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IEC 60601 Slide 6

Early on XP Power identified that to ensure the products provided the most value to the customer, the goal would be to ensure that XP Power had 2 x MOPP (Means Of Patient Protection) from input to output. As this means of protection is the same as the dielectric strength and creepage/clearance requirements in 2nd edition, it was quite easy to see how XP Power could achieve this. The difficult part was where a change of Y cap was needed. As the engineer has just explained where a bridging cap is used from primary to secondary, under 3rd edition 2 x Y1 caps are now required in series and where the engineer would have previously used a Y2 from input to ground, now a Y1 cap is required. Generally Y1 caps are bigger than Y2 caps so this presented a challenge on some products. On older products the engineer evaluated the change needed to comply with the goal and where the change was major (i.e. pcb change) XP Power decided not to make the change on standard product. On the new products (since approximately 2007) all of the medical power supplies have been designed to meet this. Some parts of the world still have not adopted 3rd edition (such as China) and as such still want to approve to 2nd edition. As it would be costly and impossible in some cases to have 2nd and 3rd edition on the products XP Power came up with a statement in the report to address this. Basically it says that the product has been tested against 3rd edition and 2nd edition but only certified to 3rd edition. With this 3rd edition certificate customers have been able to also get 2nd edition approvals on the equipment where needed.

PTM Published on: 2014-02-19