ASTM F1611-20

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Designation: F1611 − 00 (Reapproved 2018) F1611 − 20
Standard Specification for
Intramedullary Reamers
This standard is issued under the fixed designation F1611; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
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 (IMFD).(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.
2. Referenced Documents
2.1 ASTM Standards:
A564/A564M Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes
A693 Specification for Precipitation-Hardening Stainless and Heat-Resisting Steel Plate, Sheet, and Strip
A705/A705M Specification for Age-Hardening Stainless Steel Forgings
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F565 Practice for Care and Handling of Orthopedic Implants and Instruments
F899 Specification for Wrought Stainless Steels for Surgical Instruments
F983 Practice for Permanent Marking of Orthopaedic Implant Components
F1264 Specification and Test Methods for Intramedullary Fixation Devices
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 cutting head, n—the portion of the reamer, which consists of flutes, or edges, which cutcuts the bone.
3.1.2 reamer diameter, n—the diameter of the circumscribed circle of the cutting head’s cross-section (shown in Fig. 1).
3.1.3 reamer shaft diameter, n—the diameter of the circumscribed circle of the long portion of the reamer, which connects the
cutting portion of the reamer to the drill.
4. Classification
4.1 In general, intramedullary reamers consist of two types:
4.1.1 One-piece reamer—Reamer—A design where the reamer shaft and cutting head are permanently attached to each other.
4.1.2 Modular Reamer—A design where the reamer shaft and cutting head are two separate components, fixed to each other
temporarily at the time of use via a geometric connection, for example, dovetail joint.
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibliltiy of Subcommittee
F04.21 on Osteosynthesis.
Current edition approved Feb. 1, 2018Feb. 1, 2020. Published April 2018April 2020. Originally approved in 1995. Last previous edition approved in 20132018 as
F1611 – 00(2013).(2018). DOI: 10.1520/F1611-00R18.10.1520/F1611-20.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
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F1611 − 20
FIG. 1 Reamer Cutting Head
5. Dimensions and Tolerances
5.1 The reamer diameter shall be measured at the largest portion of the cutting head’s cross section and reported to the nearest
0.2 mm. The reamer diameter shall be measured using a micrometer or an appropriate ring gage.gauge. When using a micrometer
to measure reamers with an odd number of flutes, a V-anvil micrometer (with the appropriate angle, based on the number of flutes)
willshall be used to accurately determine the reamer diameter.
5.2 The tolerance of a reamer diameter shall be no more than 60.075 mm.
6. Material Requirements
6.1 The reamer’s shaft and cutting head Reamers shall be fabricated from materials with suitable strength, hardness, and
corrosion resistance.a material intended for surgical applications. In addition, the materials shall be biocompatible for the intended
application. Materials should be chosen based on the design requirements of the particular device. ASTM Committee F04 on
Medical and Surgical Materials and Devices maintains a num
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