SL Power 3rd edition Presentation Maggie Nadjmi August 23rd 2011 Overview of rd 3 edition System risk management needs to be managed by the customer. Most applications are categorized as: MOOP: Means of Operator Protection MOPP: Means of Patient Protection SL Power provides a COMPONENT – risk management at component level is not required After June 2012 all Europe medical Safety submissions must be to 3rd edition After June 2013 all UL medical Safety submissions must be to 3rd edition Products approved to prior editions are still allowed by UL So far, very few power supplies are approved to 3rd edition SL Power has started the 3rd edition upgrade IEC/EN 60601-1 2nd Ed. and IEC/EN 60601-1 3rd Ed. DIFFERENCES DESCRIPTION 2ND EDITION 3RD EDITION Earth Leakage Current: 300/500 uA NC, 500/1000 uA SFC Components in Table XA at highest ambient and components in Table XB corrected for 25 C ambient. Less stringent 5 mA NC, 10 mA SFC All components tested for highest ambient. Vrms: Less stringent. Vpk or Vdc: More stringent with switch-mode power supplies. Same for MOPP, but MOOP is less stringent (based on 60950-1 requirements). Interpolation is permitted for creepage requirements for MOOP and MOPP. Clearance table for MOOP for up to 2000 m, and 3000 m for MOPP. Multiplication factors added for higher altitudes up to 5000 m using Table 8. Temperatures determined using operating ambient: Temperature for accessible surfaces: Dielectric test voltage determined using : Creepage and clearance More stringent and no interpolation allowed. Clearance for operating altitude: Clearance table for up to 3000 m. More stringent 3 IEC/EN 60601-1 2nd Ed. and IEC/EN 60601-1 3rd Ed. DIFFERENCES Continued 4 SL Power Timeline SLPE will have all standard products developed in the last 2 years validated to 3rd edition MOOP by end Q4. (90% should qualify) MINT1065 received approval expected Priority list for 3rd edition upgrade has been generated and estimated approval dates are slated accordingly If the SYSTEM requires MOPP - a redesign may be necessary with the attendant testing. This is due to constructional / isolation requirements. Legacy products need to be analyzed to match customer application and requirements. EN60601-1 rd 3 EN60601-1 3rd Edition Summary edition is a system specification Four questions - We need to know details about the customer’s application: AC Grounding – class I or class II MOOP or MOPP If MOPP – isolation “B”, “BF” or “CF” Touch temperature in customer’s system Thank you! 7