Medical electrical equipment — Part 1-11: 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
This National Standard of Canada is equivalent to International Standard IEC 60601-1-11:2010. 1.1 * Scope This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as
ME EQUIPMENT and ME SYSTEMS, which are intended by their MANUFACTURER for use in the
HOME HEALTHCARE ENVIRONMENT, as defined in 3.2, regardless of whether the ME EQUIPMENT or
ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel. NOTE 1 HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can also be intended for use in other
environments, for example, in a professional healthcare facility. This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely
for use by emergency medical services or solely for use in professional healthcare facilities. NOTE 2 HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can frequently be used in locations with
unreliable electrical sources and poor electrical grounding.