Hi
I am brand new at this forum. I see here a lot of very useful information about ISO 13485 and medical devices generally.
I would like to ask everybody about your comments if medical gases installation (as a whole system) can be classified as a medical devices?
I'm from EU, country Poland, and I noticed that here appeared a first ISO13485 certificate regarding medical gases installation issued by TUV and product is register as medical device in local Medical devices Register (class IIb). From the other hand I know that in Germany medical gases instalation are not classified as medical devices.
Have anybody comments about this situation?
Kind Regards:
thanx:

Take a look at:

III. CLASSIFICATION

1.3. Rule 3
All non-invasive devices intended for modifying the biological or chemical
composition of blood, other body liquids or other liquids intended for infusion
into the body are in Class IIb, unless the treatment consists of
filtration, centrifugation or exchanges of gas, heat, in which case they are
in Class IIa.

Could this apply to your question?

Exactly!
But when we asked Medical devices Institute in Poland (who takes care about registering medical device) if medical gases installation is medical devices we received information that "medical gases installation is not a medical device as a whole system. A medical devices are considered only these parts of installation which have direct contact with human being". So in installation medical devices are generally only parts which "came out of the wall". They give also example of O.R. that if they would considered installation as a medical devices they would have to cosidered O.R. also as a medical devices. Strange, but the truth.
That's why I'm wondering what is situation in other countries in interpretation of this product as a medical device.
Thank you for your reply!

Hi,

Yes, Medical Gases system is definitely a Medical device and can be certified as per ISO 13485.

However, there are certain standards specially for medical gases. They are as follows :

ISO 5359, Low-pressure hose assemblies for use with medical gases
ISO 7396-1:2007, Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum
ISO 8835-3, Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
ISO 9170-2, Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems
ISO 14971, Medical devices - Application of risk management to medical devices
ISO 15001, Anaesthetic and respiratory equipment - Compatibility with oxygen
EN 1041, Information supplied by the manufacturer with medical devices
EN 13348, Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum

Thank you very much for your assistances!

During last year I implemented ISO 13485 system (and take part in certification process) in three medical gases pipeline system companies. And everything run without any problem.

One more time thank you for your help.
If anybody needs any information about ISO 13485 for medical gases pipeline systems just give me an information.

Kind Regards

Hi,

The situation around gas installations in the hospitals is not that clear!
In some european countires these gas supply systems are considered not to be medical devices (e.g. UK). In other countries such as germany some of the "Lander" consider gas supply systems as MD some others don't.

When discussing with your polish agency I would recommend to use the following comparison:

Case A) Would you consider the hose (= accessory) connecting the ventilator (=medical device) with the Oxygen cylinder (=primary container of a pharmaceutical substance) as a medical device?
Will it still be a Medical Device (=accessory) if the hose is made of copper?
Will it remain a Medical Device if the copper tubing leads to another room?

Case B)
Would you consider an infusion set (= accessory) conecting the infusion pump (= Medical device) with the primary container of a pharmaceutical substance being a medical device?

I hope this will help to clarify the situation.

If not just refer to harmonized standards on medical supply systems that a mandated by the EU commission under the medical devices directive. Why should they mandate standards for devices not being medical devices.

Good luck.