Sense this discussion has started regarding CE + CE = CE, I have one question, and by the way - I agree with Paolo's comments (and the European Commission Guidance Doc). We offer with our device an off the shelf standard PC along with a printer, monitor, etc. This interfaces with our manufactured medical device, class IIa. We have tested devices in the past to the EMC Directive and the Medical Device Directive. When we tested the device we manufacture we did not test the computer, printer, etc. However, I assure that all PC's and related peripheral devices are compliant with the EMC Directive, etc (labeled CE). Our rational is that PC's, line printers, video monitors have a life span of about a year. This would relate to us having to test new combinations about three- four times a year (our test house would like that - extra $). Our Declaration of Conformities (DoC's)reflect this. We also assure that all interface cables are EMI compliant, that is, they are braid over foil with metal hoods, etc. and are terminated to the device. We communicate via RS-232 to a remote (outside chamber) PC during testing, the cable is heavily shielded at the chamber exit point using clamp on ferrite's.
By questions are: 1) Does this scenario match anyone else's product they offer for sale internationally? 2) How do you deal with it? That is - the short life span of computers and their related peripheral devices. Also - the life span of our devices are approximately 5 years Thx in advance. -----Original Message----- From: [email protected] [mailto:[email protected]] Sent: Monday, March 27, 2000 9:51 AM To: Canio Dichirico; [email protected] Subject: Re: Is the "modular approach to EMC" the same as CE + CE = CE? Here is my understanding of the approach to systems compliance for CE marking. If all parts of the system are CE marked you are not (legally) required to re-test the system for compliance to the EMC Directive, provided you give clear instructions for assembly/installation/operation/maintenance in the instructions for use ("installation guidelines"). The Declaration of Conformity , as well as the instructions for use, must refer to the system as a whole. My understanding of the "modular approach" is that if all parts are CE-marked you are not required to put the CE mark on the system as a whole. This is the legal aspect. On the other end, I fully agree that CE + CE = CE is far from sure until you have tested the whole system for compliance ! There is a clear statement on this in the "Guide to the Application of Directive 89/336/EEC" published by the European Commission (1997). In sec. 6.4.2.1 (System assembled from only CE marked apparatus) there is a paragraph titled "Additional comment": "... combining two or more CE-marked subassemblies may not automatically produce a system which meets the requirements of the relevant standard." I fully agree with this statement, since the wirings/packaging/grounding/shielding aspects of any assembly process can determine the EMC behavior of the complete system. So my conclusion is: the safest way is to test the system as a whole, because in any case (whether you choose to follow the modular approach or not) the Declaration of Conformity refers to the whole system and manufacturer is responsible for compliance. Hope this helps. Best Regards, Paolo Roncone Compuprint - Italy "Canio Dichirico" <[email protected]> on 27/03/2000 14.30.50 Please respond to "Canio Dichirico" <[email protected]> To: "IEEE EMC List" <[email protected]> cc: (bcc: Paolo Roncone/IT/BULL) Subject: Is the "modular approach to EMC" the same as CE + CE = CE? ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected]
