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

Designation Number:

C22.2 No. 60601-1-11

Standard Type:

National Standard of Canada - Adoption of International Standard

Standard Development Activity:

New Edition

Status:

Proceeding to development

SDO Comment Period Start Date:

2014-12-02

SDO Comment Period End Date:

2014-12-23

Posted On:

2014-11-25

Scope:

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.

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.