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Old 20th February 2010, 05:28 AM
suildur's Avatar

Total Posts: 66
Re: Orthopaedic (Orthopedic) Implants - SS 316L or ISO 5832

In Reply to Parent Post by mpfizer View Post

Is CE certificate related to raw material?

for orthopaedic implants is there any law that the implants should confirm to iso 5832 then only CE certificate is granted?

our competitors say that for ce the material to be used should conform to iso 5832 only ss 316L material cannot be used

Comments please
CE is the "control and regulation" system for the "end-products" which are "put on the market", and, as it is a regulation CE is applied only for the product groups which are defined in a related "directive"; i.e. lifts, medical devices, construction products etc...

CE marking cannot be applied to an unfinished product or raw material or an end-product which will not be put on the market. For example, machines are object to CE marking, but if you design a machine to be used "only" in your own factory and then manufacture it and put it in use in your factory, that machine is not subject to CE marking.

However, if CE mark is obligatory for a product, the related directive's requirements must be applied to the product. In most cases, also, some standards are used for requirements, too. And, there will be additional requirements in the standards, which can cover the raw material which the product will be manufactured from. And, if you cannot comply with the requirements of the related harmonized standard, then you cannot grant CE marking for the product.

If you check the related harmonized standard of your product, you can be sure if the raw material is covered or not. (And, I am sure it covers)

P.S. That'a a good "live" example for buying and keeping standards! (pls see,

Last edited by suildur; 20th February 2010 at 05:36 AM.

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