What IEC 62353?
As its full name implies, IEC 62353 Medical Electrical Equipment – recurrent test and test after repair of ME equipment, defines the requirements for electrical safety testing of medical electrical (ME) equipment and systems during routine intervals.
Is IEC 62353 mandatory?
Short answer: no. IEC 62353 does not apply to manufacturers and cannot be referred to in medical device regulation. IEC 62354 is a guide only, a technical report, and again cannot be referred to in regulation.
What is the difference between IEC 60601 and IEC 62353?
Using IEC 60601-1 repeatedly can shorten the life of the medical device (Tests like the 25A PE resistance and/or 110% mains on applied parts testing). Choosing IEC 62353 will shorten the amount of testing while providing the minimum accepted electrical safety tests.
What is the maximum leakage current allowed in a medical device?
500 μA
The widely accepted limit for touch current — the term newer standards use for leakage currents from the equipment case or enclosure of patient care medical equipment — is 500 μA.
What is IEC medical device?
IEC 60601 is a series of technical standards that ensure the safety of medical electrical equipment. It is assumed that public health authorities in many countries recognise IEC 60601-1 (Edition 3.2) as a pre-requisite for the commercialisation of electrical medical equipment.
What is the maximum resistance allowed in a medical device?
The widely accepted limit for touch current — the term newer standards use for leakage currents from the equipment case or enclosure of patient care medical equipment — is 500 μA.
What is the latest version of IEC 60601-1?
IEC 60601-1 (Edition 3.2) is the newest published general standard with around 1500 single specific requirements.