Scales integrated in medical device

[EMengineer]

Hi,

I ran into an issue. Scales (which comply with EN 45501 standard) is incorporated into the medical bed. Does scales should be retested according to EN 45501? What I have found in EN 45501 clause 2.4: "The requirements of this standard apply to all devices performing the relevant functions, whether they are incorporated in an instrument or manufactured as separate units.". Does it mean that if scales complies with EN 45501 and then is incorporated into medical bed, there is no need to retest the scales?

 

[Al Rosen]

Hi,

I ran into an issue. Scales (which comply with EN 45501 standard) is incorporated into the medical bed. Does scales should be retested according to EN 45501? What I have found in EN 45501 clause 2.4: "The requirements of this standard apply to all devices performing the relevant functions, whether they are incorporated in an instrument or manufactured as separate units.". Does it mean that if scales complies with EN 45501 and then is incorporated into medical bed, there is no need to retest the scales?

It means that if your scale is incorporated into another instrument, in this case your bed, it is required to meet EN 45501. If EN 45501 requires retesting, then you must retest the scale as part of the bed.

 

[somashekar]

Hi,

I ran into an issue. Scales (which comply with EN 45501 standard) is incorporated into the medical bed. Does scales should be retested according to EN 45501? What I have found in EN 45501 clause 2.4: "The requirements of this standard apply to all devices performing the relevant functions, whether they are incorporated in an instrument or manufactured as separate units.". Does it mean that if scales complies with EN 45501 and then is incorporated into medical bed, there is no need to retest the scales?

I beg to differ in this case.
The scale you are incorporating (fixing on the medical bed) is already complying to EN 45501. (manufactured as a separate unit)
In place of fixing that scale if you fix any other scale on the medical bed not known to comply with EN 45501., then that device (your medical bed) performing the relevant function (weight measurement) must apply the EN 45501.
So you are right in that there is no need to retest the scale.....

 

[Jean_B]

First question is to determine whether it is simply an independent medical device scale.
Is its use as mounted to your medical device bed within the intended use of the medical device scale as sold to you?
Is it independent e.g. the result comes about and is used as if your bed isn't material to it? (The opposite is when it does factor into your intended use in a more integrated way, e.g. calculation, alarms).
If the answer to both is yes, you can probably make a case akin to procedure packs that you don't need to retest (but need to supply its IFU alongside your own, etc.). As a basic, an EN 45501 gap analysis showing no impact/impact and how it is addressed is the minimum. If you're being really fancy with the scales and your bed a full retest might be in order, but that needs so much information you'll probably head into confidential or proprietary matters and contract a consultant instead of this open forum.

 

[Peter Selvey]

I would lean to Somashekar's interpretation. I would assume the logic of the directive (2014/31/EU) and the associated standard EN 45501 is around making a declaration that the "measurement module" meets the directive, full stop.

The "instructions for use" should have installation conditions which if followed means the declaration and compliance are still valid, even if installed in another device.

The alternative does not work logistically: i.e. that installing the module in another device invalidates the declaration and compliance. The reason is that ensuring weighing measurement accuracy is a complex, specialised area so the end product manufacturer (e.g. bed) is not going to have the competence or experience to take responsibility for design and production of the module. The only practical way would be to have the module manufacturer become a subcontractor of the bed manufacturer. That needs legal agreements, and means the module manufacturer gets audited with every bed manufacturer etc etc. If you consider that the module manufacturer could have 100's or 1000's of end users, it all gets messy.

Hence, it makes sense that the module manufacturer can make a one time declaration of compliance. The key here is the installation instructions that need to be robust enough to ensure compliance when installed. Then, the end use manufacturer just needs to verify that they followed the instructions.