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
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!