Comments for Medical Electrical Equipment Information Blog - IEC 60601-1, ISO 13485, ISO 14971, medical devices, biomedical engineering and the like http://www.electromedicalinfo.com Mon, 25 Jan 2010 13:55:56 +0000 http://wordpress.org/?v=2.6.5 Comment on New white paper: IEC 60601-1: Changes from 2nd to 3rd Edition by Mike Schmidt http://www.electromedicalinfo.com/new-white-paper-iec-60601-1-changes-from-2nd-to-3rd-edition/#comment-2950 Mike Schmidt Thu, 23 Oct 2008 19:48:25 +0000 http://www.electromedicalinfo.com/?p=66#comment-2950 A word of caution on publications and seminars on 60601-1: 2005 (Ed. 3) and the associated collateral standards. As with any new topic, there are a lot of "experts" out there that don't know what they are talking about. As convener of one of the working groups that developed the standard and the Secretary of an associated Subcommittee, I see a lot of incomplete, misleading and just plain bad information on the 3rd Edition and 14971. Check out the credentials of anyone offering information on the 3rd Edition (did they do more than attend a seminar or just read the document?). Information that's not often mentioned: While the new 60601-1 General Standard doesn't contain too many nasty surprises itself, compliance with applicable collateral standards is now mandatory and there are 11 (12 within a year or so) that contain significant and new requirements. Health Canada has come to its senses and will not require the 3rd Edition begining this December. New "drop dead" date is 6/2012. Technically the 3rd Edition has NOT been harmonized in the EU yet but should be listed in the OJ in the first qrtr. of 09. However, for devices without a particular standard ("part two" device specific standards in the 60601 series) the forward of EN 60601-1 states that you can't use Edition 2 (EN 60601-1: 1990) after September of 2009! We expect that this will be resolved (allowing a 3 year transition) after listing as a harmonized standard but the situation merits watching! A word of caution on publications and seminars on 60601-1: 2005 (Ed. 3) and the associated collateral standards. As with any new topic, there are a lot of “experts” out there that don’t know what they are talking about. As convener of one of the working groups that developed the standard and the Secretary of an associated Subcommittee, I see a lot of incomplete, misleading and just plain bad information on the 3rd Edition and 14971. Check out the credentials of anyone offering information on the 3rd Edition (did they do more than attend a seminar or just read the document?).

Information that’s not often mentioned:

While the new 60601-1 General Standard doesn’t contain too many nasty surprises itself, compliance with applicable collateral standards is now mandatory and there are 11 (12 within a year or so) that contain significant and new requirements.

Health Canada has come to its senses and will not require the 3rd Edition begining this December. New “drop dead” date is 6/2012.

Technically the 3rd Edition has NOT been harmonized in the EU yet but should be listed in the OJ in the first qrtr. of 09. However, for devices without a particular standard (”part two” device specific standards in the 60601 series) the forward of EN 60601-1 states that you can’t use Edition 2 (EN 60601-1: 1990) after September of 2009! We expect that this will be resolved (allowing a 3 year transition) after listing as a harmonized standard but the situation merits watching!

]]> Comment on Inspection priority - FDA guidance on the use of ISO 13485 audit reports by James http://www.electromedicalinfo.com/inspection-priority-fda-guidance-on-the-use-of-iso-13485-audit-reports/#comment-2905 James Thu, 18 Sep 2008 12:49:07 +0000 http://www.electromedicalinfo.com/?p=70#comment-2905 Hi, I found your blog on this new directory of WordPress Blogs at blackhatbootcamp.com/listofwordpressblogs. I dont know how your blog came up, must have been a typo, i duno. Anyways, I just clicked it and here I am. Your blog looks good. Have a nice day. James. Hi, I found your blog on this new directory of WordPress Blogs at blackhatbootcamp.com/listofwordpressblogs. I dont know how your blog came up, must have been a typo, i duno. Anyways, I just clicked it and here I am. Your blog looks good. Have a nice day. James.

]]> Comment on MRI - Determination of essential image quality parameters by CR Systems http://www.electromedicalinfo.com/mri-determination-of-essential-image-quality-parameters/#comment-2891 CR Systems Thu, 28 Aug 2008 21:24:32 +0000 http://www.electromedicalinfo.com/2007/02/15/mri-determination-of-essential-image-quality-parameters/#comment-2891 That was a great post. I will have to bookmark this site so I can read more later. That was a great post. I will have to bookmark this site so I can read more later.

]]> Comment on Objective overview of the GHTF by David Secaecg http://www.electromedicalinfo.com/objective-overview-of-the-ghtf/#comment-2838 David Secaecg Fri, 04 Jul 2008 10:29:02 +0000 http://www.electromedicalinfo.com/objective-overview-of-the-ghtf/#comment-2838 Hi There, The global harmonization task force link doesnt seem to work, Cheers David. Hi There, The global harmonization task force link doesnt seem to work, Cheers David.

]]> Comment on Great source for electrotherapy info - electrotherapy.org and the Electrotherapy News Newsletter by Bill http://www.electromedicalinfo.com/greaat-source-for-electrotherapy-info-electrotherapyorg-and-the-electrotherapy-news-newsletter/#comment-2700 Bill Thu, 17 Apr 2008 19:55:26 +0000 http://www.electromedicalinfo.com/greaat-source-for-electrotherapy-info-electrotherapyorg-and-the-electrotherapy-news-newsletter/#comment-2700 I noticed your post on electrotherapy info and wanted to share a white paper on the subject: Multi-Modality Electrotherapy, A Safe and Cost-Effective Adjunctive Treatment for Managing Pain, Visit VQ OrthoCare's Company News page to view the research. I noticed your post on electrotherapy info and wanted to share a white paper on the subject: Multi-Modality Electrotherapy, A Safe and Cost-Effective Adjunctive Treatment for Managing Pain, Visit VQ OrthoCare’s Company News page to view the research.

]]> Comment on Canada officiallly adopts a transition period for the third edition of IEC 60601-1 by Marcelo http://www.electromedicalinfo.com/canada-officiallly-adopts-a-transition-period-for-the-third-edition-of-iec-60601-1/#comment-2659 Marcelo Tue, 11 Mar 2008 13:42:46 +0000 http://www.electromedicalinfo.com/canada-officiallly-adopts-a-transition-period-for-the-third-edition-of-iec-60601-1/#comment-2659 Hello Sue Thanks for the kind words. I´ve been to your blog and liked it a lot. Although my blog is mainly focused in the technical aspects of medical devices, my consulting practice is focused in the management (quality, risk, etc.) side of the business, and in this way your blog can help a lot. Hello Sue
Thanks for the kind words.

I´ve been to your blog and liked it a lot. Although my blog is mainly focused in the technical aspects of medical devices, my consulting practice is focused in the management (quality, risk, etc.) side of the business, and in this way your blog can help a lot.

]]> Comment on Canada officiallly adopts a transition period for the third edition of IEC 60601-1 by Sue Massey http://www.electromedicalinfo.com/canada-officiallly-adopts-a-transition-period-for-the-third-edition-of-iec-60601-1/#comment-2640 Sue Massey Wed, 27 Feb 2008 13:00:52 +0000 http://www.electromedicalinfo.com/canada-officiallly-adopts-a-transition-period-for-the-third-edition-of-iec-60601-1/#comment-2640 I found your site on google blog search and read a few of your other posts. Keep up the good work. Just added your RSS feed to my feed reader. Look forward to reading more from you. - Sue. I found your site on google blog search and read a few of your other posts. Keep up the good work. Just added your RSS feed to my feed reader. Look forward to reading more from you.

- Sue.

]]> Comment on About by Marcelo http://www.electromedicalinfo.com/about/#comment-2603 Marcelo Mon, 18 Feb 2008 12:03:40 +0000 http://www.electromedicalinfo.com/about/#comment-2603 Hello Steli Thanks for the kind words, I´m glad you like the blog. After some time turbulent times, i´m now trying to update it more regularly. Hello Steli

Thanks for the kind words, I´m glad you like the blog. After some time turbulent times, i´m now trying to update it more regularly.

]]> Comment on About by Steli Loznen http://www.electromedicalinfo.com/about/#comment-2524 Steli Loznen Fri, 15 Feb 2008 22:31:00 +0000 http://www.electromedicalinfo.com/about/#comment-2524 Hi Marcello, Well done ! Congratulation for this blog. Professional, up to date, to object, shortly:very useful ! Best Regards, Steli Loznen, Convener IEC/SC62A/WG17 and co-convener WG14 Hi Marcello,
Well done !
Congratulation for this blog.
Professional, up to date, to object, shortly:very useful !
Best Regards,
Steli Loznen,
Convener IEC/SC62A/WG17 and co-convener WG14

]]> Comment on Links by OvEle http://www.electromedicalinfo.com/links/#comment-2483 OvEle Thu, 14 Feb 2008 03:10:09 +0000 http://www.electromedicalinfo.com/links/#comment-2483 Great Blog! We are looking to expand in to the medical equipment industry, and will be watching your blog! Great Blog! We are looking to expand in to the medical equipment industry, and will be watching your blog!

]]>