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Home Standards IEC 60601-1 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance

IEC 60601-1 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as
ME EQUIPMENT and ME SYSTEMS.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within
the scope of this standard are not covered by specific requirements in this standard except in
7.2.13 and 8.4.1.
The IEC 60601 series does not apply to:

– in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which
is covered by the IEC 61010 series [61];

– implantable parts of active implantable medical devices covered by the ISO 14708
series [69]; or

– medical gas pipeline systems covered by ISO 7396-1 [68].
NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS.

The object of this standard is to specify general requirements and to serve as the basis for
particular standards.

In the IEC 60601 series, collateral standards specify general requirements for BASIC SAFETY
and ESSENTIAL PERFORMANCE applicable to:

– a subgroup of ME EQUIPMENT(e.g. radiological equipment);

– a specific characteristic of all ME EQUIPMENT not fully addressed in this standard.

Applicable collateral standards shall
apply together with this standard.
NOTE 1 When evaluating compliance with IEC 60601-1, it is permissible to independently assess compliance with
the collateral standards.

NOTE 2 When declaring compliance with IEC 60601-1, the declarer should specifically list the collateral standards
that have been applied. This allows the reader of the declaration to understand which collateral standards were
part of the evaluation.

NOTE 3 Collateral standards in the IEC 60601 family are numbered IEC 60601-1-xx. The IEC
maintains a catalogue of valid International Standards. Users of this standard should consult this
catalogue to determine which collateral standards have been published.

LISUN following instruments fully meet IEC 60601-1 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance