S
sbp9674
Hello everyone. For 60601-1 approval, is Critical Component list compilation done as per Manufacturer's discretion (like BoM) or can the notified body insist on including more such components?
Case in point, we have submitted our device along with all necessary documentation to UL for 60601-1 approval. The docs included a CCL from our side (Manufacturer version). Now UL is insisting us to add things to that list that really don't have any safety related implications at all, e.g. PCB (the entire device is a 5V DC application plus probability of PCB "failing" is negligible). These changes will reduce flexibility of vendor choice in manufacturing, so its a pain for us.
As much as I understand, the 60601-1 standard does not even mention anything about "critical components". Would really appreciate if anyone can point out if UL is well within their rights to do so. How about insulation diagram, do they have any say in it too?
Thanks in advance!
Case in point, we have submitted our device along with all necessary documentation to UL for 60601-1 approval. The docs included a CCL from our side (Manufacturer version). Now UL is insisting us to add things to that list that really don't have any safety related implications at all, e.g. PCB (the entire device is a 5V DC application plus probability of PCB "failing" is negligible). These changes will reduce flexibility of vendor choice in manufacturing, so its a pain for us.
As much as I understand, the 60601-1 standard does not even mention anything about "critical components". Would really appreciate if anyone can point out if UL is well within their rights to do so. How about insulation diagram, do they have any say in it too?
Thanks in advance!