IVD Device - ISO 13485 and Testing for Environmental Operation Specifications

M

Mark M. Sweeny

#1
Hello.

My company is manufacturing its first IVD device.

There is a long range of environmental specifications that the instrument is being evaluated against such as 15-30C, 20-80%RH, and 0-2000 m above sea level.

Is there any guidance as to the minimal amount of testing that these to be done for these types of requirements?

All comments are appreciated.

Best regards,

Mark
 
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Marcelo

Inactive Registered Visitor
#2
The only answer i can think of is: the amount is the one iyou define as needed. If your using the tests for validation purposes, you, as the manufacturer, has to define the amount of tests (and of validation in general) needed.
 
R

Roland Cooke

#3
Mmantunes is essentially correct. The amount of testing you need is determined by:

1) what is required by law (i.e. can depend on where in the world the product will be sold)

2) any additional data you need to generate to demonstrate that the device is safe and effective for use (the list of harmonised standards under the IVD Directive is a good place to start).

3) any particular commercial requirements imposed by your direct or indirect customers (e.g. non-mandatory "green" issues)
 
J

Jimmy the Brit

#4
My company is manufacturing its first IVD device.

There is a long range of environmental specifications that the instrument is being evaluated against such as 15-30C, 20-80%RH, and 0-2000 m above sea level.

Is there any guidance as to the minimal amount of testing that these to be done for these types of requirements?
Hi Mark,

In addition to the previous comments I would ask what extremes of environmental conditions would you expect to see? Are you planning to ship your device by air, in which case what is the temperature and pressure range of items in the unheated hold of an airplane? Will a box of your product sit on the tarmac in Riyadh for eight hours? If so, will these conditions have any effect on the operability of your device and can you prove it?

You have the burden of proof - can you demonstrate that your device can withstand all the conditions that it might face in its "normal" life? Sadly the only person that can define these extremes is you. :(

Jim
 
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