Re: IEC 61010 requirements
I think the spurious emissions would be a big problem. You would be amazed at the levels of EMI emitted by phones when they are in certain modes. While looking at some dual tri-mode digital phones from 3 different manufacturers (while placing digital calls in the 1800± MHz range?? or maybe the upper 800's range - I forget), I have seen emissions that were regularly 20-30+ dB above Class A from 40MHz all the way up to 1GHz (narrowband spurious, but distributed seemingly randomly all over the place). These emissions were from the phone itself on a turntable - no cables, just the phone taped to a cardboard box. Anecdotally, think of your PC speakers - I know a lot of people who know that a TDMA call is coming in when their speakers click. I must admit I haven't looked, but maybe the mall stores sell sterile faceplates? :) Best Regards, Dave Heald John Shinn wrote: If he had a LOW EMI Phone, how was he able to transmit out of the OR? It is not the incidental radiation that is the problem, it is the transmitter. Also, how was he able to answer the phone and maintain sterilization? John Shinn -Original Message- From: owner-emc-p...@majordomo.ieee.org [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of drcuthbert Sent: Monday, February 24, 2003 1:32 PM To: 'John Woodgate'; emc-p...@majordomo.ieee.org Subject: RE: IEC 61010 requirements Maybe he had a special low EMI cell phone? But seriously, a useful product would be a cell phone detector with an audible alarm, or a silent alarm to alert security. Dave Cuthbert -Original Message- From: John Woodgate [mailto:j...@jmwa.demon.co.uk] Sent: Saturday, February 22, 2003 1:05 AM To: emc-p...@majordomo.ieee.org Subject: Re: IEC 61010 requirements I read in !emc-pstc that peter merguerian pmerguerian2...@yahoo.com wrote (in 20030221231714.74613.qm...@web14806.mail.yahoo.com) about 'IEC 61010 requirements' on Fri, 21 Feb 2003: The other day, I called a surgeon and he happened to be in the operating room with his cellphone performing an operation. Does that make his cellular comply with IEC 601-1? Maybe not, but there are VERY serious EMC issues. No cell-phone should be switched on in an OR. -- Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk Interested in professional sound reinforcement and distribution? Then go to http://www.isce.org.uk PLEASE do NOT copy news posts to me by E-MAIL! --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical
RE: IEC 61010 requirements
-Original Message- From: John Woodgate [mailto:j...@jmwa.demon.co.uk] Sent: Saturday, February 22, 2003 12:05 AM To: emc-p...@majordomo.ieee.org Subject: Re: IEC 61010 requirements I read in !emc-pstc that peter merguerian pmerguerian2...@yahoo.com wrote (in 20030221231714.74613.qm...@web14806.mail.yahoo.com) about 'IEC 61010 requirements' on Fri, 21 Feb 2003: The other day, I called a surgeon and he happened to be in the operating room with his cellphone performing an operation. Does that make his cellular comply with IEC 601-1? Maybe not, but there are VERY serious EMC issues. No cell-phone should be switched on in an OR. -- Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk I would be even more concerned about fire explosion hazard. The cell phone is most likely not gas-tight. A couple of years ago, I talked with an anesthesiologist, who related his worries about oxygen and anesthesia gasses being trapped in folds of the patient's blankets (patient heat loss on an operating table is a concern) or the draping of the procedure site, thereby creating little flame or explosion zones. That surgeon's phone would just about in the worst place relative to the gasses. And another thought just arises; how did he take your call? Hard to see how he could do that without violating the isolation of the operating site. If this becomes a common practice, we'll soon hear a tale about somebody loosing a cellphone inside a patient, like what happens when they mis-count the sponges. Regards, Ed Ed Price ed.pr...@cubic.com Electromagnetic Compatibility Lab Cubic Defense Systems San Diego, CA USA 858-505-2780 (Voice) 858-505-1583 (Fax) Military Avionics EMC Is Our Specialty Shake-Bake-Shock - Metrology - Reliability Analysis This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: IEC 61010 requirements
If he had a LOW EMI Phone, how was he able to transmit out of the OR? It is not the incidental radiation that is the problem, it is the transmitter. Also, how was he able to answer the phone and maintain sterilization? John Shinn From: owner-emc-p...@majordomo.ieee.org [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of drcuthbert Sent: Monday, February 24, 2003 1:32 PM To: 'John Woodgate'; emc-p...@majordomo.ieee.org Subject: RE: IEC 61010 requirements Maybe he had a special low EMI cell phone? But seriously, a useful product would be a cell phone detector with an audible alarm, or a silent alarm to alert security. Dave Cuthbert From: John Woodgate [mailto:j...@jmwa.demon.co.uk] Sent: Saturday, February 22, 2003 1:05 AM To: emc-p...@majordomo.ieee.org Subject: Re: IEC 61010 requirements I read in !emc-pstc that peter merguerian pmerguerian2...@yahoo.com wrote (in 20030221231714.74613.qm...@web14806.mail.yahoo.com) about 'IEC 61010 requirements' on Fri, 21 Feb 2003: The other day, I called a surgeon and he happened to be in the operating room with his cellphone performing an operation. Does that make his cellular comply with IEC 601-1? Maybe not, but there are VERY serious EMC issues. No cell-phone should be switched on in an OR. -- Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk Interested in professional sound reinforcement and distribution? Then go to http://www.isce.org.uk PLEASE do NOT copy news posts to me by E-MAIL! This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: IEC 61010 requirements
Maybe he had a special low EMI cell phone? But seriously, a useful product would be a cell phone detector with an audible alarm, or a silent alarm to alert security. Dave Cuthbert From: John Woodgate [mailto:j...@jmwa.demon.co.uk] Sent: Saturday, February 22, 2003 1:05 AM To: emc-p...@majordomo.ieee.org Subject: Re: IEC 61010 requirements I read in !emc-pstc that peter merguerian pmerguerian2...@yahoo.com wrote (in 20030221231714.74613.qm...@web14806.mail.yahoo.com) about 'IEC 61010 requirements' on Fri, 21 Feb 2003: The other day, I called a surgeon and he happened to be in the operating room with his cellphone performing an operation. Does that make his cellular comply with IEC 601-1? Maybe not, but there are VERY serious EMC issues. No cell-phone should be switched on in an OR. -- Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk Interested in professional sound reinforcement and distribution? Then go to http://www.isce.org.uk PLEASE do NOT copy news posts to me by E-MAIL! This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: IEC 61010 requirements
Peter, Please let me have the name of the surgeon with the cellphone, so I'll be careful to avoid him!! Best Wishes, Jon On 21 Feb 2003 at 15:17, peter merguerian wrote: Jon, I must say that I somewhat disagree with you. A medical equipment as defined in IEC60601-1 is one that is for professional use. The surgeon's e-mails PC can also be used by his son and I do not consider it professional in the sense of the standard. Let's not exagerate here! A person with too many medical devices should stay in bed. The other day, I called a surgeon and he happened to be in the operating room with his cellphone performing an operation. Does that make his cellular comply with IEC 601-1? Peter Jon Griver jgri...@601help.com wrote: Delphina, It's not only an issue of intended use, but also a question of location. With regard to the example you give, if a PC for the surgeon's urgent emails is located within the 'patient vicinity', as defined in IEC 60601-1-1 (within about 6 feet of the patient's bed), then I believe that it should comply with IEC 60601-1, even though it's not a medical device. The reasoning behind this is that the patient could possibly touch the PC (that's the logic behind the 'patient vicinity' concept), and close a leakage current loop, together with other medical instruments with which he is in contact. This could be particularly nasty if there is a fault in the PC's earth wire. Regards, Jon Griver http://www.601help.com The Medical Device Developers Guide to IEC 60601-1 On 20 Feb 2003 at 12:38, Han, Delphina wrote: ! gt; Hi all, Thanks for your responses. When I originally asked the question, I was sure that the particular equipment I was asking about does not fall under the scope IEC60601, but I wanted to confirm if IEC61010 is the relevant standard. As you may notice, I have a copy of the IEC60601 standard but not IEC61010! I also needed to find out if there were special requirements for isolation transformers in IEC61010. From the discussion, it seems that which standard to comply with is dependent on the intended use, and not where the equipment is placed. So, if we put a PC in the hospital operating room, but it is just for the surgeon to let's say, check email (not practical...but this is just an example), would 60950 be the relevant standard? I doubt it'd have to meet 60601 requirements. How about EMC standards? (maybe I should start a ne! w thread...). Will this PC have to meet IEC 60601-1-2! for medical? Or EN 55022 for ITE? Bear in mind this is in the hospital operating room. I am familiar with medical equipment requirements but not so much with ITE, so forgive me if I'm making mistakes here. My thoughts are all from the regulatory point of view. Of course if the customer wants compliance with a more stringent requirement, that is what he gets... I appreciate all your thoughts/comments! -Delphina At 09:10 AM 2/19/2003 -0800, Han, Delphina wrote: Hi I am trying to find out safety requirements for devices that control and monitor equipment in a hospital lab (used for pathology). Does it fall under the IEC 61010 standard? If so, are there any requirements for use of isolation transformers in! that standard? Thanks in advance for your response! -Delphina --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.or! g Archive is being moved, ! we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list
Re: IEC 61010 requirements
I read in !emc-pstc that peter merguerian pmerguerian2...@yahoo.com wrote (in 20030221231714.74613.qm...@web14806.mail.yahoo.com) about 'IEC 61010 requirements' on Fri, 21 Feb 2003: The other day, I called a surgeon and he happened to be in the operating room with his cellphone performing an operation. Does that make his cellular comply with IEC 601-1? Maybe not, but there are VERY serious EMC issues. No cell-phone should be switched on in an OR. -- Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk Interested in professional sound reinforcement and distribution? Then go to http://www.isce.org.uk PLEASE do NOT copy news posts to me by E-MAIL! This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: IEC 61010 requirements
Delphina, It's not only an issue of intended use, but also a question of location. With regard to the example you give, if a PC for the surgeon's urgent emails is located within the 'patient vicinity', as defined in IEC 60601-1-1 (within about 6 feet of the patient's bed), then I believe that it should comply with IEC 60601-1, even though it's not a medical device. The reasoning behind this is that the patient could possibly touch the PC (that's the logic behind the 'patient vicinity' concept), and close a leakage current loop, together with other medical instruments with which he is in contact. This could be particularly nasty if there is a fault in the PC's earth wire. Regards, Jon Griver http://www.601help.com The Medical Device Developers Guide to IEC 60601-1 On 20 Feb 2003 at 12:38, Han, Delphina wrote: Hi all, Thanks for your responses. When I originally asked the question, I was sure that the particular equipment I was asking about does not fall under the scope IEC60601, but I wanted to confirm if IEC61010 is the relevant standard. As you may notice, I have a copy of the IEC60601 standard but not IEC61010! I also needed to find out if there were special requirements for isolation transformers in IEC61010. From the discussion, it seems that which standard to comply with is dependent on the intended use, and not where the equipment is placed. So, if we put a PC in the hospital operating room, but it is just for the surgeon to let's say, check email (not practical...but this is just an example), would 60950 be the relevant standard? I doubt it'd have to meet 60601 requirements. How about EMC standards? (maybe I should start a new thread...). Will this PC have to meet IEC 60601-1-2 for medical? Or EN 55022 for ITE? Bear in mind this is in the hospital operating room. I am familiar with medical equipment requirements but not so much with ITE, so forgive me if I'm making mistakes here. My thoughts are all from the regulatory point of view. Of course if the customer wants compliance with a more stringent requirement, that is what he gets... I appreciate all your thoughts/comments! -Delphina At 09:10 AM 2/19/2003 -0800, Han, Delphina wrote: Hi I am trying to find out safety requirements for devices that control and monitor equipment in a hospital lab (used for pathology). Does it fall under the IEC 61010 standard? If so, are there any requirements for use of isolation transformers in that standard? Thanks in advance for your response! -Delphina --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: IEC 61010 requirements
George Strictly speaking, I suppose you are correct in saying that 60601-1-1 is for medical electrical systems, but it also gives a good insight into the rationales behind the need to apply the medical standards, or allow use of equipment to non-medical standards. Therefore, if you are trying to understand where the distinction comes, then it can assist you in making a rationale and defensible decision on the choice of the standards to apply. As far as I can judge it was created to a large extent because of this confusion as to where to make that distinction, and to allow the use of commercial equipment in those locations where it is obviously safe enough. By comparison, if you (or any one else for that matter!) can cast your mind back some 20-25 years we were stuck (in the UK) with the infamous DHSS Hospital Technical Memorandum No 8 (HTM8)which was intended to apply to truely medical equipment but was often applied to anything in a hospital. That was a b* of a standard - very prescriptive and impossible for much non-medical equipment to meet (e.g. EVERY exposed metal part had to be earthed to a heavy current withstand level, regardless of whether there was any chance of it being energised under fault conditions or not - trying earthing the stainless steel metal paper catcher frame for an old line-printer to that requirement (almost impossible)!!). Therefore with the development of IEC601 (now 60601) the reins were loosened a bit to allow the acceptance of commercial standards-compliant equipment in some areas of medical facilities - that in turn lead to confusion as to where the decision point lies. But seeing 60601-1-1 for the first time a few years ago, it certainly made sense as a very useful guidance document for the selection of the required compliance standard - regardless of whether or not there was/is a medical system involved. EMC, on the other hand, is an entirely different issue as radiated EM effects can spread much further than the relatively short distances envisaged in 60601-1-1, and thus compliance with medical EMC standards may well be a requirement to ensure non-interference with the true medical equipment near to where the non-medical equipment is located. That could be a problem - which now appears to be addressed by another thread! (And system reliability for safety reasons is another area which I am also not going to get into here!) Regards John Allen From: George Brimlow [mailto:george.brim...@nottingham.ac.uk] Sent: 20 February 2003 17:40 To: emc-p...@majordomo.ieee.org Subject: Re: IEC 61010 requirements Hi, In response to John Allen's comment, my understanding would be that the medical electrical systems standard (60601-1-1) doesn't really help you here. This standard covers the situation where you have a system of either interconnected electrical medical equipment or a mixed system of interconnected electrical medical equipment and other equipment (e.g. IT). The standard outlines additional measures that may be required for the system to ensure that the patient safety is not impaired by the fact that the electrical medical equipment (meeting 60601-1) is connected to non-medical equipment (meeting e.g. 60950, 61010) or by the fact that the non-medical equipment may be within the patient environment. This is separate to the issue of whether an individual item of equipment is classed as medical. The standard could be relevant though if your equipment were required to be connected to medical equipment. Hope that helps, Regards, -- Dr George Brimlow, Principal Clinical Scientist Medical Physics Dept Queen's Medical Centre Nottingham, NG7 2UH UK Tel. +44(0)115 924 9924 ext 44889 Fax +44(0)115 942 2745 george.brim...@nottingham.ac.uk Hi Folks The basic answers to the questions of which items of medical equipment are, and are not, required to be compliant to 60601 are given in EN 60601-1-1 Medical electrical equipment Part 1-1: General requirements for safety. Collateral standard: Safety requirements for medical electrical systems This describes the requirements and has diagrams to illustrate the various combinations of 60601 and non-60601 equipments. Regards John Allen -Original Message- From: Han, Delphina [mailto:d...@strykerendo.com] Hi I am trying to find out safety requirements for devices that control and monitor equipment in a hospital lab (used for pathology). Does it fall under the IEC 61010 standard? If so, are there any requirements for use of isolation transformers in that standard? Thanks in advance for your response! -Delphina This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard
Re: (Fwd) RE: IEC 61010 requirements
Hello Jon, Thanks for the clarification. This helps in understanding which safety standards may be applied to a medical device based on its intended use. Therefore, it is very important that we understand what a medical device is versus medical equipment or laboratory equipment, as they are defined by regulatory authorities and standards development organizations. Unfortunately, we may use medical device and medical equipment interchangeably and unintentionally confuse people, just like I did. Best regards, Ron Wellman At 06:58 PM 2/20/2003 +0200, Jon Griver wrote: Ron, Classification of in-vitro devices as medical equipment, requiring regulatory approval, does not influence the choice of product safety standard to be used. If it does not fall within the scope of IEC 60601-1, and is only used in the lab, then IEC 61010 should be used, though IEC 60950 would probably be acceptable if the instrument is based on a PC. Regards, Jon Griver http://www.601help.com The Medical Device Developers Guide to IEC 60601-1 Hello Greg, I have to disagree with your interpretation. There are many in vitro devices that are classified as medical equipment and are subject to pre-market approvals in the US, Japan, and EU. There are strict regulations on labeling products in the US where even advertising is considered labeling. It's not as simple as contacting a live human, there are many other factors involved based on regulations and interpretations of regulatory authorities. Best regards, Ron Wellman At 11:15 PM 2/19/2003 -0500, Gregg Kervill wrote: Does it contact a live human - if answer no - it is not medical equipment. The purpose for the medical device directive is to protect people for harm or infection - being alive would seem to be essential for this. G --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc --- End of forwarded message --- --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Re: IEC 61010 requirements
I read in !emc-pstc that Han, Delphina d...@strykerendo.com wrote (in 4196ec6cef84454d84b90731c905c50e279...@chopin.endo.strykercorp.com) about 'IEC 61010 requirements' on Thu, 20 Feb 2003: How about EMC standards? (maybe I should start a new thread...). Will this PC have to meet IEC 60601-1-2 for medical? Or EN 55022 for ITE? Bear in mind this is in the hospital operating room. I am familiar with medical equipment requirements but not so much with ITE, so forgive me if I'm making mistakes here. You make a very important point, by implication. While safety largely stays within the physical bounds of the equipment and its cables, radiated emissions don't, by definition, and some conducted emissions may not. Immunity is even more subtle: the equipment is exposed to an environment not necessarily foreseen by the manufacturer (although you *have* foreseen it). The conclusion has to be that the 'medical' standards for emissions and immunity should be applied, but **applied with insight**. Provisions of the standards that are irrelevant for the equipment in question need not apply, but all such exceptions MUST be documented. -- Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk Interested in professional sound reinforcement and distribution? Then go to http://www.isce.org.uk PLEASE do NOT copy news posts to me by E-MAIL! This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: IEC 61010 requirements
Hi all, Thanks for your responses. When I originally asked the question, I was sure that the particular equipment I was asking about does not fall under the scope IEC60601, but I wanted to confirm if IEC61010 is the relevant standard. As you may notice, I have a copy of the IEC60601 standard but not IEC61010! I also needed to find out if there were special requirements for isolation transformers in IEC61010. From the discussion, it seems that which standard to comply with is dependent on the intended use, and not where the equipment is placed. So, if we put a PC in the hospital operating room, but it is just for the surgeon to let's say, check email (not practical...but this is just an example), would 60950 be the relevant standard? I doubt it'd have to meet 60601 requirements. How about EMC standards? (maybe I should start a new thread...). Will this PC have to meet IEC 60601-1-2 for medical? Or EN 55022 for ITE? Bear in mind this is in the hospital operating room. I am familiar with medical equipment requirements but not so much with ITE, so forgive me if I'm making mistakes here. My thoughts are all from the regulatory point of view. Of course if the customer wants compliance with a more stringent requirement, that is what he gets... I appreciate all your thoughts/comments! -Delphina At 09:10 AM 2/19/2003 -0800, Han, Delphina wrote: Hi I am trying to find out safety requirements for devices that control and monitor equipment in a hospital lab (used for pathology). Does it fall under the IEC 61010 standard? If so, are there any requirements for use of isolation transformers in that standard? Thanks in advance for your response! -Delphina --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: IEC 61010 requirements
Yes - and there are also FDA (and other) requirements on Hardware and Software traceability used to control drug manufacture - I was trying to give a simple answer to the question in the context of electrical/electronic equipment (61010) that may - or may not - contact the human body. Best regards Gregg From: owner-emc-p...@majordomo.ieee.org [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Ronald R. Wellman Sent: Thursday, February 20, 2003 9:44 AM To: Gregg Kervill; emc-p...@majordomo.ieee.org Subject: RE: IEC 61010 requirements Hello Greg, I have to disagree with your interpretation. There are many in vitro devices that are classified as medical equipment and are subject to pre-market approvals in the US, Japan, and EU. There are strict regulations on labeling products in the US where even advertising is considered labeling. It's not as simple as contacting a live human, there are many other factors involved based on regulations and interpretations of regulatory authorities. Best regards, Ron Wellman At 11:15 PM 2/19/2003 -0500, Gregg Kervill wrote: Does it contact a live human - if answer no - it is not medical equipment. The purpose for the medical device directive is to protect people for harm or infection - being alive would seem to be essential for this. G --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: IEC 61010 requirements
I would also disagree with Gregg's statement - the 3 Medical Device Directives cover a much wider range of products than he suggests, - just about any device involved in the diagnosis, monitoring, treatment, or alleviation of desease, injury or handicap. This includes many devices that the patient never even sees let alone makes contact with (diagnostic laboratory equipment as an example). This wide range of equipemnt is coverd by a correspondingly wide range of standards, one group of which is the 60601 series for medcial electrcial equipment. The scope of 60601 corresponds roughly to Gregg's definition; it applies to electrical equipment which makes physical or electrical contact with the the patient +/or involves transfer of energy to or from the patient. However the 60601 standards do not encompass all electromedcial devices, let alone all medical devices. Ged Dean From: Gregg Kervill [mailto:gr...@test4safety.com] Sent: 20 February 2003 04:15 To: emc-p...@majordomo.ieee.org Subject: RE: IEC 61010 requirements Does it contact a live human - if answer no - it is not medical equipment. The purpose for the medical device directive is to protect people for harm or infection - being alive would seem to be essential for this. G ** 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 notify the system manager. This footnote also confirms that this email message has been swept by MIMEsweeper for the presence of computer viruses. NCHT ** This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: IEC 61010 requirements
Hello all, There is some confusion between medical devices, in vitro diagnostic devices, and the scopes of possibly applicable safety standards. In the US in vitro diagnostic devices are a type of medical device and all medical devices are subject to applicable FDA regulation. In Europe, there are separate Directives for medical devices and in vitro diagnostic devices. Both IEC EN 60601-1 series and IEC EN 61010 series are appropriate safety standards for electrically powered medical devices. However, the scopes of the two documents are different. 60601 applies to the safety of MEDICAL ELECTRICAL EQUIPMENT (a defined term). MEDICAL ELECTRICAL EQUIPMENT is defined as: electrical EQUIPMENT, provided with not more than one connection to a particular SUPPLY MAINS; and intended to diagnose, treat, or monitor the PATIENT under medical supervision; and which makes physical or electrical contact with the PATIENT and/or transfers energy to or from the PATIENT and/or detects such energy transfer to or from the PATIENT the EQUIPMENT includes those ACCESSORIES as defined by the manufacturer which are necessary to enable the NORMAL USE of the EQUIPMENT Hence, only that electrical equipment that connects to the patient or controls the flow of energy into or out of the patient is in scope of 60601-1. Any other electrical equipment, intended for medical use in a hospital, is likely to be in scope of either IEC EN 61010 series or might even be medical software running on (ITE) IEC EN 60950 hardware. Both directives and the FDA have extensive quality systems (design and manufacturing), postmarket surveilance, and device specific premarket requirements. Any organization that is not familiar with these requirements should seek professional help before starting to even design products for these marketplaces. Best regards, Dave Osborn Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099 +1 978 659 3178 fax +1 978 685 5624 dave.osb...@philips.com This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Re: IEC 61010 requirements
Hi, In response to John Allen's comment, my understanding would be that the medical electrical systems standard (60601-1-1) doesn't really help you here. This standard covers the situation where you have a system of either interconnected electrical medical equipment or a mixed system of interconnected electrical medical equipment and other equipment (e.g. IT). The standard outlines additional measures that may be required for the system to ensure that the patient safety is not impaired by the fact that the electrical medical equipment (meeting 60601-1) is connected to non-medical equipment (meeting e.g. 60950, 61010) or by the fact that the non-medical equipment may be within the patient environment. This is separate to the issue of whether an individual item of equipment is classed as medical. The standard could be relevant though if your equipment were required to be connected to medical equipment. Hope that helps, Regards, -- Dr George Brimlow, Principal Clinical Scientist Medical Physics Dept Queen's Medical Centre Nottingham, NG7 2UH UK Tel. +44(0)115 924 9924 ext 44889 Fax +44(0)115 942 2745 george.brim...@nottingham.ac.uk Hi Folks The basic answers to the questions of which items of medical equipment are, and are not, required to be compliant to 60601 are given in EN 60601-1-1 Medical electrical equipment Part 1-1: General requirements for safety. Collateral standard: Safety requirements for medical electrical systems This describes the requirements and has diagrams to illustrate the various combinations of 60601 and non-60601 equipments. Regards John Allen -Original Message- From: Han, Delphina [mailto:d...@strykerendo.com] Hi I am trying to find out safety requirements for devices that control and monitor equipment in a hospital lab (used for pathology). Does it fall under the IEC 61010 standard? If so, are there any requirements for use of isolation transformers in that standard? Thanks in advance for your response! -Delphina This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
(Fwd) RE: IEC 61010 requirements
Ron, Classification of in-vitro devices as medical equipment, requiring regulatory approval, does not influence the choice of product safety standard to be used. If it does not fall within the scope of IEC 60601-1, and is only used in the lab, then IEC 61010 should be used, though IEC 60950 would probably be acceptable if the instrument is based on a PC. Regards, Jon Griver http://www.601help.com The Medical Device Developers Guide to IEC 60601-1 Hello Greg, I have to disagree with your interpretation. There are many in vitro devices that are classified as medical equipment and are subject to pre-market approvals in the US, Japan, and EU. There are strict regulations on labeling products in the US where even advertising is considered labeling. It's not as simple as contacting a live human, there are many other factors involved based on regulations and interpretations of regulatory authorities. Best regards, Ron Wellman At 11:15 PM 2/19/2003 -0500, Gregg Kervill wrote: Does it contact a live human - if answer no - it is not medical equipment. The purpose for the medical device directive is to protect people for harm or infection - being alive would seem to be essential for this. G --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Re: IEC 61010 requirements
Hello Mike, It will usually be at the hospital's discretion to impose any additional safety or certification requirements on products that are not used in the direct diagnosis or treatment of patients. However, I have never known of anyone asking for a computer monitor to be IEC 60601-1 compliant. My experience with lab equipment in a hospital Toxicology lab has been that there were no concerns about which safety standard it complied with, as long as the product is safe for its intended use and it performs its intended function. Best regards, Ron Wellman At 06:13 PM 2/19/2003 -0800, Mike wrote: My opinion is that unless there are unusual circumstances, an ITE (IEC60950) certified monitor should satisfy ordinary lab needs. Any dissent? Mike Harris/Teccom Co./Hayward CA - Original Message - From: Ronald R. Wellman rwell...@wellman.com To: Han, Delphina d...@strykerendo.com; emc-p...@majordomo.ieee.org Sent: Wednesday, February 19, 2003 5:27 PM Subject: Re: IEC 61010 requirements Hello Delphina, Laboratory equipment can be considered medical devices if you advertise them as such or claim that they can be used be physicians to form medical opinions. However, most laboratory equipment manufacturers get around this by claiming that their products are intended for research use only so they don't have to make pre-market approvals to regulatory agencies. How a hospital lab uses non-approved devices is not governed by pre-market approval regulations because the regulations are not intended to tell physicians how to practice medicine. Therefore, to answer your question concerning the use of an isolation transformer, this will depend on whether you need to conform to the leakage current requirements of IEC 61010-1 or 60101-1. I suggest that you purchase copies of both standards and understand their differences. However, based on your equipment description it appears that 61010-1 will be the safety standard you will need to use. Best regards, Ron Wellman At 09:10 AM 2/19/2003 -0800, Han, Delphina wrote: Hi I am trying to find out safety requirements for devices that control and monitor equipment in a hospital lab (used for pathology). Does it fall under the IEC 61010 standard? If so, are there any requirements for use of isolation transformers in that standard? Thanks in advance for your response! -Delphina --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc --- This message
RE: IEC 61010 requirements
Hello Greg, I have to disagree with your interpretation. There are many in vitro devices that are classified as medical equipment and are subject to pre-market approvals in the US, Japan, and EU. There are strict regulations on labeling products in the US where even advertising is considered labeling. It's not as simple as contacting a live human, there are many other factors involved based on regulations and interpretations of regulatory authorities. Best regards, Ron Wellman At 11:15 PM 2/19/2003 -0500, Gregg Kervill wrote: Does it contact a live human - if answer no - it is not medical equipment. The purpose for the medical device directive is to protect people for harm or infection - being alive would seem to be essential for this. G --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: IEC 61010 requirements
Mr Poore While you are correct in the intent and meaning of the standard; my point was, that if the customer specs product compliance with standard xyz, than the requirements of xyz becomes your design and test target. I have lost count of the number of times that a customer has spec'd 601-1 or whatever, when either x950 or x1010-1 is applicable for the intended end use. What the customer wants, the customer gets (if he pays)... Brian There are no requirements for using an isolation transformer as long as you can meet the requirements for touch current (leakage current) without one. These requirements are similiar to 950, and not as stringent as the medical requirement. Chris Poore -Original Message- From: owner-emc-p...@majordomo.ieee.org Sent: Wednesday, February 19, 2003 11:42 AM To: emc-p...@majordomo.ieee.org Subject: RE: IEC 61010 requirements If end-use wiil never see contact w/patient or test subject, and equipment can be classified as Electrical Test and/or Measurement equipment, and does NOT fall under the scope of the Med Directive, and can be scoped under the LVD, then 61010-1 is applicable standard. Of course, the customer spec can require compliance to the Med Dev Dir. Brian -Original Message- From: Han, Delphina Sent: Wednesday, February 19, 2003 9:10 AM To: emc-p...@majordomo.ieee.org Subject: IEC 61010 requirements Hi I am trying to find out safety requirements for devices that control and monitor equipment in a hospital lab (used for pathology). Does it fall under the IEC 61010 standard? If so, are there any requirements for use of isolation transformers in that standard?
RE: IEC 61010 requirements
The term monitor in the Instrumentation context does not always infers a display device. Monitor, in this context, could refer to a data acquisition device. I have not read anything in 601-x-x standards or the med directive, that would make me believe that the intended end-use of an instrument by a physician, in a lab enviroment only, requires compliance with 601-1. I would appreciate standard/clause reference if I have missed this.. thanx, Brian My opinion is that unless there are unusual circumstances, an ITE (IEC60950) certified monitor should satisfy ordinary lab needs. Any dissent? Mike Harris/Teccom Co./Hayward CA - Original Message - From: Ronald R. Wellman rwell...@wellman.com To: Han, Delphina d...@strykerendo.com; emc-p...@majordomo.ieee.org Sent: Wednesday, February 19, 2003 5:27 PM Subject: Re: IEC 61010 requirements Hello Delphina, Laboratory equipment can be considered medical devices if you advertise them as such or claim that they can be used be physicians to form medical opinions. However, most laboratory equipment manufacturers get around this by claiming that their products are intended for research use only so they don't have to make pre-market approvals to regulatory agencies. How a hospital lab uses non-approved devices is not governed by pre-market approval regulations because the regulations are not intended to tell physicians how to practice medicine. Therefore, to answer your question concerning the use of an isolation transformer, this will depend on whether you need to conform to the leakage current requirements of IEC 61010-1 or 60101-1. I suggest that you purchase copies of both standards and understand their differences. However, based on your equipment description it appears that 61010-1 will be the safety standard you will need to use. Best regards, Ron Wellman At 09:10 AM 2/19/2003 -0800, Han, Delphina wrote: Hi I am trying to find out safety requirements for devices that control and monitor equipment in a hospital lab (used for pathology). Does it fall under the IEC 61010 standard? If so, are there any requirements for use of isolation transformers in that standard?
RE: IEC 61010 requirements
Hi Folks The basic answers to the questions of which items of medical equipment are, and are not, required to be compliant to 60601 are given in EN 60601-1-1 Medical electrical equipment Part 1-1: General requirements for safety. Collateral standard: Safety requirements for medical electrical systems This describes the requirements and has diagrams to illustrate the various combinations of 60601 and non-60601 equipments. Regards John Allen Technical Consultant Safety and Risk Management ERA Technology Ltd Cleeve Rd Leatherhead Surrey KT22 7SA Tel:+44 (0) 1372-367025 (Direct) +44 (0) 1372-367000 (Switchboard) Fax:+44 (0) 1372-367102 (Fax) From: Han, Delphina [mailto:d...@strykerendo.com] Sent: 19 February 2003 17:10 To: emc-p...@majordomo.ieee.org Subject: IEC 61010 requirements Hi I am trying to find out safety requirements for devices that control and monitor equipment in a hospital lab (used for pathology). Does it fall under the IEC 61010 standard? If so, are there any requirements for use of isolation transformers in that standard? Thanks in advance for your response! -Delphina This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc _ This e-mail has been scanned for viruses by the WorldCom Internet Managed Scanning Service - powered by MessageLabs. For further information visit http://www.worldcom.com * Copyright ERA Technology Ltd. 2002. (www.era.co.uk). All rights reserved. The information supplied in this Commercial Communication should be treated in confidence. No liability whatsoever is accepted for any loss or damage suffered as a result of accessing this message or any attachments. _ This e-mail has been scanned for viruses by the WorldCom Internet Managed Scanning Service - powered by MessageLabs. For further information visit http://www.worldcom.com This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: IEC 61010 requirements
Does it contact a live human - if answer no - it is not medical equipment. The purpose for the medical device directive is to protect people for harm or infection - being alive would seem to be essential for this. G This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Re: IEC 61010 requirements
My opinion is that unless there are unusual circumstances, an ITE (IEC60950) certified monitor should satisfy ordinary lab needs. Any dissent? Mike Harris/Teccom Co./Hayward CA From: Ronald R. Wellman rwell...@wellman.com To: Han, Delphina d...@strykerendo.com; emc-p...@majordomo.ieee.org Sent: Wednesday, February 19, 2003 5:27 PM Subject: Re: IEC 61010 requirements Hello Delphina, Laboratory equipment can be considered medical devices if you advertise them as such or claim that they can be used be physicians to form medical opinions. However, most laboratory equipment manufacturers get around this by claiming that their products are intended for research use only so they don't have to make pre-market approvals to regulatory agencies. How a hospital lab uses non-approved devices is not governed by pre-market approval regulations because the regulations are not intended to tell physicians how to practice medicine. Therefore, to answer your question concerning the use of an isolation transformer, this will depend on whether you need to conform to the leakage current requirements of IEC 61010-1 or 60101-1. I suggest that you purchase copies of both standards and understand their differences. However, based on your equipment description it appears that 61010-1 will be the safety standard you will need to use. Best regards, Ron Wellman At 09:10 AM 2/19/2003 -0800, Han, Delphina wrote: Hi I am trying to find out safety requirements for devices that control and monitor equipment in a hospital lab (used for pathology). Does it fall under the IEC 61010 standard? If so, are there any requirements for use of isolation transformers in that standard? Thanks in advance for your response! -Delphina --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Re: IEC 61010 requirements
Hello Delphina, Laboratory equipment can be considered medical devices if you advertise them as such or claim that they can be used be physicians to form medical opinions. However, most laboratory equipment manufacturers get around this by claiming that their products are intended for research use only so they don't have to make pre-market approvals to regulatory agencies. How a hospital lab uses non-approved devices is not governed by pre-market approval regulations because the regulations are not intended to tell physicians how to practice medicine. Therefore, to answer your question concerning the use of an isolation transformer, this will depend on whether you need to conform to the leakage current requirements of IEC 61010-1 or 60101-1. I suggest that you purchase copies of both standards and understand their differences. However, based on your equipment description it appears that 61010-1 will be the safety standard you will need to use. Best regards, Ron Wellman At 09:10 AM 2/19/2003 -0800, Han, Delphina wrote: Hi I am trying to find out safety requirements for devices that control and monitor equipment in a hospital lab (used for pathology). Does it fall under the IEC 61010 standard? If so, are there any requirements for use of isolation transformers in that standard? Thanks in advance for your response! -Delphina --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: IEC 61010 requirements
There are no requirements for using an isolation transformer as long as you can meet the requirements for touch current (leakage current) without one. These requirements are similiar to 950, and not as stringent as the medical requirement. Chris Poore From: owner-emc-p...@majordomo.ieee.org [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of boconn...@t-yuden.com Sent: Wednesday, February 19, 2003 11:42 AM To: emc-p...@majordomo.ieee.org Subject: RE: IEC 61010 requirements If end-use wiil never see contact w/patient or test subject, and equipment can be classified as Electrical Test and/or Measurement equipment, and does NOT fall under the scope of the Med Directive, and can be scoped under the LVD, then 61010-1 is applicable standard. Of course, the customer spec can require compliance to the Med Dev Dir. Brian -Original Message- From: Han, Delphina [ mailto:d...@strykerendo.com] Sent: Wednesday, February 19, 2003 9:10 AM To: emc-p...@majordomo.ieee.org Subject: IEC 61010 requirements Hi I am trying to find out safety requirements for devices that control and monitor equipment in a hospital lab (used for pathology). Does it fall under the IEC 61010 standard? If so, are there any requirements for use of isolation transformers in that standard?
RE: IEC 61010 requirements
If end-use wiil never see contact w/patient or test subject, and equipment can be classified as Electrical Test and/or Measurement equipment, and does NOT fall under the scope of the Med Directive, and can be scoped under the LVD, then 61010-1 is applicable standard. Of course, the customer spec can require compliance to the Med Dev Dir. Brian -Original Message- From: Han, Delphina [ mailto:d...@strykerendo.com] Sent: Wednesday, February 19, 2003 9:10 AM To: emc-p...@majordomo.ieee.org Subject: IEC 61010 requirements Hi I am trying to find out safety requirements for devices that control and monitor equipment in a hospital lab (used for pathology). Does it fall under the IEC 61010 standard? If so, are there any requirements for use of isolation transformers in that standard?
