Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ENDOSCOPIC EQUIPMENT together with its INTERCONNECTION CONDITIONS and INTERFACE CONDITIONS.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ENDOSCOPIC EQUIPMENT [as defined in 201.3.204].

Note: This object includes endoscopic intense light source equipment which is part of the ENDOSCOPIC EQUIPMENT including its supply unit, therefore IEC 60601-2-57 does not apply.

201.1.3 Collateral standards

Addition:

This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard.

IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3 does not apply. All other published collateral standards in the IEC 60601-1 series apply as published.

201.1.4 Particular standards

Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.

A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number.