Re: Re: electroporation device safety requirements

2007-01-29 Thread emc-p...@ieee.org
In message 74ff013b0701290719k6cb34412o25a1854da8218...@mail.gmail.com, dated Mon, 29 Jan 2007, Jon Griver jgri...@601help.com writes It is clear that such a device would have great difficulty complying with EMC requirements, so clause 36 of IEC 60601-2-36, the particular standard for

RE: electroporation device safety requirements

2007-01-29 Thread emc-p...@ieee.org
Paolo - Not knowing what electroporation is and being curious, I did some internet poking around. Electroporation is an in-vitro process that uses high voltages. Wikipedia, for instance, mentions use of pulsed 2,400 V, when working with bacteria. See

Re: electroporation device safety requirements

2007-01-29 Thread emc-p...@ieee.org
John, You will be happy (or maybe not) to know that this approach is still alive and kicking with regard to medical equipment. A lithotriptor is a medical device used to break up kidney stones. Its method of operation is to produce shock waves in water by what is basically a spark plug. It is

Re: electroporation device safety requirements

2007-01-29 Thread emc-p...@ieee.org
: electroporation device safety requirements Paolo, I think that you will have to rely on the leakage current requirements of the base standard, IEC 60601-1. The only particular standard which may have relevance could be IEC 60601-2-2, PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH

Re: electroporation device safety requirements

2007-01-29 Thread emc-p...@ieee.org
In message 20070129134628.m27...@elen.it, dated Mon, 29 Jan 2007, Paolo Peruzzi standa...@elen.it writes Without any particular perscription, does it mean one can deliver energy without limits, provided the system is in compliance with IEC 60601-1 and it's succesfully validated for the

Re: electroporation device safety requirements

2007-01-29 Thread emc-p...@ieee.org
Regulatory Engineer El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI) Italy Tel. +39 055 8826807 FAX +39 055 8832884 http://www.elengroup.com/ From: Jon Griver jgri...@601help.com To: emc-p...@ieee.org Sent: Mon, 29 Jan 2007 14:55:54 +0200 Subject: Re: electroporation device safety

Re: electroporation device safety requirements

2007-01-29 Thread emc-p...@ieee.org
Paolo, I think that you will have to rely on the leakage current requirements of the base standard, IEC 60601-1. The only particular standard which may have relevance could be IEC 60601-2-2, PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH FREQUENCY SURGICAL EQUIPMENT. You would have to check out

electroporation device safety requirements

2007-01-29 Thread emc-p...@ieee.org
Dear all, does anybody know which particular standard (if it exist) should apply to a medical device intended to be used for electroporation? I'm mainly interested in requirements concerning limits on delivered power (voltage/current) and operation frequency contraints. Regards, Paolo Peruzzi