• IEC 60601-1-3:2008+AMD1:2013 CSV

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

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

    Superseded date:  29-01-2021

    Language(s):  English - French

    Published date:  19-04-2013

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION
    INTRODUCTION TO AMENDMENT 1
    1 Scope, object and related standards
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 ME EQUIPMENT identification, marking and documents
    6 RADIATION management
    7 RADIATION QUALITY
    8 Limitation of the extent of the X-RAY BEAM and
       relationship between X-RAY FIELD and IMAGE
       RECEPTION AREA
    9 FOCAL SPOT TO SKIN DISTANCE
    10 ATTENUATION of the X-RAY BEAM between the PATIENT
       and the X-RAY IMAGE RECEPTOR
    11 Protection against RESIDUAL RADIATION
    12 Protection against LEAKAGE RADIATION
    13 Protection against STRAY RADIATION
    Annex A (informative) - General guidance and rationale
    Annex B (normative) - Values of the series R'10 and
            R'20, ISO 497
    Annex C (informative) - Mapping between this Edition 2 of
            IEC 60601-1-3 and Edition 1
    Bibliography

    Abstract - (Show below) - (Hide below)

    IEC 60601-1-3:2008+A1:2013 applies to X-ray equipment and to subassemblies of such equipment, where radiological images of a human patient are used for diagnosis, planning or guidance of medical procedures. The object of this collateral standard is to establish general requirements for protection against X-radiation in X-ray equipment, in order that the irradiation of the human patient, the operator, staff and members of the public can be kept as low as reasonably achievable, without jeopardizing the benefit of the radiological procedure. Particular standards may specify their appropriate values and/or measures for general requirements specified in this collateral standard. The implementation of the general requirements or the reference to the particular standard instead, shall be justified in the risk management process. This collateral standard considers radiation protection aspects related to X-radiation only. Requirements for the control of the electrical energy used to generate X-radiation, which is also an important aspect of radiation protection, are included in IEC 60601-1 and in particular standards for the safety and essential performance of the equipment concerned. This document cancels and replaces the first edition of IEC 60601-1-3, published in 1994 (which replaced IEC 60407 issued in 1973). It constitutes a technical revision. This edition has been restructured and aligned to IEC 60601-1(2005) and focussed on general requirements for RADIATION PROTECTION that apply to all diagnostic X-RAY EQUIPMENT. Requirements particular to specific equipment have been removed and will be covered in particular standards. For a description of the changes, see the mapping in Annex C. This consolidated version consists of the second edition (2008) and its amendment 1 (2013). Therefore, no need to order amendment in addition to this publication.

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    Committee TC 62/SC 62B
    Development Note Supersedes IEC 60407, IEC 60407A (03/2001) Supersedes IEC 60601-2-32. (11/2012) Stability Date: 2019. (09/2017)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Superseded By
    Supersedes

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

    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
    DIN 6857-2:2016-08 Radiation protection accessories for medical use of X-radiation - Part 2: Quality control of protective clothes being in use
    16/30342393 DC : 0 BS EN 60601-2-65:2013/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT
    BS EN 61331-1 : 2014 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 1: DETERMINATION OF ATTENUATION PROPERTIES OF MATERIALS
    CSA C22.2 No. 60601.2.11 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-11: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF GAMMA BEAM THERAPY EQUIPMENT
    ISO 80601-2-61:2017 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
    BS EN 50637:2017 Medical electrical equipment. Particular requirements for the basic safety and essential performance of medical beds for children
    BS EN ISO 80601-2-13:2012 Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation
    BS 5724-2.8(1998) : 1998 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR THERAPEUTIC X-RAY EQUIPMENT OPERATING IN THE RANGE 10 KV TO 1 MV
    BS EN 61674:2013 Medical electrical equipment. Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
    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
    BS 5724-2.128(1993) : 1993 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR X-RAY SOURCE ASSEMBLIES AND X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    BS EN ISO 80601-2-72:2015 Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
    11/30199851 DC : 0 BS EN 60601-2-63 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT
    BS EN 61331-2 : 2014 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 2: TRANSLUCENT PROTECTIVE PLATES
    13/30264413 DC : 0 BS EN ISO 80601-2-72 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    17/30338756 DC : 0 BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY
    08/30188786 DC : 0 IEC 60613 - ELECTRICAL, THERMAL AND LOADING CHARACTERISTICS OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    DIN EN ISO 80601-2-72 E : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015)
    CEI EN 60731 : 2012 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY
    CSA C22.2 No. 60601-2-28 : 2012 : R2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    NF EN 60731 : 2012 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY
    BS EN 62467-1:2015 (published 2015-11) Medical electrical equipment. Dosimetric instruments as used in brachytherapy Instruments based on well-type ionization chambers
    BS EN ISO 80601-2-56:2017 Medical electrical equipment Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
    BS ISO 11197 : 2016 MEDICAL SUPPLY UNITS
    13/30258863 DC : 0 BS EN 61910-1 ED 1.0 - MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION - PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY
    DIN 6814-8:2016-08 TERMS IN THE FIELD OF RADIOLOGICAL TECHNIQUE - PART 8: RADIOTHERAPY
    PREN ISO 11197 : DRAFT 2012 MEDICAL SUPPLY UNITS (ISO/DIS 11197:2012)
    BS PD IEC TR 60788 : 2004 MEDICAL ELECTRICAL EQUIPMENT - GLOSSARY OF DEFINED TERMS
    09/30194820 DC : 0 BS EN 60731 - MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY
    08/30176368 DC : 0 BS EN 60601-2-28 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    CSA C22.2 No. 60601-2-28 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    BS 5724-2.44(1999) : 1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    BS 5724-2.1(1998) : 1998 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ELECTRON ACCELERATORS IN THE RANGE 1 MEV TO 50 MEV
    DIN EN ISO 80601-2-72:2016-04 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
    I.S. EN ISO 80601-2-56:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT (ISO 80601-2-56:2017)
    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
    BS 5724-2.32(1995) : 1995 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ASSOCIATED EQUIPMENT FOR X-RAY EQUIPMENT
    DIN EN 60601-2-32 : 1995 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ASSOCIATED EQUIPMENT OF X-RAY EQUIPMENT
    13/30267930 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
    10/30206860 DC : 0 BS EN 61217 - RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES
    11/30227744 DC : DRAFT SEP 2011 BS EN 60627 - DIAGNOSTIC X-RAY IMAGING EQUIPMENT - CHARACTERISTICS OF GENERAL PURPOSE AND MAMMOGRAPHIC ANTI-SCATTER GRIDS
    CEI EN 60601-2-11 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-11: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF GAMMA BEAM THERAPY 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)
    12/30242781 DC : 0 BS EN 61331-2 - PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 2: TRANSLUCENT PROTECTIVE PLATES
    16/30342390 DC : 0 BS EN 60601-2-63:2015/AMENDMENT 1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT
    CAN/CSA-C22.2 NO. 80601-2-70:17 Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations)
    14/30290166 DC : 0 BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    BS EN 60601-2-32 : 1995 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PART 2-32: SPECIFICATION FOR ASSOCIATED EQUIPMENT OF X-RAY EQUIPMENT
    BS EN 60601-2-68 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
    BS ISO 16142-1:2016 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    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
    BS EN 61331-3 : 2014 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 3: PROTECTIVE CLOTHING, EYEWEAR AND PROTECTIVE PATIENT SHIELDS
    BS EN 60613 : 2010 ELECTRICAL AND LOADING CHARACTERISTICS OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    02/564070 DC : DRAFT SEP 2002 BS EN 60601-2-17 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE SAFETY OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT
    BS EN 60627:2015 DIAGNOSTIC X-RAY IMAGING EQUIPMENT - CHARACTERISTICS OF GENERAL PURPOSE AND MAMMOGRAPHIC ANTI-SCATTER GRIDS
    UNI EN ISO 80601-2-12 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
    BS EN 60522 : 1999 DETERMINATION OF THE PERMANENT FILTRATION OF X-RAY TUBE ASSEMBLIES
    17/30341814 DC : DRAFT JUL 2017 BS EN 61010-2-091 - SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-091: PARTICULAR REQUIREMENTS FOR CABINET X-RAY SYSTEMS
    17/30362279 DC : 0 BS EN 61223-3-6 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-6: ACCEPTANCE AND CONSTANCY TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC TOMOSYNTHESIS MODE OF OPERATION OF MAMMOGRAPHIC X-RAY EQUIPMENT
    BS IEC 61223-2.11 : 1999 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2-11: CONSTANCY TESTS - EQUIPMENT FOR GENERAL DIRECT RADIOGRAPHY
    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
    08/30149952 DC : DRAFT MAY 2008 BS EN 60601-2-54 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    BS 5724-2.44(2001) : 2001 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    10/30217545 DC : 0 BS EN 61674 - MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMI-CONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING
    16/30342399 DC : 0 BS EN 60601-2-43:2010/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    BS 5724-2.120(1997) : 1997 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR TRANSPORT INCUBATORS
    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
    NF EN 60601-1 : 2007-01 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    11/30227728 DC : 0 BS EN 60601-2-65 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT
    BS EN 60601-2-11:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-11: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF GAMMA BEAM THERAPY EQUIPMENT
    BS EN 61910-1 : 2014 MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION - PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY
    16/30316718 DC : 0 BS EN ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
    I.S. EN 60613:2010 ELECTRICAL AND LOADING CHARACTERISTICS OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    BS EN 60601-2-29 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 2-29: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RADIOTHERAPY SIMULATORS
    14/30296597 DC : 0 BS EN 60601-2-54/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    GOST R IEC 60601-2-44 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    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
    BS EN 61223-3-1 : 1999 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - ACCEPTANCE TESTS - IMAGING PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHIC AND RADIOSCOPIC SYSTEMS
    15/30329747 DC : 0 BS EN 60601-2-28 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    NF 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
    07/30144241 DC : 0 BS IEC 60601-2-29 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-29: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RADIOTHERAPY SIMULATORS
    CEI EN 60601-2-28 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    BS EN 60601-2-43:2010 Medical electrical equipment Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
    AAMI ID26:2004 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS
    AAMI ID26 : 2004 : R2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS
    16/30312315 DC : 0 BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    NEMA XR 31 : 2016 STANDARD ATTRIBUTES ON X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    08/30173546 DC : DRAFT JAN 2008 BS ISO 4073 - DENTISTRY - INFORMATION SYSTEM ON THE LOCATION OF DENTAL EQUIPMENT IN THE WORKING AREA OF THE ORAL HEALTH CARE PROVIDER
    AAMI ID26 : 2004 : R2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS
    CSA C22.2 No. 60601.2.29 : 2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-29: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RADIOTHERAPY SIMULATORS
    BS EN 60601-2-28:2010 (published 2010-07) Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
    NF EN 61910-1 : 2015 MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION -PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY
    BS EN 61223-3-2 : 2008 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-2: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC 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 (IEC 60601-2-63:2012)
    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
    IEC 80601-2-30 REDLINE : 2ED 2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
    ISO 11197:2016 Medical supply units
    CEI EN 60613 : 2010 ELECTRICAL AND LOADING CHARACTERISTICS OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    NF EN 60601 2-45 : 2011 AMD 1 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
    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
    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
    ISO 80601-2-56:2017 Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
    IEC 60601-2-46 : 3.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OPERATING TABLES
    CAN/CSA-C22.2 NO. 80601-2-72:17 Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations)
    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
    I.S. EN 50637:2017 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS FOR CHILDREN
    ISO 16142-1:2016 Medical devices Recognized essential principles of safety and performance of medical devices Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    CSA C22.2 No. 80601-2-55 : 2014(R2019) MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    BS EN 60731 : 2012 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY
    I.S. EN 60601-2-11:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-11: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF GAMMA BEAM THERAPY EQUIPMENT
    I.S. EN 60601-2-29:2008 MEDICAL ELECTRICAL EQUIPMENT - PART 2-29: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RADIOTHERAPY SIMULATORS (IEC 60601-2-29:2008 (EQV))
    I.S. EN 61331-1:2014 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 1: DETERMINATION OF ATTENUATION PROPERTIES OF MATERIALS
    I.S. EN 62467-1:2015 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS
    I.S. EN 60627:2015 DIAGNOSTIC X-RAY IMAGING EQUIPMENT - CHARACTERISTICS OF GENERAL PURPOSE AND MAMMOGRAPHIC ANTI-SCATTER GRIDS
    I.S. EN ISO 80601-2-55:2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2018)
    NF EN 61331-3 : MAY 2015 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 3: PROTECTIVE CLOTHING, EYEWEAR AND PROTECTIVE PATIENT SHIELDS
    I.S. EN 60522:1999 DETERMINATION OF THE PERMANENT FILTRATION OF X-RAY TUBE ASSEMBLIES
    I.S. EN 60601-2-28:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    EN 60601-2-68 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT (IEC 60601-2-68:2014)
    UNI EN ISO 80601-2-55 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    BS EN ISO 80601-2-12:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO/IEC 80601-2-12:2011)
    I.S. EN 61331-3:2014 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 3: PROTECTIVE CLOTHING, EYEWEAR AND PROTECTIVE PATIENT SHIELDS
    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
    I.S. EN ISO 80601-2-72:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015)
    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
    CEI EN 60627 : 2016 DIAGNOSTIC X-RAY IMAGING EQUIPMENT - CHARACTERISTICS OF GENERAL PURPOSE AND MAMMOGRAPHIC ANTI-SCATTER GRIDS
    ISO 80601-2-74:2017 Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
    EN ISO 11197:2016 MEDICAL SUPPLY UNITS (ISO 11197:2016)
    CEI EN 61674 : 2014 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMI-CONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING
    I.S. EN 61910-1:2014 MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION -PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY
    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
    CSA C22.2 No. 60601.1 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    I.S. EN ISO 11197:2016 MEDICAL SUPPLY UNITS (ISO 11197:2016)
    13/30254355 DC : 0 BS ISO 80601-2-70 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-70: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SLEEP APNEOA BREATHING THERAPY EQUIPMENT
    I.S. EN 61331-2:2014 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 2: TRANSLUCENT PROTECTIVE PLATES
    EN 60601-2-43:2010/A1:2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES (IEC 60601-2-43:2010/A1:2017)
    I.S. EN ISO 80601-2-13:2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION (ISO 80601-2-13:2011)
    BS PD IEC TR 60601-4-3 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 4-3: GUIDANCE AND INTERPRETATION - CONSIDERATIONS OF UNADDRESSED SAFETY ASPECTS IN THE THIRD EDITION OF IEC 60601-1 AND PROPOSALS FOR NEW REQUIREMENTS
    CSA C22.2 No. 60601-2-68 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
    NF EN 60601-2-54 : 2009 AMD 1 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    CAN/CSA C22.2 No. 60601.2.43 : 2011(R2016) MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    CSA C22.2 No. 601.2.32 : 1998 :R 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ASSOCIATED EQUIPMENT OF X-RAY EQUIPMENT
    CSA C22.2 No. 601.2.19 : 1992 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF BABY INCUBATORS
    CSA C22.2 No. 60601.2.43 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    NEMA/MITA XR 30 : 2016 QUALITY CONTROL TOOLS FOR DIGITAL PROJECTION RADIOGRAPHY
    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 80601-2-56:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT (ISO 80601-2-56:2017)
    IEC 60601-2-28 : 3.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    12/30262133 DC : 0 BS ISO 11197 - MEDICAL SUPPLY UNITS
    IEC 60601-2-68:2014 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
    IEC 61223-2-11:1999 Evaluation and routine testing in medical imaging departments - Part 2-11: Constancy tests - Equipment for general direct radiography
    I.S. EN 60601-2-68:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
    I.S. EN 60601- 1:2006&A1:2013&AC:2014&A12:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    CSA C22.2 No. 601.2.20 : 1992 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF TRANSPORT INCUBATORS
    CSA C22.2 No. 80601-2-12 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
    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))
    CEI EN 60522 : 2001 DETERMINATION OF THE PERMANENT FILTRATION OF X-RAY TUBE ASSEMBLIES
    ISO 80601-2-70:2015 Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
    EN ISO 80601-2-55 : 2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2018)
    I.S. EN 61223-3-2:2008 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-2: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT
    ISO 80601-2-55:2018 Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
    I.S. EN 61674:2013 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMICONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING (IEC 61674:2012 (EQV))
    I.S. EN ISO 80601-2-12:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011)
    I.S. EN 60601-2-43:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    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
    IEC 60601-2-54:2009+AMD1:2015 CSV Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy
    I.S. EN 60731:2012 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY (IEC 60731:2011 (EQV))
    IEC 60601-2-43:2010+AMD1:2017 CSV Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
    IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    IEC 60601-2-28:2017 RLV Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
    AAMI ES60601-1 : 2005 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    AAMI ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    AAMI ES60601-1 : 2005 : R2012 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    IEC 60522:1999 Determination of the permanent filtration of X-ray tube assemblies
    BS EN ISO 80601-2-13:2012+A2:2019 Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation
    IEC 60522:1976 Inherent filtration of an X-ray tube assembly
    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)
    EN ISO 80601-2-12:2011/AC:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011)
    ISO 80601-2-12:2011 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
    NF EN 60601-2-43 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    DIN EN ISO 4073:2009-10 DENTISTRY - INFORMATION SYSTEM ON THE LOCATION OF DENTAL EQUIPMENT IN THE WORKING AREA OF THE ORAL HEALTH CARE PROVIDER
    UNE-EN 61331-1:2015 Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials
    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)
    UNE-EN 61331-2:2015 Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates
    IEC 61223-3-1:1999 Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems
    BS EN 60601-1 : 2006 MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    IEC 61223-3-2:2007 Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
    IEC 61910-1:2014 Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
    UNE-EN ISO 80601-2-13:2013 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
    UNE-EN 61331-3:2015 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields
    IEC 61223-3-3:1996 Evaluation and routine testing in medical imaging departments -Part 3-3: Acceptance tests - Imaging performance of X-ray equipmentfor digital subtraction angiography (DSA)
    IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
    IEC 62467-1:2009 Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-2-65:2012+AMD1:2017 CSV Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
    ISO 4073:2009 Dentistry Information system on the location of dental equipment in the working area of the oral health care provider
    IEC 61331-2:2014 Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates
    UNE-EN ISO 4073:2010 Dentistry - Information system on the location of dental equipment in the working area of the oral health care provider (ISO 4073:2009)
    ISO 80601-2-72:2015 Medical electrical equipment Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
    IEC 60731:2011+AMD1:2016 CSV Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
    IEC 60601-2-45:2011+AMD1:2015 CSV 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 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
    00/565497 DC : DRAFT DEC 2000 BS IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY AND ESSENTIAL PERFORMANCE
    IEC 60601-2-29:2008 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
    ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
    IEC 60601-2-11:2013 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
    IEC 61674:2012 Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
    IEC 60627:2013 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
    BS EN 61217:2012 RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES
    IEC 61331-3:2014 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields
    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)
    UNI EN ISO 80601-2-13 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION
    IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales
    04/30106146 DC : DRAFT MARCH 2004 BS EN 60601-1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    IEC 61331-1:2014 Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials
    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
    CSA C22.2 No. 80601-2-12 : 2012(R2017) MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
    I.S. EN ISO 4073:2009 DENTISTRY - INFORMATION SYSTEM ON THE LOCATION OF DENTAL EQUIPMENT IN THE WORKING AREA OF THE ORAL HEALTH CARE PROVIDER
    I.S. EN 61217:2012 RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES (IEC 61217:2011 (EQV))
    NF EN 60522 : 2003 DETERMINATION OF THE PERMANENT FILTRATION OF X-RAY TUBE ASSEMBLIES
    EN 61223-3-1:1999 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - ACCEPTANCE TESTS - IMAGING PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHIC AND RADIOSCOPIC SYSTEMS
    IEC 60601-2-46:2016 Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
    EN 60522 : 1999 DETERMINATION OF THE PERMANENT FILTRATION OF X-RAY TUBE ASSEMBLIES
    EN ISO 80601-2-13:2012 (edition 2) Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
    EN 60627:2015 DIAGNOSTIC X-RAY IMAGING EQUIPMENT - CHARACTERISTICS OF GENERAL PURPOSE AND MAMMOGRAPHIC ANTI-SCATTER GRIDS (IEC 60627:2013)
    EN 60601-2-28:2010 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
    EN 61331-1:2014 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 1: DETERMINATION OF ATTENUATION PROPERTIES OF MATERIALS (IEC 61331-1:2014)
    IEC 60601-2-28:2017 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
    EN 61223-3-3 : 1996 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - ACCEPTANCE TESTS - IMAGING PERFORMANCE OF X-RAY EQUIPMENT FOR DIGITAL SUBTRACTION ANGIOGRAPHY (DSA)
    EN 62467-1 : 2015 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS (IEC 62467-1:2009)
    EN 61217:2012 Radiotherapy equipment - Coordinates, movements and scales
    EN 60601-2-11:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-11: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF GAMMA BEAM THERAPY EQUIPMENT (IEC 60601-2-11:2013)
    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 61223-3-2:2008 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-2: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT
    EN 61331-3:2014 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 3: PROTECTIVE CLOTHING, EYEWEAR AND PROTECTIVE PATIENT SHIELDS
    EN 61910-1 : 2014 MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION - PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY (IEC 61910-1:2014)
    EN 60601-2-32 : 1994 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ASSOCIATED EQUIPMENT OF X-RAY EQUIPMENT
    EN 50637:2017 Medical electrical equipment - Particular requirements for the basic safety and essential performance of medical beds for children
    EN 61674:2013 Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
    EN 60613:2010 ELECTRICAL AND LOADING CHARACTERISTICS OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    EN 60731:2012 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY (IEC 60731:2011)
    EN 61331-2:2014 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 2: TRANSLUCENT PROTECTIVE PLATES (IEC 61331-2:2014)
    EN 60601-2-29:2008/A11:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-29: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RADIOTHERAPY SIMULATORS
    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
    EN ISO 80601-2-72 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015)
    IEC 80601-2-30:2018 RLV Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    EN ISO 4073:2009 DENTISTRY - INFORMATION SYSTEM ON THE LOCATION OF DENTAL EQUIPMENT IN THE WORKING AREA OF THE ORAL HEALTH CARE PROVIDER
    UNI EN ISO 4073 : 2009 DENTISTRY - INFORMATION SYSTEM ON THE LOCATION OF DENTAL EQUIPMENT IN THE WORKING AREA OF THE ORAL HEALTH CARE PROVIDER

    Standards Referencing This Book - (Show below) - (Hide below)

    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
    IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60522:1999 Determination of the permanent filtration of X-ray tube assemblies
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    ISO 7004:2002 Photography Industrial radiographic films Determination of ISO speed, ISO average gradient and ISO gradients G2 and G4 when exposed to X- and gamma-radiation
    IEC 62220-1:2003 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    IEC 60601-2-28 : 3.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    IEC 60580:2000 Medical electrical equipment - Dose area product meters
    IEC 60601-2-43:2010+AMD1:2017 CSV Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
    IEC 60627:2013 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
    ISO 497:1973 Guide to the choice of series of preferred numbers and of series containing more rounded values of preferred numbers
    IEC 60601-2-29:2008 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
    IEC 60601-2-45:2011+AMD1:2015 CSV 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 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
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