In the EU, product specific standards are to be used if they exist. If not,
then product standards if they exist. If none of the above exist, then the
generic standard is to be used. So, in your case, if the ISM or the ITE
standard applies (both are product family standards), it must be used. In
the US, Part 18 alone would be used only if it is ISM.

How you package and ship your products is entirely up to you.

The DOC can be a problem. If your company name is on the OEM product and not
the OEM name, you are considered to be the manufacturer and you must issue
the DOC. If the OEM's name is on the product, they may issue the DOC. In
both cases, the original DOC must be kept by someone in the EU - either the
importer or a designated representative.

There is no legal requirement to include the DOC with the equipment.


Richard Woods
Sensormatic Electronics
[email protected]
Views expressed by the author do not necessarily represent those of
Sensormatic.






> ----------
> From:         Richard Cass[SMTP:[email protected]]
> Reply To:     Richard Cass
> Sent:         Thursday, August 20, 1998 10:11 AM
> To:   [email protected]
> Subject:      Re[2]: ultrasonic cleaners
> 
>      My thanks to Mr. Woods and Mr. Briggs for their help.
>      
>      Their responses bring up some questions in my mind: 
>      It is my understanding that if something is ISM
> (Industrial,Scientific, 
>      Medical) then Part 18 of CFR 47 applies for FCC certification and
> CISPR 11 
>      (EN55011) would apply for the EMC directive.  But would that be in
> addition 
>      to or instead of Part 15 and EN 50081-1?  That is keeping in mind
> that the 
>      ISM device would have to operate in close proximity to ITE devices.
>      
>      Also, if you sell a small device classified as ISM with a larger
> device 
>      classified as ITE, can they be packaged together (i.e. small box from
> one 
>      manufacturer A inside a big crate from manufacturer B)?  Assuming I
> get a 
>      D.O.C. from the ultrasonic cleaner manufacturer (which looks likely
> at this 
>      point) can I just include a copy of it with the D.O.C. for our ITE
> device? 
>      Or do I just simply leave a copy of the ISM device's D.O.C. in it's
> small 
>      box (in side the big box)?
>      
>      Apologies if these are dumb questions but I find I know just enough
> about 
>      this stuff to really confuse myself.
>      
>      Thanks again, 
>      Richard Cass
>      
>      P.S. Just a note of clarification (if it matters): The cleaner's
> function 
>      in this case is not to clean jewelry.  Some people just refer to it
> as that 
>      because that is their most common use that people are familiar with
> and I 
>      used that description so people in this esteemed group could easily 
>      envision what it looks like.  In this case it will be used to clean
> small 
>      parts of the ink delivery system in a printing device.
>      RC
>      
>      
>      
>      
> ______________________________ Reply Separator
> _________________________________
> Subject: RE: ultrasonic cleaners
> Author:  Mark Briggs <[email protected]> at internet 
> Date:    8/19/98 11:42 AM
>      
>      
> What frequency is the ultrasonic section working at ?  This may well 
> classify as ISM equipment if it is intentionally using rf (above 9kHz) to 
> perform its intended function (clean jewelry) and so EN 55011 would 
> apply.  Choice of Class A or B, as appropriate.  Class A if not used in a 
> residential environment, Class B if it is.  I would recommend Class B 
> since it could be used in a shop located beneath an apartment.
>      
> For immunity I agree with Richard - EN50082-1 and would recommend the 
> 1997 version of this standard.
>      
> Mark
> [email protected]
>      
> >In my opinion, the cleaner is not an accessory to the ITE since it has no
> 
> >connections to it whatsoever. Therefore, the cleaner must stand as a
> product 
> >in its own right. I would consider it to be business equipment, so it
> must 
> >comply with EN 60950 for safety and EN 50081-1 for emissions and EN
> 50082-1 
> >for immunity. I strongly recommend that you make the OEM responsible for 
> >performing the compliance tests.  I also recommend that you require the
> OEM 
> >to provide an agency safety mark such as TUV. That way, the agency will 
> >perform survalence on the product to ensure continued safety compliance.
> If 
> >you are the importer you will be responsible for the Declaration of 
> >Conformity.
> >
> >
> >Richard Woods
> >Sensormatic Electronics
> >[email protected]
> >Views expressed by the author do not necessarily represent those of 
> >Sensormatic.
> >
> >
> >> ----------
> >> From:  Richard Cass[SMTP:[email protected]] 
> >> Reply To:  Richard Cass
> >> Sent:  Wednesday, August 19, 1998 10:33 AM 
> >> To:  [email protected]
> >> Subject:  ultrasonic cleaners
> >> 
> >> Greetings,
> >> What CE directives and hence what test standards apply to a small 
> >> ultrasonic cleaner (sometimes referred to as a jewelry cleaner) when 
> >> it is included as an accessory to an ITE product?  The ultrasonic  
> >> cleaner is an off the shelf product from another manufacturer.  As 
> >> received from the manufacturer it does not appear to be CE marked.  The
> 
> >> ITE product that it will accompany is used exclusively in commercial
> and
> >> light industrial environments (i.e. not for home use).  It is a not  
> >> attached to or in any  way physically part of the ITE product.  The 
> >> ultrasonic cleaner is sold in both 120V/60Hz and 240V/50Hz versions 
> >> (different part numbers).  I am going to have a discussion about 
> >> certification with our supplier of these and I just want to 
> >> be armed with some accurate information.    
> >>      Thanks in advance for the help. 
> >>      
> >>      Regards,
> >>      Richard Cass
> >>      Iris Graphics, Inc.
> >>      USA
> >> 
>      
>      
> +------------------------------------+ 
> +    Mark Briggs MSc CEng, MIEE      + 
> +  Manager, EMC Consulting Services  + 
> + Elliott Labs, 684 W Maude Avenue   + 
> +        Sunnyvale,  CA 94086        + 
> +                                    + 
> +   Phone: +1 (408) 245 7800 x238    + 
> +     Fax: +1 (408) 245 3499         +
> +                                    +             
> +   Email: [email protected]   +  
> +     http://www.elliottlabs.com     + 
> +------------------------------------+
>      
>      
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