ISO/NP 24085-1

Implants for Surgery — Partial and total shoulder joint replacement — Part 1: Determination of resistance to torque of head fixation of modular humeral components

Scope

This document describes a method of determining the torque required, under specified laboratory conditions, to loosen the fixation of the humeral head of modular anatomic shoulder joint replacement in which the humeral head is not intended to rotate relative to the humeral component.
This test method is used to evaluate humeral components of total or partial shoulder joint replacements in which the humeral head and humeral component are secured together by a connector(s) (see Figure A.1) assembled by a compressive load and in which the humeral head and humeral component are separate components, and which are made of metallic or non-metallic materials. There can be one, two or three connectors as part of the modular anatomic shoulder joint replacement. (see Figure A.3).
This document does not cover methods of examining the test specimens after testing.