SRPS EN 60601-2-49:2017

Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

Scope

IEC 60601-2-49:2011 applies to the basic safety and essential performance requirements of multifunction patient monitoring equipment. It applies to medical electrical equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Medical electrical 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 medical electrical equipment intended for connection to a single patient that has either two or more applied parts or multiple functions on an applied part. This second edition cancels and replaces the first edition of IEC 60601-2-49, published in 2001. This edition constitutes a technical revision to the new structure of IEC 60601-1:2005 (third edition).

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.