Hi Roger
How's life in Singapore? Please note 62353 is an internationally accepted standard that can be used in Singapore as much as anywhere else. There is no other standard that is such widely accepted for routine testing of medical devices. You'll see one of the leading hospitals in Singapore test to this standard soon. Although IEC 60601 has been around for decades, you'll find little guidance in the standard dealing with your circumstances ie routine testing (and PPM) Thus the tests you are doing are simply ones interpretation of IEC 60601. Do you do the Hipot test at 1500V and 4000 V as well? Do you carry out earthbond at 25A for 10-30 secs and wait for all connections to heat up and perhaps to fuse? Do you carry around an isolation transformer with you so all testing is done at isolated supply (and at 110% of mains)? Do you apply 230V on the communication ports and check for patient leakage? Do you test in a temp / humidity controlled environment (you probably do but not many people do)?
This is what IEC 60601 is about... type testing and making sure the design is safe. People mainly "pick and mix" (see earlier posts)from the 60601 standard and claim they test to IEC 60601. The problem is, you can walk into 10 different hospitals and all will do something different as it is their interpretation, experience, know-how, recommendation etc that tells them what to do. Following IEC 60601 is not wrong, in fact it is very solid however, 62353 provides many benefits over the 60601.
I hope this answered your question in some way. There are already 1000's of biomeds now testing to 62353 (worldwide) and this number is likely to increase because of the benefits it provides (and clarity).
regards,
John
Embrace change, don’t run away from it.
