Electromedical devices
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IEC 60601-1:2024 SER
IEC 60601-1:2024 SER Medical electrical equipment - ALL PARTS
1/9/2024 - PDF - English, French - IEC
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IEC 60601-1-3:2008/AMD2:2021
IEC 60601-1-3:2008/AMD2:2021 Amendment 2 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
1/26/2021 - PDF - English, French - IEC
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IEC TR 60601-4-5:2021
IEC TR 60601-4-5:2021 Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications
1/18/2021 - PDF - English - IEC
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IEC 60601-2-1:2020
IEC 60601-2-1:2020 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
10/28/2020 - PDF - English, French - IEC
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IEC 60601-2-35:2020
IEC 60601-2-35:2020 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
9/21/2020 - - - IEC
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IEC 60601-2-20:2020 + Redline
IEC 60601-2-20:2020 (Redline version) Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
9/2/2020 - - - IEC
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IEC 60601-2-19:2020 + Redline
IEC 60601-2-19:2020 (Redline version) Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
9/2/2020 - - - IEC
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IEC 60601-2-50:2020 + Redline
IEC 60601-2-50:2020 (Redline version) Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
9/2/2020 - - - IEC
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IEC 60601-1-2:2014+AMD1:2020 Edition 4.1
IEC 60601-1-2:2014+AMD1:2020 (Consolidated version) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
9/1/2020 - - - IEC
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IEC 60601-1:2005+AMD1:2012+AMD2:2020 Edition 3.2
IEC 60601-1:2005+AMD1:2012+AMD2:2020 (Consolidated version) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
8/20/2020 - - - IEC
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IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 Edition 2.2
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 (Consolidated version) 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
7/23/2020 - - - IEC
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IEC 60601-1-10:2007/AMD2:2020
IEC 60601-1-10:2007/AMD2:2020 Amendment 2 - 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
7/22/2020 - PDF - English, French - IEC
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IEC 60601-1-11:2015/AMD1:2020
IEC 60601-1-11:2015/AMD1:2020 Amendment 1 - 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
7/22/2020 - PDF - English, French - IEC
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IEC 60601-1-12:2014/AMD1:2020
IEC 60601-1-12:2014/AMD1:2020 Amendment 1 - Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
7/22/2020 - PDF - English, French - IEC
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IEC 60601-1-6:2010/AMD2:2020
IEC 60601-1-6:2010/AMD2:2020 Amendment 2 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
7/22/2020 - PDF - English, French - IEC
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IEC 60601-1-9:2007/AMD2:2020
IEC 60601-1-9:2007/AMD2:2020 Amendment 2 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
7/22/2020 - PDF - English, French - IEC
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IEC 60601-1-9:2007+AMD1:2013+AMD2:2020 Edition 1.2
IEC 60601-1-9:2007+AMD1:2013+AMD2:2020 (Consolidated version) Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
7/22/2020 - - - IEC
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IEC 60601-2-31:2020
IEC 60601-2-31:2020 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
1/17/2020 - - - IEC
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IEC 60601-2-22:2019
IEC 60601-2-22:2019 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
11/20/2019 - - - IEC
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IEC 60601-2-66:2019 + Redline
IEC 60601-2-66:2019 (Redline version) Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
10/16/2019 - - - IEC
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IEC 60601-2-83:2019
IEC 60601-2-83:2019 Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
5/22/2019 - - - IEC
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IEC TR 60601-4-3:2018
IEC TR 60601-4-3:2018 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
12/13/2018 - - - IEC
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IEC 60601-2-76:2018
IEC 60601-2-76:2018 Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment
4/10/2018 - - - IEC
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IEC 60601-2-4:2010/AMD1:2018
IEC 60601-2-4:2010/AMD1:2018 Amendment 1 - Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
2/28/2018 - PDF - English, French - IEC
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IEC TR 60601-4-4:2017
IEC TR 60601-4-4:2017 Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related requirements
8/17/2017 - PDF - English - IEC
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IEC 60601-2-63:2012/AMD1:2017
IEC 60601-2-63:2012/AMD1:2017 Amendment 1 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
7/7/2017 - PDF - English, French - IEC
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IEC 60601-2-28:2017 + Redline
IEC 60601-2-28:2017 (Redline version) Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
6/16/2017 - - - IEC
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IEC 60601-2-75:2017
IEC 60601-2-75:2017 Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
5/30/2017 - - - IEC
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IEC TR 60601-4-1:2017
IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
5/22/2017 - PDF - English - IEC
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IEC 60601-2-65:2012/AMD1:2017
IEC 60601-2-65:2012/AMD1:2017 Amendment 1 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
5/17/2017 - PDF - English, French - IEC
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IEC 60601-2-65:2012+AMD1:2017 Edition 1.1
IEC 60601-2-65:2012+AMD1:2017 (Consolidated version) Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
5/17/2017 - - - IEC
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IEC 60601-2-6:2012/AMD1:2016
IEC 60601-2-6:2012/AMD1:2016 Amendment 1 - Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
4/29/2016 - PDF - English, French - IEC
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IEC 60601-2-10:2012/AMD1:2016
IEC 60601-2-10:2012/AMD1:2016 Amendment 1 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
4/29/2016 - PDF - English, French - IEC
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IEC 60601-2-3:2012/AMD1:2016
IEC 60601-2-3:2012/AMD1:2016 Amendment 1 - Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
4/29/2016 - PDF - English, French - IEC
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IEC 60601-2-44:2009/AMD2:2016
IEC 60601-2-44:2009/AMD2:2016 Amendment 2 - Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
3/31/2016 - PDF - English, French - IEC
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IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 Edition 3.2
IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 (Consolidated version) Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
3/31/2016 - - - IEC
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IEC 60601-2-8:2010/AMD1:2015
IEC 60601-2-8:2010/AMD1:2015 Amendment 1 - Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
9/29/2015 - PDF - English, French - IEC
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IEC 60601-2-8:2010+AMD1:2015 Edition 2.1
IEC 60601-2-8:2010+AMD1:2015 (Consolidated version) Medical electrical equipment - Part 2-8: Particular requirements forthe basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
9/29/2015 - - - IEC
Learn More€510.00 -
IEC 60601-2-45:2011/AMD1:2015
IEC 60601-2-45:2011/AMD1:2015 Amendment 1 - Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
6/18/2015 - - - IEC
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IEC 60601-2-45:2011+AMD1:2015 Edition 3.1
IEC 60601-2-45:2011+AMD1:2015 (Consolidated version) Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
6/18/2015 - - - IEC
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IEC 60601-2-52:2009/AMD1:2015
IEC 60601-2-52:2009/AMD1:2015 Amendment 1 - Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
3/18/2015 - PDF - English, French - IEC
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IEC 60601-2-52:2009+AMD1:2015 Edition 1.1
IEC 60601-2-52:2009+AMD1:2015 (Consolidated version) Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
3/18/2015 - - - IEC
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IEC 60601-1-11:2015
IEC 60601-1-11:2015 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
1/20/2015 - - - IEC
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IEC 60601-2-64:2014
IEC 60601-2-64:2014 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
9/3/2014 - PDF - English, French - IEC
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IEC 60601-1-12:2014
IEC 60601-1-12:2014 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
6/19/2014 - - - IEC
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IEC 60601-2-36:2014
IEC 60601-2-36:2014 Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
4/10/2014 - PDF - English, French - IEC
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IEC 60601-2-17:2013
IEC 60601-2-17:2013 Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
11/27/2013 - PDF - English, French - IEC
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IEC 60601-1-10:2007/AMD1:2013
IEC 60601-1-10:2007/AMD1:2013 Amendment 1 - 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
11/27/2013 - PDF - English, French - IEC
Learn More€23.00 -
IEC 60601-1-10:2007+AMD1:2013 Edition 1.1
IEC 60601-1-10:2007+AMD1:2013 (Consolidated version) Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
11/27/2013 - - - IEC
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IEC 60601-1-6:2010/AMD1:2013
IEC 60601-1-6:2010/AMD1:2013 Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
10/29/2013 - PDF - English, French - IEC
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IEC 60601-1-6:2010+AMD1:2013 Edition 3.1
IEC 60601-1-6:2010+AMD1:2013 (Consolidated version) Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
10/29/2013 - - - IEC
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IEC 60601-2-62:2013
IEC 60601-2-62:2013 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
7/9/2013 - PDF - English, French - IEC
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IEC 60601-1-9:2007/AMD1:2013
IEC 60601-1-9:2007/AMD1:2013 Amendment 1 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
6/18/2013 - PDF - English, French - IEC
Learn More€12.00 -
IEC 60601-1-9:2007+AMD1:2013 Edition 1.1
IEC 60601-1-9:2007+AMD1:2013 (Consolidated version) Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
6/18/2013 - - - IEC
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IEC 60601-1-3:2008/AMD1:2013
IEC 60601-1-3:2008/AMD1:2013 Amendment 1 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
4/19/2013 - PDF - English, French - IEC
Learn More€12.00 -
IEC 60601-2-11:2013
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
1/16/2013 - PDF - English, French - IEC
Learn More€325.00 -
IEC 60601-1-8:2006/AMD1:2012
IEC 60601-1-8:2006/AMD1:2012 Amendment 1 - 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
11/28/2012 - PDF - English, French - IEC
Learn More€232.00 -
IEC 60601-2-24:2012
IEC 60601-2-24:2012 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
10/19/2012 - PDF - English, French - IEC
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IEC 60601-2-44:2009/AMD1:2012
IEC 60601-2-44:2009/AMD1:2012 Amendment 1 - Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
8/30/2012 - PDF - English, French - IEC
Learn More€232.00 -
IEC 60601-1:2005+AMD1:2012 Edition 3.1
IEC 60601-1:2005+AMD1:2012 (Consolidated version) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
8/20/2012 - - - IEC
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IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD1:2012 Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
7/13/2012 - PDF - English, French - IEC
Learn More€447.00 -
IEC 60601-2-10:2012
IEC 60601-2-10:2012 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
6/27/2012 - - - IEC
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IEC 60601-2-6:2012
IEC 60601-2-6:2012 Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
4/27/2012 - - - IEC
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IEC 60601-2-3:2012
IEC 60601-2-3:2012 Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
4/20/2012 - - - IEC
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IEC 60601-2-47:2012
IEC 60601-2-47:2012 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
2/16/2012 - PDF - English, French - IEC
Learn More€423.00 -
IEC 60601-2-25:2011
IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
10/19/2011 - PDF - English, French - IEC
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IEC 60601-2-27:2011
IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
3/30/2011 - PDF - English, French - IEC
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IEC 60601-2-23:2011
IEC 60601-2-23:2011 Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
2/25/2011 - PDF - English, French - IEC
Learn More€325.00 -
IEC 60601-2-4:2010
IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
12/8/2010 - - - IEC
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IEC 60601-2-8:2010
IEC 60601-2-8:2010 Medical electrical equipment - Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
11/10/2010 - - - IEC
Learn More€510.00 -
IEC 60601-2-18:2009
IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
8/12/2009 - PDF - English, French - IEC
Learn More€325.00 -
IEC 60601-2-5:2009
IEC 60601-2-5:2009 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
7/30/2009 - PDF - English, French - IEC
Learn More€290.00 -
IEC 60601-2-29:2008
IEC 60601-2-29:2008 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
6/11/2008 - PDF - English, French - IEC
Learn More€180.00 -
IEC 60601-1-3:2008
IEC 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
1/22/2008 - - - IEC
Learn MoreFrom: €574.00 -
IEC 60601-1-10:2007
IEC 60601-1-10:2007 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
11/21/2007 - - - IEC
Learn MoreFrom: €539.00 -
IEC 60601-1-8:2006
IEC 60601-1-8:2006 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
10/25/2006 - - - IEC
Learn MoreFrom: €1,114.00