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

1.1 * Scope
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. 

Note: See also 4.2. 

This Standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability. 

In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series 2). This Standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1 3). 

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

1.3 * Collateral 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 become normative at the date of their publication and 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: Members of IEC maintain a register of valid International Standards. Users of this standard should consult this register to determine which collateral standards have been published. 

If a collateral standard applies to ME EQUIPMENT for which a particular standard exists, then the particular standard takes priority over the collateral standard. 

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

Note: Members of IEC and ISO maintain registers of valid International Standards. Users of this standard should consult these registers to determine which particular standards have been published. 

A requirement of a particular standard takes priority over this standard.