YY 9706.111-2021 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

Scope

This part specifies the basic safety and performance requirements for medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME systems) used in home care environments.
This part applies to ME equipment and ME systems intended for use in home care environments as specified in the manufacturer's user manual. The application of this part does not consider whether the ME equipment or ME systems are used by inexperienced operators or by trained medical personnel.
Home care environments include:
——The residence where the patient lives;
——Other indoor and outdoor environments where the patient is located, excluding professional medical institutions where trained operators are available whenever the patient visits.
This part does not apply to ME equipment and ME systems intended for use only in emergency medical service environments as described in YY 9706.112 or in professional medical institutions as described in GB 9706 (excluding the additional content of YY 9706.112 or this part). However, ME equipment or ME systems intended for use in multiple environments, as long as they can also be used in home care environments, are within the scope of this standard.
Example: ME equipment or ME systems intended for use in home care environments and professional medical institutions.
Note 1: ME equipment and ME systems in home care environments may often be used in places with unstable power supply and unreliable grounding protection.
Note 2: An asterisk (*) as the first character of a title or the beginning of a paragraph or table heading indicates that there are guidelines and principle explanations related to the item in Appendix A.

Development Information

Same series standard

Referenced Standards

Adopt standards

Related Standards