What does 'Shelf Life' of Sterile Implantable Orthopaedic Devices mean?

P

pangchiaboon

#1
Dear Sir,
When we talk about "shelf life" of sterile implantable medical devices, does it means the expiry date of sterilization or how long the device can serve its intended purpose in human body? Hope to learn from you.

Thank you.
Pang Chia Boon
 
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somashekar

Staff member
Super Moderator
#2
Dear Sir,
When we talk about "shelf life" of sterile implantable medical devices, does it means the expiry date of sterilization or how long the device can serve its intended purpose in human body? Hope to learn from you.

Thank you.
Pang Chia Boon
The sterilization valid life as you store it in recommended storage condition.
 

Ajit Basrur

Staff member
Admin
#3
Dear Sir,
When we talk about "shelf life" of sterile implantable medical devices, does it means the expiry date of sterilization or how long the device can serve its intended purpose in human body? Hope to learn from you.

Thank you.
Pang Chia Boon
The shelf life refers to that period which preserves the functionality and safety of the device throughout its declared shelf-life.
 
P

pangchiaboon

#4
Dear Sir,
If i understand correctly, what you means is the shelf life not only the sterilization expiry date (before implant), but also the time where the implantable device stays in the human body (after implanted), correct?

Thank you.
Pang Chia Boon
 

harry

Super Moderator
#5
...............what you means is the shelf life not only the sterilization expiry date (before implant), but also the time where the implantable device stays in the human body (after implanted) ...................
The clue is in the word 'shelf'. Shelf life means how long the part remains good while it is on the shelf (on the shelf means not sold or sold but not used). Once the part is implanted (used or put into service) we talk about useful life or service life.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
The clue is in the word 'shelf'. Shelf life means how long the part remains good while it is on the shelf (on the shelf means not sold or sold but not used). Once the part is implanted (used or put into service) we talk about useful life or service life.
:agree1:

Shelf life relates not only to maintaining sterility, but to deterioration in the quality of the device as well. Shelf life ends when the device is either put into use; discarded; or deteriorates to a point where it no longer conforms with its specification.
 
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