AC Line leakage Test - Medical Devices Group

Carl W Tope

Field Service Professional

May 2015

< 1 min reading time

My company services Clinical pathology equipment. i.e. microtomes Cryostats Tissue process, stainer, embedders etc. Since theya re not directly hooked to the patient I believe they are class 2 devices. We are exploring doing AC leakage testing on these in the course of a PM as a value added for our customers. Anybody out there know what standards these machines fall under. IEC? EN? I am task with finding a quality tester that will fit our budget.<$1000

source: https://www.linkedin.com/groups/78665/78665-6008307132527624196

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Posted by Carl W Tope

Asked on May 24, 2015 12:00 am

49 views

	Private answer Stephen Glassic You might want to check out BC Biomedical or Netech. They both have basic safety analyzers that won't break the bank. If you want high quality, Fluke is a good bet, but even a basic unit from them might be above your budget. Here is a link to a page from ECRI that gives a brief overview on electrical safety requirements. http://www.mdsr.ecri.org/summary/detail.aspx?doc_id=8286 Marked as spam Report spam
	Private answer Carl W Tope Thanks for the leads Stephen, yest the Fluke models I ran across were in the $4k range but other companies offerings were even more. There seems to be 3 or 4 different tests that can be performed. I am mostly concerned with the Line to Gnd leakage and the device case isolation. Marked as spam Report spam
	Private answer Carl W Tope Thanks Ray! I'll look that one up and put it in the stack with the BC instruments device. Marked as spam Report spam
	Private answer Ray Gonzales fluke 360, $759 @ techni-tool.com Marked as spam Report spam
	Private answer Gunalan Dass Most of the pathology equipment is referring to IEC61010, so if you going to do safety test your EST analyzer need have this standard. Marked as spam Report spam
	Private answer I would cheek if Spectrum Technologies has a used device that fits the requirements Marked as spam Report spam
	Private answer Peter Nutt Hi Carl In Australia, that equipment would not be considered Biomedical for electrical safety testing as it has no patient connection etc, would fall under AS 3760 portable electrical appliances and would only require a test and tag, these devices range in price from 600 to several thousand dollars Koyritsu make a basic tester for well under 1000 USD Marked as spam Report spam
	Private answer I suggest you put a cold towel on your head and work through 60101 (not a small task). If you are not connected to the patient, I am surprised that you have to worry about line leakage. Marked as spam Report spam
	Private answer Carl W Tope Chris, I know what you mean, just sorting through all the different standards to see which one is applicable is enough reading! As Peter points out many countries have different standards. We have reference labs that undergo periodic inspections and this is something that they are supposed to provide to show that the med techs are using safe equipment.. Marked as spam Report spam
	Private answer Peter Nutt Hi Carl Safe equipment in a non patient environment really does not require the same leakage tests, with earth open cct and neutral open cct IMHO, this is not a patient environment and as long as power circuits have RCD protection where practicable then all reasonable precautions have been taken Marked as spam Report spam
	Private answer Ray Gonzales Check OSHA, AAMI, IEEE websites, regarding related standards on leakage current on medical devices. Although the instruments you mentioned does not have direct connection to patient, they do have direct contact with operators. Marked as spam Report spam

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