• IEC 60601-2-32:1994

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  12-10-2012

    Language(s):  English - French, Spanish, Castilian

    Published date:  04-03-1994

    Publisher:  International Electrotechnical Committee

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    Table of Contents - (Show below) - (Hide below)

    Committees responsible
    National foreword
    Foreword
    Section one - General
    1. Scope and object
    2. Terminology and definitions
    3. General requirements for tests
    4. Identification, marking and documents
    Section two - Environmental conditions
    Section three - Protection against electric shock hazards
    Section four - Protection against mechanical hazards
    21. Mechanical strength
    22. Moving parts
    24. Stability in NORMAL USE
    28. Suspended masses
    Section five - Protection against hazards from unwanted
    or excessive radiation
    Section six - Protection against hazards of ignition of
    flammable anaesthetic mixtures
    Section seven - Protection against excessive temperatures
    and other safety hazards
    Section eight - Accuracy of operating data and protection
    against hazardous output
    Section nine - Abnormal operation and fault conditions;
    environmental tests
    Section ten - Constructional requirements
    Tables
    101. Drop height
    102. Static load
    Appendix L - References - Publications mentioned in
    this Standard
    Annex AA - Index of defined terms
    Annex ZA - (normative) Other international publications
    quoted in this standard with the references of the
    relevant European publications
    Annex ZB - (informative) Other international publications
    quoted in this standard with the references of the
    relevant European publications

    Abstract - (Show below) - (Hide below)

    Applies to equipment and devices associated to X-ray equipment as used for supporting and relatively positioning the functional components including the patient support used for the application of the X-radiation.This standard applies to all associated equipment not covered by other Particular Standards.

    General Product Information - (Show below) - (Hide below)

    Development Note Also numbered as BS EN 60601-2.32 & BS 5724-2.32(1995). (11/2005) Stability Date: 2011. (10/2012)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS 5724-2-45(2001) : 2001 MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE SAFETY OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
    09/30170496 DC : 0 BS EN 60601-2-45 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
    06/30107360 DC : 0 IEC 60601-1-3 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT
    EN 60601-2-63:2015 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
    BS EN 60601-2-63:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
    BS EN 60601-2-54:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    EN 60601-2-65:2013 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
    I.S. EN 61223-2-6:2007 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2-6: CONSTANCY TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT
    EN 60601-2-7:1998 Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
    BS EN 61223-3-5:2004 Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of computed tomography X-ray equipment
    03/304751 DC : DRAFT APR 2003 IEC 61223-3-5 ED.1.0 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-5: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT
    BS EN 60601-2-44 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009)
    BS EN 60601-2-65:2013 Medical electrical equipment Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
    I.S. EN ISO 11073-10406:2012 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012)
    DIN EN 60601-2-7 : 2000 MEDICAL ELECTRICAL EQUIPMENT - PART 2-7: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH-VOLTAGE GENERATORS OF DIAGNOSTIC X-RAY GENERATORS
    I.S. EN 60601-2-54:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    I.S. EN 60601-2-65:2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT (IEC 60601-2-65:2012 (EQV))
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    ISO/IEEE 11073-10418:2014 Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor
    I.S. EN 60601-1-3:2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT
    EN 60601-1-3 : 2008 AMD 11 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008/A1:2013)
    VDE 0750-2-7 : 2000 MEDICAL ELECTRICAL EQUIPMENT - PART 2-7: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH-VOLTAGE GENERATORS OF DIAGNOSTIC X-RAY GENERATORS
    BS 5724-1.3(1995) : 1995 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: GENERAL REQUIREMENTS FOR RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT
    BS 5724-2.45(1999) : 1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
    07/30136476 DC : DRAFT APR 2007 IEC 60601-2-44 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    BS EN ISO 11073-10418:2014 Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor
    BS EN 60601-2-7:1998 Medical electrical equipment. Particular requirements for safety Specification for high voltage generators of diagnostic X-ray generators
    UNE-EN 60601-2-44:2010 Medical electrical equipment -- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
    I.S. EN 60601-2-63:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRAORAL X-RAY EQUIPMENT
    IEC 61223-3-5:2004 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
    UNE-EN 60601-2-54:2010 Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
    04/30124942 DC : DRAFT NOV 2004 BS EN 61223-2-6 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2-6: CONSTANCY TESTS - X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    BS 5724-2.44(1999) : 1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    07/30166162 DC : 0 BS IEC 60601-2-44 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    BS EN 60601-2-45 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
    17/30341818 DC : 0 BS EN 60601-2-54 ED 1.0/A2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    I.S. EN ISO 11073-10418:2014 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01)
    I.S. EN 61223-3-5:2004 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-5: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT
    EN 60601-2-44:2009/A2:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009/A2:2016)
    IEC 61223-2-6:2006 Evaluation and routine testing in medical imaging departments ­ - Part 2­-6: Constancy tests ­ imaging performance of computed tomography X-ray equipment
    ISO/IEEE 11073-10406:2012 Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    BS EN 60601-1-3 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008)
    BS EN 61223-2-6:2007 Evaluation and routine testing in medical imaging departments Constancy tests. Imaging performance of computed tomography X-ray equipment
    I.S. EN 60601-2-65:2013/A1:2020 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intraoral X-ray equipment (IEC 60601-2-65:2012/A1:2017)
    IEC 60601-2-7:1998 Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
    EN ISO 11073-10406:2012 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    BS EN ISO 11073-10406:2012 Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    CSA C22.2 No. 60601.2.7 : 0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-7: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH-VOLTAGE GENERATORS OF DIAGNOSTIC X-RAY GENERATORS
    CSA C22.2 No. 60601-2-63 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT
    I.S. EN 60601-2-45:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
    UNI EN ISO 11073-10406 : 2013 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
    I.S. EN 60601-2-44:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    CEI EN 60601-2-65 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT
    CAN/CSA-C22.2 No. 60601-2-65 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT
    EN ISO 11073-10418:2014/AC:2016 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)
    EN 61223-2-6:2007 Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
    EN 60601-2-45:2011/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES (IEC 60601-2-45:2011/A1:2015)
    EN 61223-3-5:2004 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
    EN 60601-2-54:2009/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
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