ASTM F1877

ISO 17853: Wear of implant materials – Polymer and metal wear particles – Isolation, characterization and quantification ASTM F561: Standard Practice for Retrieval and Analysis of Medical

Scope of certification

Scope of certification Test laboratory for medical devices according to ISO 17025 Certificate Scope View our Certificate and Scope ANSI/AAMI NS 28 : 1988/I 2006

Simulators

The EndoLab Simulators Global leaders in medical device testing Hip Simulator Knee Simulator

ASME V&V40

Historically, regulatory bodies participating in the evaluation of orthopaedic implants (e.g. US FDA, TÜV, BSI) have been reluctant to accept the results of Computational Model

ISO 19023

ISO 19023: Dentistry — Orthodontic anchor screws ASTM F543: Standard Speciﬁcation and Test Methods for Metallic Medical Bone Screws This specification provides requirements and test

ISO 22683

ISO 22683: Dentistry — Rotational adaptability test between implant body and implant abutment in dental implant systems The rotation clearance angle between the implant body

PI-100 (ISO DIS 18967-1)

PI-100: Implants for surgery – Bone anchoring systems – Part 1: Impact, expandable and threaded suture anchors requirements ISO DIS 18967-1 was transferred into an

PI-99 (ASTM F2091)

PI 99: Standard Specification for Acetabular Prostheses ASTM F2091-15 has been withdrawn in 2023. Standard specifications for acetabular prostheses can now be found in ISO

ASTM F3631

ASTM F3631: Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices ASTM F3631 establishes standardized procedures for evaluating the impact durability

ASTM F3495

ASTM F3495: Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components ASTM F3495 outlines two test methods designed to evaluate