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Dear Members of biomch-l@hearn.nic.surfnet.nl
My name is Michele Tassinari and I am working as Responsible of Quality in
the Laboratory for Biomaterials Technology of the Rizzoli Orthopaedic
Institute in Bologna (Italy).
In our laboratory we execute mechanical tests on total hip joint prostheses
according to international standards (ISO, ASTM) or to internally defined
protocols if an international normative does not exist.
The 93/42/CEE directive affirms that total hip joint prostheses have to be
approved with the CE mark in order to be circulated freely within the
European Economic Community (CEE).
To mark the hip joint prostheses we need to clearly understand two things:
1) what are all the tests that the total hip joint prostheses have
to pass to receive the CE mark.
2) what are the risk factors of the total hip joint prostheses (in
fact to mark these prostheses we have to know exactly the risk factors)
Any information which you can give will be most welcome.
Best regards.
Michele Tassinari
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Michele Tassinari
Laboratorio di Tecnologia dei Materiali tel. 0039-51-6366864
Istituti Ortopedici Rizzoli
via di barbiano 1/10, 40136 - Bologna, Italy fax. 0039-51-6366863
E-mail: michele@tecno.ior.it
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My name is Michele Tassinari and I am working as Responsible of Quality in
the Laboratory for Biomaterials Technology of the Rizzoli Orthopaedic
Institute in Bologna (Italy).
In our laboratory we execute mechanical tests on total hip joint prostheses
according to international standards (ISO, ASTM) or to internally defined
protocols if an international normative does not exist.
The 93/42/CEE directive affirms that total hip joint prostheses have to be
approved with the CE mark in order to be circulated freely within the
European Economic Community (CEE).
To mark the hip joint prostheses we need to clearly understand two things:
1) what are all the tests that the total hip joint prostheses have
to pass to receive the CE mark.
2) what are the risk factors of the total hip joint prostheses (in
fact to mark these prostheses we have to know exactly the risk factors)
Any information which you can give will be most welcome.
Best regards.
Michele Tassinari
------------------------------------------------------------------------------
Michele Tassinari
Laboratorio di Tecnologia dei Materiali tel. 0039-51-6366864
Istituti Ortopedici Rizzoli
via di barbiano 1/10, 40136 - Bologna, Italy fax. 0039-51-6366863
E-mail: michele@tecno.ior.it
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