Is IEC 60601-1-11 recommended or mandatory for devices manufactured after June 2013?

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Francesco Sgarro

Hi all,
can you clarify this doubt about this standard? is it recommended or mandatory for devices manufactured after June 2013 in Europe?

my understanding is that 2 devices intended for use in homecare environment are equivalent if they are compliant to MDD 93/42 (first device - manufactured before june 2013) and 60601-1-11 ( second device - after June 2013).

is there any competitive advantage versus devices that are not compliant with these standard?

thank you for your help
 

Marcelo

Inactive Registered Visitor
Re: Is IEC 60601-1-11 recommended or mandatory for devices manufactured after June 20

Hi all,
can you clarify this doubt about this standard? is it recommended or mandatory for devices manufactured after June 2013 in Europe?

It's neither recommended nor mandatory, standards are voluntary. However, if you use a harmonized standard, you gain presumption of conformity with the related essential requirements that the standard covers.

my understanding is that 2 devices intended for use in homecare environment are equivalent if they are compliant to MDD 93/42 (first device - manufactured before june 2013) and 60601-1-11 ( second device - after June 2013).

I'm not sure I understand your question, what have equivalency to do here? Equivalency, in the regulations, is only related to clinical evaluation.
 
F

Francesco Sgarro

Re: Is IEC 60601-1-11 recommended or mandatory for devices manufactured after June 20

Thank you Marcelo. I'll try to explain my question with an example. i'm not an expert in RA but I would like to understand if there is a competitive difference between these two devices.

First ME is compliant with 93/42, intended for use in homecare environment as per SOM

Second ME is complaint with 93/42, intended for use in homecare environment and compliant with 60601-1-11 as per SOM

Can we say that Second ME is better than the first one? are they equivalent? being compliant with 60601-1-11 offer any advantage versus ME compliant only with 93/42?

thank you
 

Marcelo

Inactive Registered Visitor
Re: Is IEC 60601-1-11 recommended or mandatory for devices manufactured after June 20

Thank you Marcelo. I'll try to explain my question with an example. i'm not an expert in RA but I would like to understand if there is a competitive difference between these two devices.

First ME is compliant with 93/42, intended for use in homecare environment as per SOM

Second ME is complaint with 93/42, intended for use in homecare environment and compliant with 60601-1-11 as per SOM

Can we say that Second ME is better than the first one? are they equivalent? being compliant with 60601-1-11 offer any advantage versus ME compliant only with 93/42?

thank you

Hum, I don't think it's wise to mix these things.

Both devices would be compliant with the required regulation.

Saying that something is "better" or "equivalent" would require more specific definitions for comparison, and you really cannot use the regulations for that.
 

Peter Selvey

Leader
Super Moderator
Re: Is IEC 60601-1-11 recommended or mandatory for devices manufactured after June 20

In principle, both devices should comply with or at least "use" IEC 60601-1-11 if they are being sold now in the EU.

It is common to quote the "no mandatory standards" but this is a dangerous oversimplification.

The actual law states that if a harmonised standard is not applied, you must document your own alternate solution against the relevant essential requirements. In that context you still need to be aware of what is in the standard and make sure to cover it by your alternate solution.

The standard IEC 60601-1-11 covers issues like:
- environmental stress tests, like vibration, thermal shock, water ingress, use in high temp/RH, use in low temp etc
- special usability issues in the home environment
- special EMC considerations

So, it is OK not to apply the specific requirements in IEC 60601-1-11, but you will still need to somehow address the issues raised above, e.g. by your own modified tests for vibration, thermal shock etc, water ingress test, or by a justification why it is not critical for your particular devices.

So, to answer the question the first ME is probably illegal (unless they really documented the alternate solutions, which is unlikely), so the second ME has a strong competitive advantage.
 
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