Shelf-Life vs. Lifetime of Medical Laser Device

Hello,

What's the difference between Shelf-life and life time of medical laser device?

For shelf-life, the laser system is resuable and does not has a restricted shelf-life. Do we need to address the shelf-life into the user manual or other labels? If yes, what we should address?

For lifetime, we analyze the critical components's lifetime to determine our product's lifetime.


Leon

Re: Shelf-life vs. lifetime of medical device

luloo117117 said:

Hello,

What's the difference between Shelf-life and life time of medical laser device?

For shelf-life, the laser system is resuable and does not has a restricted shelf-life. Do we need to address the shelf-life into the user manual or other labels? If yes, what we should address?

For lifetime, we analyze the critical components's lifetime to determine our product's lifetime.


Leon

Click to expand...

I believe lifetime refers to the patient's lifetime; think in terms of an implantable device.

Re: Shelf-life vs. lifetime of medical device

I think it's a matter of terminology. Lifetime or life-span is a term used for reusable medical equipment, shelf-life is more often associated with consumables. One exception is where your reusable medical device is battery powered - the device may be good for 10 years, but the shelf life may be 6 months due to the battery needing replacement/recharging.

Here's an article giving some typical life-spans and the reasons behind them:
http://www.fbe.org.au/BEAG_public/B...Biomedical Devices - Guidance Paper Final.pdf

Re: Shelf-life vs. lifetime of medical device

Hello, I'm new to the Forums. I'm Japanese so I don' t think I'm the best person to answer, but....

Both words show up in ISO13485.
In Japanese translation of the Standard, they are a little different.
Plus my understanding is....

Lifetime: period until the product becomes useless

Shelf life: Period the product can be sold

For lifetime, we analyze the critical components's lifetime to determine our product's lifetime

Click to expand...

I think you're right, Leon.
In Japan, we have to address the product lifetime, conforming to JGMP/QMS.

I hope it helps you.

Reiko

Re: Shelf-life vs. lifetime of medical device

Lifetime: period until the product becomes useless

Shelf life: Period the product can be sold

Click to expand...

That's what I understand or interpret from a consumers angle.


Welcome to the Cove Reiko,

We look forward to see more of your countryman joining us here.