Accelerated Ageing Test for Orthopedic Implants -- ASTM F 1980 or ISO 11607 or both are applicable ?

mpfizer

Involved In Discussions
#1
Hi,

What are the ASTM or ISO standards to be followed for the above ... ASTM F 1980 or ISO 11607 OR both ?

Has the stability studies to be done at higher temperature AND Humidity OR only higher temperature.

what should the ambient temperature be taken as ... it can vary from say 15 to 40 degree ( centigrade ) ... or do we need to do study at 15 and 40 deg. temperature

Any help would be appreciated.

Thanks

michelle
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
Are you studying the shelf life of the sterile (or otherwise) packaging, the shelf life of the implant or the use life of the implants?

Both standards you mention apply to the (sterile) packaging. For the implants, you need a careful engineering analysis or a device-specific standard. Otherwise you risk GIGO.
 

QM_123

Starting to get Involved
#3
Hi,

What are the ASTM or ISO standards to be followed for the above ... ASTM F 1980 or ISO 11607 OR both ?

Has the stability studies to be done at higher temperature AND Humidity OR only higher temperature.

what should the ambient temperature be taken as ... it can vary from say 15 to 40 degree ( centigrade ) ... or do we need to do study at 15 and 40 deg. temperature

Any help would be appreciated.

Thanks

michelle
As Ronen says, these standards for sterile packaging. We perform this to be sure for shelf life of the device (according to ISO 11607 you shall start real-time shelf life determination study within 3 months after AAT) . Regarding your question related with temperature: You know there is a calculation, if you prefer high temperature, your testing time will decrease or if you prefer lower temperature your test may last more than you expect. I suggest you to consider you packaging material specifications to determine the temperature and humidity. I assume you are asking this for shelf life and answer is related with that. If your concern is device aging it is very complicated.
 

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