Medical devices – an excerpt from our testing portfolio

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 –
Part 1-1:
General requirements for safety –
Collateral standard: Safety requirements
for medical electrical systems

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 –
Part 1-3: General requirements for basic safety and essential performance –
Collateral Standard: Radiation protection in diagnostic X-ray 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 –
Part 1-8: General requirements for safety – Collateral standard: General requirements, tests
and guidance for alarm systems in medical electrical equipment and medical electrical systems

DIN EN 60601-1-10:2008

IEC 60601-1-10:2007/AMD1:2013

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

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 –
Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

DIN EN 60601-2-4:2012

IEC 60601-2-4:2010

IEC 60601-2-4:2010/AMD1:2018

 

Medical electrical equipment –
Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

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:
Particular requirements for the safety of lung ventilators – Critical care ventilators

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 –
Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

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 –
Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

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 –
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

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
IEC 60601-2-40:2016

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 –
Part 2-43: Particular requirements for the basic safety and essential performance
of X-ray equipment for interventional procedures

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 –
Part 2-46: Particular requirements for the basic safety and essential performance
of operating tables

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 —
Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

DIN EN ISO 80601-2-56:2020

ISO 80601-2-56:2017/AMD1:2018

Medical electrical equipment —
Part 2-56:
Particular requirements for basic safety
and essential performance of clinical thermometers for body temperature measurement

DIN EN 60601-2-57:2011

IEC 60601-2-57:2011

Medical electrical equipment –
Part 2-57: Particular requirements for the basic safety and essential performance
of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

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 —
Part 2-61:
Particular requirements for basic safety
and essential performance of puls oximeter 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 –
Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment

 

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
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