Excessive Temperature - Parts of equipment not intended to supply heat

P

Pauling

#1
Hi, all,

Our product inhaler is heating water to get the pressure to atomize the medicine. At 40deg environment temperature, the output mist is higher than 41deg, that could not meet the requirement of CL 42.3.
Here is my question: If this part intended to supply heat or not.If no, how to do can meet the requirement? If we could clarify the environment temperature is under 40 deg, but i doubt, little change environment could get the product meeting the requirement.
Any comment will be appreciated. Many thanks.


BR,
Pauling
 
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D

DrM2u

#2
Here is my question: If this part intended to supply heat or not.If no, how to do can meet the requirement?
The answer is in your own statement:
Our product inhaler is heating water to get the pressure to atomize the medicine.
The water is heated to boiling temperature in order to create the vapor and pressure necessary to atomize the medicine. Basic thermodynamics and heat transfer principles show that the temperature of the vapor is affected by the amount of time it is exposed to the environment and the temperature of the environment. The temperature and materials of the nebulizer's components also play a role but not the major role. Therefore, warmer outside temperatures will cause higher vaport temperatures. The design of the nebulizer should take in account all these variables to meet the applicable specifications. Seem to me like you are looking at an engineering problem here.

See the link below for the basic principles behind a nebulizer/atomizer:
http://en.wikipedia.org/wiki/Nebulizer
 
P

Pauling

#3
Hi, DrM2u,
Thanks for your comment...
Yes, It's an engineering problem, just have a little expectation for "intended to supply heat"...

BR.
Pauling
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi, DrM2u,
Thanks for your comment...
Yes, It's an engineering problem, just have a little expectation for "intended to supply heat"...

BR.
Pauling
Hi,

From an engineering point of view (and without any knowledge of your specific design, so it may be not applicable) - if you're concerned with the tempertaure you can lower the pressure and get a similar physical effect at lower tempertaures.

Just a thought.

Cheers,
Ronen.
 
P

Pauling

#5
Hi, Ronen,

Thanks for your comment.
We must boil the water to get the pressure.So to lower the temperature is not applicable for our equipment.

BR.
Pauling
 
D

DrM2u

#6
Hi, DrM2u,
Thanks for your comment...
Yes, It's an engineering problem, just have a little expectation for "intended to supply heat"...

BR.
Pauling
I don't think that the device is intended to supply heat. The intent for the device is to supply medicine to the user via the airways. The heat is a by-product (secondary effect) of the device. As you have confirmed, the device has to boil water to create enough vapor pressure to atomize the medicine into the air stream for the user to inhale. A few areas to review:
- Is the equipment creating more pressure than necessary to atomize the medicine? More pressure means more heat (I remember this equation: PV=nRT). There might be an opportunity to optimize or reduce the pressure, therefore reducing the vapor temperature.
- Is the equipment delivering a volume of vapor more than necessary? The larger the volume the longer it takes to cool down; therefor the higher inhalation temperature.

I am not sure if this answers your question ...
 
P

Pauling

#7
Hi, DrM2u,

Yes,i agree that it's not the one intended to supply heat...
For the creating/delivering pressure, since the mould of boiler is been developed and the outlet of pressure is small, i guess both are not appropriate for our product.
Thanks.

Best Regards
Pauling
 
C

CMC68

#8
Here's a thought. Maybe it will help. I don't know much about designing nebulizers. I think the 3rd edition of the standard has slightly different temperature requirements and doesn't exactly have the "intended to supply heat" escape anymore.

Instead it has a different method of dealing with temps a little on the high side and I think it makes sense...better for everyone.

My interpretation of the clause is that for applied parts, regardless of whether you intend to supply heat (there are separate clauses, but they are similar for these purposes), you are required to identify and minimize risks and include the analysis in your risk management file. If all engineering options to reduce surface temp have been exhausted, conduct a thorough review and documentation of residual risk in your RMF and ensure the temperature and effects, if any, are disclosed in the instructions for use. Perhaps you would include a restriction on use to temperatures somewhere below 40C. It's up to you to come up with ways to minimize risk.

I recognize that picking and choosing clauses from the new edition would tend not to go over well, but I thought I'd throw it out there.
 

Marcelo

Inactive Registered Visitor
#9
If all engineering options to reduce surface temp have been exhausted, conduct a thorough review and documentation of residual risk in your RMF and ensure the temperature and effects, if any, are disclosed in the instructions for use. Perhaps you would include a restriction on use to temperatures somewhere below 40C. It's up to you to come up with ways to minimize risk.
You are correct. In this case, it would mean that you cannot reduce your risk any further and you would need to perform a risk/benefit analysis according to ISO 14971 to claim compliance with this requirement of IEC 60601-1 third edition.

From a theoretical point of view, this rationale would be the same for the second edition also.
 
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