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This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of...
1.1 This standard is intended to provide guidance for the static testing of small bone metallic plates used for fracture fixation. Small bone plates referred to in this standard would be used in minimally load-bearing anatomical areas of the far extremities, such as the fingers and toes, and in the...
This specification covers the general workmanship aspects of inserted and noninserted 410, 410K, 416, 420, 420A, and 420B martensitic stainless steel scissors intended for reuse in surgery. Inserts should be made of stellite, tungsten carbide, or other suitable materials. The instruments should...
5.1 This specification describes the compositional requirements, physical requirements, mechanical requirements, and test methods for rigid unicellular polyurethane foam for use in testing orthopaedic devices or instruments. 5.2 This foam described in this specification is not intended to replicate...
5.1 Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for...
1.1 This specification covers the acceptable dimensions and tolerances for bits of screwdrivers to insert and remove metal screws used as surgical implants. 1.2 This specification is based, in part, upon ISO 8319-1, ISO 8319-2, and ISO 10664. 1.3 The screwdrivers with the bits described in...
This test method covers conducting galvanic corrosion tests to characterize the behavior of two dissimilar metals in electrical contact that are to be used in the human body as medical implants or as component parts to medical implants. Examples of the types of devices that might be assessed...
1.1 This test method covers conducting galvanic corrosion tests to characterize the behavior of two dissimilar metals in electrical contact that are to be used in the human body as medical implants or as component parts to medical implants. Examples of the types of devices that might be assessed...
1.1 This test method provides a screening test for determining the amount of metal loss from plates and screws used for osteosynthesis (internal fixation of broken bones) due to fretting corrosion in the contact area between the screw head and the plate hole countersink area. The...
These specifications and test methods provide standard specifications that specify material, labeling, and handling requirements for components used in surgical fixation of the spinal skeletal system such as metallic spinal screws, spinal plates, and spinal rods. The specifications and test...
These specifications and test methods are intended to provide a comprehensive reference for the components of systems used in the surgical fixation of the spinal skeletal system. The document catalogs standard specifications that specify material, labeling, and handling requirements. The...
This test method provides a screening test for determining the amount of metal loss from plates and screws used for osteosynthesis (internal fixation of broken bones) due to fretting corrosion in the contact area between the screw head and the plate hole countersink area. The implants...
This document specifies the design, dimensions, material and requirements of screw-neck glass bottles (veral) for pharmaceutical preparations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. This document is...
This document specifies the design, dimensions, material and requirements of screw-neck glass bottles for pharmaceutical preparations in liquid form (syrups). Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. This document is applicable to...
This document specifies the test methods for determining the torsional yield strength, maximum torque, and breaking angle of metallic bone screws for surgery with asymmetrical thread. Mechanical and surface finish requirements for solid cylindrical metal bone screws with asymmetrical...
This test method assesses metal or other ions released from single-use, metallic, implantable medical devices, or components thereof, by exposing the device to solutions simulating the in-vivo environment and temperature in a container for a predetermined time frame with regular sampling at...
1.1 This test method assesses metal or other ions released from single-use, metallic, implantable medical devices, or components thereof, by exposing the device to solutions simulating the in-vivo environment and temperature in a container for a predetermined time frame with regular sampling at...
This document specifies general requirements for reservoir connectors, which convey fluids in healthcare applications. These reservoir connectors are used in medical devices or accessories intended for use with a patient. This document also specifies the healthcare fields in which these reservoir...
