Biocompatibility tests in AAA LAC Laboratory

Juzaili

Starting to get Involved
#1
hi everyone,
Can you please help me about AAA LAC requirement to do our product testing.

My Director told me we dont need to do our product testing in AAA LAC lab because our product is only class 1 (like urine specimen container, sputum cup).

is there any directive of letter for me to give to my Director so that i can support and comply to our Auditor requirement to all our product to do test (Biocompatibility tests).

need your opinion pls.

*the reason my boss said that we only sold our product locally(Malaysia) so the is no evident that we need to do a test in AAA LAC lab. arcoding to Malaysia medical device act 737.
:thanks:
 
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Ajit Basrur

Staff member
Admin
#2
Re: Biocompatibility tests in AAA LAC Lab

Did you refer the AAALAC to Association for Assessment and Accreditation of Laboratory Animal Care ?

If yes, it is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs and thus is not a requirement.
 

Juzaili

Starting to get Involved
#3
Re: Biocompatibility tests in AAA LAC Lab

Thank you..
But our auditor need us to do Biocompatibility tests in AAA LAC Lab.

i go through ISO 10993 standards but no evident that we need to do in AAA LAC lab. So can i counter back our auditor?<- can this impact our audit if we not take auditor advice?:(
 

Juzaili

Starting to get Involved
#5
Re: Biocompatibility tests in AAA LAC Lab

Thank You Ajit Basrur for your respond..

What do i need to do now to close our NC about this?

no evidence on Biocompatibility in our products? (urine container,sputum cup)

newbie in Medical Device..

:confused:
 
M

MIREGMGR

#6
Go to ISO 10993-1, "Scope". ISO 10993 does not apply to devices that do not have direct or indirect patient contact. Direct contact is obvious. Indirect contact is usually considered to be contact with another object or substance that then contacts the patient, i.e. an injection syringe body or inflowing tubing set.

This would be a fairly basic mistake for an auditor to make, so perhaps you should allow for the possibility that you've misunderstood what the auditor actually was after, explain to the auditor what you think he or she meant, and ask if you've correctly understood.
 
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