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Osteosynthesis

ASTM is one of the leading standards developers for medical devices. With 24 categories, addressing everything from surgical implements to automated analysis, ASTM medical device standards cover a truly wide range. With how much research and training goes into the medical industry, standardization plays a key role in productively actualizing that effort. Organized below for your convenience by usage, industry, and theme are over 300 standards. This list includes standards related to Osteosynthesis.

ASTM F366-17

Standard Specification for Fixation Pins and Wires

1.1 This specification covers functional dimensions for fixation pins and wires. 1.2 In recognition of many broad and varied uses of such pins and wires, many options are included. A variety, but not necessarily all, of the options are illustrated in Figs. 1- 3 . FIG. 1 Fixation Pins and Wires Note 1: Pins and wires may be smooth shank or threaded. Note 2: Point angle and helix angle, where applicable, is as specified by the manufacturer. Note 3: On square or triangular shanks, flats are equal and corners are on the same circumference as the pin diameter. Shank diameters on pins larger than 3.2 mm may be reduced. Note 4: Optional designs, both ends pointed or point with suture hole. FIG. 2 Fixation Pin-Knowles Type Note 1: Shall be made of one piece of material; that is, not an assembly of two or more pieces. Note 2: Thread major diameter may be the same or larger than the shaft diameter. Note 3: Thread length shall be optional to suit the intended medical application. Note 4: Optional marking in this location. FIG. 3 Fixation Pin-Hagie Type Note 1: Thread major diameter may be the same or larger than the shaft diameter. Note 2: Thread length shall be optional to suit the intended medical application. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F564-17

Standard Specification and Test Methods for Metallic Bone Staples

1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the musculoskeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples. 1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples: 1.2.1 Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples Annex A1 . 1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone Staples Annex A2 . 1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples Annex A3 . 1.2.4 Test Method for Elastic Static Bending of Metallic Bone Staples Annex A4 . 1.3 The values stated in SI units are to be regarded as standard. Any other units of measurement included in this standard are shown for reference only. 1.4 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F1541-17

Standard Specification and Test Methods for External Skeletal Fixation Devices

1.1 This specification provides a characterization of the design and mechanical function of external skeletal fixation devices (ESFDs), test methods for characterization of ESFD mechanical properties, and identifies needs for further development of test methods and performance criteria. The ultimate goal is to develop a specification, which defines performance criteria and methods for measurement of performance-related mechanical characteristics of ESFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of the devices, as insufficient knowledge is available to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living. Furthermore, it is not the intention of this specification to describe or specify specific designs for ESFDs. 1.2 This specification describes ESFDs for surgical fixation of the skeletal system. It provides basic ESFD geometrical definitions, dimensions, classification, and terminology; material specifications; performance definitions; test methods; and characteristics determined to be important to the in-vivo performance of the device. 1.3 This specification includes a terminology and classification annex and five standard test method annexes as follows: 1.3.1 Classification of External Fixators Annex A1 . 1.3.2 Test Method for External Skeletal Fixator Connectors Annex A2 . 1.3.3 Test Method for Determining In-Plane Compressive Properties of Circular Ring or Ring Segment Bridge Elements Annex A3 . 1.3.4 Test Method for External Skeletal Fixator Joints Annex A4 . 1.3.5 Test Method for External Skeletal Fixator Pin Anchorage Elements Annex A5 . 1.3.6 Test Method for External Skeletal Fixator Subassemblies Annex A6 . 1.3.7 Test Method for External Skeletal Fixator/Constructs Subassemblies Annex A7 . 1.4 A rationale is given in Appendix X1 . 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods 1.7 The following safety hazards caveat pertains only to the test method portions ( Annex A2 Annex A6 ): 1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F2180-17

Standard Specification for Metallic Implantable Strands and Cables

1.1 This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables. 1.2 This specification is intended to assist in the development of specific strand and cable specifications. It is particularly appropriate for high load bearing applications. It is not intended however, to address all of the possible variations in construction, material, or properties. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F382-17

Standard Specification and Test Method for Metallic Bone Plates

1.1 This specification and test method is intended to provide a comprehensive reference for bone plates used in the surgical internal fixation of the skeletal system. The standard establishes consistent methods to classify and define the geometric and performance characteristics of bone plates. The standard also presents a catalog of standard specifications that specify material; labeling and handling requirements; and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of bone plates. 1.2 It is not the intention of the standard to define levels of performance or case-specific clinical performance for bone plates, as insufficient knowledge is available to predict the consequences or their use in individual patients for specific activities of daily living. Futhermore, it is not the intention of the standard to describe or specify specific designs for bone plates used in the surgical internal fixation of the skeletal system. 1.3 This document may not be appropriate for all types of bone plates. The user is cautioned to consider the appropriateness of the standard in view of a particular bone plate and its potential application. 1.4 This document includes the following test methods used in determining the following bone plate mechanical performance characteristics: 1.4.1 Standard Test Method for Single Cycle Bend Testing of Metallic Bone Plates Annex A1 , and 1.4.2 Standard Test Method for Determining the Bending Fatigue Properties Of Metallic Bone Plates Annex A2 . 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. In most instances, only a subset of the herein described test methods will be required. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and determine the applicability of regulatory limitations prior to use. FIG. 1 Bone Plate Cross-sections 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F1264-16e1

Standard Specification and Test Methods for Intramedullary Fixation Devices

1.1 This specification is intended to provide a characterization of the design and mechanical function of intramedullary fixation devices (IMFDs), specify labeling and material requirements, provide test methods for characterization of IMFD mechanical properties, and identify needs for further development of test methods and performance criteria. The ultimate goal is to develop a standard which defines performance criteria and methods for measurement of performance-related mechanical characteristics of IMFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of these devices, as insufficient knowledge to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living is available. It is not the intention of this specification to describe or specify specific designs for IMFDs. 1.2 This specification describes IMFDs for surgical fixation of the skeletal system. It provides basic IMFD geometrical definitions, dimensions, classification, and terminology; labeling and material specifications; performance definitions; test methods and characteristics determined to be important to in-vivo performance of the device. 1.3 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods.

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ASTM F565-21

Standard Practice for Care and Handling of Orthopedic Implants and Instruments

1.1 This practice covers recommended procedures for the handling of orthopedic implants and instruments. 1.2 Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage to orthopedic implants and instruments. 1.3 This practice does not cover producer level handling and packaging procedures. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F983-86(2018)

Standard Practice for Permanent Marking of Orthopaedic Implant Components

1.1 It is common practice for orthopaedic implant manufacturers to apply permanent identification to implant components. In this regard, Practice F86 describes recommended locations and methods of marking for metallic implants. 1.2 The purpose of this practice is to ( 1 ) recommend that orthopaedic implants be permanently marked, and ( 2 ) recommend practical amounts of information that should be included in the marking. It is recognized, however, that marking is not practical in some cases (see 4.1 ). 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F1611-20

Standard Specification for Intramedullary Reamers

1.1 This specification provides requirements for material, dimensions and tolerances, finish and marking, and care and handling for reamers intended to cut a cylindrical path along the medullary canal of diaphyseal bone. 1.2 Intramedullary reamers are commonly used to prepare the medullary canal for the insertion of intramedullary fixation devices (IMFDs). As such, the relationship between the intramedullary reamer diameter and the IMFD's diameter are considered. 1.3 Units The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F543-17

Standard Specification and Test Methods for Metallic Medical Bone Screws

1.1 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. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification. 1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:... 1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods. 1.6 This standard may involve the use of hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F116-12(2021)

Standard Specification for Medical Screwdriver Bits

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 specification are suitable for use with screws described in Specification F543 , ISO 5835, and ISO 9268. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F384-17

Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

1.1 These specifications and test methods provide a comprehensive reference for angled devices used in the surgical internal fixation of the skeletal system. This standard establishes consistent methods to classify and define the geometric and performance characteristics of angled devices. This standard also presents a catalog of standard specifications that specify material, labeling, and handling requirements, and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of angled devices. 1.2 It is not the intention of this standard to define levels of performance or case-specific clinical performance for angled devices, as insufficient knowledge is available to predict the consequences of their use in individual patients for specific activities of daily living. Futhermore, this standard does not describe or specify specific designs for angled devices used in the surgical internal fixation of the skeletal system. 1.3 This standard may not be appropriate for all types of angled devices. The user is cautioned to consider the appropriateness of this standard in view of a particular angled device and its potential application. Note 1: This standard is not intended to address intramedullary hip screw nails or other angled devices without a sideplate. 1.4 This standard includes the following test methods used in determining the following angled device mechanical performance characteristics:... 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F1839-08(2021)

Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

1.1 This specification covers rigid unicellular polyurethane foam for use as a standard material for performing mechanical tests utilizing orthopaedic devices or instruments. The specification is applicable to sheets or blocks of foam, or foam that is made by the user using a two-part liquid mixture. 1.2 This specification covers polyurethane foam material that is used in the laboratory for mechanical testing, as described in 1.1 . These materials are not intended for implantation into the human body. 1.3 The foam described herein possesses mechanical properties which are on the order of those reported for human cancellous bone. See Appendix X1 , Rationale, for further information regarding the appropriateness of using the specified foam as a model for human cancellous bone. 1.4 This specification covers compositional requirements, physical requirements, mechanical requirements, and test methods for rigid polyurethane foam in the solid final form. 1.5 This specification provides qualification criteria for vendor or end user processes and acceptance criteria for individual material lots. 1.6 This specification provides mechanical properties of five different grades of foam in the solid final form. A foam that does not meet the specified mechanical properties shall be identified as an ungraded foam. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.8 The following precautionary statement pertains to the test method portion only, Section 8 , of this specification : This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F2502-17

Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants

1.1 This specification and test methods cover the mechanical characterization of plates and screws for orthopedic internal fixation. Covered devices are fabricated from one or more hydrolytically degradable polymer (from this point on referred to as absorbable ) resins or resin composites. 1.2 This specification establishes a common terminology to describe the size and other physical characteristics of absorbable implants and performance definitions related to the performance of absorbable devices. 1.3 This specification establishes standard test methods to consistently measure performance-related mechanical characteristics of absorbable devices when tested under defined conditions of pretreatment, temperature, humidity, and testing machine speed. 1.4 This specification may not be appropriate for all absorbable devices, especially those that possess limited hydrolytic susceptibility and degrade in vivo primarily through enzymatic action. The user is cautioned to consider the appropriateness of the standard in view of the particular absorbable device and its potential application. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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