The third edition of IEC 60601-1 was published in December 2005, but few certification bodies (CB) certificates have actually been issued to this version of the standard and few agency mark projects ...
The IEC 60601-1 standard – which addresses many of the risks associated with electronic medical devices – has become a de facto requirement by most companies for electro-medical products. The IEC ...
Some of the most challenging leakage-current-testing requirements are those for patient-monitoring devices—both invasive and noninvasive. Such testing can be time-consuming and expensive, so it is ...
The IEC 60601 standards series is one part of putting together a technical file or a 510(k) submission. It’s about more than electrical safety — it covers mechanical safety, labeling and risk ...
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