I’ve said this before, but laboratory equipment is the Redheaded Stepchild of Regulatory Compliance. It’s like the powers-to-be didn’t know what to do with us so the latest move was to toss us in the mix with Industrial Machinery. But the MD is not a good marriage. Our users are not the same. The environment is not the same.
Laboratory Equipment is not new. It’s been around for hundreds of years. Scientists, engineers, technicians, chemists, etc. perform tests on materials using fire, heat, ovens, ice, liquid nitrogen, electricity (ever see a Frankenstein Movie), sharp tools, glass containers, chemicals, solvents, flammable liquids, plasma, lasers, tools and machines that cut, grind, polish, crush, vibrate, pulverize, burn, ionize, liquefy, vaporize, and nebulize materials for scientific analysis. The users of such equipment are trained and educated to work in such an environment without getting hurt. Take the average person off the street, put them in a laboratory, and they will most likely get injured or be dead before lunch. Put the same person in an Industrial factory, give them 10 minutes of instruction, and they can run a press for 20 years without losing a finger. Why, because the safety rules and training of Users are completely different. Most of you work in an EMC, Product Safety, Engineering, or R&D Laboratory so you should know what I’m talking about. You know by personal experience that there are hazards you are exposed to everyday that are just part of the job. Bring an OSHA or Union Inspector through your lab and they’ll probably shut you down (unless they are knowledgeable in such matters, which most are not). Ultimately, manufacturers of laboratory equipment needs some kind of representation in Europe. But because of the small volumes we deal with, we are mostly small companies who just do not have the resources. We must rely on consultants, 3rd party labs, and discussion groups, like this one, for advice on what to do. But our greatest burden is dealing with inspectors at our customer site who doesn’t know what a Thermographic Analyzer is so they review it as a an Industrial Factory machine under the MD and write up a list of non-compliances. And though we have to work through dozens of these every year costing us hundreds of thousands of dollars in manpower, we have never had to make a mechanical change to even one of our instruments. They have all been resolved through educating inspectors and providing information and test results they cannot perform in the field. Who pays for this? Many believe that if we declared to the LVD instead of the MD, that our products would be looked upon differently from inspectors and they wouldn’t be forced to try and apply the EHSR of the MD to products that just don’t fit. All I know for sure is that before the 2006 version of the MD, life was good. I dream of better days. The Other Brian From: Pete Perkins [mailto:[email protected]] Sent: Friday, March 31, 2017 12:54 PM To: [email protected] Subject: Re: [PSES] MD vs LVD for Laboratory Equipment All, Well letting it stew longer usually makes the soup thicker. The mfgrs of semi processing equipment worked to get clarification hoping to use 61010 as the basis for the electrical portion of their CE certification but using the needed machinery standards for mechanical hazards. This would allow a full CE cert invoking both the MD and the LVD. The EU fathers, however, didn’t want to go that direction so another part of 60204 has been developed to with cover these units – done in parallel the TC66 efforts to develop their -2-120 machinery standard covering the needed mechanical req’mts. So it appears that those folks have two paths to full certification and could invoke both the MD and the LVD in their Declaration (which, it seems, is most pleasing to low level approval folks who have to accept the Declaration and don’t want to spend too much time deciding if all the necessary things have been covered. The nightmare is spreading, equipment is getting more complex and larger so the boundaries are being stretched or broken down. Hopefully, the system will get some sense and work to allow any combo of technical requirements to show compliance – electrical requirements for the LVD and mechanical requirements for the MD. We’ve done that many times in the past and it has worked well technically. o I vote for watering the soup and not serve stew. :>) br, Pete Peter E Perkins, PE Principal Product Safety & Regulatory Affairs Consultant PO Box 23427 Tigard, ORe 97281-3427 503/452-1201 [email protected]<mailto:[email protected]> From: Peter Tarver [mailto:[email protected]] Sent: Friday, March 31, 2017 9:05 AM To: [email protected]<mailto:[email protected]> Subject: Re: [PSES] MD vs LVD for Laboratory Equipment I’m with you here, Dave. Just because a product contains a cooling fan should not mean the MD applies. But then, the products you cite are explicitly excluded from the scope of the MD (I’m sure you know this, since it appears you took the text directly form the MD). However, in Article 2 of the MD, where the text Doug mentions is located, goes on to say that they’re, “intended for lifting loads and whose only power source is directly applied human effort.” This encompasses: • automotive lifts and jacks • come-alongs • block and tackle sets (if sold as a unit) Peter Tarver From: Nyffenegger, Dave Sent: Thursday, March 30, 2017 17:40 But there are products meeting that definition of machine that are covered by the LVD and specifically excluded from the MD: — household appliances intended for domestic use, — information technology equipment, — ordinary office machinery, -Dave From: Douglas Nix Sent: Thursday, March 30, 2017 5:20 PM I concur with Michael Loerzer. IMO, the test labs didn’t feel comfortable doing MD evaluations, so they used the “out” that was in the text of the previous MD (98/37/EC) that said that if the hazards were ‘predominantly electrical in nature” then the MD needn’t apply. Many machines were “slid-past” based on this misuse of the text of the MD, which is why the text was changed in the 2006 edition. If the device is “an assembly of linked parts, at least one of which moves” it’s a machine. -- Doug Nix [email protected]<mailto:[email protected]> The information contained in this message may be privileged and confidential. It is intended to be read only by the individual or entity to whom it is addressed or by their designee. If the reader of this message is not the intended recipient, you are on notice that any distribution of this message, in any form, is strictly prohibited. If you have received this message in error, please immediately notify the sender and delete or destroy any copy of this message! - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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