Re: [PSES] weird stuff in agency agreement form
Hello, I think Nick is correct, except that the requirement may not originate from the Notified Body directly. I was at a meeting with a Medical Directive Notified Body recently and, chatting over coffee, he mentioned that his company now needs to make these unannounced visits. A roll of the eyes and a shake of the head. A requirement of the accreditation body. I think you're correct that it comes from the breast implant issue and from what I can tell, it is all part of the duel-factory idea. A manufacturer has one sparkly nice factory in location A which is used on accreditation day; and one other factory in location B which is used for the other 364 days of the year. With the breast implant issue, I believe, I am told, that the NB had inspected the factory but the implants were not being manufactured at the factory which had been inspected. The idea is that the Notified Body must be able to turn up and check. At least, that's what I was told. Michael. Michael Derby Senior Regulatory Engineer Director ACB Europe From: Nick Williams [mailto:nick.willi...@conformance.co.uk] Sent: 11 September 2014 23:03 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] weird stuff in agency agreement form I'm not a betting man, but if I were, I'd lay a few quid on this having come from an EU Notified Body which has a presence in the medical devices market. It looks very like a reaction to the PIP breast implant scandal. Think of it in the context of the NB trying to be seen to react to the lessons from that and it may make a bit more sense. Doesn't make it any more enforceable though. Nick. On 11 Sep 2014, at 19:13, Brian Oconnell oconne...@tamuracorp.com wrote: Am looking at the latest 'agency' general agreement form that all CABs make their clients sign in blood. A new clause states ... has the right to conduct unannounced audits at the manufacture's premises as well as the premises of the manufacturers component supplier and has the right to take samples. It is the obligation of the holder of the certificate to ensure that an audit at the component supplier's premises can be conducted. Unless all of my suppliers have previously signed this agreement, or if we can somehow get all of my bazillion suppliers to sign an agreement, it would seem that the test house is attempting to enforce a 'transitive' legal property. Do not see how this can fly in most North American jurisdictions. Is this something peculiar to EU law? Brian Nick Williams Director Direct line: +44 1298 873811 Mobile: +44 7702 995135 email: nick.willi...@conformance.co.uk - Conformance Ltd - Product safety, approvals and CE-marking consultants The Old Methodist Chapel, Great Hucklow, Buxton, SK17 8RG England Tel. +44 1298 873800, Fax. +44 1298 873801, www.conformance.co.uk Registered in England, Company No. 3478646 - 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) http://www.ieee-pses.org/list.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas emcp...@radiusnorth.net 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 emcp...@radiusnorth.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: dhe...@gmail.com
Re: [PSES] weird stuff in agency agreement form
I’d agree that this will have been driven by the accreditation body rather than by the Notified Body themselves. It may also be worth pointing out that the opportunity for unannounced visits has always been in the Directive, it’s just that no-one ever did it. TuV Rheinland’s failure to do unannounced visits was one of the key factors in the judgement going against them in the court case which followed the scandal. The fact that there has actually been no change in the legislation may be a good arguing point when negotiating the contract renewal with the NB. Nick. On 12 Sep 2014, at 07:07, Michael Derby micha...@acbcert.com wrote: Hello, I think Nick is correct, except that the requirement may not originate from the Notified Body directly. I was at a meeting with a Medical Directive Notified Body recently and, chatting over coffee, he mentioned that his company now needs to make these unannounced visits. A roll of the eyes and a shake of the head. A requirement of the accreditation body. I think you’re correct that it comes from the breast implant issue and from what I can tell, it is all part of the duel-factory idea. A manufacturer has one sparkly nice factory in location A which is used on accreditation day; and one other factory in location B which is used for the other 364 days of the year. With the breast implant issue, I believe, I am told, that the NB had inspected the factory but the implants were not being manufactured at the factory which had been inspected. The idea is that the Notified Body must be able to turn up and check. At least, that’s what I was told. Michael. Michael Derby Senior Regulatory Engineer Director ACB Europe From: Nick Williams [mailto:nick.willi...@conformance.co.uk] Sent: 11 September 2014 23:03 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] weird stuff in agency agreement form I’m not a betting man, but if I were, I’d lay a few quid on this having come from an EU Notified Body which has a presence in the medical devices market. It looks very like a reaction to the PIP breast implant scandal. Think of it in the context of the NB trying to be seen to react to the lessons from that and it may make a bit more sense. Doesn’t make it any more enforceable though. Nick. On 11 Sep 2014, at 19:13, Brian Oconnell oconne...@tamuracorp.com wrote: Am looking at the latest 'agency' general agreement form that all CABs make their clients sign in blood. A new clause states ... has the right to conduct unannounced audits at the manufacture's premises as well as the premises of the manufacturers component supplier and has the right to take samples. It is the obligation of the holder of the certificate to ensure that an audit at the component supplier's premises can be conducted. Unless all of my suppliers have previously signed this agreement, or if we can somehow get all of my bazillion suppliers to sign an agreement, it would seem that the test house is attempting to enforce a 'transitive' legal property. Do not see how this can fly in most North American jurisdictions. Is this something peculiar to EU law? Brian - 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 emcp...@radiusnorth.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: dhe...@gmail.com
Re: [PSES] weird stuff in agency agreement form
In message 80ca2086-8589-4b72-83fe-a248e5e52...@conformance.co.uk, dated Fri, 12 Sep 2014, Nick Williams nick.willi...@conformance.co.uk writes: I’d agree that this will have been driven by the accreditation body rather than by the Notified Body themselves. It may also be worth pointing out that the opportunity for unannounced visits has always been in the Directive, Which Directive? it’s just that no-one ever did it. The point, surely, is that a manufacturer can agree that the NB can make unannounced visits to his premises, but no way can he agree to the NB making unannounced visits to his suppliers. He has no legal authority to give such an undertaking. If the NB wants to do that, it (not the manufacturer) has to make a legal agreement with each supplier. -- OOO - Own Opinions Only. With best wishes. See www.jmwa.demon.co.uk Quid faciamus nisi sit? John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK - 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 emcp...@radiusnorth.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: dhe...@gmail.com
[PSES] OJEU publication of harmonised standards under the RTTE Directive
FYI http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1410509109080uri=OJ:JOC_2014_313_R_0001 Note, this is now in landscape format. There is an extra column (3) for the “First publication OJ” date etc. Regards Nick Nick Hooper BSc(Eng) CEng MIET SMIEEE Chairman RTTE CA UL Grove House Business Centre, Chineham Court, Lutyens, Basingstoke, Hampshire, RG24 8AG, England T: +44 1256 31 2097 | F: +44 1256 31 2001 | M: +44 7970 429 665 E: nick.hoo...@ul.com | W: www.ul.com This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. If you have received this email in error please delete it, destroy all copies of it and notify the sender. This e-mail may contain privileged or confidential information. If you are not the intended recipient: (1) you may not disclose, use, distribute, copy or rely upon this message or attachment(s); and (2) please notify the sender by reply e-mail, and then delete this message and its attachment(s). Underwriters Laboratories Inc. and its affiliates disclaim all liability for any errors, omissions, corruption or virus in this message or any attachments. - 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 emcp...@radiusnorth.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: dhe...@gmail.com
Re: [PSES] Visible - legible
To my knowledge the fixed height requirement is actually a minimum height. The guidance also does not include a location, however I always advise near a rating plate or label which means it could be on the back of equipment. As for readability from a distance, this applies to equipment operating displays. I believe some standards do reference this such as IEC 69204-1. Thanks, - dougDouglas Powellhttp://www.linkedin.com/in/dougp01 From: Gary McInturffSent: Friday, September 12, 2014 8:30 AMTo: EMC-PSTC@LISTSERV.IEEE.ORGReply To: Gary McInturffSubject: [PSES] Visible - legible Does anyone have a standards definition of visible â legible? In this particular instance itâs for the WEEE symbol for an ITE product. I donât see a reference to the definition here. Anybody else? Is it a fixed height say 4mm, or is there some reference to readable from 1 meter (another non-definition because readable isnât defined), Gary McInturff Reliability/Compliance Engineer Esterline Interface Technologies Featuring ADVANCED INPUT, GAMESMAN, and LRE MEDICAL products 600 W. Wilbur Avenue Coeur dâAlene, ID 83815-9496 Toll Free: 800-444-5923 X1XXX Tel: (208) 635-8 Fax: (208) 635-8 www.esterline.com/interfacetechnologies Technology, Innovation, Performance⦠"Information in or attached to this e-mail message may be subject to export control restrictions of the International Traffic in Arms Regulations (ITAR) (22 CFR pts. 120-130) or the Export Administration Regulations (EAR) (15 CFR pts. 730-774).Before exporting this information outside the United States or releasing it to a foreign person in the United States, you need to determine whether a license under the EAR or the ITAR is required to do so. If you have any questions about this obligation, please contact me." - 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 emcp...@radiusnorth.net 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 emcp...@radiusnorth.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher j.bac...@ieee.org David Heald dhe...@gmail.com
Re: [PSES] Visible - legible
Gary: Needed: 1) A unique identification of the producer (Brand name, registration number,.) 2) The crossed-out wheeled bin in accordance with Directive 3) Put on market after 13 august 2005 shall be identified by at least one of the following: a) Date of manufacture/put on market, in uncoded text per ISO 8601 or other coded text, for which the code shall be made available for treatment facilities. b) Additional mark used in conjunction with the crossed-out wheeled bin (underline) The directive has the dimensional proportions. Height of the bin itself is 4mm minimum. The crossed out wheeled bin symbol to be displayed in a visible, legible and indelible form on the product itself, near Producer ID, except for in exceptional cases where this is not possible because of the size or function of the product. If the symbol cannot be applied to the product due to product size or function, then the marking shall be printed on the packaging, in the instructions for use, and in the warranty. The directive has the dimensional proportions. Height of the bin itself is 4mm minimum. From: Gary McInturff [mailto:gary.mcintu...@esterline.com] Sent: Friday, September 12, 2014 10:30 AM To: EMC-PSTC@LISTSERV.IEEE.ORGmailto:EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] Visible - legible Does anyone have a standards definition of visible - legible? In this particular instance it's for the WEEE symbol for an ITE product. I don't see a reference to the definition here. Anybody else? Is it a fixed height say 4mm, or is there some reference to readable from 1 meter (another non-definition because readable isn't defined), Gary McInturff Reliability/Compliance Engineer Esterline Interface Technologies Featuring ADVANCED INPUT, GAMESMAN, and LRE MEDICAL products 600 W. Wilbur Avenue Coeur d'Alene, ID 83815-9496 Toll Free: 800-444-5923 X1XXX Tel: (208) 635-8 Fax: (208) 635-8 www.esterline.com/interfacetechnologieshttp://www.esterline.com/interfacetechnologies Technology, Innovation, Performance... Information in or attached to this e-mail message may be subject to export control restrictions of the International Traffic in Arms Regulations (ITAR) (22 CFR pts. 120-130) or the Export Administration Regulations (EAR) (15 CFR pts. 730-774). Before exporting this information outside the United States or releasing it to a foreign person in the United States, you need to determine whether a license under the EAR or the ITAR is required to do so. If you have any questions about this obligation, please contact me. - 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.orgmailto: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)http://www.ieee-pses.org/list.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas emcp...@radiusnorth.netmailto:emcp...@radiusnorth.net Mike Cantwell mcantw...@ieee.orgmailto:mcantw...@ieee.org For policy questions, send mail to: Jim Bacher j.bac...@ieee.orgmailto:j.bac...@ieee.org David Heald dhe...@gmail.commailto: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 emcp...@radiusnorth.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: dhe...@gmail.com
[PSES] Crossed-out wheeled bin symbol
Dear All, I have learnt that in near future, the black bar below the crossed-out wheeled bin symbol will be removed similar to the one used in battery directive. Have anyone heard the same? Thanks and regards, Scott On 12 Sep, 2014, at 10:56 pm, Denis Ryskamp denis_rysk...@trimble.com wrote: Gary: Needed: 1) A unique identification of the producer (Brand name, registration number,…..) 2) The crossed-out wheeled bin in accordance with Directive 3) Put on market after 13 august 2005 shall be identified by at least one of the following: a) Date of manufacture/put on market, in uncoded text per ISO 8601 or other coded text, for which the code shall be made available for treatment facilities. b) Additional mark used in conjunction with the crossed-out wheeled bin (underline) The directive has the dimensional proportions. Height of the bin itself is 4mm minimum. The crossed out wheeled bin symbol to be displayed in a visible, legible and indelible form on the product itself, near Producer ID, except for in exceptional cases where this is not possible because of the size or function of the product. If the symbol cannot be applied to the product due to product size or function, then the marking shall be printed on the packaging, in the instructions for use, and in the warranty. The directive has the dimensional proportions. Height of the bin itself is 4mm minimum. From: Gary McInturff [mailto:gary.mcintu...@esterline.com] Sent: Friday, September 12, 2014 10:30 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] Visible - legible Does anyone have a standards definition of visible – legible? In this particular instance it’s for the WEEE symbol for an ITE product. I don’t see a reference to the definition here. Anybody else? Is it a fixed height say 4mm, or is there some reference to readable from 1 meter (another non-definition because readable isn’t defined), Gary McInturff Reliability/Compliance Engineer Esterline Interface Technologies Featuring ADVANCED INPUT, GAMESMAN, and LRE MEDICAL products 600 W. Wilbur Avenue Coeur d’Alene, ID 83815-9496 Toll Free: 800-444-5923 X1XXX Tel: (208) 635-8 Fax: (208) 635-8 www.esterline.com/interfacetechnologies Technology, Innovation, Performance… Information in or attached to this e-mail message may be subject to export control restrictions of the International Traffic in Arms Regulations (ITAR) (22 CFR pts. 120-130) or the Export Administration Regulations (EAR) (15 CFR pts. 730-774). Before exporting this information outside the United States or releasing it to a foreign person in the United States, you need to determine whether a license under the EAR or the ITAR is required to do so. If you have any questions about this obligation, please contact me. - 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 emcp...@radiusnorth.net 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 emcp...@radiusnorth.net 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
Re: [PSES] weird stuff in agency agreement form
On 9/12/2014 2:07 AM, Michael Derby wrote: I think you're correct that it comes from the breast implant issue and from what I can tell, it is all part of the duel-factory idea. This smacks of push-back by inspecting agencies wanting to get rid of responsibility for identifying use of conflict minerals. Good luck. Cortland Richmond - 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 emcp...@radiusnorth.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: dhe...@gmail.com
