Reference Date Title Language EN 61223-3-5:2004 2004-09-23 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment     EN 60601-2-8:1997 1997-09-09 Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV     EN 61675-2:1998 1998-02-23 Radionuclide imaging devices - Characteristics and test conditions - Part 2: Single photon emission computer tomographs     EN 60601-2-11:1997/A1:2004 2004-09-21 Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment     EN 61223-2-4:1994 1994-06-09 Evaluation and routine testing in medical imaging departments - Part 2-4: Constancy tests - Hard copy cameras     EN 61675-1:1998 1998-02-23 Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs     EN 60601-2-23:2000 2000-03-15 Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment     EN 60580:2000 2000-05-05 Medical electrical equipment - Dose area product meters     EN 61674:1997 1997-11-28 Medical electrical equipment - Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnostic imaging     EN 61331-2:2002 2002-04-23 Protective devices against diagnostic medical X-radiation - Part 2: Protective glass plates     EN 60601-2-24:1998 1998-04-14 Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers     EN 60601-2-25:1995 1995-11-30 Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs     EN 61262-2:1994 1994-09-02 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 2: Determination of the conversion factor     EN 60601-2-1:1998 1998-08-14 Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV     EN 60601-2-8:1997/A1:1997 1997-09-09 Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV     EN 61675-2:1998/A1:2005 2005-02-08 Radionuclide imaging devices - Characteristics and test conditions - Part 2: Single photon emission computer tomographs     EN 60601-2-52:2010 2010-04-09 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds     EN 60336:2005 2005-07-07 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots     EN 60526:2004 2004-09-07 High-voltage cable plug and socket connections for medical X-ray equipment     EN 60806:2004 2004-06-03 Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis     EN 60601-2-33:2002/A1:2005 2005-11-30 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis     EN 62274:2005 2005-06-15 Medical electrical equipment - Safety of radiotherapy record and verify systems     EN 61267:2006 2006-01-27 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics     EN 62304:2006 2006-07-12 Medical device software - Software life-cycle processes     EN 61223-2-6:2007 2007-05-09 Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment     EN 62353:2008 2008-01-25 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment     EN 62220-1-2:2007 2007-09-20 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography     EN 62464-1:2007 2007-05-04 Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters     EN 60601-2-33:2002 2002-10-08 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis     EN 61676:2002 2002-12-17 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology     EN 60601-2-51:2003 2003-07-31 Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs     EN 60601-2-1:1998/A1:2002 2002-06-07 Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV     EN 61674:1997/A1:2002 2002-09-26 Medical electrical equipment - Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnostic imaging     EN 60731:1997/A1:2002 2002-09-13 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy     EN 60601-2-17:2004 2004-04-06 Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment     EN 61675-3:1998 1998-04-22 Radionuclide imaging devices - Characteristics and test conditions - Part 3: Gamma camera based wholebody imaging systems     EN 61331-3:1999 1999-01-20 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing and protective devices for gonads     EN 60601-2-46:1998 1998-08-14 Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables     EN 60601-2-10:2000/A1:2001 2001-11-09 Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators     EN 60601-2-45:2001 2001-07-30 Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices     EN 61223-3-4:2000 2000-09-07 Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment     EN 61217:1996/A1:2001 2001-02-22 Radiotherapy equipment - Coordinates, movements and scales     EN 60627:2001 2001-11-12 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids     EN 60601-2-49:2001 2001-10-26 Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment     EN 60601-2-18:1996/A1:2000 2000-12-22 Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment     EN 60601-2-10:2000 2000-11-13 Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators     EN 60601-2-26:2003 2003-07-31 Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs     EN 60601-2-30:2000 2000-05-18 Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment     EN 60601-3-1:1996 1996-12-16 Medical electrical equipment - Part 3-1: Essential performance requirements for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment     EN 60601-2-25:1995/A1:1999 1999-06-03 Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs     EN 60601-2-3:1993/A1:1998 1998-11-06 Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment     EN 60601-2-11:1997 1997-09-30 Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment     EN 60522:1999 1999-04-01 Determination of the permanent filtration of X-ray tube assemblies     EN 60406:1997 1997-05-27 Cassettes for medical X-ray diagnosis - Radiographic cassettes and mammographic cassettes     EN 61223-3-3:1996 1996-12-19 Evaluation and routine testing in medical imaging departments - Part 3-3: Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiography (DSA)     EN 60731:1997 1997-10-17 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy     EN 61262-6:1994 1994-09-02 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 6: Determination of the contrast ratio and veiling glare index     EN 61262-1:1994 1994-09-02 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 1: Determination of the entrance field size     EN 61262-3:1994 1994-09-02 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 3: Determination of the luminance distribution and luminance non-uniformity     EN 61262-4:1994 1994-09-09 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 4: Determination of the image distortion     EN 61262-5:1994 1994-09-09 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 5: Determination of the detective quantum efficiency     EN 61223-2-5:1994 1994-06-09 Evaluation and routine testing in medical imaging departments - Part 2-5: Constancy tests - Image display devices     EN 60601-2-36:1997 1997-05-07 Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy     EN 60601-2-4:2003 2003-01-31 Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators     EN 60601-2-18:1996 1996-09-30 Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment     EN 60601-2-16:1998 1998-04-09 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment     EN 60601-2-40:1998 1998-04-14 Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment     EN 60601-2-5:2000 2000-12-19 Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment     EN 61262-7:1995 1995-11-24 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 7: Determination of the modulation transfer function     EN 61331-1:2002 2002-04-23 Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials     EN 60601-2-43:2000 2000-12-19 Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures     EN 60601-2-3:1993 1993-04-22 Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment     EN 50077:1993 1993-06-04 Low-profile connector for implantable cardiac pacemakers     HD 395.1 S2:1988/A1:1993 1993-01-26 Safety of medical electrical equipment - Part 1: General requirements     EN 60789:2005 2005-12-01 Medical electrical equipment - Characteristics and test conditions of radionuclide imaging devices - Anger type gamma cameras     EN 61303:1995 1995-01-09 Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance     EN 60601-1-2:2007 2007-07-31 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests     EN 60976:2007 2007-12-07 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics     EN 60601-2-19:2009 2009-05-20 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators     EN 60601-2-20:2009 2009-11-26 Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators     EN 61168:1994 1994-02-22 Radiotherapy simulators - Functional performance characteristics     EN 61223-3-2:2008 2008-07-25 Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment     EN 61217:1996/A2:2008 2008-02-22 Radiotherapy equipment - Coordinates, movements and scales     EN 61675-1:1998/A1:2008 2008-07-17 Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs     EN 62220-1-3:2008 2008-09-03 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging     EN 60601-1-8:2007 2007-07-31 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems     EN 60601-2-21:2009 2009-05-20 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers     EN 60601-2-31:2008 2008-07-25 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source     EN 61217:1996 1996-09-05 Radiotherapy equipment - Coordinates, movements and scales     EN 60601-2-37:2008 2008-01-31 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment     EN 62220-1:2004 2004-01-14 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency     EN 60601-2-27:2006 2006-04-05 Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment     EN 60601-2-13:2006/A1:2007 2007-03-16 Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems     EN 60601-1-10:2008 2008-04-24 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers     EN 60601-1:2006 2006-10-20 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance     EN 60601-2-12:2006 2006-06-28 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators     EN 60601-2-13:2006 2006-06-28 Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems     EN 60601-2-33:2002/A2:2008 2008-03-05 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis     EN 60601-2-39:2008 2008-04-24 Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment     EN 60601-2-4:2011 2011-08-19 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators     EN 80601-2-35:2009 2009-12-11 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use     EN 61676:2002/A1:2009 2009-04-02 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology     EN 60601-2-43:2010 2010-06-11 Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures     EN 80601-2-30:2010 2010-09-10 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers     EN 60601-2-54:2009 2009-09-18 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy     EN 60601-2-46:2011 2011-08-19 Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables     EN 60601-2-28:2010 2010-05-07 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis     EN 60613:2010 2010-04-16 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis     EN 60601-1-3:2008 2008-04-24 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment     EN 80601-2-58:2009 2009-02-06 Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery     EN 62083:2009 2009-12-11 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems     EN 60601-2-41:2009 2009-12-23 Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis     EN 80601-2-59:2009 2009-12-23 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening     EN 60601-2-29:2008 2008-11-28 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators     EN 60601-2-44:2009 2009-05-20 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography     EN 62494-1:2008 2008-11-19 Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography     EN 60601-2-2:2009 2009-05-20 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories     EN 60601-2-50:2009 2009-05-20 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment     EN 60601-1-9:2008 2008-04-29 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design     EN 62366:2008 2008-01-25 Medical devices - Application of usability engineering to medical devices     EN 62464-2:2011 2011-02-11 Magnetic resonance equipment for medical imaging - Part 2: Classification criteria for pulse sequences     EN 61674:2013 2013-02-22 Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging     EN 60601-2-31:2008/A1:2011 2011-08-12 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source     EN 61217:2012 2012-04-13 Radiotherapy equipment - Coordinates, movements and scales     EN 60601-2-34:2000 2000-12-19 Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment     EN 60601-2-47:2001 2001-10-26 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems     EN 60601-2-45:2011 2011-03-18 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices     EN 60731:2012 2012-04-06 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy     EN 60601-1-6:2010 2010-04-16 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability     EN 62563-1:2010 2010-03-05 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods     EN 60601-1-11:2010 2010-06-04 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment     EN 60601-2-33:2010 2010-10-15 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis     EN 80001-1:2011 2011-03-18 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities     EN 60601-1-8:2007/A1:2013 2013-03-22 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems     EN 60601-2-52:2010/AC:2011 2011-04-01 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds     EN 60601-1:2006/A11:2011 2011-10-14 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance     EN 60601-2-2:2009/A11:2011 2011-10-14 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories     EN 60601-2-19:2009/A11:2011 2011-10-14 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators     EN 60601-2-20:2009/A11:2011 2011-10-14 Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators     EN 60601-2-21:2009/A11:2011 2011-10-14 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers     EN 60601-2-29:2008/A11:2011 2011-10-14 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators     EN 60601-2-33:2010/A11:2011 2011-10-14 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis     EN 80601-2-35:2009/A11:2011 2011-10-14 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use     EN 60601-2-37:2008/A11:2011 2011-10-14 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment     EN 60601-2-39:2008/A11:2011 2011-10-14 Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment     EN 60601-2-44:2009/A1:2012 2012-10-19 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography     EN 60601-2-41:2009/A11:2011 2011-10-14 Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis     EN 60601-2-44:2009/A11:2011 2011-10-14 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography     EN 60601-2-50:2009/A11:2011 2011-10-14 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment     EN 80601-2-58:2009/A11:2011 2011-10-14 Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery     EN 60601-2-65:2013 2013-01-11 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment