Moshe, 

I have dealt with situations similar to what you describe in item 2, and
long discussions with a Competent Body regarding them. What I got out of
those conversations is that you must build your equipment to operate
properly in the environment that it is intended for and any reasonably
foreseeable interferences that may exist in that environment. Even if
you were only considering the EMC directive (generally NOT a safety
related standard), if the 10 KV disturbance are the result of reasonably
foreseeable events in the customers environment, you would still have to
design your equipment to withstand them. 

Remember, your compliance obligation is to the EMC Directive, the
standards only let you presume compliance to the Directive. In this
case, it seems, the presumption was in error. 

You did not describe how the 10 kV discharges are occurring, so it is
difficult to provide an opinion on whether you are in the realm of
"reasonably foreseeable".

Above and beyond that, you say that these discharges create an unsafe
condition with your equipment. For the sake of the Machinery Directive
you must address them also. Even though the Machinery Directive does
offer you a hierarchy of design out, label and warn in documentation,
good ESD-proof design is not so cutting edge that you can fall back on
labeling or warning in documentation. If you end up in court, I don't
think you would have much of a defense. 

My bottom line opinion....Fix the design!

Cheers, 
Lauren Crane
[email protected]
[all ideas implied or expressed are not my employer's]


> -----Original Message-----
> From: [email protected] [SMTP:[email protected]]
> Sent: Monday, November 02, 1998 9:59 PM
> To:   [email protected]
> Subject:      machinery directive related questions
> 
> Hello Everyone,
> 
> here are 2 questions:
> 
> 1. Is Risk/hazard Analysis required as part of formal documentation
> (TCF?). Which standard 
> defines the format of the analysis?
> 
> 2. The machine complies with ESD (up to 8KV) immunity, but still I
> have safety related 
> incidents at customer sites, which are obviously related to ESD (they
> are simulated at 
> 10KV). What are my options? Should I do nothing? Should I fix the
> design (up to ?KV)? Should 
> I just document the issue, require antistatic carpets/humidifiers etc
> from the user?
> 
> Thanks in advance
> Moshe
> --------------------------------------------
> Name: moshe valdman
> E-mail: [email protected]
> Phone: 972-52-941200
> Telefax: 972-3-5496369
> Date: 2/11/98
> Time: 19:58:48
> You are most welcome to visit my homepage at:
> 
> http://www.geocities.com/CapeCanaveral/5233/
> --------------------------------------------
> 
> 
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