SGS Germany GmbH is accredited by DAkkS (ILAC) and according to the IECEE CB Scheme for testing active medical devices. SGS offers the full range of product testing according to various standards of the IEC 60601/80601 standards series, related to product safety, design, environment, mechanics, and Electromagnetic Compatibility (EMC), as part of a comprehensive testing solution at one location. The respective programs, parameters and sequences for the tests are individually designed by our experienced test engineers in line with the manufacturer's requirements.
Further information about our medical technology services
DIN – German Institute for Standardization
EN – European Standard
IEC – International Electrical Committee
ISO – International Organization for Standardization
|
Number |
Title in English |
|---|---|
|
DIN EN 60601-1:2013 IEC 60601-1:2005/AMD1:2020 IEC 60601-1:2005/AMD2:2020 |
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance |
|
DIN EN 60601-1-1:2002-08 IEC 60601-1-1:2000 |
Medical electrical equipment – |
|
DIN EN 60601-1-2:2016 IEC 60601-1-2:2014 IEC 60601-1-2:2014/AMD1:2020 |
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests |
|
DIN EN 60601-1-3:2014 IEC 60601-1-3:2008/AMD1:2013 IEC 60601-1-3:2008/AMD2:2021 |
Medical electrical equipment – |
|
DIN EN 60601-1-6:2016-02 IEC 60601-1-6:2010/AMD1:2013 IEC 60601-1-6:2010/AMD2:2020 |
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
|
DIN EN 60601-1-8: 2014-04 IEC 60601-1-8:2006/AMD1:2012 IEC 60601-1-8:2006/AMD2:2020 |
Medical electrical equipment – |
|
DIN EN 60601-1-10:2008 IEC 60601-1-10:2007/AMD1:2013 |
Medical electrical equipment – |
|
DIN EN 60601-1-11: 2016-04 IEC 60601-1-11:2015 IEC 60601-1-11:2015/AMD1:2020 |
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 |
|
DIN EN 60601-1-12:2016 IEC 60601-1-12:2014 IEC 60601-1-12:2014/AMD1:2020 |
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 |
|
DIN EN 60601-2-2:2018 DIN EN 60601-2-2:2014 IEC 60601-2-2:2017 |
Medical electrical equipment – |
|
DIN EN 60601-2-4:2012 IEC 60601-2-4:2010 IEC 60601-2-4:2010/AMD1:2018
|
Medical electrical equipment – |
|
DIN EN 60601-2-10:2017 IEC 60601-2-10:2012 IEC 60601-2-10:2012/AMD1:2016 |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
|
DIN EN ISO 80601-2-12:2020 DIN EN ISO 80601-2-12:2012 ISO 80601-2-12:2020 ISO 80601-2-12:2011
|
Medical electrical equipment –Part 2-12: |
|
DIN EN 60601-2-18:2016 IEC 60601-2-18:2009 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
|
DIN EN 60601-2-22:2015 IEC 60601-2-22:2007/AMD1:2012 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
|
DIN EN 60601-2-24:2016 IEC 60601-2-24:2012 |
Medical electrical equipment - Part 2-24: Particular requirements for basic safety and essential performance of infusion pumps and controllers |
|
DIN EN 60601-2-25:2016 IEC 60601-2-25:2011 |
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
|
DIN EN 60601-2-26: 2016 IEC 60601-2-26:2012 |
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
|
DIN EN 60601-2-27:2015 IEC 60601-2-25:2011 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
|
DIN EN 60601-2-28:2020 DIN EN 60601-2-28:2010 IEC 60601-2-28:2017
|
Medical electrical equipment – |
|
DIN EN 80601-2-30:2020 DIN EN 80601-2-30:2016 IEC 80601-2-30:2009/AMD1:2013 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 |
|
DIN EN 60601-2-33:2017 DIN EN 60601-2-33:2011 IEC 60601-2-33:2010/AMD2:2015 |
Medical electrical equipment – |
|
DIN EN 60601-2-34:2015 IEC 60601-2-34:2011 |
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
|
DIN EN 80601-2-35:2017 IEC 80601-2-35:2009/AMD1:2016 |
Medical electrical equipment – |
|
DIN EN 60601-2-36:2015 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 |
|
DIN EN 60601-2-37:2016 IEC 60601-2-37:2007/AMD1:2015 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
|
DIN EN 60601-2-40:2019 |
Medical electrical equipment – Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment |
|
DIN EN 60601-2-41:2016 IEC 60601-2-41:2009/AMD1:2013 |
Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
|
DIN EN 60601-2-43:2020 IEC 60601-2-43:2010/AMD2:2019 |
Medical electrical equipment – |
|
DIN EN 60601-2-44:2017 IEC 60601-2-44:2009/AMD2:2016 |
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
|
DIN EN 60601-2-45:2017 IEC 60601-2-45:2011/AMD1:2015 |
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
|
DIN EN 60601-2-46:2020 DIN EN 60601-2-46:2011 IEC 60601-2-46:2016 IEC 60601-2-46:2010 |
Medical electrical equipment – |
|
DIN EN 60601-2-47:2016 IEC 60601-2-47:2012 |
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
|
DIN EN IEC 80601-2-49:2020 IEC 80601-2-49:2018 DIN EN 60601-2-49:2016 IEC 60601-2-49:2011 |
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
|
DIN EN 60601-2-52:2016 IEC 60601-2-52:2009/AMD1:2015 |
Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds |
|
DIN EN 60601-2-54:2020 IEC 60601-2-54:2009/AMD2:2018 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
|
DIN EN ISO 80601-2-55:2019 ISO 80601-2-55:2018 |
Medical electrical equipment — |
|
DIN EN ISO 80601-2-56:2020 ISO 80601-2-56:2017/AMD1:2018 |
Medical electrical equipment — |
|
DIN EN 60601-2-57:2011 IEC 60601-2-57:2011 |
Medical electrical equipment – |
|
DIN EN 80601-2-60:2016 IEC 80601-2-60:2012 |
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
|
DIN EN ISO 80601-2-61:2019 ISO 80601-2-61:2017 |
Medical electrical equipment — |
|
DIN EN 60601-2-63:2020 IEC 60601-2-63:2012 |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
|
DIN EN 60601-2-65:2016 IEC 60601-2-65:2012 |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
|
DIN EN ISO 80601-2-72:2016 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 |
|
DIN EN 61010-2-040:2016 IEC 61010-2-040:2015 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
|
DIN EN 61010-2-101:2017 IEC 61010-2-101:2018 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
|
DIN EN 61326-2-6:2013 IEC 61326-2-6:2020 IEC 61326-2-6:2012 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – |
Contact
Armin Hudetz
t: +49 89 78 74 75-133
f: +49 89 12 50 40 64-133
E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
Customer Service Team
t: +49 89 78 74 75-222
f: +49 89 12 50 40 64-100
E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.