Jon Thx for the info, however, I re-checked the two known US standards (UL2601, Appendix D - Manufacturer's Responsibilities, Construction Considerations and Requirements for Factory Tests) (NFPA 99, Grounding Circuit Continuity - Measurement of Resistance). UL defines "Production Line Grounding Continuity Test Equipment" as: Any suitable continuity indication device (such as an ohmmeter, a battery and buzzer combination, or the like) may be used to determine compliance with Grounding Continuity Test requirements. The NFPA std is even less definitive on this matter. EN60601-1, Appendix B - "Testing During Manufacture and/or Installation", Not Used. See rational to sub-clause 4.1. Which states - Tests described in this standard are type tests.
I checked all of the amendments including EN60601-1 for medical systems, and I do not see anything changing this. My questions remains, where does it state to use the 10-25Amp, 50 or 60Hz @ 6Volt for 5 seconds test? Is this a carry over from another EN standard? Why wouldn't a simple continuity tests as defined by UL be appropriate from equipment coming off of the production line (assuring that the protective earth circuit in intake)? Appreciate your feedback Jon! & thanks again. Does anyone else on this forum have any input - would appreciate it. -----Original Message----- From: Jon Griver [mailto:[email protected]] Sent: Monday, May 21, 2001 9:16 AM To: Dick Grobner Subject: RE: Production Line Test Requirements - Medical Devices Dick, The requirements for production tests of medical equipment generally are: 1. Hipot at 1500AC - between live and neutral connected together and earth. 2. Earth continuity at 25A between earth pin on plug and enclosure (choose a point that may be problematic if there are manufacturing problems) 3. Earth and/or patient leakage. Whether you do both, one or neither of these tests depends on the product. As the production tests are intended to find production problems (as opposed to type tests which are intended to find design problems), choose the tests that you think make sense from the production engineering point of view. Document the reasoning behind your choice. IT equipment only requires Hipot and earth continuity tests. Hope this helps, Jon > -----Original Message----- > From: Dick Grobner [mailto:[email protected]] > Sent: Monday, May 21, 2001 16:36 > To: 'Jon Griver' > Subject: RE: Production Line Test Requirements - Medical Devices > > > Jon > Thanks, you have confirmed what I thought I knew. We just had our > annual ISO > 9001 audit (2 weeks ago). One issue that one of the two auditors > raised was > why are you not doing the ground integrity test (25 Amp test) on 100% of > your production units? I asked "do you mean ground continuity > (Ohm test) and > he said no, the ground integrity test". That's when I started digging into > the standards. UL (and the former ETL) states high potential and ground > continuity tests on all production units. EN60601-1 states that all tests > within this document are "type" tests. The auditor gave me no reference to > any EN, etc. when I asked. So, I have a suspicion that this is > his wish and > not stated in any EN (at least that I know of so far). SO - I > will continue > to pursue with other outside sources (but not this one auditor!) > Thanks for the reply back! > PS - does ITE equipment require this test (ground integrity ((25 > Amp)) test? > > > -----Original Message----- > From: Jon Griver [mailto:[email protected]] > Sent: Sunday, May 20, 2001 1:34 AM > To: [email protected] > Subject: FW: Production Line Test Requirements - Medical Devices > > > > Dick, > > To the best of my knowledge there is no EN standard or guidance on > production tests for medical equipment (There is a standard, EN 50116, for > IT equipment). > Your best bet is to discuss this with your Notified Body and to come to a > mutually acceptable set of tests. > > Regards, > > Jon Griver > Medson Ltd. > > > > Good Day Everyone > > Question I have - Does anyone out there know if an EN standard > or guidance > > document exists that deals with production line test requirements of > > finished medical devices. > > Reading in EN60601-1 it states that the test (ground resistance, high > > potential, etc.) are type test only (See appendix B, and then paragraph > > 4.1). Thus - they are not identified as production line tests. > I know that > > the NRTL's in the USA (UL/ETL) specifically call out what tests > are to be > > performed after the production build of equipment. > > Any input would be appreciated. > > Thx > > > > Dick Grobner > > Medical Graphics Corporation > > 350 Oak Grove Parkway > > St Paul MN 55127 > > 651-766-3395 > > 651-766-3389 (fax) > > [email protected] > > > > > > > > ------------------------------------------- > > This message is from the IEEE EMC Society Product Safety > > Technical Committee emc-pstc discussion list. > > > > Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ > > > > To cancel your subscription, send mail to: > > [email protected] > > with the single line: > > unsubscribe emc-pstc > > > > For help, send mail to the list administrators: > > Michael Garretson: [email protected] > > Dave Heald [email protected] > > > > For policy questions, send mail to: > > Richard Nute: [email protected] > > Jim Bacher: [email protected] > > > > All emc-pstc postings are archived and searchable on the web at: > > http://www.rcic.com/ click on "Virtual Conference Hall," > > > > > > > ------------------------------------------- > This message is from the IEEE EMC Society Product Safety > Technical Committee emc-pstc discussion list. > > Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ > > To cancel your subscription, send mail to: > [email protected] > with the single line: > unsubscribe emc-pstc > > For help, send mail to the list administrators: > Michael Garretson: [email protected] > Dave Heald [email protected] > > For policy questions, send mail to: > Richard Nute: [email protected] > Jim Bacher: [email protected] > > All emc-pstc postings are archived and searchable on the web at: > http://www.rcic.com/ click on "Virtual Conference Hall," > ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [email protected] Dave Heald [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.rcic.com/ click on "Virtual Conference Hall,"
