CE Mark Technical File
CE Mark Technical File
(OP)
Hello
I'm from Canada and am trying to certify a product for the European market. The ATEX and EMC directives apply to the product.
I've read some guides about CE Marking and some say (for example http://www.industry.gatech.edu/quality/quality_news_textfile.html )
that the Technical File should be two parts. Basically one is a small version with no test reports or quality system information and the other is a larger version with everything the small one has plus test reports and quality system information.
The guides on the European Union On-line site (http://europa.eu.int/comm/enterprise/atex/guide/index.htm) and the directives themselves make no mention of this. Since these guides are made by the European Commision I would follow them rather than other guides.
Is the two part technical file necessary?
Also would anyone happen to have or know where I could find some example technical files?
Thanks
I'm from Canada and am trying to certify a product for the European market. The ATEX and EMC directives apply to the product.
I've read some guides about CE Marking and some say (for example http://www.industry.gatech.edu/quality/quality_news_textfile.html )
that the Technical File should be two parts. Basically one is a small version with no test reports or quality system information and the other is a larger version with everything the small one has plus test reports and quality system information.
The guides on the European Union On-line site (http://europa.eu.int/comm/enterprise/atex/guide/index.htm) and the directives themselves make no mention of this. Since these guides are made by the European Commision I would follow them rather than other guides.
Is the two part technical file necessary?
Also would anyone happen to have or know where I could find some example technical files?
Thanks





RE: CE Mark Technical File
RE: CE Mark Technical File
Consider how you are going to manufacture the equipment.
If you are going to manufacture many products that may vary across a range or change over time then I would consider having a number of technical documents held together under one master index.
This will allow you to make use through reference of common practices and procedures and it will make it easier to change documents in the future.
RE: CE Mark Technical File
RE: CE Mark Technical File
Follow the EU guidelines! I can't see any reasons for a part technical file.
In principle, a technical file must contain all documents that support your statement that the product in question complies with all relevant EU directives.
A technical file very often contains company internal information why it can be difficult to obtain an example.
Rgds
PG Nilsson
RE: CE Mark Technical File
Normally your file should consist of reports and test data to support each Directive and standard used to show conformance, your company Product Licenses and Certificates if applicable, Photographs, Critical component list with Declarations of confomity or EU license for each critical component, All design information (Ratings, Schematics, layout drawings, mechnaical drawings etc.)Installation, Operation, Maintenance and Service manuals, Photographs and any other inhouse test data or safety critical information.
Christopher Caserta
ccaserta@us.tuv.com
Ph:904-225-0360
RE: CE Mark Technical File
RE: CE Mark Technical File
(a) a technical construction file comprising:
- an overall drawing of the machinery together with drawings of the control circuits,
- full detailed drawings, accompanied by any calculation notes, test results, etc., required to check the conformity of the machinery with the essential health and safety requirements,
- a list of:
- the essential requirements of this Directive,
- standards, and
- other technical specifications, which were used when the machinery was designed,
- a description of methods adopted to eliminate hazards presented by the machinery,
- if he so desires, any technical report or certificate obtained from a competent body or laboratory (1),
- if he declares conformity with a harmonised standard which provides therefor, any technical report giving the results of tests carried out at his choice either by himself or by a competent body or laboratory (2),
- a copy of the instructions for the machinery;
(b) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.
RE: CE Mark Technical File