Serial Testing of Bioburden for Medical Devices

P

Philipp

#1
Hi all,
I have a question about the quantity of samples for the bioburden testing of radiation sterilized (VDmax 25) medical devices.

According to ISO 11137-1 it is allowed to verify the bioburden for a product every three months
"12.1.2 Frequency of determinations of bioburden
12.1.2.1 For product of average bioburden greater than or equal to 1,5, the maximum interval of time between determinations of bioburden shall be three months."

The determination of the average bioburgen shall be done with 10 samples (ISO 11137-2).
?10.3.3.2 Determine the bioburden of each of 10 product items and calculate the average bioburden.?

My question is, how many samples should be used to verify the bioburden (every three month)?
And whether single values or average values should be used for these determination?


Thanks :thanx:
Philipp
 
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Ajit Basrur

Staff member
Admin
#3
Hello Philipp,

You may also want to refer ISO 11737-1 as this standard is used in conjunction with ISO 11137-1.

There is a mention on bioburden samples as below but the ISO 11737-1 has very valuable info on bioburden.

Section A8 mentions "It is common practice to use a sample size of between 3 to 10 items for routine monitoring of bioburden levels"
 
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