Hello group, UL does in fact issue Classification Marks for products that only comply with part of a UL (or ANSI) Standard - all medical devices with the UL "Mark" are Classified, since UL does not address biocompatibility, EMC, etc. which are all clauses of UL 60601-1. Med devices are under item (1) of the definition Gary posted below, and the Classification Markings on each product say such. AHJs have accepted this for years now.
A fully "listed" medical device would have to have UL evaluate EMC and biocompatibility, as well as the basic safety aspects. UL does not employ qualified people to address biocomp....EMC maybe. Bryce Stammerjohan ________________________________________ From: McInturff, Gary [[email protected]] Sent: Thursday, November 01, 2012 9:34 AM To: [email protected] Subject: Re: [PSES] Listing or Classification in the field? CLASSIFICATION SERVICE - A service whereby UL determines that a manufacturer has demonstrated the ability to produce a product that complies with UL requirements for the purpose of classification or evaluation with respect to one or more of the following: (1) specific risks only, e.g., casualty, fire or shock, (2) performance under specified conditions, (3) regulatory codes, (4) other standards, including international standards, or (5) such other conditions as UL may consider desirable. UL authorizes the manufacturer to use the Classification Mark on products that comply with UL requirements and establishes follow-up service as a check of the means the manufacturer exercises to maintain compliance with UL requirements. This is from their web site and somewhat supports your contention, although I don’t know if you can say there is not a standard, maybe. Sheet rock for example is UL classified, as are roofing materials and both of them have a single performance issue – fire rating. I think that (4) applies to sheetrock. The ability to contain a fire for X amount of time. That rating is used by local authorities in the NEC and building codes around the country. Between floors of living spaces 3/8 in sheet rock must be used because it has a flame rating acceptable to the building codes. I suspect that the classified items were done at the behest or in conjunction with national authorities to identify basic functional requirements. Conjecture more than absolute knowledge Gary From: Ted Eckert [mailto:[email protected]] Sent: Thursday, November 01, 2012 8:53 AM To: [email protected] Subject: Re: [PSES] Listing or Classification in the field? Hello Carl, Some inspectors may not know the difference between Classified and Listed marks, and they may accept Classified equipment. However, you may run into problems in some jurisdictions without Listing for electrical products. The National Electrical Code says “Listed” and that is what some inspectors look for. Some NRTLs may not be willing to issue a classified mark where an appropriate UL standard exists. Others can correct me if I am wrong, but I believe that UL uses the Classified mark for products where a UL standard does not exist, yet UL has verified that the product meets the requirements of a non-UL standard. UL would not likely allow the use of their Classified mark to show that a product has been tested to only a portion of a UL standard. An example is cable trays. UL will verify that cable trays meet the grounding and bonding requirements of the National Electrical Code. Classified cable trays<http://database.ul.com/cgi-bin/XYV/template/LISEXT/1FRAME/showpage.html?&name=CYNW.GuideInfo&ccnshorttitle=Cable+Trays&objid=1074080954&cfgid=1073741824&version=versionless&parent_id=1073985303&sequence=1> are only tested to the NEC requirement and not a UL standard. Other NRTLs may use different terms for the same idea. If a product isn’t Listed and an appropriate UL standard exists, the question will always arise of why the product doesn’t comply with all the Listing requirements. I would recommend Listing where Listing standard exists. Ted Eckert Compliance Engineer Microsoft Corporation [email protected]<mailto:[email protected]> The opinions expressed are my own and do not necessarily reflect those of my employer. From: Carl Newton [mailto:[email protected]] Sent: Thursday, November 01, 2012 6:42 AM To: [email protected] Subject: Listing or Classification in the field? Group, I'm working with a company that manufactures high-end exercise equipment that is used in both therapeutic and general fitness applications. They want to consider NRTL Classification in lieu of Listing in order to reduce cost and complexity of compliance. My primary concern is acceptance of Classified devices by local inspectors in USA and Canada. Can any of you on the list speak to this question? I've not been able to get what I consider to be solid evidence from one NRTL that there won't be acceptance issues by local inspectors if the device is Classified. Thanks in advance, Carl - ---------------------------------------------------------------- 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 <[email protected]<mailto:[email protected]>> 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://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- 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 <[email protected]<mailto:[email protected]>> 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://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- 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 <[email protected]<mailto:[email protected]>> 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://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- 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 <[email protected]> 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://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
