How to verify the Storage and Transport environmental condition for Medical Device

Kuldeep Singh

Involved In Discussions
#1
As we manufacture the Class IIb medical devices.

We define Storage and transport condition like 0-40 degree and relative humidity upto 90% RH. Our NB raised a question about verification of define temp and Humidity along with vibration parameters. Although we prepare a road transport verification report.Then they raise a question about verification of Sea and Air transport.

So it is not practically possible to verify via Sea or Air during design stage. How can we resolve this.

Thanks in advance for your valuable feedback.
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
Who designed your environmental design criteria test plan(s)? Sea and air, as I remember, are sine vibration profiles, and road transport is broadband random vibration profile.
 

Kuldeep Singh

Involved In Discussions
#3
Who designed your environmental design criteria test plan(s)? Sea and air, as I remember, are sine vibration profiles, and road transport is broadband random vibration profile.
Thanks for sharing your knowledge.

#Our Design team specify the storage and transport condition on the basis of solid state image receptor using within the device. which is image capturing and main component of device.

#As our packed product have weight range upto 800kg .Vibration tests as you mentioned above, I read about it and having test condition of performing tests in in X-axis, Y-axis and Z-Axis . is it possible with this weight range?

Should we mention the vibration limit in our transport and storage condition? and then verify the specify limit. Please clarify if possible
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
There are places such as Wyle who have shakers that could accomodate you, but what a cost.

If I was you I'd get a professional as a consultant to help you. I worked in electronics when I wrote EDC test plans, and both changes over time and the products I wrote them for are significant factors.
 
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