IEC 60601-1: Safety for Medical Electrical Equipment

Principle Objective of IEC 60601-1:

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.

Scope of IEC 60601-1:

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.

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;

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

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

Electrical equipment having an Applied Part or transferring energy to or from the Patient or detecting such energy transfer to or from the Patient and which is:

• provided with not more than one connection to a particular Supply Mains; and

• intended by its Manufacturer to be used in the diagnosis, treatment, or monitoring of a Patient; or for compensation or alleviation of disease, injury or disability

MEDICAL ELECTRICAL SYSTEM – ME System

A combination, as specified by its Manufacturer, of items of equipment, at least one of which is ME Equipment to be inter-connected by Functional Connection or by use of a Multiple Socket-Outlet

60601-1 Annex A – Essential Performance

It has long been recognized that Medical Electrical Equipment or a Medical Electrical System that does not perform properly could result in unacceptable Risk for Patients, Operators, or others. Hence the concept of “safety” has been broadened from the Basic Safety considerations in the first and second editions of this standard to include Essential Performance matters.

In order to achieve its Intended Use, the ME Equipment or ME System needs to perform within certain limits. These limits are usually specified by the Manufacturer, but could be specified by this standard, for example a collateral standard or a particular standard in the IEC 60601 family.

Examples of Essential Performance are:

• correct administration of a drug by a syringe pump where inaccuracy/incorrect administration would cause an unacceptable Risk to the Patient;

• the ability of an electrocardiograph/monitor to recover from the effects of the discharge of a defibrillator where the failure to recover could lead to an incorrect response by the medical staff that would present an unacceptable Risk to the Patient;

• correct operation of an Alarm System in an intensive care or operating room monitoring system where an incorrect/missing Alarm Signal could lead to an incorrect response by the medical staff that would present an unacceptable Risk to the Patient; or

• correct output of diagnostic information from ME Equipment that is likely to be relied upon to determine treatment, where incorrect information could lead to an inappropriate treatment that would present an unacceptable Risk to the Patient.

For purposes of this standard, performance related to Basic Safety aspects of the ME Equipment, such as the performance of Basic Insulation, is not considered to be Essential Performance.