ISO 10993-5:2009 vs. ISO 10993-5:2003 differences - Cytotoxicity Testing

#1
hi all ,

Do any one know about this updated standard of cytotoxicity testing . when will it apply to europe.
what is the difference between 10993-5:2003 and this new one?

Thanks
 
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Ajit Basrur

Staff member
Admin
#2
hi all ,

Do any one know about this updated standard of cytotoxicity testing . when will it apply to europe.
what is the difference between 10993-5:2003 and this new one?

Thanks
Hi waziz,

The old ISO 10993 was 1999 and not 2003. Refer the ISO website.

The standard to be available as EN ISO 10993-1:2009 was 10 Jun 09 - refer page 26 and 36 HERE - I have no update above this.

Let us see if there are more responses :)
 

RUBI

Registered
#5
Hi,
I have carried out cytotoxicty test (as per ISO 10993-5) on raw material of the medical device. Now is it necessary to carry out a test on medical device as well or is it okay to establish equivalence with the report of raw material?
If yes, how can i show the equivalence?


Thankyou
 

planB

Super Moderator
#6
Rubi,

per ISO 10993-1:2018 (or 2009), you have to evaluate the biocompatibility of the _final_ device according to its intended use as it comes into patient contact. Testing, including a cytotoxicity test, is only warranted if your existing data does not allow you address all trelevant biologiocal endpoint via material characterization - refer to Table A.1.

Cytotoxicity testing of raw material alone is typically not sufficient to establish biocompatibility of your medical device.

What kind of equivalence do you want to show?

HTH,

Gerhard
 

RUBI

Registered
#7
Rubi,

per ISO 10993-1:2018 (or 2009), you have to evaluate the biocompatibility of the _final_ device according to its intended use as it comes into patient contact. Testing, including a cytotoxicity test, is only warranted if your existing data does not allow you address all trelevant biologiocal endpoint via material characterization - refer to Table A.1.

Cytotoxicity testing of raw material alone is typically not sufficient to establish biocompatibility of your medical device.

What kind of equivalence do you want to show?

HTH,

Gerhard
Thank you for your reply,
i want to show equivalence of cytotoxicity test of raw material(SS) with finished product for same test not for all biocomapatibility tests. Is it possible?
 

planB

Super Moderator
#8
Rubi,

yes, you can establish equivalence in terms of cytotoxicity: ISO 10993-5:2009, section 8.5, provides you with a qualitative and quantitative scoring system. If you reach at the same score for two materials after the same test, you could claim equivalence in terms of cytotoxicty.

Please note the caveat that I mentioned above: this evidence alone is not sufficient, as ISO 10993-5 specifically says in section 10, Assessment in results:

The overall assessment of the results shall be carried out by a person capable of making informed decisions based on the test data. Cytotoxicity data shall be assessed in relation to other biocompatibility data and the intended use of the product. The interpretation of the results of the cytotoxicity test shall take into account the classification of the device as given in ISO 10993-1. [...]
Any cytotoxic effect can be of concern. However, it is primarily an indication of potential for in vivo toxicity and the device cannot necessarily be determined to be unsuitable for a given clinical application based solely on cytotoxicity data.
The key to establishing biocompatibility is a risk assessment according to ISO 10993-1 and a thorough material characterization according to ISO 10993-18.

HTH,

Gerhard
 
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