IEC 60601-1-11: Medical electrical equipment — General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The home healthcare environment includes:
– the dwelling place in which a patient lives
– other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present
-non hospital clinics
IEC 60601-1-11 outlines the additional requirements under the assumption that no medical professions will be using MEDICAL EQUIPMENT or MEDICAL SYSTEMS, or providing care to patients. More stringent temperature and humidity requirements are included, as well as additional requirements for handling, storage, and cleaning.
IEC 60601-1-11 can be used in part to show compliance with the US-FDA, Canada-Health Canada, and the EU Medical Device directive 93/42/EEC.
Additional requirements are found for home healthcare environments in IEC 60601-1-2 which covers electromagnetic compatibility.
To determine if home healthcare requirements are needed for your compliance requirements, contact the D.L.S. staff today.