Effects of Irradiation Sterilization on Medical Electronics - Li Coin Cell Batteries

S

sudeepd

#1
Hello all-
We are currently designing a simple LED light system into our disposable medical device. It consists of two 3V Li coin cell batteries, a switch and a high brightness white LED. We have two questions that we'd like to put up for discussion.

1. Short of doing a full performance test on samples and spending a lot of money on figuring out the effects, we were wondering if anyone has any experience packaging similar coin cell batteries and used radiation (Gamma and/or E-Beam) to sterilize the product, and what can be expected.

2. Also, does E-beam radiation affect low powered magnets? We have a small magnet reed switch in the design and would like to know if there is any effect on the magnet/magnetized metal from E-beam radiation.

Your suggestions and guidance are most appreciated.

Thank you.
SD
 
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M

MIREGMGR

#2
Re: Effects of Irradiation Sterilization on Medical Electronics - Li Coin Cell Batter

A caveat to this response: I don't regularly use or design for either E-beam or gamma sterilization.

I'm under the impression that E-beam may set up prodigious voltages in conductors, so that completion of a conductive path via either leakage current or arcing standoff distance becomes an issue. E-beam also is notorious for causing disintegration of some high-resistivity polymers; a lithium cell that had PTFE insulation exposed at its can surface, for instance, could have that PTFE rapidly destroyed.

I believe I've read in application notes in the past that in at least one instance, a lithium cell maker instructed that their products were not to be gamma sterilized because of radiation effects on chemistry and physics of insulative components.
 
G

greensal

#3
Re: Effects of Irradiation Sterilization on Medical Electronics - Li Coin Cell Batter

Hi all,

I am having a similar challenge to that of sudeepd.

We are currently designing a disposable medical device which contains a two 3V Li coin cell batteries, a switch and a high brightness white LED.

The challenge we are facing is in sterilizing the product. We are considering either Gamma or E-Beam. Based on preliminary research, Li coin batteries do not like high temperatures. We know we can sterilize using EtO method, yet the turn around time is not feasible.

Your suggestions and guidance on this topic is highly appreciated.
Thank you,

GS
 
M

MIREGMGR

#4
Re: Effects of Irradiation Sterilization on Medical Electronics - Li Coin Cell Batter

In addition to the prior adverse mechanisms...in E-beam, charge/voltage buildup resulting in circuit failure, and in both means, damage to polymers...gamma tends to directly destroy semiconductor junctions at the nuclear level.
 
G

greensal

#5
Re: Effects of Irradiation Sterilization on Medical Electronics - Li Coin Cell Batter

Thank you MIREGMGR for your input
Would a shield around the battery make any difference either during E-Beam or Gamma?
Also are there any Collateral standards (60601-1-X) that define the requirements for certain aspects of safety and performance for battery powered medical device?

Regards,
GS
 
M

MIREGMGR

#6
Re: Effects of Irradiation Sterilization on Medical Electronics - Li Coin Cell Batter

Shielding for gamma would have to be lead, and quite thick. The LED, being a semiconductor, would have to be shielded. Not very practical if you want your device to be portable and emit light.

E-beam shielding with a Faraday cage is possible, but that'll prevent sterilization of the enclosed elements and again would interfere with light emission and switch operation. Very generally speaking, any opening in a Faraday cage larger in its largest dimension than a half wavelength of the applied RF field, defeats the shielding.

My guess is that you aren't going to end up using E-beam or gamma.
 
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