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Gynecology Chair - Applicable EU Standards

C

czar323

#1
Hello to everyone!
Our company encountered some problems with obtaining information upon EU applicable harmonized standards for Gynecology chairs (manual and electric) and Obstetric aid table. We conducted a research, but did not found any applicable standards. Maybe somebody can clear out what to do if there are no such applicable standards. Greatly appreciated!
 
G

Guillaume Prom

#2
Re: Gynecology chair EU applicable standards

Hi,

there are no harmonized standards specifically for your products.
But you must apply a lot of general standards (60601-1, 980, 1041,...).

I used EN 15373 to do mechanical testing of a weighing chair.

hope this helps !
 
C

czar323

#3
Re: Gynecology chair EU applicable standards

Thanks a lot Guillaume Prom? for the information!:)
Standards that you mentioned (980, 1041, EN 15373) are BS and DIN standard…how are the applicable for obtaining right to affix CE Mark to our products?. The reason why I’m asking this question is because our company located in Belarus (former Soviet Union) and all CE mark processes are very much new to this area.
 
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#4
Standards are usually voluntary (and they are voluntary in the CE marking process).

Using harmonized standards means that, using them, you gain what is called a "presumption of conformity" to the related essential requirements of the directive.

If you don?t use harmonized standards (or there are no harmonized standards for your product, such as the case), you have to justify what you use, and the NB would need to verify that it really covers the related essential principles.

So, you can use any standard, and as mentioned, in your case you probably should (not must) use different tests from different standards (note that even in this case they are not mandatory, you could, for example, develop your testing for your device that you think cover the related essential principles, however, using one or more standards developed by an SDO - Standard Developing Organization - means that you are using consensus testing and thus packs more punch and usually makes it easier for you to get agreement from your NB.
 
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C

czar323

#5
Greatly appreciate Marcelo Antunes for your explanations!
Our company is 13485 certified and gynecology chair is Class 1 medical device. So if I understand correctly we don’t have to involve NB to affix the CE mark. Basically, as a company, can determine ourselves which standards to apply to show the conformity to MDD requirements?
 
#6
gynecology chair is Class 1 medical device. So if I understand correctly we don?t have to involve NB to affix the CE mark. Basically, as a company, can determine ourselves which standards to apply to show the conformity to MDD requirements?
Oh yes, sorry, forgot that detail. If the device is class I without sterilization or measurement, you do not need to involve an NB.

Anyway, yes, it?s up to the manufacturer to choose how to comply with the requirements. Standards are one way to comply, and harmonized standards additionally give presumption of conformity.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#7
Re: Gynecology chair EU applicable standards

Thanks a lot Guillaume Prom? for the information!:)
Standards that you mentioned (980, 1041, EN 15373) are BS and DIN standard…how are the applicable for obtaining right to affix CE Mark to our products?. The reason why I’m asking this question is because our company located in Belarus (former Soviet Union) and all CE mark processes are very much new to this area.
Please also note that a BS version or a DIN version of an EN standard is acceptable as a harmonized standard since they are required by law to be identical in terms of requirements. I.e. if you're looking at EN 1041 then BS EN 1041 and DIN EN 1041 (as well as many other national transpositions) are acceptable. Perhaps even Belarus has its own national versions in your own language, which might be more convenient (sorry, I don't have any Belarus related experience so I don't know its system).

Cheers,
Ronen.

PS For the electrical models you might want to look at the EN 60601 standards family.
 
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C

czar323

#8
Good day to everyone!
Small question about the standards?We decided to use some parts of 60601-2-52 (Basic safety and essential performance of medical beds). When I am looking to purchase this standard it gives me 3 standards and they all differ in price:
EN 60601-2-52:2010/AC:2011
EN 60601-2-52:2010
IEC 60601-2-52:2009
Do I need to have all 3 of them?
Thanks for your kind help!
 
G

Guillaume Prom

#9
EN 60601-2-52:2010 (harmonized European standard, based on IEC 60601-2-52:2009)
+
EN 60601-2-52:2010/AC:2011 (errata, isn't it free ?)

PS: I'm not sure that 60601-2-52 is OK for Obstetric aid table, see medical bed definition (60601-2-52 ?201.3.212):
"device for which the intended use is sleeping/resting that contains a mattress support platform and intended to assist in diagnosis, monitoring, prevention, treatment, alleviation of disease or compensation for an injury or handicap
Note 1 to entry: A bed-lift and/or a detachable mattress support platform in combination with a compatible nonmedical bed as specified by the manufacturer is also considered a medical bed.
Note 2 to entry: Excluded are devices for which the intended use is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table)
."
 
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#10
PS: I'm not sure that 60601-2-52 is OK for Obstetric aid table, see medical bed definition (60601-2-52 ?201.3.212):
"device for which the intended use is sleeping/resting that contains a mattress support platform and intended to assist in diagnosis, monitoring, prevention, treatment, alleviation of disease or compensation for an injury or handicap
Note 1 to entry: A bed-lift and/or a detachable mattress support platform in combination with a compatible nonmedical bed as specified by the manufacturer is also considered a medical bed.
Note 2 to entry: Excluded are devices for which the intended use is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table)."
In this particular case, the applicability of the standard does not matter thattttt much.

From what the OP said, it seems he?s looking for verification testing, ways to verify that the device meets the requirements. So, if he has to verify that the patient will not fall from his chair, he would need to design a test for this requirement. There are some standards that already have a test like this, including 60601-2-52. As a good practice, he should evaluate if the test (which as you pointed out, was created based on a medical bed which is clear defined) can really be applied to his device, but probably it can be applied directly (or by changing some parameters, for example).

The high level idea on the discussion is that testing from a standard is simply nothing more than an verification test that you use to prove conformity to some requirement. Knowing the requirement, you need to choose the best way to verify it. Product standards are collections of possible testing and verification solutions, and they are easy to use because someone (the WG that created the standard) has already thought about the test. Otherwise the manufacturer would need to design the test itself. One of the main problems we have is that people usually blindly follow standards, without this background understanding of what a standard really is.

But again, as noted, it?s important to verify that the standard testing does fit the testing need. When creating ISO 24971, which has details on how to use standards with risk management, I remember a particular request from the FDA about a problem related to blind following standards and requirements that I also had experience noting - a lot of manufacturers were using tests which did not match the requirement - example, the particular testing was created for a patient with a maximum 100 kg. If your intended patient can have more that that weight, you could still use the testing principle, but would need to change the testing parameters (and, depending on the case, either change the testing itself, or not use the testing because changing the parameters would invalid the testing itself.

All in all, understand what you are doing and select the correct solution :)
 
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