SRPS EN 60601-1-1:2010

Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

Scope

Applies to the safety of medical electrical systems, as defined as follows: combination of items of equipment, at least one of which must be medical electrical equipment and inter-connected by functional connection or use of a multiple portable socket-outlet. Describes the safety requirements necessary to provide protection for the patient, the operator and surroundings. Cancels and replaces the first edition published in 1992 and its amendment 1 (1995) and constitutes a technical revision.

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.

Regulation