Medical Gas Pressure Regulators - Anybody had testing conducted at 450 bar? ISO 10524

S

SteveK

#1
#1
Is any one else out there familiar with a specific medical device standard for ‘Pressure regulators for use with medical gases’ – ISO 10524-1:2006? One test for mechanical strength (5.4.10.1) requires that the high pressure side of the regulator shall be capable of withstanding 2.25 times its inlet pressure for 5 minutes. Now a new product of ours is to be used with gas cylinders at 200bar i.e. this means testing at 450bar. Personally I would not be in the same street with something at that pressure. A test laboratory will have to be used and I do know a likely place to approach. The question is, has any body out there actually conducted or requested testing to this pressure level? Bit of a long shot I know - but if you don't ask.

Steve
 
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ScottK

ScottK

Not out of the crisis
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#2
#2
Re: Medical Gas Pressure Regulators - Anybody had testing conducted at 450 bar? ISO 1

SteveK said:
Is any one else out there familiar with a specific medical device standard for ‘Pressure regulators for use with medical gases’ – ISO 10524-1:2006? One test for mechanical strength (5.4.10.1) requires that the high pressure side of the regulator shall be capable of withstanding 2.25 times its inlet pressure for 5 minutes. Now a new product of ours is to be used with gas cylinders at 200bar i.e. this means testing at 450bar. Personally I would not be in the same street with something at that pressure. A test laboratory will have to be used and I do know a likely place to approach. The question is, has any body out there actually conducted or requested testing to this pressure level? Bit of a long shot I know - but if you don't ask.

Steve
Click to expand...
wow. for those of use that measure in PSI that's 6527.

My company makes regulators for the same market, Steve. We might even be competetors. :mg:

I'm looking at the CGA E-7 spec now which is what we use. CGA requires 4 times.

It can be done hydrostatically. Our designs were proof tested long ago so I don't know if they were done in-house or sent out. We have a pretty high pressure hydrostatic test rig, but it's relatively new.
 
S

SteveK

#3
#3
Re: Medical Gas Pressure Regulators - Anybody had testing conducted at 450 bar? ISO 1

Hi Scott,

As you indicate hydrostatic testing would be the safest bet - the standard I quoted does not say specifically test with gas pressure (sort of infers it though). Anyway we do not supply the North American market – so we cannot be competitors there at least!:)

Cannot imagine having to test at 4x!

It's nice to know there is somebody else in the Cove who works in the same field - I thought I'd end up being a bit lonely.:(

Steve
 
M

Marcelo

Inactive Registered Visitor
#4
#4
Re: Medical Gas Pressure Regulators - Anybody had testing conducted at 450 bar? ISO 1

I´ve seen both gas and hydrostatic tests in standards, so i would say that both would be acceptable if there were no explicit requirement.

This is great, you might choose between a potential explosion and a potential flood.
 
Last edited:
ScottK

ScottK

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#5
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Re: Medical Gas Pressure Regulators - Anybody had testing conducted at 450 bar? ISO 1

mmantunes said:
I´ve seen both gas and hydrostatic tests in standards, so i would say that both would be acceptable if there were no explicit requirement.

This is great, you might choose between a potential explosion and a potential flood.
Click to expand...
I'll take the flood any day....
 
ScottK

ScottK

Not out of the crisis
Leader
Super Moderator
#6
#6
Re: Medical Gas Pressure Regulators - Anybody had testing conducted at 450 bar? ISO 1

SteveK said:
Hi Scott,

As you indicate hydrostatic testing would be the safest bet - the standard I quoted does not say specifically test with gas pressure (sort of infers it though). Anyway we do not supply the North American market – so we cannot be competitors there at least!:)

Cannot imagine having to test at 4x!

It's nice to know there is somebody else in the Cove who works in the same field - I thought I'd end up being a bit lonely.:(

Steve
Click to expand...
You're never lonely at the Cove. There's always someone who has a similar issue and misery loves company. :D
 
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