Is it mandatory to have medical electrical equipment tested to 60601?
The safety of most medical electrical equipment is demonstrated by compliance with 60601-1, the applicable collateral standards and any Part 2 or other specific standard that relates to the item under consideration.
Is third party testing mandatory? The answer is no, testing is not mandatory but compliance is. (Equivalent safety is allowable but extremely difficult to establish.)
The next question is, can one ensure compliance without testing? The only possibility is by a rigorous design process which allows no room for error. This means in turn that the designer must be completely familiar with all the requirements down to the smallest detail and the construction of the equipment and the components must be error free. This is an unrealisable goal for all but the simplest equipment.
An alternative for the biggest companies only is to do in-house testing with a fully equipped lab, a full complement of calibrated test instrument and an experienced tester.
Otherwise go to a competent accredited test house such as TUV SÜD.
I hear a lot about the second edition and third editions of the standard. What really is the difference between them?
ReplyDeleteWhen do I have to be third edition compliant for the USA?
Both editions are running side by side, the acceptability of the 2nd edition will be valid until 01 June 2013 in the USA.
ReplyDeleteThe main differences between 2nd and 3rd edition include different requirements for the power supply, requirement to have a specific risk management file, the ability to interpelate on test voltages, specific requirements for use at altitude, the introduction of MOPPS and MOOPS - means of patient protection and means of operator protection and major new requirements for mechanical safety.
For a more detailed explanation you should contact the Medical Department at TUV SUD Product Service Ltd.