EN 10204 vs USP class VI

[cal6404]

Hi,

I am wondering if EN 10204 2.1, 2.2 and 3.1 cover tractability. for example, if we have a diaphragm and we wanted to one day trace it as there was a quality issue, could these certificates allow us to know exactly where it came from and what manufacturing batch? Also, is USP class VI the same as EN 10204 or is it a completely different standard? would EN 10204 3.1 cover the USP class VI or should we be asking for two completely different certs

 

[The Obturator]

EN10204 Covers inspection certification for METALLIC Products. As far as I understand USP IV is for Medical Devices. Since you posted in an engineering forum, I'll offer some guidance for EN10204.

2.1 is basically a manufacturers certificate of compliance.
2.2 Is the same as 2.1 but would include test certification which may not necessarily be traceable.
3.1 Is test certification traceable to a component/part or a test issued by a manufacturers independent (of production)inspector.
3.2 Is traceable certification and issued by a manufacturer and verified by a third party inspector appointed by the purchaser.

Per ISO-4126, only the term Safety Valve is used regardless of application or design.

 

[bcd]

Usually rubber diaphragms are marked with the manufacturers identification code and a date code. It is typically molded into the part. If something is documented in a file, you need some way to link the part to the file. Heat code or some other unique numbering system. So the part has to be marked with something.

 

[gerhardl]

A general answer:

1. As a buyer, you are the one to specify what exact parameters you want to be included in a test certificate and added documents. and to what standard. You just have to check that the standard cover what you want. (Example: The certificate documents must also include full traceability of part xx. with yy information according to norm/standard zz with tests of ww according to standard aa)

2. A certificate's wording (Like ENxxx) is a unique document. You have no guarantee that a similar stanard issued by another authority has the same exact wording or is altered or improved at the exact same time to incorporate exact same details. In this way two standards covering the same general issues, but from two different authoroties, can never be guaranteed to be 'equal'.

However: As a buyer or issuer/tester to a standard you stand free to test to any standard you like, or accept several different standards for the same quality tested. The question is what the end-user or surrounding world requires.

Good luck!