Orthopaedic (Orthopedic) Implants - SS 316L or ISO 5832

mpfizer

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#1
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
 

suildur

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#4
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:D)

P.S. That'a a good "live" example for buying and keeping standards! (pls see, http://elsmar.com/Forums/showthread.php?t=39307)
 
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#5
Materials defined according to Harmonized standards to get CE marking for orthopedic implants are:
ISO 5832-1:2007
Implants for Surgery – Metallic materials – Part 1: Wrought stainless steel
ISO 5832-1:2007/Corr1:2008
ISO 5832-2:1999
Implants for surgery – Metallic materials – Part 2: Unalloyed titanium
Health Canada List of Recognized Standards for Medical Devices
Revised Date: 2016/09/19; Effective Date: 2016/10/25 17
ISO 5832-3:1996
Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium
alloy
ISO 5832-4:1996
Implants for surgery – Metallic materials – Part 4: Cobalt-chromium-molybdenum casting
alloy
ISO 5832-5:2005
Implants for surgery – Metallic materials – Part 5: Wrought cobalt-chromium-tungsten-nickel
alloy
ISO 5832-6:1997
Implants for surgery – Metallic materials – Part 6: Wrought cobalt-nickel-chromiummolybdenum
alloy
ISO 5832-9:2007
Implants for surgery – Metallic materials – Part 9: Wrought high nitrogen stainless steel
ISO 5832-11:1994
Implants for surgery – Metallic materials – Part 11: Wrought titanium 6-aluminium 7-niobium
alloy
ISO 5832-12:2007
Implants for surgery – Metallic materials – Part 12: Wrought cobalt-chromium-molybdenum
alloy
ISO 5832-12:2007/Cor.1:2008

These standard contains material configuration and properties.
One can have CE certification only if material complies to these grades, but lot of companies still manufacturing implants with 316 L and having CE certification too.
 
#6
This is a rather old thread to reply to!

To correct a statement above, it is not a requirement to comply with harmonised standards. It only leads to presumed conformity when authorities assess.

The requirement is for the manufacturer to demonstrate compliance with the essential requirements, how they do this is their choice. Although if harmonised standards are not followed, they should be prepared to have their justification scrutinised more thoroughly
 

Remus

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#7
You don't have to comply 5832, however in that case you have to provide more data. More PMCF work, longer biocompatibility test... etc.
 

mpfizer

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#8
can u please check up if there are any additions recently
i am interested to use ASTMF745 and ASTMF 75 for hip and knee joints are they allowed?
 

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