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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.