201.1 Scope, object and related standards
Clause 1 of the general standard 1 applies, except as follows:
201.1.1 * Scope
Replacement :
This particular standard applies to basic safety and essential performance requirements of multifunction patient monitoring equipment as defined in 201.3.63, hereafter referred to as me equipment . This particular standard applies to me equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport.
M e equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to me equipment for those environments of use.
The scope of this standard is restricted to me equipment intended for connection to a single patient that has either two or more applied parts or multiple functions on an