ASTM F1611-00(2009)
(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 (IMFD). As such, the relationship between the intramedullary reamer diameter and the IMFD's diameter are considered.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
General Information
Relations
Buy Standard
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F1611 −00(Reapproved 2009)
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 3. Terminology
3.1 Definitions of Terms Specific to This Standard:
1.1 This specification provides requirements for material,
3.1.1 cutting head, n—the portion of the reamer, which
dimensions and tolerances, finish and marking, and care and
consists of flutes, or edges, which cut the bone.
handling for reamers intended to cut a cylindrical path along
the medullary canal of diaphyseal bone.
3.1.2 reamer diameter, n—thediameterofthecircumscribed
circle of the cutting head’s cross-section (shown in Fig. 1).
1.2 Intramedullary reamers are commonly used to prepare
the medullary canal for the insertion of intramedullary fixation 3.1.3 reamer shaft diameter, n—the diameter of the circum-
scribed circle of the long portion of the reamer, which connects
devices (IMFD). As such, the relationship between the in-
tramedullary reamer diameter and the IMFD’s diameter are the cutting portion of the reamer to the drill.
considered.
4. Classification
1.3 The values stated in SI units are to be regarded as
4.1 In general, intramedullary reamers consist of two types:
standard. No other units of measurement are included in this
4.1.1 One-piece reamer—A design where the reamer shaft
standard.
and cutting head are permanently attached to each other.
4.1.2 Modular Reamer—A design where the reamer shaft
2. Referenced Documents
and cutting head are two separate components, fixed to each
2.1 ASTM Standards:
othertemporarilyatthetimeofuseviaageometricconnection,
A564/A564M Specification for Hot-Rolled and Cold-
for example, dovetail joint.
Finished Age-Hardening Stainless Steel Bars and Shapes
A693 Specification for Precipitation-Hardening Stainless
5. Dimensions and Tolerances
and Heat-Resisting Steel Plate, Sheet, and Strip
5.1 The reamer diameter shall be measured at the largest
A705/A705M Specification for Age-Hardening Stainless
portion of the cutting head’s cross section and reported to the
Steel Forgings
nearest 0.2 mm. The reamer diameter shall be measured using
F86 Practice for Surface Preparation and Marking of Metal-
a micrometer or an appropriate ring gage. When using a
lic Surgical Implants
micrometer to measure reamers with an odd number of flutes,
F565 Practice for Care and Handling of Orthopedic Implants
a V-anvil micrometer (with the appropriate angle, based on the
and Instruments
number of flutes) will be used to accurately determine the
F899 Specification for Wrought Stainless Steels for Surgical
reamer diameter.
Instruments
5.2 The tolerance of a reamer diameter shall be no more
F983 Practice for Permanent Marking of Orthopaedic Im-
than 60.075 mm.
plant Components
F1264 Specification and Test Methods for Intramedullary
6. Material Requirements
Fixation Devices
6.1 The reamer’s shaft and cutting head shall be fabricated
from materials with suitable strength, hardness, and corrosion
1 resistance. The materials described in Specifications A564/
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibliltiy of A564M, A693, A705/A705M, and F899 have been found to be
Subcommittee F04.21 on Osteosynthesis.
suitable for this use.
Current edition approved April 1, 2009. Published April 2009. Originally
approved in 1995. Last previous edition approved in 2004 as F1611 – 00(2004).
7. Finish and Marking
DOI: 10.1520/F1611-00R09.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
7.1 The shaft and cutting head shall be free from burrs,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
nicks, dents, and scratches when examined in accordance with
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. Practice F86.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1611−00 (2009)
7.3.4 Reamer shaft diameter, if the shaft diameter is not
uniform along its length, for example, a tapered shaft, then
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:F1611–95
Standard Terminology for Sizing of IMFDs for Application to
Reamed Diaphyseal Bone and Associated
InstrumentationDesignation: F 1611 – 00 (Reapproved 2009)
Standard Specification for
Intramedullary Reamers
This standard is issued under the fixed designation F 1611; 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
1.1This terminology defines basic terms and considerations related to diameter measurement and designation specifications for
reamers, reamed holes, and intramedullary fixation devices (IMFDs) for application in the medullary canal prepared by reaming.
1.2The values stated in SI units are to be regarded as the standard.
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). As such, the relationship between the intramedullary reamer diameter and the IMFD’s diameter are considered.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
2. Referenced Documents
2.1 ASTM Standards:
F86Practice for Surface Preparation and Marking of Metallic Surgical Implants
F138Specification for Stainless Steel Bar and Wire for Surgical Implants (Special Quality)
2 2
F139Specification for Stainless Steel Sheet and Strip for Surgical Implants (Special Quality)
A 564/A 564M Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes
A 693 Specification for Precipitation-Hardening Stainless and Heat-Resisting Steel Plate, Sheet, and Strip
A 705/A 705M Specification for Age-Hardening Stainless Steel Forgings
F339Specification for Cloverleaf Intramedullary Pins
F899Specification for Stainless Steel Billet, Bar, and Wire for Surgical Instruments 86 Practice for Surface Preparation and
Marking of Metallic Surgical Implants
F 565 Practice for Care and Handling of Orthopedic Implants and Instruments
F 899 Specification for Wrought Stainless Steels for Surgical Instruments
F 983 Practice for Permanent Marking of Orthopaedic Implant Components
F 1264 Specification and Test Methods for Intramedullary Fixation Devices
3. Terminology
3.1Definitions:
IMFD diameter—the diameter of the circumscribed circle of the IMFD’s uniform cross section, intended to fit in the reamed
portion of the diaphyseal bone (see Specification F339, Dimension A).
IMFDforreamedapplication—anyIMFDthatisrecommendedforuseinthemedullarycanalofadiaphysealbonethathasbeen
prepared by reaming.
IMFD reamer diameter—the diameter of the circumscribed circle of the cutting portion of the reamer’s cross section.
This terminologyspecification is under the jurisdiction of ASTM Committee F-4 F04 on Medical and Surgical Materials and Devices and is the direct responsibililtiy
of Subcommittee F04.21 on Osteosynthesis.
Current edition approved Aug. 15, 1995. Published September 1995.
Current edition approved April 1, 2009. Published April 2009. Originally approved in 1995. Last previous edition approved in 2004 as F 1611 – 00(2004).
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 13.01.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.
F 1611 – 00 (2009)
reamed diameter—the diameter of the hole cut by the reamer.
3.2
3.1 Definitions of Terms Specific to This Standard: tolerance—the dimensional standard met by the reamer at the time of
manufacture.
3.1.1 cutting head, n—the portion of the reamer, which consists of flutes, or edges, which cut 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
4.1Types of considerations covered by this terminology are as follows:
4.1.1Measurement of standard dimensions, and
4.1.2Meaning of designated sizes.
4.1 In general, intramedullary reamers consist of two types:
4.1.1 One-piece 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.
5. Ordering Information
5.1The diameter of the reamer should be designated by the diameter of the hole that it is intended to make, or the reamed
diameter as defined in . 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. 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)
will 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. Significance and Use
6.1This terminology is intended to provide a simple means of establishing useful, consistent, and reproducible information on
the function and application of reamers for IMFDs and the relationship of the reamer size designation to the size designation of
the IMFDs. The surgeon can better determine the proper instruments and the proper IMFD for each application by predicting the
size of the reamed hole without respect to reamer design and knowing the real meaning of the size designation
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.