RE: D of C for medical P.S.
Makes sense to me, but we are not shipping to a customer on this side of the pond... So the consensus is, that I write the power supply's D of C to conform to the LVD, and cite EN 60601-1 (the standard referenced in the unit's agency certifications and CB Report). thanks much, Brian >Would my customer (manufacturer of the end-use medical device) have any >trouble in Europe when the D of C for the unit's power supply is lists the >LVD? >After the power supply arrives at your customer's facility, no European >authority will ever ask to see the power supply DOC. Once the power supply >is installed in the end product, the only Declaration of Conformity of >interest to European authorities will be your customer's MDD declaration on >the overall product. >>Thanks for the ideas. But as the LVD specifically precludes medical stuff, >> how can I declare conformity? Has any NCB issued a "formal recomendation" >>for this particular combination? >A **power supply** is not a 'medical device', unless you intend it to be >used for ECT or electro-cautery or something similar. If it's a power >supply for any unspecified medical instrument, it's not, in itself, a >medical instrument.
Re: D of C for medical P.S.
>Would my customer (manufacturer of the end-use medical device) have any trouble in Europe when the D of C for the unit's power supply is lists the LVD? After the power supply arrives at your customer's facility, no European authority will ever ask to see the power supply DOC. Once the power supply is installed in the end product, the only Declaration of Conformity of interest to European authorities will be your customer's MDD declaration on the overall product. Greg Galluccio www.productapprovals.com 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: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Re: D of C for medical P.S.
I read in !emc-pstc that boconn...@t-yuden.com wrote (in ) about 'D of C for medical P.S.' on Wed, 26 Feb 2003: >Thanks for the ideas. But as the LVD specifically precludes medical stuff, >how can I declare conformity? Has any NCB issued a "formal recomendation" >for this particular combination? > A **power supply** is not a 'medical device', unless you intend it to be used for ECT or electro-cautery or something similar. If it's a power supply for any unspecified medical instrument, it's not, in itself, a medical instrument. -- Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk Interested in professional sound reinforcement and distribution? Then go to http://www.isce.org.uk PLEASE do NOT copy news posts to me by E-MAIL! 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: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: D of C for medical P.S.
Gentlemen Thanks for the ideas. But as the LVD specifically precludes medical stuff, how can I declare conformity? Has any NCB issued a "formal recomendation" for this particular combination? Would my customer (manufacturer of the end-use medical device) have any trouble in Europe when the D of C for the unit's power supply is lists the LVD? thanks much, Brian <3E5C9943.14190.33FECD@localhost>) about 'D of C for medical P.S.' on Wed, 26 Feb 2003: >You are right not issuing a D of C to the MDD, as your product is not a medical >device or an >accessory ot a medical device. > >On the other hand I see no reason not to issue a D of C to the LVD. Compliance >with a standard in >the list of Harmonised Standards is not the only way to demonstrate compliance >with the LVD. It >does not take very much effort to draw up a comparison table showing that the >requirements for a >power supply in IEC 60601-1 are more stringent than say, IEC 60950 or IEC >61010-1. Using >engineering judgment on this basis, I believe that you can issue a D of C to the >LVD, specifying >IEC 60601-1 as the applied standard. You can present your comparison table to >anyone who questions >this, demonstrating the engineering basis for your declaration. That's what I would recommend, but I don't know enough about 60601-1 to be definite. -- Regards, John Woodgate
Re: D of C for medical P.S.
I read in !emc-pstc that Jon Griver wrote (in <3E5C9943.14190.33FECD@localhost>) about 'D of C for medical P.S.' on Wed, 26 Feb 2003: >You are right not issuing a D of C to the MDD, as your product is not a medical >device or an >accessory ot a medical device. > >On the other hand I see no reason not to issue a D of C to the LVD. Compliance >with a standard in >the list of Harmonised Standards is not the only way to demonstrate compliance >with the LVD. It >does not take very much effort to draw up a comparison table showing that the >requirements for a >power supply in IEC 60601-1 are more stringent than say, IEC 60950 or IEC >61010-1. Using >engineering judgment on this basis, I believe that you can issue a D of C to the >LVD, specifying >IEC 60601-1 as the applied standard. You can present your comparison table to >anyone who questions >this, demonstrating the engineering basis for your declaration. That's what I would recommend, but I don't know enough about 60601-1 to be definite. -- Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk Interested in professional sound reinforcement and distribution? Then go to http://www.isce.org.uk PLEASE do NOT copy news posts to me by E-MAIL! 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: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Re: D of C for medical P.S.
>From the end-user's point of view, the power supply must meet the requirements of EN 60601-1. That is the standard that will be applied when the OEM product is evaluated. Any declaration of conformity or CE marking that goes on the component will serve only one purpose, and that is to move the product through customs. The LVD seems most appropriate. I would be quite surprised if a customs agent saw either EN 60601 or EN 60950 on the declaration and questioned it's applicability, and I would be further surprised (and perhaps alarmed) if a simple explanation didn't serve to clear up the matter. Greg Galluccio www.productapprovals.com 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: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
AW: D of C for medical P.S.
Brian,Jon, we have done several investigations of medical PC in accordance to IEC60601. The requirements of IEC60601-1 is different from IEC60950 mainly in regards of spacing, dielectric testing, leakage and the insulation of the interfaces. This has to be documented well in the IEC60601 report. The report should be in the CB -scheme format. (no CB certificate is required) The EMC testing should be done to IEC60601-1-2. There is no problem to declare a medical PC and issue a D . of . C accordingly. When you like to sell it as medical PC in Europe, then you will also require D. of. C for a medical components. With best regards Horst Haug INNOVA Product Service GmbH Ampferweg 6 Germany 87677 Stottwang Tel: (49) 8345-952727 Von: owner-emc-p...@majordomo.ieee.org [mailto:owner-emc-p...@majordomo.ieee.org]Im Auftrag von Jon Griver Gesendet: Mittwoch, 26. Februar 2003 09:39 An: emc-p...@majordomo.ieee.org Betreff: Re: D of C for medical P.S. Brian, You are right not issuing a D of C to the MDD, as your product is not a medical device or an accessory ot a medical device. On the other hand I see no reason not to issue a D of C to the LVD. Compliance with a standard in the list of Harmonised Standards is not the only way to demonstrate compliance with the LVD. It does not take very much effort to draw up a comparison table showing that the requirements for a power supply in IEC 60601-1 are more stringent than say, IEC 60950 or IEC 61010-1. Using engineering judgment on this basis, I believe that you can issue a D of C to the LVD, specifying IEC 60601-1 as the applied standard. You can present your comparison table to anyone who questions this, demonstrating the engineering basis for your declaration. Regards, Jon Griver http://www.601help.com On 25 Feb 2003 at 13:40, boconn...@t-yuden.com wrote: > > Good people of PSTC > One of our custom (component) SMPS is evaluated/certified to IEC/EN60601-1. The LVD precludes > medical stuff, and the MDD is ambiguous on "components" or "materials" being scoped by the MDD. > The customer has determined that indicated conformance should be the LVD. If the unit's D of C > claims conformance to the LVD, then there is no applicable standard, within the scope of the LVD > that can be stated. > So what is the correct content of the unit's Declaration of Conformity? Can anyone please cite > normative OJ guidance? > thanx much. > R/S, > Brian 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: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc 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: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Re: D of C for medical P.S.
Brian, You are right not issuing a D of C to the MDD, as your product is not a medical device or an accessory ot a medical device. On the other hand I see no reason not to issue a D of C to the LVD. Compliance with a standard in the list of Harmonised Standards is not the only way to demonstrate compliance with the LVD. It does not take very much effort to draw up a comparison table showing that the requirements for a power supply in IEC 60601-1 are more stringent than say, IEC 60950 or IEC 61010-1. Using engineering judgment on this basis, I believe that you can issue a D of C to the LVD, specifying IEC 60601-1 as the applied standard. You can present your comparison table to anyone who questions this, demonstrating the engineering basis for your declaration. Regards, Jon Griver http://www.601help.com On 25 Feb 2003 at 13:40, boconn...@t-yuden.com wrote: > > Good people of PSTC > One of our custom (component) SMPS is evaluated/certified to IEC/EN60601-1. The LVD precludes > medical stuff, and the MDD is ambiguous on "components" or "materials" being scoped by the MDD. > The customer has determined that indicated conformance should be the LVD. If the unit's D of C > claims conformance to the LVD, then there is no applicable standard, within the scope of the LVD > that can be stated. > So what is the correct content of the unit's Declaration of Conformity? Can anyone please cite > normative OJ guidance? > thanx much. > R/S, > Brian 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: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
D of C for medical P.S.
Good people of PSTC One of our custom (component) SMPS is evaluated/certified to IEC/EN60601-1. The LVD precludes medical stuff, and the MDD is ambiguous on "components" or "materials" being scoped by the MDD. The customer has determined that indicated conformance should be the LVD. If the unit's D of C claims conformance to the LVD, then there is no applicable standard, within the scope of the LVD that can be stated. So what is the correct content of the unit's Declaration of Conformity? Can anyone please cite normative OJ guidance? thanx much. R/S, Brian
