Understanding, interpreting and implementing standards is a challenge in all industries. Medical standards for electronics can be particularly onerous, and while it is uncommon for regulatory changes to effect products already in production, the third edition of 60601-1 is an exception. IEC 60601-1 applies to all electrical and electronic medical devices and their accessories. The 3rd edition was adopted by global regulatory authorities, and on a national level, regulatory affectivity dates are harmonized across global jurisdictions. Medical OEMs need to carefully manage vendors for their chargers and other accessories as these changes take place. This white paper will provide an outline and update of the standard, as well as compliance guidelines for portable medical devices.
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