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Need for IEC60601-1 2nd edition certification?




I work in a company manufacturing electronic sub-systems for medical X-ray imaging systems. Our products are CE marked, and UL or Curtis-Straus (NTRL) marked.

I am wandering, is it still worthwhile to get certification of our new products to IEC60601-1 2nd edition? It seems to be an extra cost, as we have to comply to 3rd edition (for CE mark). Up to now we did the job with both 2nd and 3rd editions, but can we now drop down the 2nd edition certification effort?

My understanding of the situation is that we should maintain the 2nd edition certifications as long as OSHA doesn't recognize IEC60601-1 3rd edition. But I cannot find when will OSHA forget the old version and accept 3rd edition. Does anybody has a better view on this topic?

Thanks for any help,


The markets your product goes to drives what edition you need. Some countries require 2nd and some 3rd. If you are shipping globally, you will most likely need to still do both. As for NRTL certification in the US, OSHA now accepts 3rd Ed, however there are not yet any NRTL's (to my knowledge) that are accredited by OSHA to do certification to the 3rd Ed. Also, 2nd Ed has not been withdrawn by OSHA. Hope this helps
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