[PSES] CE Declaration of Conformity
Hi folks, I design and manufacture light machinery that includes some sub-assemblies which we purchase and integrate. The sub-assemblies come with their own DoI. In particular I may integrate automatic and non-automatic weighing scales that would come with a DoI or DoC for the machinery and directive and a DoC or DoI for the EMC, 2004/22/EC Measuring Instruments, and 2009/23/EC Non-automatic Weighing Instruments directives. I do not modify the weighing functionality of the scales nor do I do any additional certification on them. The metrology directives require special marking, the CE mark as well as the M mark and notified body ID which come already on the units I integrate. There are no weighing devices that I directly manufacturer that are part of the machinery. What I'm not clear on is whether I should claim compliance to the 2004/22/EC Measuring Instruments and 2009/23/EC Non-automatic Weighing Instruments directives on my DoC and/or product nameplate for the complete machine or whether I should just include the OEM's DoC along with my DoC in the paperwork supplied with the machine (and technical file). I don't know if this situation is different than any are CE marked component within the machine but it would seem so. The EU directives do not actually apply directly to many components that the OEM marks and claims compliance to CE to make it easier for system builders like me. (Some actually state that on their DoCs). The Metrology directives are specific to the scales. Does anyone have any experience with this or something similar? thanks David P. Nyffenegger, PMP, SM-IEEE Product Development Manager - 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.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas sdoug...@ieee.org Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: dhe...@gmail.com
Re: [PSES] CE Declaration of Conformity
Dunno, as my only experience was doing some power converters for an industrial scale. My customer used the WELMEC organization to advise on scoped directives and standards and marks. Have you read 2014/32/EU ? Brian -Original Message- From: Nyffenegger, Dave [mailto:dave.nyffeneg...@bhemail.com] Sent: Friday, January 16, 2015 10:14 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] CE Declaration of Conformity Hi folks, I design and manufacture light machinery that includes some sub-assemblies which we purchase and integrate. The sub-assemblies come with their own DoI. In particular I may integrate automatic and non-automatic weighing scales that would come with a DoI or DoC for the machinery and directive and a DoC or DoI for the EMC, 2004/22/EC Measuring Instruments, and 2009/23/EC Non-automatic Weighing Instruments directives. I do not modify the weighing functionality of the scales nor do I do any additional certification on them. The metrology directives require special marking, the CE mark as well as the M mark and notified body ID which come already on the units I integrate. There are no weighing devices that I directly manufacturer that are part of the machinery. What I'm not clear on is whether I should claim compliance to the 2004/22/EC Measuring Instruments and 2009/23/EC Non-automatic Weighing Instruments directives on my DoC and/or product nameplate for the complete machine or whether I should just include the OEM's DoC along with my DoC in the paperwork supplied with the machine (and technical file). I don't know if this situation is different than any are CE marked component within the machine but it would seem so. The EU directives do not actually apply directly to many components that the OEM marks and claims compliance to CE to make it easier for system builders like me. (Some actually state that on their DoCs). The Metrology directives are specific to the scales. Does anyone have any experience with this or something similar? thanks David P. Nyffenegger, PMP, SM-IEEE Product Development Manager - 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.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas sdoug...@ieee.org Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: dhe...@gmail.com
Re: [PSES] CE Declaration of Conformity
Dave A DoI is only defined for the Machinery Directive, it has no application for other directives (though perhaps your suppliers are not aware of this). I would not pass-on a supplier's paperwork (e.g., DoCs) with your own product, but retain them in your technical file as a partial basis for your own declarations. Declare to 2004/22/EC Measuring Instruments, and 2009/23/EC Non-automatic Weighing Instruments directives if you believe your product is in scope. Incorporating a component in scope can effectively repurpose it out of scope. For example if you incorporate a gas meter (generally sold for monitoring and billing consumers) into a product just to measure gas feed into e.g., a toxic gas burner (and no public interest is involved per se), then I do not think it would be in scope of 20014/22/EC for that use. Regards, Lauren Crane KLA-Tencor -Original Message- From: Nyffenegger, Dave [mailto:dave.nyffeneg...@bhemail.com] Sent: Friday, January 16, 2015 12:14 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] CE Declaration of Conformity Hi folks, I design and manufacture light machinery that includes some sub-assemblies which we purchase and integrate. The sub-assemblies come with their own DoI. In particular I may integrate automatic and non-automatic weighing scales that would come with a DoI or DoC for the machinery and directive and a DoC or DoI for the EMC, 2004/22/EC Measuring Instruments, and 2009/23/EC Non-automatic Weighing Instruments directives. I do not modify the weighing functionality of the scales nor do I do any additional certification on them. The metrology directives require special marking, the CE mark as well as the M mark and notified body ID which come already on the units I integrate. There are no weighing devices that I directly manufacturer that are part of the machinery. What I'm not clear on is whether I should claim compliance to the 2004/22/EC Measuring Instruments and 2009/23/EC Non-automatic Weighing Instruments directives on my DoC and/or product nameplate for the complete machine or whether I should just include the OEM's DoC along with my DoC in the paperwork supplied with the machine (and technical file). I don't know if this situation is different than any are CE marked component within the machine but it would seem so. The EU directives do not actually apply directly to many components that the OEM marks and claims compliance to CE to make it easier for system builders like me. (Some actually state that on their DoCs). The Metrology directives are specific to the scales. Does anyone have any experience with this or something similar? thanks David P. Nyffenegger, PMP, SM-IEEE Product Development Manager - 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.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas sdoug...@ieee.org Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: dhe...@gmail.com - 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.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas sdoug...@ieee.org Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: dhe...@gmail.com
Re: [PSES] CE Declaration of Conformity
The supplied DoI is for the machinery directive (and EMC). They actually supply a separate DoC for the weighing directive. I miss-stated that in my original email. I suppose that logic trumps the requirement that all declarations are supposed to be together. They could have combined the weighing and EMC declarations. -Dave -Original Message- From: Crane, Lauren [mailto:lauren.cr...@kla-tencor.com] Sent: Friday, January 16, 2015 1:41 PM To: Nyffenegger, Dave; EMC-PSTC@LISTSERV.IEEE.ORG Subject: RE: CE Declaration of Conformity Dave A DoI is only defined for the Machinery Directive, it has no application for other directives (though perhaps your suppliers are not aware of this). I would not pass-on a supplier's paperwork (e.g., DoCs) with your own product, but retain them in your technical file as a partial basis for your own declarations. Declare to 2004/22/EC Measuring Instruments, and 2009/23/EC Non-automatic Weighing Instruments directives if you believe your product is in scope. Incorporating a component in scope can effectively repurpose it out of scope. For example if you incorporate a gas meter (generally sold for monitoring and billing consumers) into a product just to measure gas feed into e.g., a toxic gas burner (and no public interest is involved per se), then I do not think it would be in scope of 20014/22/EC for that use. Regards, Lauren Crane KLA-Tencor -Original Message- From: Nyffenegger, Dave [mailto:dave.nyffeneg...@bhemail.com] Sent: Friday, January 16, 2015 12:14 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] CE Declaration of Conformity Hi folks, I design and manufacture light machinery that includes some sub-assemblies which we purchase and integrate. The sub-assemblies come with their own DoI. In particular I may integrate automatic and non-automatic weighing scales that would come with a DoI or DoC for the machinery and directive and a DoC or DoI for the EMC, 2004/22/EC Measuring Instruments, and 2009/23/EC Non-automatic Weighing Instruments directives. I do not modify the weighing functionality of the scales nor do I do any additional certification on them. The metrology directives require special marking, the CE mark as well as the M mark and notified body ID which come already on the units I integrate. There are no weighing devices that I directly manufacturer that are part of the machinery. What I'm not clear on is whether I should claim compliance to the 2004/22/EC Measuring Instruments and 2009/23/EC Non-automatic Weighing Instruments directives on my DoC and/or product nameplate for the complete machine or whether I should just include the OEM's DoC along with my DoC in the paperwork supplied with the machine (and technical file). I don't know if this situation is different than any are CE marked component within the machine but it would seem so. The EU directives do not actually apply directly to many components that the OEM marks and claims compliance to CE to make it easier for system builders like me. (Some actually state that on their DoCs). The Metrology directives are specific to the scales. Does anyone have any experience with this or something similar? thanks David P. Nyffenegger, PMP, SM-IEEE Product Development Manager - 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.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas sdoug...@ieee.org Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: dhe...@gmail.com - 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.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas sdoug...@ieee.org Mike Cantwell mcantw
Re: [PSES] CE Declaration of Conformity
This makes sense. Thanks -Dave -Original Message- From: Nick Williams [mailto:nick.willi...@conformance.co.uk] Sent: Friday, January 16, 2015 2:46 PM To: Nyffenegger, Dave Cc: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] CE Declaration of Conformity Surely if you declare compliance with any particular Directive on your Declaration then you must follow the attestation procedures for that Directive. On the basis of a quick look, there is no attestation route under the NAWID which does not require some form of Notified Body intervention. I know that this is not completely true for the MID, but in practice most measuring instruments do require NB intervention for CE marking under the MID. Therefore, it seems to me that unless you engage an NB to help you declare compliance for your complete machine, you cannot include a declaration of compliance to the NWAID or the MID on the Declaration of the complete machine. The Machinery Directive says that you also need to identify any other applicable Directives on your Declaration: a sentence expressly declaring that the machinery fulfils all the relevant provisions of this Directive and where appropriate, a similar sentence declaring the conformity with other Directives and/or relevant provisions with which the machinery complies.” (2006/42/EC annex II (1 )A item 4). A strict reading of this means you have to declare compliance with the NWAID in addition to the Machienry Directive, but applying my logic above that would imply involving an NB to be involved in attestation of the complete machine, something I’m sure you won’t want to do. My advice is to issue a Declaration in which you claim compliance only for those Directives where you have competed the correct attestation procedure (likely to be Machinery, EMC and RoHS in this case) and supply a copy of the weighing machine’s DofC alongside your machinery DofC. If you attempt to ‘badge' the weighing machine as your own by not supplying the OEM’s Declaration then I think you will need to comply with the NWAID and/or the MID which means applying the relevant procedures from these directives. Nick. On 16 Jan 2015, at 18:13, Nyffenegger, Dave dave.nyffeneg...@bhemail.com wrote: Hi folks, I design and manufacture light machinery that includes some sub-assemblies which we purchase and integrate. The sub-assemblies come with their own DoI. In particular I may integrate automatic and non-automatic weighing scales that would come with a DoI or DoC for the machinery and directive and a DoC or DoI for the EMC, 2004/22/EC Measuring Instruments, and 2009/23/EC Non-automatic Weighing Instruments directives. I do not modify the weighing functionality of the scales nor do I do any additional certification on them. The metrology directives require special marking, the CE mark as well as the M mark and notified body ID which come already on the units I integrate. There are no weighing devices that I directly manufacturer that are part of the machinery. What I'm not clear on is whether I should claim compliance to the 2004/22/EC Measuring Instruments and 2009/23/EC Non-automatic Weighing Instruments directives on my DoC and/or product nameplate for the complete machine or whether I should just include the OEM's DoC along with my DoC in the paperwork supplied with the machine (and technical file). I don't know if this situation is different than any are CE marked component within the machine but it would seem so. The EU directives do not actually apply directly to many components that the OEM marks and claims compliance to CE to make it easier for system builders like me. (Some actually state that on their DoCs). The Metrology directives are specific to the scales. Does anyone have any experience with this or something similar? thanks David P. Nyffenegger, PMP, SM-IEEE Product Development Manager - 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.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas sdoug...@ieee.org Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: dhe...@gmail.com
Re: [PSES] CE Declaration of Conformity
Surely if you declare compliance with any particular Directive on your Declaration then you must follow the attestation procedures for that Directive. On the basis of a quick look, there is no attestation route under the NAWID which does not require some form of Notified Body intervention. I know that this is not completely true for the MID, but in practice most measuring instruments do require NB intervention for CE marking under the MID. Therefore, it seems to me that unless you engage an NB to help you declare compliance for your complete machine, you cannot include a declaration of compliance to the NWAID or the MID on the Declaration of the complete machine. The Machinery Directive says that you also need to identify any other applicable Directives on your Declaration: a sentence expressly declaring that the machinery fulfils all the relevant provisions of this Directive and where appropriate, a similar sentence declaring the conformity with other Directives and/or relevant provisions with which the machinery complies.” (2006/42/EC annex II (1 )A item 4). A strict reading of this means you have to declare compliance with the NWAID in addition to the Machienry Directive, but applying my logic above that would imply involving an NB to be involved in attestation of the complete machine, something I’m sure you won’t want to do. My advice is to issue a Declaration in which you claim compliance only for those Directives where you have competed the correct attestation procedure (likely to be Machinery, EMC and RoHS in this case) and supply a copy of the weighing machine’s DofC alongside your machinery DofC. If you attempt to ‘badge' the weighing machine as your own by not supplying the OEM’s Declaration then I think you will need to comply with the NWAID and/or the MID which means applying the relevant procedures from these directives. Nick. On 16 Jan 2015, at 18:13, Nyffenegger, Dave dave.nyffeneg...@bhemail.com wrote: Hi folks, I design and manufacture light machinery that includes some sub-assemblies which we purchase and integrate. The sub-assemblies come with their own DoI. In particular I may integrate automatic and non-automatic weighing scales that would come with a DoI or DoC for the machinery and directive and a DoC or DoI for the EMC, 2004/22/EC Measuring Instruments, and 2009/23/EC Non-automatic Weighing Instruments directives. I do not modify the weighing functionality of the scales nor do I do any additional certification on them. The metrology directives require special marking, the CE mark as well as the M mark and notified body ID which come already on the units I integrate. There are no weighing devices that I directly manufacturer that are part of the machinery. What I'm not clear on is whether I should claim compliance to the 2004/22/EC Measuring Instruments and 2009/23/EC Non-automatic Weighing Instruments directives on my DoC and/or product nameplate for the complete machine or whether I should just include the OEM's DoC along with my DoC in the paperwork supplied with the machine (and technical file). I don't know if this situation is different than any are CE marked component within the machine but it would seem so. The EU directives do not actually apply directly to many components that the OEM marks and claims compliance to CE to make it easier for system builders like me. (Some actually state that on their DoCs). The Metrology directives are specific to the scales. Does anyone have any experience with this or something similar? thanks David P. Nyffenegger, PMP, SM-IEEE Product Development Manager - 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.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas sdoug...@ieee.org Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: dhe...@gmail.com
Re: [PSES] CE Declaration of Conformity
As an aside, I wish that many other directives would include the DoI concept for components - and then we might be able to get away from the type of comment about a component that has a CE marking and a DoC and so it must be OK and we don't need to do anything else (like ensuring that when installed in the final product then that product does still meet the end-product standard?). John Allen W.London, UK. -Original Message- From: Nyffenegger, Dave [mailto:dave.nyffeneg...@bhemail.com] Sent: 16 January 2015 20:05 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] CE Declaration of Conformity The supplied DoI is for the machinery directive (and EMC). They actually supply a separate DoC for the weighing directive. I miss-stated that in my original email. I suppose that logic trumps the requirement that all declarations are supposed to be together. They could have combined the weighing and EMC declarations. -Dave -Original Message- From: Crane, Lauren [mailto:lauren.cr...@kla-tencor.com] Sent: Friday, January 16, 2015 1:41 PM To: Nyffenegger, Dave; EMC-PSTC@LISTSERV.IEEE.ORG Subject: RE: CE Declaration of Conformity Dave A DoI is only defined for the Machinery Directive, it has no application for other directives (though perhaps your suppliers are not aware of this). I would not pass-on a supplier's paperwork (e.g., DoCs) with your own product, but retain them in your technical file as a partial basis for your own declarations. Declare to 2004/22/EC Measuring Instruments, and 2009/23/EC Non-automatic Weighing Instruments directives if you believe your product is in scope. Incorporating a component in scope can effectively repurpose it out of scope. For example if you incorporate a gas meter (generally sold for monitoring and billing consumers) into a product just to measure gas feed into e.g., a toxic gas burner (and no public interest is involved per se), then I do not think it would be in scope of 20014/22/EC for that use. Regards, Lauren Crane KLA-Tencor -Original Message- From: Nyffenegger, Dave [mailto:dave.nyffeneg...@bhemail.com] Sent: Friday, January 16, 2015 12:14 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] CE Declaration of Conformity Hi folks, I design and manufacture light machinery that includes some sub-assemblies which we purchase and integrate. The sub-assemblies come with their own DoI. In particular I may integrate automatic and non-automatic weighing scales that would come with a DoI or DoC for the machinery and directive and a DoC or DoI for the EMC, 2004/22/EC Measuring Instruments, and 2009/23/EC Non-automatic Weighing Instruments directives. I do not modify the weighing functionality of the scales nor do I do any additional certification on them. The metrology directives require special marking, the CE mark as well as the M mark and notified body ID which come already on the units I integrate. There are no weighing devices that I directly manufacturer that are part of the machinery. What I'm not clear on is whether I should claim compliance to the 2004/22/EC Measuring Instruments and 2009/23/EC Non-automatic Weighing Instruments directives on my DoC and/or product nameplate for the complete machine or whether I should just include the OEM's DoC along with my DoC in the paperwork supplied with the machine (and technical file). I don't know if this situation is different than any are CE marked component within the machine but it would seem so. The EU directives do not actually apply directly to many components that the OEM marks and claims compliance to CE to make it easier for system builders like me. (Some actually state that on their DoCs). The Metrology directives are specific to the scales. Does anyone have any experience with this or something similar? thanks David P. Nyffenegger, PMP, SM-IEEE Product Development Manager - 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.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas sdoug...@ieee.org Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: dhe...@gmail.com - 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
