ISO/TC 150/SC 5 - Osteosynthesis and spinal devices

This document specifies requirements for the mechanical assessment of spinal intervertebral body fusion devices (IBFDs) used in spinal arthrodesis procedures. This document focuses on mechanical requirements and does not intend to cover all assessments for various types of IBFDs.

ISO 19213:2017 specifies mechanical test methods for characterizing cortical bone model materials for use as a standard model for performing mechanical tests for devices or instruments used in orthopaedic surgery, plastic surgery, neurosurgery, and oral and maxillofacial surgery. The document specifies static mechanical test and properties. Dynamic and viscoelastic/poroelastic tests and properties are not included in the scope of ISO 19213:2017.

ISO 18192-3:2017 defines a test procedure to simulate and evaluate lumbar spinal disc prostheses wear under adverse impingement conditions.

This part of ISO 5838 specifies general requirements for metallic skeletal pins and wires for use in bone surgery, excluding wires for binding and twisting.

ISO 9714-1:2012 specifies materials and mechanical properties, dimension and marking requirements for drill bits, taps and countersink cutters made of stainless steel for use in orthopaedic surgery with bone screws specified in ISO 5835.

ISO 18192-1:2011 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.

ISO 18192‑2:2010 defines a test procedure for spinal nucleus prostheses under the relative angular movement conditions specified by ISO 18192‑1. ISO 18192‑2:2010 is applicable to both lumbar and cervical prostheses. It is not applicable to total disc replacements and facet joint replacements. The method includes wear and fatigue testing. Additional mechanical tests such as creep tests can be required. ISO 18192‑2:2010 does not reproduce the complex in vivo loads and motions. The wear and fatigue data obtained with this test method will enable comparison between different types of implant but can differ from the clinical wear performance. The user of ISO 18192‑2:2010 should consider running additional tests addressing specific safety issues of the individual implant design to be tested.

ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants. In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

ISO 12189:2008 specifies methods for fatigue testing of spinal implant assemblies (for fusion or motion preservation) using an anterior support. It is intended to provide a basis for the assessment of intrinsic static and dynamic strength of spinal implants.

ISO 15142-3:2003 specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, classifying and giving other requirements and dimensions for the devices used to insert, remove or both insert and remove intramedullary nails. It also provides a means of measuring reamer diameter. It is applicable to all metal intramedullary fixation devices used for temporary fixation of long bones in the human body, except drive connections for locking elements.

ISO 15142-2:2003 specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, classifying and giving requirements for the locking components of intramedullary nails. It is applicable to all metal intramedullary fixation devices used for temporary fixation of long bones in the human body, except unlockable nails.

ISO 15142-1:2003 specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, defining terms and giving requirements for intramedullary nails. It is applicable to all metal intramedullary fixation devices used for temporary fixation of long bones in the human body.

Specifies the dimensions, tolerances, mechanical properties and performance requirements of the working end of keys to be used for metal bone screws with hexagon drive sockets, used as surgical implants.

Specifies the dimensions and mechanical properties and gives test methods. The mechanical properties specified are tensile strength, elongation, and resistance to damage in bending and in torsion. Surface finish is not covered.

Specifies the characteristics (dimensions, ends, marking and packaging) of Kirschner wires. Material and mechanical requirements are covered by ISO 5838-1.

Specifies the materials, dimensions, surface finish, packaging and marking. Applies to nails and screws, nail plates and blade plates, fixation devices. Several figures illustrate form and finish.

Specifies the dimensions. Material and mechanical requirements are covered by ISO 5838-1. Dimensions shall be according to figure 1 to figure 5 and table 1 to table 3. The ends, form A - plain, form B - square and form C - triangular, shall comply with the figures 3 to 5 and tables 2 and 3.

Gives dimensions and tolerances and the code for screw thread. Screws with shallow thread shall be as given in figures 1 and 2 and tables 1 and 2. Screws with deep thread shall be as given in figures 3 and 4 and tables 3 and 4. Marking and packaging shall be in accordance with ISO 6018. An example for combined screw is given in annex A. An interrelationship of International Standards dealing with bone screws, bone plates and relevant tools is given in annex B. Bibliography is given in annex C.

Describes a test method for straight plates but may also be used for ones having a small initial curvature. The method is neither recommended for plates of a length less than 50 mm nor for those designed to be used with, or forming parts of, intramedullary devices.

This standard does not relate to all safety problems concerned with application. It bases on the dimensions of bone screws given in ISO 5835 and ISO 5832-1. The results obtained does not have a direct correlation to the application of screws. Annex A is normative and contains mechanical requirements to bone screws made from stainless steel. The informative Annexes B and C show the intercorrelations of international standards for bone screws, plates and the corresponding tools and a bibliography.

Bone screws for particular applications are not covered by this standard. The different forms are illustrated. The informative annex A shows the interrelationship of International Standards dealing with bone screws, bone plates and relevant tools.

Specification of dimensions and tolerances of the holes and slots in bone plates used as surgical implants so as to facilitate correct fixing using screws complying with ISO 9268. This standard does not deal with the shape and dimensions of plates or with the spacing of the holes and slots. The different forms are illustrated. The informative annex A shows the interrelationship of International Standards dealing with bone screws, bone plates and relevant tools.

Specification of the dimensions and tolerances of holes in bone plates so as to facilitate correct fixing using screws complying with ISO 5835. It does not deal with the shape and dimensions of the plates or with the spacing of the holes. Annex A shows a bibliography of the International Standards dealing with bone srews, bone plates and relevant tools for information.

Specification of dimensions, tolerances, forms and designation of staples. The different forms are illustrated. The informative annex gives guidance on the selection and use of staples.

The purpose is to ensure that the essential requirements of all screw keys are achieved without imposing undue restriction on design features. This standard specifies the requirements for screwdrivers used in orthopaedic surgery for inserting and removing bone screws. Screw keys with the working end specified are suitable for use with screws which conform to ISO 9268.

Specifies the main and fitting dimensions for intramedullary nails of the cross-section mentioned. It also specifies extracting hooks and recommends the diameters of the guide wires to be used with the nails.

ISO 18192-1:2008 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 to be used for the wear testing of total intervertebral spinal disc prostheses. Both lumbar and cervical prostheses are addressed.

Specifies materials and mechanical requirements for skeletal pins and wires for use in bone surgery, excluding wires for binding and twisting. Replaces the first edition, of which it constitutes a technical revision.

Part 1 of ISO 9714 specifies materials and mechanical properties, dimensions and marking requirements for the mentioned instruments made of stainless steel for use in orthopaedic surgery with bone screws as specified in ISO 5835. Instruments made of other materials and coatings may be included at a later revision. The interrelationship of International Standards dealing with bone screws and relevant tools is shown for information in annex A.

Specification of material, method of manufacture, surface finish, main dimensions and requirements for medullary pins used in the bone surgery.