Standards Development

Scope

 The Scope clause is a mandatory element of the text. For rules on the drafting of the Scope, refer to the ISO/IEC Directives, Part 2:2018, Clause 14.

This document applies to medical electrical equipment and medical electrical systems, hereafter referred to as MEE and MES.

This document specifies the general requirements for the basic safety and essential performance of MEE and MES, intended for use by the specific users and in the specific environments of use as specified in the instructions for use (IFU).

This document applies to software integrated into an MEE (SiMD). This document applies to software as a medical device (SaMD) in an MES when the SaMD contributes to basic safety or essential performance.

This document can be applied to sub-assemblies of MEE or MES.

EXAMPLE Power supply unit or x-ray tube assembly.

Hazards related to the intended physiological effect of MEE or MES are not covered by the specific requirements of this document except in xxx (formerly 7.2.13) and xxx (formerly 8.4.1).

NOTE 1 See also xxx (formerly 4.2).

The IEC 60601 series does not apply to:

– in vitro diagnostic medical device that does not fall within the definition of MEE, which is covered by the IEC 61010 series;

– implantable parts of active implantable medical devices covered by the ISO 14708 series; or

– medical gas pipeline systems covered by ISO 7396-1.

NOTE 2 ISO 7396-1 applies the requirements for alarm systems to certain monitoring and alarm signals.