The EU has a precedent for certain medical devices intended for use by professional users.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:0031:en:PDF On Mon, Nov 14, 2016 at 10:43 AM, Kortas, Jamison <jamison.kor...@ecolab.com > wrote: > Thanks Pete, > > > > In one of the standards we use frequently (UL 921), a printed manual is > called out specifically: > > > > “16.1 Each dishwasher shall be accompanied by printed instructions stated > in clearly understandable > > language, which separately cover dishwasher installation and user > operation and maintenance. These > > instructions are to be included in an installation manual, an operator’s > manual, or both.” > > > > I know that one route is to address it within the development process for > the individual standard, but sometimes when technology outpaces a standard, > the organization will address the issue prior to making formal changes to > standards. Plus, we list to 15+ standards, so we’d prefer a broader > approach. > > > > Thanks, > > > > Jamison > > > > *From:* Pete Perkins [mailto:peperkin...@cs.com <peperkin...@cs.com>] > *Sent:* Monday, November 14, 2016 12:00 PM > *To:* Kortas, Jamison <jamison.kor...@ecolab.com>; > EMC-PSTC@LISTSERV.IEEE.ORG > *Subject:* RE: [PSES] Paper Manuals? > > > > Jamison, et al, > > > > It’s less the responsibility of the standards writing > organization to dictate the manual paper or electronic rather to indicate > clearly what information is required to be provided to the user to ensure > that the product can safely be installed and operated by the user. > > > > It’s more the responsibility of the certifier to insist > that the information provided be adequate to inform the installer and user > in safe practice. > > > > This division of responsibility allows for differences to > exist for equipments which are installed and operated by folks with > different skill levels – more detail for less trained users. > > > > Both are used today in many products. Typically there is > insistence on the need for clear, concise installation instructions (quite > often called a quick start guide) including the hazard warnings on paper. > This is not unreasonable, in my opinion. > > > > :>) br, Pete > > > > Peter E Perkins, PE > > Principal Product Safety & Regulatory Affairs Consultant > > PO Box 23427 > > Tigard, ORe 97281-3427 > > > > 503/452-1201 <(503)%20452-1201> > > > > p.perk...@ieee.org > > > > *From:* Kortas, Jamison [mailto:jamison.kor...@ecolab.com > <jamison.kor...@ecolab.com>] > *Sent:* Monday, November 14, 2016 9:05 AM > *To:* EMC-PSTC@LISTSERV.IEEE.ORG > *Subject:* [PSES] Paper Manuals? > > > > Good Morning, > > > > Has anyone had any success in getting standards writers and/or evaluation > organizations to accept an electronic version of a manual as an equivalent > alternative to a paper version even when the standard refers to a paper > manual? I am getting mixed signals from various individuals within > organizations and wanted to pool ask the group for any insight. > > > > I would think, particularly for equipment that is installed by trained > professionals and not lay people, there might be an appetite for this sort > of change. > > > > Thanks, > > > > Jamison > > - > ---------------------------------------------------------------- > > This message is from the IEEE Product Safety Engineering Society emc-pstc > discussion list. 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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 <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> > -- Scott Aldous | Regulatory Compliance Program Manager | scottald...@google.com | 650-253-1994 - ---------------------------------------------------------------- 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>
