• There are no items in your cart

AAMI ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)

Available format(s)

Hardcopy , PDF

Superseded date

30-05-2020

Language(s)

English

Published date

01-01-2012

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of IEC 60601-1:2005
AAMI deviations from IEC 60601-1:2005
Foreword
Introduction
1 Scope, object, and related standards
   1.1 Scope
   1.2 Object
   1.3 Collateral standards
   1.4 Particular standards
2 Normative references
3 Terminology and definitions
4 General requirements
   4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
   4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS
   4.3 ESSENTIAL PERFORMANCE
   4.4 EXPECTED SERVICE LIFE
   4.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS
   4.6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
   4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
   4.8 Components of ME EQUIPMENT
   4.9 Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in
         ME EQUIPMENT
   4.10 Power supply
   4.11 Power input
5 General requirements for testing ME EQUIPMENT
   5.1 TYPE TESTS
   5.2 Number of samples
   5.3 Ambient temperature, humidity, atmospheric pressure
   5.4 Other conditions
   5.5 Supply voltages, type of current, nature of supply,
         frequency
   5.6 Repairs and modifications
   5.7 Humidity preconditioning treatment
   5.8 Sequence of tests
   5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS
6 Classification of ME EQUIPMENT and ME SYSTEMS
   6.1 General
   6.2 Protection against electric shock
   6.3 Protection against harmful ingress of water or
         particulate matter
   6.4 Method(s) of sterilization
   6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT
   6.6 Mode of operation
7 ME EQUIPMENT identification, marking, and documents
   7.1 General
   7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
   7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts
   7.4 Marking of controls and instruments
   7.5 Safety signs
   7.6 Symbols
   7.7 Colors of the insulation of conductors
   7.8 Indicator lights and controls
   7.9 ACCOMPANYING DOCUMENTS
8 Protection against electrical HAZARDS from ME EQUIPMENT
   8.1 Fundamental rule of protection against electric shock
   8.2 Requirements related to power sources
   8.3 Classification of APPLIED PARTS
   8.4 Limitation of voltage, current, or energy
   8.5 Separation of parts
   8.6 Protective earthing, functional earthing, and potential
         equalization of ME EQUIPMENT
   8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
   8.8 Insulation
   8.9 CREEPAGE DISTANCES and AIR CLEARANCES
   8.10 Components and wiring
   8.11 MAINS PARTS, components, and layout
9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
   ME SYSTEMS
   9.1 MECHANICAL HAZARDS of ME EQUIPMENT
   9.2 HAZARDS associated with moving parts
   9.3 HAZARD associated with surfaces, corners, and edges
   9.4 Instability HAZARDS
   9.5 Expelled parts HAZARD
   9.6 Acoustic energy (including infra- and ultrasound)
         and vibration
   9.7 Pressure vessels and parts subject to pneumatic
         and hydraulic pressure
   9.8 HAZARDS associated with support systems
10 Protection against unwanted and excessive radiation HAZARDS
   10.1 X-Radiation
   10.2 Alpha, beta, gamma, neutron, and other particle radiation
   10.3 Microwave radiation
   10.4 Lasers and light emitting diodes
   10.5 Other visible electromagnetic radiation
   10.6 Infrared radiation
   10.7 Ultraviolet radiation
11 Protection against excessive temperatures and other HAZARDS
   11.1 Excessive temperatures in ME EQUIPMENT
   11.2 Fire prevention
   11.3 Constructional requirements for fire ENCLOSURES of
         ME EQUIPMENT
   11.4 ME EQUIPMENT and ME SYSTEMS intended for use with
         flammable anesthetics
   11.5 ME EQUIPMENT and ME SYSTEMS intended for use in
         conjunction with flammable agents
   11.6 Overflow, spillage, leakage, ingress of water or
         particulate matter, cleaning, disinfection,
         sterilization, and compatibility with substances
         used with the ME EQUIPMENT
   11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS
   11.8 Interruption of the power supply/SUPPLY MAINS to ME
         EQUIPMENT
12 Accuracy of controls and instruments and protection against
   hazardous outputs
   12.1 Accuracy of controls and instruments
   12.2 USABILITY
   12.3 Alarm systems
   12.4 Protection against hazardous output
13 HAZARDOUS SITUATIONS and fault conditions
   13.1 Specific HAZARDOUS SITUATIONS
   13.2 SINGLE FAULT CONDITIONS
14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
   14.1 General
   14.2 Documentation
   14.3 RISK MANAGEMENT plan
   14.4 PEMS DEVELOPMENT LIFE-CYCLE
   14.5 Problem resolution
   14.6 RISK MANAGEMENT PROCESS
   14.7 Requirement specification
   14.8 Architecture
   14.9 Design and implementation
   14.10 VERIFICATION
   14.11 PEMS VALIDATION
   14.12 Modification
   14.13 Connection of PEMS by NETWORK/DATA COUPLING to other
         equipment
15 Construction of ME EQUIPMENT
   15.1 Arrangements of controls and indicators of ME EQUIPMENT
   15.2 Serviceability
   15.3 Mechanical strength
   15.4 ME EQUIPMENT components and general assembly
   15.5 MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and
         transformers providing separation in accordance with 8.5
16 ME SYSTEMS
   16.1 General requirements for the ME SYSTEMS
   16.2 ACCOMPANYING DOCUMENTS of an ME SYSTEM
   16.3 Power supply
   16.4 ENCLOSURES
   16.5 SEPARATION DEVICES
   16.6 LEAKAGE CURRENTS
   16.7 Protection against MECHANICAL HAZARDS
   16.8 Interruption of the power supply to parts of an ME SYSTEM
   16.9 ME SYSTEM connections and wiring
17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Annexes
A - General guidance and rationale
B - Sequence of testing
C - Guide to marking and labelling requirements for ME EQUIPMENT
    and ME SYSTEMS
D - Symbols on marking
E - Examples of the connection of the measuring device (MD) for
    measurement of the PATIENT LEAKAGE CURRENT and PATIENT
    AUXILIARY CURRENT
F - Suitable measuring supply circuits
G - Protection against HAZARDS of ignition of flammable
    anesthetic mixtures
H - PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE, and documentation
I - ME SYSTEMS aspects
J - Survey of insulation paths
K - Simplified PATIENT LEAKAGE CURRENT diagrams
L - Insulated winding wires for use without interleaved insulation
Bibliography
Index
Index of abbreviations and acronyms

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

DevelopmentNote
Supersedes AAMI ES1. (02/2006) AMD 1 2012 includes AMD C1 2009 & AMD 2 2010. (05/2015)
DocumentType
Standard
Pages
428
ProductNote
Reconfirmed 201200
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
IEC 60112:2003+AMD1:2009 CSV Method for the determination of the proof and the comparative tracking indices of solid insulating materials
IEC 60320-1:2015 Appliance couplers for household and similar general purposes - Part 1: General requirements
IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
IEC 61672-2:2013+AMD1:2017 CSV Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests
ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
IEC 61558-2-1:2007 Safety of power transformers, power supplies, reactors and similar products - Part 2-1: Particular requirements and tests for separating transformers and power supplies incorporating separating transformers for general applications
IEC 60245-1:2003+AMD1:2007 CSV Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 1: General requirements
ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
IEC 60384-14:2013+AMD1:2016 CSV Fixed capacitors for use in electronic equipment - Part 14: Sectional specification - Fixed capacitors for electromagnetic interference suppression and connection to the supply mains
UL 1439:5ED 2015-04-21 Tests for Sharpness of Edges on Equipment
IEC 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
IEC 60127-6:2014 Miniature fuses - Part 6: Fuse-holders for miniature fuse-links
IEC 60050-195:1998 International Electrotechnical Vocabulary (IEV) - Part 195: Earthing and protection against electric shock
IEC 60695-1-1:1999 Fire hazard testing - Part 1-1: Guidance for assessing the fire hazard of electrotechnical products - General guidelines
IEC 60364-4-41:2005+AMD1:2017 CSV Low voltage electrical installations - Part 4-41: Protection for safety - Protection against electric shock
IEC 60073:2002 Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators
IEC 61558-2-4:2009 Safety of transformers, reactors, power supply units and similar products for supply voltages up to 1 100 V - Part 2-4: Particular requirements and tests for isolating transformers and power supply units incorporating isolating transformers
IEC TR 62354:2014 General testing procedures for medical electrical equipment
ISO 23529:2016 Rubber General procedures for preparing and conditioning test pieces for physical test methods
ISO 2882:1979 Rubber, vulcanized — Antistatic and conductive products for hospital use — Electrical resistance limits
ISO 9614-1:1993 Acoustics — Determination of sound power levels of noise sources using sound intensity — Part 1: Measurement at discrete points
IEC 60050-151:2001 International Electrotechnical Vocabulary (IEV) - Part 151: Electrical and magnetic devices
IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV Plugs and socket-outlets for household and similar purposes - Part1: General requirements
IEC 61000-4-11:2004+AMD1:2017 CSV Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests
IEC 60050-441:1984 International Electrotechnical Vocabulary (IEV) - Part 441: Switchgear, controlgear and fuses
ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
IEC 60332-2-2:2004 Tests on electric and optical fibre cables under fire conditions - Part 2-2: Test for vertical flame propagation for a single small insulated wire or cable - Procedure for diffusion flame
IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
IEC 61558-2-23:2010 Safety of transformers, reactors, power supply units and combinations thereof - Part 2-23: Particular requirements and tests for transformers and power supply units for construction sites
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
IEC 60127-1:2006+AMD1:2011+AMD2:2015 CSV Miniature fuses - Part 1: Definitions for miniature fuses andgeneral requirements for miniature fuse-links
IEC 60851-6:2012 Winding wires - Test methods - Part 6: Thermal properties
IEC 60079-5:2015 RLV Explosive atmospheres - Part 5: Equipment protection by powder filling "q"
IEC 60601-2-22:2007+AMD1:2012 CSV Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60851-5:2008+AMD1:2011 CSV Winding wires - Test methods - Part 5: Electrical properties
IEC 60227-1:2007 Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements
IEC 60332-1-2:2004+AMD1:2015 CSV Tests on electric and optical fibre cables under fire conditions - Part 1-2: Test for vertical flame propagation for a single insulatedwire or cable - Procedure for 1 kW pre-mixed flame
ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
EN 563:1994/A1:1999/AC:2000 SAFETY OF MACHINERY - TEMPERATURES OF TOUCHABLE SURFACES - ERGONOMICS DATA TO ESTABLISH TEMPERATURE LIMIT VALUES FOR HOT SURFACES
IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60085:2007 Electrical insulation - Thermal evaluation and designation
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
IEC 61558-1:2017 Safety of transformers, reactors, power supply units and combinations thereof - Part 1: General requirements and tests
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
ISO 3746:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
IEC 60447:2004 Basic and safety principles for man-machine interface, marking and identification - Actuating principles
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
ISO 780:2015 Packaging Distribution packaging Graphical symbols for handling and storage of packages
ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
MIL-HDBK-217 Revision F:1991 RELIABILITY PREDICTION OF ELECTRONIC EQUIPMENT
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
IEC 61058-1:2016 Switches for appliances - Part 1: General requirements
NFPA 99 : 2018 HEALTH CARE FACILITIES CODE
IEC 60068-2-2:2007 Environmental testing - Part 2-2: Tests - Test B: Dry heat
IEC 60695-11-10:2013 Fire hazard testing - Part 11-10: Test flames - 50 W horizontal and vertical flame test methods
IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60079-6:2015 Explosive atmospheres - Part 6: Equipment protection by liquid immersion "o"
IEC 60079-0:2011 Explosive atmospheres - Part 0: Equipment - General requirements
ISO 8041:2005 Human response to vibration Measuring instrumentation
IEC 60851-3:2009+AMD1:2013 CSV Winding wires - Test methods - Part 3: Mechanical properties
IEC 62079:2001 Preparation of instructions - Structuring, content and presentation
ISO 80000-1:2009 Quantities and units — Part 1: General
ISO 13857:2008 Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs
ISO 2878:2017 Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance
IEC 60086-1:2015 Primary batteries - Part 1: General
IEC 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
IEC 62471:2006 Photobiological safety of lamps and lamp systems
ISO 3864-1:2011 Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs and safety markings
IEC 60252-1:2010+AMD1:2013 CSV AC motor capacitors - Part 1: General - Performance, testing andrating - Safety requirements - Guidance for installation and operation
ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
IEC 60050-826:2004 International Electrotechnical Vocabulary (IEV) - Part 826: Electrical installations
IEC 61965:2003 Mechanical safety of cathode ray tubes
IEC 60364-7-707:1984 Electrical installations of buildings. Part 7: Requirements for special installations or locations. Section 707: Earthing requirements for the installation of data processing equipment
ISO 5349-1:2001 Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements
ISO 14971:2007 Medical devices Application of risk management to medical devices
IEC 60086-4:2014 Primary batteries - Part 4: Safety of lithium batteries
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
IEC 60317-43:1997+AMD1:2010 CSV Specifications for particular types of winding wires - Part 43: Aromatic polyimide type wrapped round copper wire, class 240
IEC 61140:2016 Protection against electric shock - Common aspects for installation and equipment
ISO 1853:2011 Conducting and dissipative rubbers, vulcanized or thermoplastic Measurement of resistivity
IEC 60309-1:1999+AMD1:2005+AMD2:2012 CSV Plugs, socket-outlets and couplers for industrial purposes - Part 1: General requirements
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
IEC 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC TR 61258:2008 Guidelines for the development and use of medical electrical equipment educational materials
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC 60695-1-10:2016 Fire hazard testing - Part 1-10: Guidance for assessing the fire hazard of electrotechnical products - General guidelines
IEC 60445:2017 Basic and safety principles for man-machine interface, marking and identification - Identification of equipment terminals, conductor terminations and conductors
IEC 60664-1:2007 Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
IEC 60990:2016 Methods of measurement of touch current and protective conductor current
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 5805:1997 Mechanical vibration and shock — Human exposure — Vocabulary
IEC 60730-1:2013+AMD1:2015 CSV Automatic electrical controls - Part 1: General requirements
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

€979.88
Excluding VAT

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.