Dave
Directive are "higher level" documents that won't prescribe how you must do things. Tables of "critical components" are typically listed in safety test reports, such as tables for EN 60950 clause 1.5.1. As Rich says, "Critical components lists" are things that help manufacturers in that they allow you to clearly identify components that are "safeguards" . Once you have such a list, flag all included items on your PDM system to (try and) stop second sourcing alternative parts without appropriate checks and sign-off being done first. Don't just list them in your Technical File, add a flag to your PDM system - that way you have a fighting chance of controlling what happens in reality :) Regards Charlie -----Original Message----- From: Nyffenegger, Dave [mailto:dave.nyffeneg...@bhemail.com] Sent: 11 March 2014 22:30 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] Critical Components definitions Related to my original question, we normally keep the critical components list in the technical file. Looking at the 2006/42/EC New Machinery Directive Annex VII requirements for the technical file I don't see anything see anything that specifically refers to a critical components list. So I'm wonder where the interpretation of that requirement comes from and the details normally provided in the list. There is a reference " calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements" and " any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative,". Are the critical components lists including the manufacturer, their part number, applicable standards and NRTL markings that we normally include in the file for each component being used to fulfill the requirements for the above for purchased critical components? Or is it just customary to include this information in a critical components list and include the list in the technical file? thanks -Dave -----Original Message----- From: Brian Oconnell [mailto:oconne...@tamuracorp.com] Sent: Monday, February 24, 2014 1:38 PM To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG> Subject: Re: [PSES] Critical Components definitions Concur with Mr. Nute. Was once asked to provide a "clear definition of a safety-critical component". To comprise a definition, provided a parametric and descriptive listing of 27 items. The last line was: 27. Any component or material or process that I deem critical to safety and/or critical to a regulatory requirement. Brian -----Original Message----- From: Richard Nute [mailto:ri...@ieee.org] Sent: Saturday, February 22, 2014 12:13 PM To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG> Subject: Re: [PSES] Critical Components definitions Hi Dave: There are no "standard" definitions for critical components. However, do a Google search for "critical components list" and you will find a number of examples and opinions as to a definition of critical components. For example, http://www.tracglobal.com/sites/tracglobal.com/files/pdfs/componentacceptabilityforceproductsafety.pdf I prefer to think of a "critical component" as a "safeguard." A safeguard is a component, part, or assembly that provides protection against one or more hazardous energy sources. Basic insulation, supplementary insulation, and reinforced insulation are safeguards against electric shock. Failure of a safeguard can lead to an injury, or calls into play a supplementary safeguard such as supplementary insulation or grounding. The enclosure may be a supplementary safeguard against electric shock or against spread of fire or against both. The point is, you must know the safety function of the component, part, or assembly before you can identify it as a "safeguard" or "critical component." In practice, however, a critical component is any component the certification engineer says is a critical component. Best regards, Rich - ---------------------------------------------------------------- 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<mailto: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<mailto:emcp...@radiusnorth.net>> Mike Cantwell <mcantw...@ieee.org<mailto:mcantw...@ieee.org>> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org<mailto:j.bac...@ieee.org>> David Heald: <dhe...@gmail.com<mailto: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<mailto: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<mailto:emcp...@radiusnorth.net>> Mike Cantwell <mcantw...@ieee.org<mailto:mcantw...@ieee.org>> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org<mailto:j.bac...@ieee.org>> David Heald: <dhe...@gmail.com<mailto: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>
