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

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CSA Group
Standards Development Organisation:
Working Program:
Designation Number:
CAN/CSA-C22.2 No. 60601-1-11
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Reaffirmation
ICS code(s):
11.040
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

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 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.

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.

Project need:

Project Need
To review the Standard within the required 5 year period.

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.