Accreditation - Certificate

Questmed GmbH is an accredited testing laboratory for medical devices according DIN EN ISO/IEC 17025:2018. We present and secure our tests with our quality managent system.
In the medical devices sector the international agreements have currently been made with the European Community with regard to the mutual recognition of conformity assessment with United States of America, Australia, New Zealand, and Switzerland as well as ILAC MRA.
Concurrently Questmed GmbH guarantees compliance with effective medical device laws.

Questmed GmbH is an accredited testing laboratory for physical and physical-chemical testing of non-active implants in the field of medical devices according DIN EN ISO/IEC 17025:2018 by DAkkS.


Accreditation

Questmed Accreditation

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Standard Test method
Spine 🔗
ASTM F1717 Static and dynamic strength test of spinal fixators
ASTM F1798 Static and fatigue test of interconnection mechanisms used in Spinal Arthrodesis Implants (without torsion test)
ASTM F2077 Static and dynamic tests of intervertebral body fusion devices
ASTM F2193 Specifications and static and dynamic test of spinal fixators
ASTM F2267 Subsidence under static axial compression test for intervertebral body fusion devices
AW-10
ASTM F1839
ASTM F2077
ASTM F2267 		Pull out resistance in the expulsion test for intervertebral body fusion devices
Knee 🔗
ISO 7207-1 Geometric data and Classification
ISO 14243-1
ISO 14243-2
ISO 14243-3
ASTM F3141 		Determination of tribological properties in the knee simulator
ISO 14879-1
ASTM F1800
ASTM F2083 		Fatigue test, Endurance, Durability
ISO 5834-3
ASTM F2003 		PE accelerated aging
ASTM F2083, Chapter 6.3.1 and 6.4 Testing of standard specification for knee replacement prosthesis
Hip 🔗
ISO 7206-1 Geometric data and Classification
ASTM F2068 General requirements
ISO 7206-4 Endurance properties and performance of hip endoprosthesis stems
AW-03
ASTM F2068 		Endurance properties of prosthesis stems with torsional loading
ISO 7206-6 Endurance properties
  • Head and neck
  • Bearing balls
Ankle 🔗
ISO 22622
ASTM F2665 		Wear of ankle endoprostheses
Shoulder 🔗
AW-13
ASTM F1378
ASTM F1829
ASTM F2028
DIN EN ISO 10523 		Wear of shoulder endoprotheses
AW-18
ASTM F1829
ASTM F2028
Static and dynamic strength test of shoulder endoprostheses
Elbow 🔗
ASTM F2887 Wear testing, Endurance properties
Osteosynthesis 🔗
AW-17
ASTM F382
ASTM F1717 		Static and dynamic strength tests of osteosynthesis system
ASTM F382 Bending strenght of bone plates
ASTM F543 Bone screw tests:
  • Torsion test
  • Bending test
  • Insertion/removal torque
  • Pullout strength
ASTM F1264 Intramedullary fixation devices tests:
  • Torsion test
  • Bending test
Dental 🔗
ISO 14801 Fatigue test
ISO 10271 Corrosion tests:
  • Sulfide tarnish test (cyclic immersion)
  • Sulfide tarnish test (static immersion)
  • Preparation and sampling for static immersion test
Cardiovascular implants 🔗
ISO 22679
ASTM F3211 		Occluder - Durability under axial and hydrodynamic load
ISO 25539-1
ISO 25539-2
ASTM F3211 		Stent - Fatigue and durability
ISO 25539-3
ASTM F3211 		Vena Cava Filter IVC - Fatigue and durability
Surgical Instruments and Gloves 🔗
DIN EN 455-1 Requirements and testing for freedom from holes of medical gloves
Ion release and Corrosion🔗
ASTM F3306 Ion release evaluation of medical implants
ISO 10271 Dental implants - Corrosion tests:
  • Sulfide tarnish test (cyclic immersion)
  • Sulfide tarnish test (static immersion)
  • Preparation and sampling for static immersion test