CSA C22.2 No. 60601-1-11:15
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 Appareils électromédicaux — Partie 1-11 : Exigences générales pour la sécurité de base et les performances essentielles — Norme Collatérale : Exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l’environnement des soins à domicile
1.1 * Scope
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME
HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the
instructions for use. This International Standard applies regardless of whether the
ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare
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.
This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely
for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT, covered by IEC 60601-1-12 or
solely for use in professional healthcare facilities covered by IEC 60601-1 without the
additions of IEC 60601-1-12 or this collateral standard. Nonetheless, ME EQUIPMENT or
ME SYSTEMS can be intended for multiple use environments, and as such, if also intended for
use in the HOME HEALTHCARE ENVIRONMENT, are within the scope of this standard.
EXAMPLE ME EQUIPMENT or ME SYSTEMS intended for both the HOME HEALTHCARE ENVIRONMENT and the
professional healthcare facility environment.
NOTE HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can frequently be used in locations with
unreliable electrical sources and poor electrical grounding.
This Standard covers ME EQUIPMENT and ME SYSTEMS that are intended to be installed or used in
accordance with CSA C22.1, Canadian Electrical Code, Part I.