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Subject:Re: CE Mark? From:"Simon North" <Simon -dot- North -at- synopsys -dot- com> To:"TECHWR-L" <techwr-l -at- lists -dot- raycomm -dot- com> Date:Tue, 04 Nov 2003 10:48:19 +0100
Hi Aimee,
The CE Marking is no more than a manufacturer's declaration that the
essential requirements of the relevant EU directives have been
complied with. Contrary to a lot of hype that consulting companies
will feed you (and try and lighten your billfold), the CE marking
regulations were actually intended to prevent any individual European
countries from preventing the sale of goods from other European
countries by throwing up artificial boundaries in the form of product
requirements.
In most cases the requirements for the technical documentation are
included as (a minor) part of the directive covering the type of
equipment your employer manufactures. For example, there are specific
EU directives for the following:
73/23/EEC Low voltage
87/404/EEC Simple pressure vessels
88/378/EEC Safety of toys
89/336/EEC Electromagnetic compatibility
89/686/EEC Personal protective equipment
90/384/EEC Non-automatic weighing instruments
90/385/EEC Active implantable medical devices
90/396/EEC Appliances burning gaseous fuels
93/15/EEC Explosives for civil uses
93/42/EEC Medical devices
94/9/EC Equipment and protective systems intended for use in
potentially explosive atmospheres
94/25/EC Recreational craft
95/16/EC Lifts
96/48/EC Interoperability of the Trans-European high-speed rail
system
97/23/EC Pressure equipment
98/37/EC Machinery
98/79/EC In vitro diagnostic medical devices
99/5/EC Radio and telecommunications terminal equipment
A lot of the directives can be obtained free of charge online via:
Often, however, the requirements are strict governing a so-called
technical file, while saying little about the technical documentation
itself. Check whether your product type is covered and if not you may
(IANAL) be fairly free to do what you think is best.
If there isn't a directive to cover your product type, the situation
is rather chaotic ... Many European countries have made attempts to
set general national standards for user documentation (like the
Netherlands, where I live, where I had the honor as a foreigner to be
one of the authors of the Dutch national standard NEN 5509:1998 "User
manuals;Contents, structure, formulation and presentation", and the
UK which has BS 8888:2002 - Technical product documentation (TPD)),
but a lot do not and even where a standard exists compliance may not
be a legal requirement. Compliance (IANAL!) with any one national
standard may be sufficient, unless a specific target country imposes
stricter requirements.
The directives on safety information (see Directive 92/59/EEC) are
generally concerned with markings on the product itself. However,
most applicable directives do insist very strongly that the user is
properly informed about the safety and so there has been a general
trend for manufacturers to include a separate safety chapter in the
documentation, even when this information is duplicate (covering all
the bases).
If I was you, I would simply take what he says as true. It might be
wrong, but it can't do much harm and to be quite honest you are
probably taking on a hobby for life if you set out to establish what
really is needed.
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