Hi Brian,
I will get back to you by tomorrow evening European time with my detailed experiences with German market surveillance authorities, the conflict between IEC TC 66 with the new standard IEC 61010-2-120 and IEC TC 44, the FAILED voting for FprEN 61010-2-120, the rejected mandate by CENELEC for the machinery directive (see note in <http://j.tinyurl.com/fpren-61010-2-120> http://j.tinyurl.com/fpren-61010-2-120) and other “blooper”. General comment: if an electrical product (category) is not listed in article 1 section 2 lit. k) of 2006/42/EC such kind of electrical products with machine functions are machinery! That is the “black and white” understanding of Brussels between the LVD and MD. Our German market surveillance authorities are enforcing “wrong declarations of conformity” for such kind of products. Michael Von: Kunde, Brian [mailto:[email protected]] Gesendet: Donnerstag, 30. März 2017 20:19 An: [email protected] Betreff: [PSES] MD vs LVD for Laboratory Equipment Sorry to say, this issue has once again reared its ugly head. I appreciate any and all input. History: For many many years, laboratory equipment fell under the Low Voltage Directive (LVD), even products with moving parts. It was specifically excluded from the Machinery Directive (MD). The Safety Standard for Laboratory Equipment EN 61010-1 is harmonized to the LVD. Life was good. Then a new version of the MD was released which did not exclude Laboratory Equipment. Many of the EHSR from annex I did not apply and there were no harmonized standards specific to laboratory equipment. So the same set of safety rules that apply to Industrial/Factory Machinery must somehow be applied to Carbon Analyzers, Calorimeters, Hardness Testers, and Mass Spectrometers. Life sucks. BUT then the New Safety Standards EN 61010-1 3rd Ed. was released which included hazards from Moving Parts and referenced a Risk Assessment for any hazards not covered by the standard. The standard now covered all hazardous conditions associated with Laboratory Equipment including moving parts, electrical, chemical, hot/cold temperatures, radiation, pressurized fluids, everything. AND THEN the new LVD was released which was aligned with the NLF. Can Life be Good Again? The Topper: Recently we have been contacted by two different Notified Bodies in Europe which has informed us that we should be using the LVD and not the MD. When I asked for a reason why they basically said what I just typed above. One NB lab in Italy just performed a Safety Evaluation on one of our Cut-Off Saws (considered a prep machine for scientific analysis) and they evaluated it to the EN 61010-1:2010 and the LVD. When I questioned this and inquired about the MD, they argued that the LVD and EN 61010-1 NOW covers all hazards assessed within the product and the MD would not be the appropriate Directive. We have also started to see several of our business partners (companies we work with to produce buy/sell options and laboratory peripherals with moving parts like sample loaders) declaring compliance to the LVD instead of the MD. As first I tried to correct them but then they sent us test reports from NB labs in Europe evaluating their products to the LVD. Whodathunkit? However, I checked with the TUV:SUD lab we use here in the states and they are still saying that the MD is the correct directive to use. Ok, now I’m officially confused. So, has it officially changed? Or is it changing? Can manufacturers of laboratory equipment go back to declaring compliance to the LVD even if their products have moving parts? Has anyone seen any official new releases, articles, decisions, on this topic? Does anyone want to research and write an Article on this topic? Is there an official authority who can once and for all settle this topic of continuing conflict, nightmares, and ulcers? Thanks for your time. The Other Brian _____ LECO Corporation Notice: This communication may contain confidential information intended for the named recipient(s) only. If you received this by mistake, please destroy it and notify us of the error. Thank you. - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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