What IEC 62353?
IEC 62353: 2014 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.
What is IEC compliance?
IEC stands for International Electrotechnical Commission. IEC provides a standardized approach to testing and certification. IEC testing brings together the agreed upon set of rules, specifications, and terminology that allow manufacturers to have their devices tested for conformity.
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 medical electrical equipment?
Medical electrical equipment is defined in the standard as electrical equipment, which: has an applied part – the part of the medical electrical equipment that, in normal use, necessarily comes into physical contact with the patient for the medical electrical equipment or system to perform its function.
When was the first version of ul 60601-1 published?
Note: In order to more closely align the UL standard number with the IEC standard number, UL published the first edition of UL 60601-1 in April 2003 to replace UL 2601-1. The following are the main differences between UL 60601-1 and IEC 60601-1.
Do you need ul 60601-1 for lithium batteries?
You should consult UL 60601-1 for full information. Components: Certain components must comply with the relevant ANSI/UL standards for those components, e.g. Lithium batteries must comply with UL 1642, fuseholders with UL 512, etc.
Which is more stringent IEC 60601 or UL 2601-1?
Leakage current: UL 60601-1 has more stringent leakage current requirements than IEC 60601-1 Moving parts: Where moving parts may cause injury, the maximum travel of those part must be limited by end stops or other mechanical means.
Can a NRTL accept components from an ul?
In general UL will only accept components which have been approved by UL itself, though other NRTL’s (National Recognized Testing Laboratories) may have more flexible policies concerning component approvals. Leakage current: UL 60601-1 has more stringent leakage current requirements than IEC 60601-1