S
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
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
