ISO 18192-1:2011 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test
This part of ISO 18192 defines a test procedure for the relative angular movement between articulating
components, and specifies the pattern of the applied force, speed and duration of testing, sample
configuration and test environment for use for the wear testing of total intervertebral spinal disc prostheses.
Both lumbar and cervical prostheses are addressed. This part of ISO 18192 is not applicabe to partial disc
replacements, such as nucleus replacements or facet joint replacements. The test method focuses on wear
testing. Additional mechanical tests, such as fatigue testing, can be required.
This part of ISO 18192 does not reproduce the complex in vivo loads and motions. The wear data obtained
with this test method enables comparison between different types of implants, but can differ from the clinical
wear performance. The user of this part of ISO 18192 can consider running additional wear tests addressing
specific safety issues of the individual implant design under test.
ISO 18192-1:2011 Referenced Document
ISO 14242-2 Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement*, 2016-09-01 Update
ISO 18192-1:2011 history
2018ISO 18192-1:2011/Amd 1:2018 Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test — Amendmen
2011ISO 18192-1:2011 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test
2008ISO 18192-1:2008 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test