Standards that exist regarding Sterilization of Polypropylene?

T

tdeardorff

#1
Hello! I am looking for some information on any standards that are in existance concerning acceptable and effectiveness of sterilization of polypropylene material. We produce a very simple (but Class IIa according to the EU) dental device called an HVE tip- it is used to attach to the suction unit in a dental office...most are disposable BUT we do have one that the dentists actually autoclave and re-use. We specify the normal autoclaving times of 121 degrees C for 15 mins which is an industry standard autoclave cycle. The problem is that this "industry standard" is not identified anywhere specifically for polypropylene. Does anyone out there have any experience with this or can you point me in the right direction? If we can locate a specific standard or accredited testing(publication in journal of medicing, AMI or ADA publication) already completed in autoclaving polyprop, it will save us(me) a lot of headaches in getting testing completed.
 
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Al Rosen

Staff member
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#2
I posted the list of harmonized standards yesterday. You should be able to find a standard within that list. There are also some threads addressing the subject of sterilization including standards that you can search for. Also, scroll down towards the bottom of this page there should be a list of similar threads.
 
W

wrodnigg

#3
I assume you want to use moist heat, then you need the standard
EN 554:1994 “Sterilisation of medical devices. Validation and routine control of sterilisation by moist heat”.

This is the basic guideline and tells you how to proceed with the design and validation of a sterilization process.

For estimation of the Bioburden you should take a look at EN 1174-1 -2:1996 “Sterilisation of medical devices. Estimation of the population of microorganisms on products. Part 1 Requirements, Part 2: guidance“

It does not help, if you just take standard parameters from a third source, because you have to have records from your sterilization validation process (described in EN 554).

Beside that, the 121°C over 15 minutes is a recommendation from the European Pharmacopoeia. And the temperature shall be on/in the product, not on the controller or display of the sterilizer. Also when using these standard parameters, you have to provide the documented evidence, that these parameters are effective for sterilization of your products (as described in EN 554).
 
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