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CE Certification & Directives

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Ditch:
Ok. Thanks for your replies.

I'll have to find a test lab and speak with them but will the test labs create the technical files on my behalf?

It's one thing sending products to be tested but I will still need to create the technical file.

Benta:

--- Quote from: Ditch on April 04, 2021, 01:22:56 pm ---Ok. Thanks for your replies.

I'll have to find a test lab and speak with them but will the test labs create the technical files on my behalf?

It's one thing sending products to be tested but I will still need to create the technical file.

--- End quote ---

A test lab will do it all, if you like. It's a question of your wallet size.

AndyC_772:
The technical file is an on-going process, not just a 'create and forget' part of the testing.

It contains details of how the product is made, what critical components it contains, and the standards to which they comply. Over time, it also contains details of design changes, substitutions to any critical parts, and anything else which might reasonably affect the EMC performance of the product.

For that reason if nothing else, I doubt a lab can or will create it for you. They can, however, review it and let you know if they believe it's sufficiently complete and accurate on the day when they do their assessment, and give you some advice on what changes you'll need to incorporate over time.

Benta:

--- Quote from: AndyC_772 on April 04, 2021, 06:41:56 pm ---For that reason if nothing else, I doubt a lab can or will create it for you. They can, however, review it and let you know if they believe it's sufficiently complete and accurate on the day when they do their assessment, and give you some advice on what changes you'll need to incorporate over time.

--- End quote ---

What you have to realise is, that test labs (if they're competent) are incredibly well networked, and will shop out this sub-job to a friendly engineering consultant.
It's a one-stop-shop, if you want.

keef46:
You will pay a lot to get a CE test house to do the whole thing.... But the CE Mark Association can also offer help and advice, online courses.

https://www.cemarkingassociation.co.uk/

I started from much the same position as you... I have done a few courses, we pay them to carry some compliance testing (mostly EMC) - but now I think I have a handle on it all.

They can also supply you with Technical file checklists, Risk Assessment templates etc... these helped me a lot.

Remember its self assessment for most things, some directives - like ATEX might require you to involve a notified body. LVD, EMC are self assessment. EMC is hard to do yourself though - unless you have all the equipment needed to carry out all the tests. Nom one will ever tell you specifically "do it like this"....

In short though - your technical file should contain;
>A document describing the product, like sales literature
>Technical drawings, circuit diagrams for the main assembly and sub-assemblies (i include datasheets for components too)
>A BOM
>A document listing the CE directives and standards you have used
>A risk assessment for your product (this i think is the hardest bit to do)
>Evidence of conformity to the directives, photo's of tests, test reports and results.
>Conformity certificates for components in the product
>Details of your factory controls to ensure conformity remains during manufacturing
>Copies of labels and markings on the product that you how its used (ie power supply ratings, IP ratings etc...)
>A copy of your final declaration certificate

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