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
|Publication Date:||1 April 2010|
|ICS Code (Medical equipment):||11.040|
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.
The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.