Is it necessary to submit medical equipment to China if one has a CB report to EN-60601 medical standards? Our customer, a large multinational, now wants to enter China and reports that China safety standards wants higher water ingress protection than their current North America and Western Europe standards – and customers. We are running the tests ourselves at the moment but analysis tells me that we will be able to meet the higher ingress levels with the current design. Obviously we and they would like to keep the configurations and technical files etc to remain constant. The most obvious way to do this is to got to UL and request that they run the tests to accept the higher IPXX rating and state that in the report and in the CB report. Then submit the new reports to China and hopefully get approval based on that.
On the other hand if China isn’t going to accept the CB report there is no reason to go to the expense updating these reports. We would simply submit the product to China and control two paper only differences for the product line. Obviously the first path is the least complicated in the long run – but there isn’t much sense in spending the money twice UL/CB and then have to repeat for China anyway. By the way you might reasonably ask why a large multinational wouldn’t know this already, me too but there you have it. In many many years I’ve never had the need to import to China so I’m digging for answers. - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <emcp...@socal.rr.com> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher <j.bac...@ieee.org> David Heald <dhe...@gmail.com>
