Brexit Regarding differentiation of CE & UKCA

H

Harsh

Involved In Discussions
Hello,

I have recently started my career as a Certification engineer. & I do have some doubts regarding the CE & UKCA declaration.

Can you please provide the info regarding the harmonized standards for both the declaration? I am working in a company which manufactures lab devices like centrifuge, rollers etc. so I do want to know that IEC standards can be used as the harmonized standards? & can be mentioned in the certificate of conformity for both CE & UKCA.

And also is there any need to provide test report numbers in the declaration?

Please also provide which category these lab instrument products fall in?
 
CharlieUK

CharlieUK

Quite Involved in Discussions
Depending on exactly what your lab equipment does, some items might not fall under any medical directives/regulations and fall under EMC and LVD instead.
You don't list test report numbers on your DoC
The DoC should list all standards "applied" whether they are Harmonised or not, but it either case, you don't put the country prefix on the front of hte standard number
 
H

Harsh

Involved In Discussions
Thank you for the info dgrainger & CharlieUK.

But can you please provide a bit more info regarding the IEC standards that can those be harmonized?

& also the category in which the products like lab centrifuge fall in?
 
T

Trebor123

Involved In Discussions
Harsh said:
Hello,

I have recently started my career as a Certification engineer. & I do have some doubts regarding the CE & UKCA declaration.

Can you please provide the info regarding the harmonized standards for both the declaration? I am working in a company which manufactures lab devices like centrifuge, rollers etc. so I do want to know that IEC standards can be used as the harmonized standards? & can be mentioned in the certificate of conformity for both CE & UKCA.

And also is there any need to provide test report numbers in the declaration?

Please also provide which category these lab instrument products fall in?
Click to expand...
I dont think the authorities know either ! spoke to the Department running this in the UK, was switched between 6 different people and not one coudl answer any questions, I think its a bit hit and miss ! left it to the Companies to figure it out !!!
 
CharlieUK

CharlieUK

Quite Involved in Discussions
If your product is just a centrifuge - in that it just spins around and then stops and that any analysis is done using other equipment, then it's not medical equipment and would be lab equipment - so I would be looking at these standards: EN 61326-1 for EMC and EN 61010-1 and 61010-2-20 for safety
 
H

Harsh

Involved In Discussions
Hello there

Thanks Trebor123 & CharlieUK for the info.

From my research I do have understand that for harmonised standards it is better to opt for the EN standards. I have seen lots of declarations available online for CE & all of them do have one thing in common that there is mention of EN standards as the harmonised standards.

But still not clear regarding EN IEC standards.
 
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