R
ryosaeba
Could any body clarify me the exact difference 
between USP class VI versus ISO 10993, Please.
between USP class VI versus ISO 10993, Please. 
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 it´s 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 (there´s 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, there´s some tests done on animals, if i remember corrrectly, but most of them are not. Well, that´s what i can think of in a hurry. Cheers.
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 it´s 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 (there´s 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, there´s some tests done on animals, if i remember corrrectly, but most of them are not. Well, that´s what i can think of in a hurry. Cheers.
Re: USP class VI versus ISO 10993
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
Could any body clarify me the exact difference
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
R
ryosaeba
Re: USP class VI versus ISO 10993
. That cleared me a bit.
. That cleared me a bit.
Re: USP class VI versus ISO 10993
So do you still have some queries
So do you still have some queries
G
g1853
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?
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?
M
MIREGMGR
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.
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.
S
SK Vision
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.
Is there any centralized respository for material testing results? How would one obtain access to already tested materials?
Like Stainless Steel or TIN Coating.
M
MIREGMGR
Re: USP class VI versus ISO 10993
With regard to FDA regulation, the most common materials--particularly metals--are defined per Recognized Consensus Standards.
Thus if a metal material is certified by the maker, or by a distributor if cert traceability exists up to the maker, as being compositionally consistent with an applicable standard, that material is regarded as biocompatible as defined in the applicable Recognized Consensus Standard.
With regard to FDA regulation, the most common materials--particularly metals--are defined per Recognized Consensus Standards.
Thus if a metal material is certified by the maker, or by a distributor if cert traceability exists up to the maker, as being compositionally consistent with an applicable standard, that material is regarded as biocompatible as defined in the applicable Recognized Consensus Standard.
F
fabtur
Re: USP class VI versus ISO 10993
Search and take a look to page 8 of the Ensinger_Medical_Brochure_for_2006. The picture should make clear the common part of the two regulations. They both have different testing methods to asses biocompatibility, and In-vitro acute systematictxicity or intracutane reactivity is the common method.
Hope this helps
Search and take a look to page 8 of the Ensinger_Medical_Brochure_for_2006. The picture should make clear the common part of the two regulations. They both have different testing methods to asses biocompatibility, and In-vitro acute systematictxicity or intracutane reactivity is the common method.
Hope this helps