Appareils électromédicaux - Partie 2-40: Règles particulières de sécurité pour les électromyographes et les appareils à potentiel évoqué

This clause of the General Standard applies except as follows:

1. Scope

Addition:

This Particular Standard applies to ELECTROMYOGRAPHS as defined in 2.1.101 and EVOKED RESPONSE EQUIPMENT as defined in 2.1.102, hereinafter referred to as EQUIPMENT.

1.2 Object

Replacement:

The object of this Particular Standard is to establish particular requirements for the safety of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT as defined in 2.1.101 and 2.1.102, respectively.

1.3 Particular Standards

Addition:

This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment - Part 1: General requirements for safety as amended by its amendment 1 (1991) and amendment 2 (1995).

For brevity, IEC 60601-1 is referred to in this Particular Standard either as the "General Standard" or as the "General Requirement(s)".

The numbering of sections, clauses and subclauses of this Particular Standard corresponds to that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words:

"Replacement" means that the clause or subclause of the General Standard is replaced completely by the text of this Particular Standard.

"Addition" means that the text of the Particular Standard is additional to the requirements of the General Standard.

"Amendment" means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard.

Subclauses or figures which are additional to those of the General Standard are numbered starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

The term "this Standard" is used to make references to the General Standard and this Particular Standard taken together.

Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard, although possibly not relevant, applies without modification; where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard.

The requirements of this Particular Standard take priority over those of the General Standard.

1.5 Collateral Standards

Addition:

Collateral Standards IEC 60601-1-1 as amended by its amendment 1 and IEC 60601-1-2 have been taken into consideration in this Particular Standard (see 6.8.2 and clause 36).