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

F

Francesco Sgarro

#1
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
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
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

#3
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
#4
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

Staff member
Moderator
#5
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.
 
Thread starter Similar threads Forum Replies Date
P Recommended Books on Electrical Safety Compliance for IEC 60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
H IEC 60601-1 ME equipment or ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R IEC 60601-1 - 11.1.3 e) Test criteria - Temperature Measurements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 - Magnesium oxide used for the electrical insulation of heating elements IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Z IEC 60601-2-25; Frequency response test Medical Device and FDA Regulations and Standards News 1
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B IEC 60601 - Creepage Distance - Relay that acts as a means of physical mechanical protection Process Maps, Process Mapping and Turtle Diagrams 0
T Single Fault Condition IEC 60601 Clause 8.7.1 shorting Cr/Cl in Patient Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M What to Expect from Next IEC 60601-1 and IEC 60601-1-2 Amendments? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
D IEC 60601-1 - Service life testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
R Hand transmitted vibration 9.6.3 of IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A IEC 60601 11.2.2.1 Risk of Fire in an Oxygen Rich Environment, Source of Ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
E PEMS Hazards - IEC 60601 Clause 14.6 - Internal data use - Pressure sensor IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
W IEC 60601 - Essential performance c.2.34 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 60601-2-43 - Clause 203.6.103 - Physical button? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M IEC 60601-1 1988 - Device developed in 2012 with standard of 1988 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A IEC 60601-1 Dielectric Strength test for battery operated devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E IEC 60601-1 - Unearthed Medical Device Metal Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 - Different methods of achievement of the isolation IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K What is mean by Oxygen Rich Environment as per the IEC 60601-1 clause no 11.2.2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
K Dielectric strength test as per IEC 60601-1 -Infant incubator IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Unused SIP/SOPs - IEC 60601-1 and IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Sequence of testing in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 60601-2-10 - Accuracy of Pulse Parameters - Required Measurement Uncertainty IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
DitchDigger IEC 60601-1 subclause 5.1 - Adequate evaluation in lieu of testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 60601 Cl. 8.4.3 - ME EQUIPMENT intended to be connected to a power source by a plug / Plug discharge IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Transformer Requirements - IEC 60601-1 vs. IEC 61558-2-15 IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
T Clearance and Creepage according to Subclause 8.9.1 for MOPP IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A IEC 60601-1 and IEC 60601-2-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M IEC 60601-1-2 EMC Tables IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
T Iec 60601 Impedance and current-carrying capability IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Bookmarking my security protected IEC 60601-1 .pdf file IEC 60601 - Medical Electrical Equipment Safety Standards Series 16
G Is impact test according to IEC 60601-1 applicable for HAND-HELD equipment if also classified as BODY-WORN? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
shimonv IEC 60601-1 Essential Performance - Is the signal accuracy specification an essential requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
E ECG device without ECG REPORTS - IEC 60601-2-25: 2011 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M IEC 60601 7.1.3 Durability of Markings - Methylated Spirit or Ethanol? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C ABS plastic : which IEC 60601-1 tests to redo? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
Q Isolation/Insulation Diagrams - IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A IEC 60601-2-2 - Defib-proof test amendment to base standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
pashah Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6 IEC 62366 - Medical Device Usability Engineering 4
P Testing lab in India IEC 60601-2-25 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2

Similar threads

Top Bottom