On 16.OCT.2025, we received our new Accreditation Certificate from DAkkS, the German Accreditation Authority. Again, we used this opportunity to enlarge our accredited scope with new procedures and updates from revised standards.
The most important changes are summarized below:
ISO 14607:2024 Annex B Tests of shell integrity
ISO 14607:2024 Annex C.1 Fatigue test
ISO 14607:2024 Annex C.2 Impact resistance test
ISO 14607:2024 Annex C.3 Endurance load level
ISO 14607:2024 Annex D Valve competence
ISO 14607:2024 Annex E Cohesion
ISO 14607:2024 Annex G Surface classification with Surface roughness, Surface complexity, and Porosity
ASTM F88-2023 Packaging test
ASTM F382-2024 Metallic bone plates
ASTM F384-2024 Metallic Angled Orthopedic Fracture Fixation Devices
ASTM F1089-2024 Corrosion test for surgical Instruments
ASTM F1147-2024 Tension Testing of Calcium Phosphate and Metallic Coatings
ASTM F1264-2024 Intramedullary Fixation Devices
ASTM F1886-2024 Integrity of Seals for Flexible Packaging
ASTM F1929-2023 Dye Penetration test
ASTM F2077-2024 Intervertebral Body Fusion Devices
DIN EN 455-1 and -2 Medical Gloves
New procedures in accredited scope:
