Medical devices – testing and certification

Home Industries Medical devices

Safety is our top priority

Medical devices and systems are subject to particularly high standards: they must function reliably, be user-friendly, often compact, but above all, safe. Whether for diagnosis, therapy, monitoring, or resuscitation – patients and operators rely on flawless performance under all operating conditions. Different environmental conditions present significant challenges to safety, durability, and usability.

SGS supports you in testing and certifying medical devices according to national and international standards and regulations, such as the EU Medical Device Regulation (MDR (EU) 2017/745), In Vitro Diagnostic Regulation (IVDR (EU) 2017/746), EN ISO 13485, or the IEC 60601-x series. With our competence center in Puchheim, near Munich, and a global network of accredited testing laboratories and certification bodies, we offer all services from a single source:

CE marking & international certifications

  • Extensive support for CE marking and certifications for international market access for almost all active and many non-active medical devices
  • Efficient combination of testing and audits, e.g., according to EMC or RED directives, ISO 13485 for quality management systems, and the Medical Device Regulation (MDR)
  • Local qualified contacts for your MDR certification in collaboration with our Notified Body SGS Fimko (CE 0598, Finland)

Further information on the certification spectrum and process is available here.

Product safety testing

As part of our accreditations, e.g., to DIN EN ISO/IEC 17025, and our recognition as a CB Test Laboratory under the IECEE CB Scheme, we offer the following services for the testing and certification of your medical devices and systems:

  • Safety testing according to DIN EN IEC 60601 / 80601 for global recognition, including verification of national deviations and specifics such as USA: ANSI AAMI, Canada: CAN CSA, Japan: JIS T, or Korea: KS C
  • Examples from our test spectrum:
    • Diagnostic X-ray equipment (IEC 60601-1-3, -2-43, -2-54)
    • Patient monitoring and vital signs (IEC 60601-2-25, -2-27, IEC/ISO 80601-2-30, -2-49, -2-55, -2-56, -2-61)
    • Emergency & intensive care equipment (IEC 60601-2-4, ISO 80601-2-12, -2-84)
    • Assistive and surgical robots (IEC 80601-2-78, IEC 80601-2-77)
    • Devices for home use (IEC 60601-1-11)
    • Devices for emergency use, e.g., in ambulances, helicopters, or aircraft (IEC 60601-1-12, EN 1789, EN 13718, RTCA DO-160G) – further information on out-of-hospital tests
    • Software testing (IEC 62304) and usability testing (IEC 62366-1)
    • Active implantable medical devices (ISO 14708-1/-2/-3/-7; formerly DIN EN 45502)
    • Laboratory and measurement technology as well as IVD (IEC 61010-1/-2-101)
    • Lithium battery testing (IEC 62133-2)
  • International approvals:
    • Testing and certification under the IECEE CB Scheme
    • US-NRTL certification according to ANSI/AAMI ES60601-1 and CAN/CSA-C22.2 No. 60601-1
    • INMETRO certification for access to the Brazilian market

Additionally, we offer development-supportive testing, design and gap analyses according to IEC 60601-1 Ed. 3.1 to 3.2, as well as workshops, training, and webinars. Our extensive test spectrum can be found .

Electromagnetic compatibility (EMC)

In our internationally accredited EMC laboratory in Puchheim, near Munich, experienced test engineers and high-quality equipment are at your disposal. We test medical devices and systems, such as diagnostic X-ray units, emergency and intensive care devices, patient monitoring systems, assistive robots, OR equipment, lighting, and much more. Our portfolio includes, for example:

  • EMC testing according to DIN EN IEC 60601-1-2, considering applicable particular standards (IEC/ISO 60601-2-xx, 80601-2-xx), including review and verification of test plans, risk analysis, and instructions for use
  • Our immunity testing includes verification of basic safety and essential performance, based on IEC TS 60601-4-2 guidelines for performance. Simulators and monitoring devices for various device types can be made available upon request.
  • Seminars on the content, normative interpretations, and effective application of IEC 60601-1-2:2014 (+AMD1:2020), including guidance on test plan creation, EMC risk management, and consideration of national deviations
  • Testing for potential interference from RFID/EAS systems using currently recognized “proximity to magnetic fields” methods (30 kHz, 134.2 kHz, 13.56 MHz) in accordance with IEC 60601-1-2:2014 + AMD1:2020 and AIM 7351731 
  • “Out-of-hospital” testing for devices and systems used outside professional clinical environments, e.g., in home settings or in emergencies (ambulances, helicopters, etc.) (CISPR 25, ISO 7637-2, RTCA DO-160G) 
  • “Combined equipment” testing for medical devices and systems integrating wireless technologies (ETSI EG 203 367 with EN 301 489-x and, for instance, EN 300 220 or EN 300 328)
  • Testing of in vitro diagnostics (IVD) and laboratory equipment, e.g., according to EN IEC 61326-2-6 

Further information on electromagnetic compatibility (EMC) testing of medical devices can be found here.

Further medical technology services within the SGS Group

  • EU conformity assessment according to MDR, including ISO 13485
  • Certification according to MDR Article 16(3) for importers and distributors
  • Certification for devices without an intended medical purpose according to MDR Annex XVI
  • Functional safety & cybersecurity (AAMI TIR57, AAMI TIR97, AAMI SW96, UL2900-2-1, IEC TR 60601-4-5) 
  • Battery testing (lithium-ion, NiMH) according to IEC 62133-1 and IEC 62133-2 
  • Packaging testing according to ISTA 
  • Biocompatibility testing according to ISO 10993 and ISO 18562 
  • Environmental simulation: mechanical, climatic, and corrosive influences such as IP protection tests, leakage tests, transport tests, qualification of connectors, and connection technologies – further information on environmental simulation
  • Chemical product testing for undesirable and prohibited substances and RoHS compliance 
  • Material & failure analysis: particle analyses/identification, media resistance of materials, material analyses and functional layers, failure and damage analyses, component counterfeiting (fake chips)

Testing services in accredited partner laboratories

  • Cleaning validation: ISO 17664-1/2:2021, ISO 15883-5:2021, ANSI/AAMI ST98:2022, ASTM F3208-18
  • Disinfection validation: ISO 17664-1/2:2021, ISO 15883-2:2009, AAMI TIR12:202; testing of high-, 
    medium-, and low-level disinfection processes
  • Sterilization validation: ISO 17664-1:2021, ISO 17665-1:2006; verification of sterility assurance level including validation of inoculation methods
  • Reprocessing validation throughout product life cycle: visual and tactile evaluation, color assessment, hardness and mass assessment, functional assessment
  • Highly accelerated life-cycle tests (HALT): simulation of extreme conditions to identify weak points and lifespan limits
  • Resistance to cleaning and disinfecting agents (material compatibility testing): ISO 21530:2004, spray tests, soak tests, contact tests; BIFMA HCP8.1-2017, wipe tests
  • Material assessment
    • Quantitative: mass, color, opacity, whiteness, hardness, corrosion, dimensional stability
    • Qualitative: visual appearance, tactile assessment 

Why SGS?

  • Our DIN EN ISO/IEC 17025 accreditations by DAkkS are internationally recognized through ILAC (International Laboratory Accreditation Cooperation).
  • We offer a complete service from a single source – local contacts combined with global expertise.
  • We offer long-standing, in-depth experience and a worldwide network for comprehensive solutions.

Download

Contact

Armin Hudetz
t: +49 89 787 475-133
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Customer Service Team
t: +49 89 787 475-222
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.