Validity of Old Biocompatibility Data (1999) - Catheter

#1
Dear All ,


can anyone please explain me about the validity of old biocompatibility data. we are going to use a Catheter whose biocompatibility testing were performed back in 1999 ...

Can we use this catheter without performing any further biocompatibility testing ? would this results be acceptable to Notified body in EU .

Thanks for your help in advance
 
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Marcelo

Inactive Registered Visitor
#2
If you can justify why you would not need to perform further updated tests, that would be ok.

But, as you´re asking this, you don´t know, so i would advise to test again.

Also, it would be really difficult to justify this, as there´s a lot of recent updates to the harmonized standards regarding biocompatibility testing (the ISo 10993 series).
 
#3
If you can justify why you would not need to perform further updated tests, that would be ok.

But, as you´re asking this, you don´t know, so i would advise to test again.

Also, it would be really difficult to justify this, as there´s a lot of recent updates to the harmonized standards regarding biocompatibility testing (the ISo 10993 series).

Thanks for you reply ... Can you please elaborate me , what kind of recent changes happen. Does these changes really make old biocompatibility testing nonvalid? thats mean if a company have a device in market since last 10 years then they need to test again and again ad the harmonised standard particularly iso 10993 changes

i am not aware of the kind of changes happen in iso 10993 , so please elaborate me a little bit .

Thanks
 

Marcelo

Inactive Registered Visitor
#4
I don´t know what are the changes. To know that, you should know what standards you used in the tests to demonstrate compliance with the essential requirements of the MD directives, and then analyse if the changes to the standards means that you need to re-test or if the changes are not significant enough for a re-test.

There are a lot of discussions on harmonized standards on the cove, but the main point is, generally: the standards in the list of harmonized standards are the "golden standard" be used in demonstrating conformance with the essential principles - EP. If you use a harmonised standard, you have presumption of conformity with the related EP on the directive; if you use any other standard, you have to justify that the level of safety acquired is the same as if you used a harmonized standard. Old standards loose their presumption of conformity status onde a new version is published and the date of withdraw is reached. So, in this case, if you used old standards which does not give presumption of conformity anymore , you have to justify why using them gives the same level of safety as if you were using the new editions.

Note that a lot of standards of the ISO 10993 series in the list of harmonised standards are new. There´s also some with are from 1998 and 1999. You need to analyse which standards you used for testing and demonstrating compliance with the EP. If the standards you used for testing does not give presumption of compliance anymore, you have to justify keeping using them, or you simply have to test again if you cannot justify.

Please note that, for this, you need to know the standards and the changes made in newer versions (this is a technical analysys). If you do not, or cannot, or do not want to know, you probably should simply test again anyway.
 
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