There are two parts to your question, so I'll address one separately.
In the most common case, a device has a shelf life because, while on the shelf, some important characteristic changes over time. Eventually, it will go out of specification, so after that point, the customer should not use the device.
To determine the shelf life, you need to know a) what characteristic changes, b) the rate of change, c) the value of the characteristic at release for distribution. With this information, you can calculate the shelf life. The calculation should include a "guard band" so the labeled shelf life is shorter than the calculation.
To determine the characteristics that changes in Polyamide 12, conduct a literature search.
To determine the rate of change, there are three methods: a) obtain information from the manufacturer of the material, b) conduct an accelerated life test on the product, or c) conduct a real time life test on the product.
Set the initial value of the characteristic, if possible, by manufacturing process control. For example, if there is a bi-lateral specification, set the value near one specification limit, to get longer times before crossing the other specification limit. Do not center the process.
For labeling, there is a symbol to put on the label as well as the date. The US requires a specific format that includes the year, month, and day. If the label has a shelf-life, then it is one of the UDI production identifiers and the Access GUDID record shows whether the device uses that production identifier. You should also check Access GUDID for similar competitor's products to determine if they specify a shelf-life.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 22-Nov-2021 10:24
From: Nadine Adia
Subject: polyamide 12 cutting guide shelf life
Dear team,
Please could some one help me to find the shelf life of a non-sterile surgical Polyamide 12 cutting guide (transient use device).
How could I determine this please or what is generally mention in the labels.
Thank you in advance for your response.
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Nadine Adia
Quebec QC
Canada
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