IEC 60601-1 Ed. 3.0 b:2005

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.

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. This standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1.

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.

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.

2 * Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ATTENTION: Additional collateral standards of the IEC 60601 series, which are issued subsequent to publication of this standard, become normative at the date of their publication and shall be considered as being included among the normative references below. See 1.3.

NOTE Informative references are listed in the Bibliography on page 743.

IEC 60065:2001, Audio, video and similar electronic apparatus – Safety requirements

IEC 60068-2-2:1974, Environmental testing – Part 2: Tests. Tests B: Dry heat
Amendment 1 (1993)
Amendment 2 (1994)

IEC 60079-0, Electrical apparatus for explosive gas atmospheres – Part 0: General requirements

IEC 60079-2, Electrical apparatus for explosive gas atmospheres – Part 2: Pressurized enclosures "p"

IEC 60079-5, Electrical apparatus for explosive gas atmospheres – Part 5: Powder filling "q"

IEC 60079-6, Electrical apparatus for explosive gas atmospheres – Part 6: Oil-immersion "o"

IEC 60083, Plugs and socket-outlets for domestic and similar general use standardized in member countries of IEC

IEC 60085, Electrical insulation – Thermal classification

IEC 60086-4, Primary batteries – Part 4: Safety of lithium batteries

IEC 60112, Method for the determination of the proof and the comparative tracking indices of solid insulating materials

IEC 60127-1, Miniature fuses – Part 1: Definitions for miniature fuses and general requirements for miniature fuse-links

IEC 60227-1:1993, Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V – Part 1: General requirements
Amendment 1 (1995)
Amendment 2 (1998)

IEC 60245-1:2003, Rubber insulated cables – Rated voltages up to and including 450/750 V – Part 1: General requirements

IEC 60252-1, AC motor capacitors – Part 1: General – Performance, testing and rating – Safety requirements – Guide for installation and operation

IEC 60320-1, Appliance couplers for household and similar general purposes – Part 1: General requirements

IEC 60335-1:2001, Household and similar electrical appliances – Safety – Part 1: General requirements

IEC 60364-4-41, Electrical installations of buildings – Part 4-41: Protection for safety – Protection against electric shock

IEC 60384-14:2005, Fixed capacitors for use in electronic equipment – Part 14: Sectional specification: Fixed capacitors for electromagnetic interference suppression and connection to the supply mains

IEC 60417-DB:2002 , Graphical symbols for use on equipment

IEC 60445, Basic and safety principles for man-machine interface, marking and identification – Identification of equipment terminals and of terminations of certain designated conductors, including general rules for an alphanumeric system

IEC 60447, Basic and safety principles for man-machine interface, marking and identification – Actuating principles

IEC 60529:1989, Degrees of protection provided by enclosures (IP Code) 6)
Amendment 1 (1999)

IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests

IEC 60601-1-3, Medical electrical equipment – Part 1: General requirements for safety – 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment

IEC 60601-1-6, Medical electrical equipment – Part 1-6: General requirements for safety – Collateral standard: Usability

IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for safety – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 60664-1:1992, Insulation coordination for equipment within low-voltage systems – Part 1: Principles, requirements and tests
Amendment 1 (2000)
Amendment 2 (2002)

IEC 60695-11-10, Fire hazard testing – Part 11-10: Test flames – 50 W horizontal and vertical flame test methods
IEC 60730-1:1999, Automatic electrical controls for household and similar use – Part 1: General requirements
Amendment 1 (2003)

IEC 60825-1:1993, Safety of laser products – Part 1: Equipment classification, requirements and user's guide
Amendment 1 (1997)
Amendment 2 (2001)

IEC 60851-3:1996, Winding wires – Test methods – Part 3: Mechanical properties
Amendment 1 (1997)
Amendment 2 (2003)

IEC 60851-5:1996, Winding wires – Test methods – Part 5: Electrical properties
Amendment 1 (1997)
Amendment 2 (2004)

IEC 60851-6:1996, Winding wires – Test methods – Part 6: Thermal properties
Amendment 1 (1997)

IEC 60878:2003, Graphical symbols for electrical equipment in medical practice

IEC 60884-1, Plugs and socket-outlets for household and similar purposes - Part 1: General requirements

IEC 60950-1:2001, Information technology equipment – Safety – Part 1: General requirements

IEC 61058-1:2000, Switches for appliances – Part 1: General requirements
Amendment 1 (2001)

IEC 61558-1:1997, Safety of power transformers, power supply units and similar – Part 1: General requirements and tests Amendment 1 (1998)

IEC 61558-2-1, Safety transformers, power supply units and similar – Part 2: Particular requirements for separating transformers for general use

IEC 61672-1, Electroacoustics – Sound level meters – Part 1: Specifications

IEC 61672-2, Electroacoustics – Sound level meters – Part 2: Pattern evaluation tests

IEC 61965, Mechanical safety of cathode ray tubes

ISO 31 (all parts), Quantities and units

ISO 780, Packaging – Pictorial marking for handling of goods

ISO 1000, SI units and recommendations for the use of their multiples and of certain other units

ISO 1853, Conducting and dissipative rubbers, vulcanized or thermoplastic – Measurement of resistivity

ISO 2878, Rubber, vulcanized – Antistatic and conductive products – Determination of electrical resistance

ISO 2882 14), Rubber, vulcanized – Antistatic and conductive products for hospital use – Electrical resistance limits

ISO 3746, Acoustics – Determination of sound power levels of noise sources using sound pressure – Survey method using an enveloping measurement surface over a reflecting plane

ISO 3864-1:2002, Graphical symbols – Safety colours and safety signs – Part 1: Design principles for safety signs in workplaces and public areas

ISO 5349-1, Mechanical vibration – Measurement and evaluation of human exposure to handtransmitted vibration – Part 1: General requirements

ISO 7000-DB:2004 15), Graphical symbols for use on equipment – Collection of symbols

ISO 7010:2003, Graphical symbols – Safety colours and safety signs – Safety signs used in workplaces and public areas

ISO 9614-1, Acoustics – Determination of sound power levels of noise sources using sound intensity – Measurement at discrete points

ISO 10993 (all parts), Biological evaluation of medical devices

ISO 11134, Sterilization of health care products – Requirements for validation and routine control – Industrial moist heat sterilization

ISO 11135, Medical devices – Validation and routine control of ethylene oxide sterilization

ISO 11137, Sterilization of health care products – Requirements for validation and routine control – Radiation sterilization

ISO 13852, Safety of machinery – Safety distances to prevent danger zones being reached by the upper limbs

ISO 14971:2000, Medical devices – Application of risk management to medical devices

ISO 15223, Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied

ISO 23529, Rubber – General procedures for preparing and conditioning test pieces for physical test methods