoEs and Contract Manufacturing), backed by the best 5-year warranty in the industry!

For further information, please contact GlobTek online, email sales@globtek.us or call 1-201-784-1000

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