ASTM F1611-20
(Specification)Standard Specification for Intramedullary Reamers
Standard Specification for Intramedullary Reamers
ABSTRACT
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. Intramedullary reamers are commonly used to prepare the medullary canal for the insertion of intramedullary fixation devices (IMFD). As such, the relationship between the intramedullary reamer diameter and the IMFD's diameter are considered. In general, intramedullary reamers consist of two types: one-piece reamer—a design where the reamer shaft and cutting head are permanently attached to each other; and 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.
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 (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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Standards Content (Sample)
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.
Designation: F1611 −20
Standard Specification for
1
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 F983 Practice for Permanent Marking of Orthopaedic Im-
plant Components
1.1 This specification provides requirements for material,
F1264 Specification and Test Methods for Intramedullary
dimensions and tolerances, finish and marking, and care and
Fixation Devices
handling for reamers intended to cut a cylindrical path along
the medullary canal of diaphyseal bone.
3. Terminology
1.2 Intramedullary reamers are commonly used to prepare
3.1 Definitions of Terms Specific to This Standard:
the medullary canal for the insertion of intramedullary fixation
3.1.1 cutting head, n—the portion of the reamer, which
devices (IMFDs). As such, the relationship between the in-
consists of flutes, or edges, which cuts the bone.
tramedullary reamer diameter and the IMFD’s diameter are
3.1.2 reamer diameter, n—thediameterofthecircumscribed
considered.
circle of the cutting head’s cross-section (shown in Fig. 1).
1.3 Units—The values stated in SI units are to be regarded
3.1.3 reamer shaft diameter, n—the diameter of the circum-
as standard. No other units of measurement are included in this
scribed circle of the long portion of the reamer, which connects
standard.
the cutting portion of the reamer to the drill.
1.4 This international standard was developed in accor-
dance with internationally recognized principles on standard-
4. Classification
ization established in the Decision on Principles for the
4.1 In general, intramedullary reamers consist of two types:
Development of International Standards, Guides and Recom-
4.1.1 One-piece Reamer—A design where the reamer shaft
mendations issued by the World Trade Organization Technical
and cutting head are permanently attached to each other.
Barriers to Trade (TBT) Committee.
4.1.2 Modular Reamer—A design where the reamer shaft
and cutting head are two separate components, fixed to each
2. Referenced Documents
othertemporarilyatthetimeofuseviaageometricconnection,
2
2.1 ASTM Standards:
for example, dovetail joint.
A564/A564M Specification for Hot-Rolled and Cold-
Finished Age-Hardening Stainless Steel Bars and Shapes
5. Dimensions and Tolerances
A693 Specification for Precipitation-Hardening Stainless
5.1 The reamer diameter shall be measured at the largest
and Heat-Resisting Steel Plate, Sheet, and Strip
portion of the cutting head’s cross section and reported to the
A705/A705M Specification for Age-Hardening Stainless
nearest 0.2 mm. The reamer diameter shall be measured using
Steel Forgings
a micrometer or an appropriate ring gauge. When using a
F86 Practice for Surface Preparation and Marking of Metal-
micrometer to measure reamers with an odd number of flutes,
lic Surgical Implants
a V-anvil micrometer (with the appropriate angle, based on the
F565 Practice for Care and Handling of Orthopedic Implants
number of flutes) shall be used to accurately determine the
and Instruments
reamer diameter.
F899 Specification for Wrought Stainless Steels for Surgical
Instruments 5.2 The tolerance of a reamer diameter shall be no more
than 60.075 mm.
1
This specification is under the jurisdiction of ASTM Committee F04 on
6. Material Requirements
Medical and Surgical Materials and Devices and is the direct responsibliltiy of
Subcommittee F04.21 on Osteosynthesis.
6.1 Reamers shall be fabricated from a material intended for
Current edition approved Feb. 1, 2020. Published April 2020. Originally
surgical applications. In addition, the materials shall be bio-
approved in 1995. Last previous edition approved in 2018 as F1611 – 00(2018).
DOI: 10.1520/F1611-20.
compatible for the intended application. Materials should be
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
chosen based on the design requirements of the particular
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
device. ASTM Committee F04 on Medical and Surgical
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. Materials and Devices maintains a number of specifications for
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F1611 − 20
7.3 When space permits, the following information shou
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1611 − 00 (Reapproved 2018) F1611 − 20
Standard Specification for
1
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
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.
1
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.
2
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
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 i
...
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