Medical Gas Change Over Unit - Which Standard to use?

S

SteveK

#1
Hi,

When creating technical files for medical devices (to meet ISO 13485 & MDD 93/42/EC) they are appraised and tested against the appropriate (harmonized or national) standard/clauses e.g. to BS EN ISO 15002:2008 for medical gas flow-meters. My company is developing an automatic gas change over unit – to fit between two (oxygen) gas cylinders and their regulators. The aim is maintain a continuous supply when one cylinder runs out (note this is for vehicles, not hospitals). First off we are assuming it is a medical device (Class IIa). However, that being the case, there appears to be no dedicated Standard for such a (medical) device. There are bits in ISO 7396-1 (Medical gas pipeline systems) that I can use. It is not a Regulator (also does not have regulators fitted), so not covered by ISO 10524 series. There are items out there that do this job (including items and a standard – BS EN 13786:2004 - for non-medical uses e.g. for propane bottles) but often they are complex and take in other standards (some of the ones indicated). Any ideas/experience in such matters out there, do I utilize a non-medical standard for example? Any help/advice would be appreciated.

Steve
 
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S

SteveK

#3
Hi Al,

Thanks for trying. Aware of this product/web site. The standards referenced (which I have) are for the regulators/manifolds and gauges which are used in the overall set-up. However, they do not cover anything to do with the actual change-over part, which automatically switches cylinders. Our proposed product will not have regulators or gauges.

Steve
 

Raffy

Quite Involved in Discussions
#5
Hi, :bigwave:
I don't know if this is related with the Medical Gas Change.
I have a concern on Medical Grade Oxygen in Cylinders.
I browse the web and it is PNS103:2003.
Our supplier for Medical Grade Oxygen, uses this standard, and as a customer,
I would like to know the validity of the said standard? Please advice.
What could be the content of this standard? Is there a new standard following this one?
I am newbie in this field. :confused:
Thanks in advance.
Best regards,
Raffy :cool:
 
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