BS ISO 18192-1:2011+A1:2018 Implants for surgery. Wear of total intervertebral spinal disc prostheses. Loading and displacement parameters for wear testing and corresponding environmental conditions for test

BS ISO 18192-1:2011+A1:2018

Implants for surgery. Wear of total intervertebral spinal disc prostheses. Loading and displacement parameters for wear testing and corresponding environmental conditions for test

Status : Current   Published : March 2011

Format
PDF

Format
HARDCOPY



What is this standard about?

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.




Standard NumberBS ISO 18192-1:2011+A1:2018
TitleImplants for surgery. Wear of total intervertebral spinal disc prostheses. Loading and displacement parameters for wear testing and corresponding environmental conditions for test
StatusCurrent
Publication Date31 March 2011
Normative References(Required to achieve compliance to this standard)ISO 14242-2
Informative References(Provided for Information)ISO 14243-1, ISO 14630, ISO 14242-1
ReplacesBS ISO 18192-1:2008
International RelationshipsISO 18192-1:2011/Amd 1:2018,ISO 18192-1:2011/Amd.1:2018
Amended ByAmendment, January 2019
Draft Superseded By18/30373720 DC
DescriptorsMechanical testing, Wear tests, Test equipment, Supports (orthopaedic), Endurance testing, Bones, Loading, Prosthetic devices, Orthopaedic equipment, Prosthesis, Testing conditions, Implants (surgical), Orthopaedics
ICS11.040.40
Title in FrenchImplants chirurgicaux. Usure des prothèses totales de remplacement des disques intervertébraux lombaires Paramètres de charge et de déplacement pour essais d'usure et conditions environnementales correspondantes
CommitteeCH/150/5
ISBN978 0 539 00043 6
PublisherBSI
FormatA4
DeliveryYes
Pages34
File Size1.897 MB
Price£214.00


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