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USP Class VI vs. ISO 10993 - What are the differences?


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iso 10993 - biological evaluation of medical devices, usp (biological reactivity tests), usp class vi
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  Post Number #1  
Old 23rd November 2006, 06:34 AM
ryosaeba

 
 
Total Posts: 2
Please Help! USP Class VI vs. ISO 10993 - What are the differences?

Could any body clarify me the exact difference between USP class VI versus ISO 10993, Please.

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  Post Number #2  
Old 23rd November 2006, 07:54 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,751
Re: USP class VI versus ISO 10993

I do not know USP class VI, and know just the necessary of ISO 10993, but reading a little on the net about USP class VI it seems itīs comprised of two specific tests (systemic injection and intracutaneous) made on animals. Well, ISO 10993 is a series of standards which describes a lot of tests (thereīs 19 standards in the series and the fisrt is the general one, so it seems to exist at least some 18 different tests, i am not sure of this). The tests to be made depends on some characteristics of the product being tested, for exemple contact time. Also, thereīs some tests done on animals, if i remember corrrectly, but most of them are not. Well, thatīs what i can think of in a hurry. Cheers.
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
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  Post Number #3  
Old 23rd November 2006, 10:58 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,885
Re: USP class VI versus ISO 10993

Quote:
In Reply to Parent Post by ryosaeba View Post

Could any body clarify me the exact difference between USP class VI versus ISO 10993, Please.
Hi, use the search function available at the top or at bottom of the thread and you will come across many threads. One of the most informative for this subject is Biocompatibility - USP Class VI vs. ISO 10933
Thanks to Ajit Basrur for your informative Post and/or Attachment!
  Post Number #4  
Old 23rd November 2006, 01:22 PM
ryosaeba

 
 
Total Posts: 2
Re: USP class VI versus ISO 10993

. That cleared me a bit.
  Post Number #5  
Old 23rd November 2006, 09:45 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,885
Re: USP class VI versus ISO 10993

Quote:
In Reply to Parent Post by ryosaeba View Post

. That cleared me a bit.
So do you still have some queries
  Post Number #6  
Old 1st May 2009, 04:11 PM
g1853

 
 
Total Posts: 6
Re: USP class VI versus ISO 10993

If a material is found to be USP class 6 compliant and meets the standards of 10993-1, must a med device company repeat those tests, or may they thoroughly document the material is deemed safe?
  Post Number #7  
Old 1st May 2009, 07:28 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: USP class VI versus ISO 10993

USP class qualification was a key method for establishing material biocompatibility at least as far back as 1976, until the 1987 adoption of the Tripartitite Agreement.

Tripartite introduced the first expectations of biocompatibility testing specifically focused on device-related material biocompatibility environments, such as implantation and fluid communication. The relevant guidance memo was G87-1. This is still available on the FDA website.

Under Tripartite, USP class qualification was sometimes accepted as sufficient for lower-risk applications. Tripartite was the FDA biocompatibility approach until 1995.

In 1995, the FDA adopted ISO 10993 as its biocompatibility approach. This is their current stance today. The guidance memo was/is G95-1. USP class qualification no longer plays any role in medical device materials evaluation.

Up-to-date materials manufacturers provide both USP and ISO 10993 test data, to support both pharma and device customers.

See G95-1 for a summary table of the ISO 10993 qualifications required for a given degree of patient contact. A minimum of three qualifications (i.e. test types) is needed for even limited-term unbroken-skin contact.

It is not necessary to repeat material-manufacturer-conducted testing, assuming that the material in fact is identical, the testing is relevant, the documentation is complete and properly prepared, and the testing was done to GLP standards by a registered lab.
Thanks to MIREGMGR for your informative Post and/or Attachment!
  Post Number #8  
Old 5th August 2009, 02:14 PM
SK Vision

 
 
Total Posts: 20
Re: USP class VI versus ISO 10993

Is there any centralized respository for material testing results? How would one obtain access to already tested materials?

Like Stainless Steel or TIN Coating.
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