X-ray based NDT Test Equip. Mfger. seeking CE Mark - Must X-Ray Source be included?

[w_grunfeld]

A manufacturer of X-ray based NDT test equipment is seeking CE mark for the tester. The tester can work with different X- ray generators which are purchased by users separately, in fact requires different types of sources as a function of the inspected item.
Based on the above arguments , the manufacturer would like to exclude the X-ray source from the CE conformity assessment/testing. My advice to him is that he cannot do this as the tester cannot perform its intended function without an X source. I also think that if different sources are required for different item types to be inspected by the test equipment, it needs to be assessed /tested with each. Any thoughts on this?

[Stijloor]

A Quick Bump!

Can someone help Willy?

Thank you very much!!

[Mikishots]

In Reply to Parent Post by w_grunfeld

A manufacturer of X-ray based NDT test equipment is seeking CE mark for the tester. The tester can work with different X- ray generators which are purchased by users separately, in fact requires different types of sources as a function of the inspected item.
Based on the above arguments , the manufacturer would like to exclude the X-ray source from the CE conformity assessment/testing. My advice to him is that he cannot do this as the tester cannot perform its intended function without an X source. I also think that if different sources are required for different item types to be inspected by the test equipment, it needs to be assessed /tested with each. Any thoughts on this?

If those purchasable generators are not the ones specified by the manufacturer, the device as a whole does not comply with the CE directive.

If a product is sold that has a design feature that allows peripheral or optional parts, the CE mark is intended to apply to the product with each of those parts. The source cannot be excluded from the technical package.

[Ronen E]

Have all applicable EC Directives, Regulations, Decisions etc. been identified? Typically, the governing directive would have the definitions and requirements to answer such questions, right in the first few articles.

In general I tend to agree that the CE marking relates to product use together with any specified accessories (= elements required for allowing it to achieve its designated goal).

[w_grunfeld]

Ronen,
The governing Directive is the LVD- I didn't find in it any hint.
Willy

[CharlieUK]

I would imagine that you will also be considering the EMC directive.

You should consider how using different sources might affect the safety or EMC performance of you device.
You should ensure that your product can be used whilst adhering to typical safety/handling/operating requirements for X-ray sources (I don't know what these are)