Standards for Medical Fasteners
Standards for medical fasteners address the nuances specific to medical usage of fasteners, such as the potentially catastrophic interactions between the human body and surgical implants. Medical fastener standards cover their mechanical requirements, dimensions, test methods, and the design of plates for screws to interact with.
ISO 8319-1:1996
Orthopaedic instruments -- Drive connections -- Part 1: Keys for use with screws with hexagon socket heads
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.
ISO 8319-2:1986
Orthopaedic instruments -- Drive connections -- Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws
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.
ISO 5835:1991
Implants for surgery -- Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread -- Dimensions
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.
ISO 5836:1988
Implants for surgery -- Metal bone plates -- Holes corresponding to screws with asymmetrical thread and spherical under-surface
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.
ISO 6475:1989
Implants for surgery -- Metal bone screws with asymmetrical thread and spherical under-surface -- Mechanical requirements and test methods
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.
ISO 9268:1988
Implants for surgery -- Metal bone screws with conical under-surface of head -- Dimensions
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.
ISO 9269:1988
Implants for surgery -- Metal bone plates -- Holes and slots corresponding to screws with conical under-surface
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.
