How to elect one product to be representative of a Family of Devices

R

rcjpedro

#1
Hi!

Can anyone please point me in the right direction regarding how to elect one product to be representative of a family of devices? This elected device would then be submitted to a certified laboratory to undergo 60601-1 and 60601-1-2 tests.

Motors creating a vacuum source for anaesthetic gas.

These are very simple devices with no patient contact. They differ only in their capacity. Already certified for industrial use.



Thanks.
 
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somashekar

Leader
Admin
#2
Re: Family of Devices

Hi!

Can anyone please point me in the right direction regarding how to elect one product to be representative of a family of devices? This elected device would then be submitted to a certified laboratory to undergo 60601-1 and 60601-1-2 tests.

Motors creating a vacuum source for anaesthetic gas.

These are very simple devices with no patient contact. They differ only in their capacity. Already certified for industrial use.



Thanks.
A good certified lab should be able to assist you in this.
When the motors are of the same construction, but different rating, the highest rating in your family can be considered.
 
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