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ASTM F1611-00(2013)

(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

Status
Historical
Publication Date
30-Sep-2013
ICS
11.040.30 - Surgical instruments and materials
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.21 - Osteosynthesis
Current Stage
Ref Project

Relations

Replaces
ASTM F1611-00(2009) - Standard Specification for Intramedullary Reamers
Effective Date
01-Oct-2013
Replaced By
ASTM F1611-00(2018) - Standard Specification for Intramedullary Reamers
Effective Date
01-Feb-2018
Referred By
ASTM F1264-16e1 - Standard Specification and Test Methods for Intramedullary Fixation Devices
Effective Date
01-Oct-2013

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ASTM F1611-00(2013) - Standard Specification for Intramedullary ReamersASTM F1611-00(2013) - Standard Specification for Intramedullary Reamers
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ASTM F1611-00(2013) - Standard Specification for Intramedullary Reamers
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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 2013)
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 Oct. 1, 2013. Published October 2013. Originally
approved in 1995. Last previous edition approved in 2009 as F1611 – 00(2009).
7. Finish and Marking
DOI: 10.1520/F1611-00R13.
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 (2013)
7.3.4 Reamer shaft diameter, if the shaft diameter is not
uniform along its length, for example, a tapered shaft, then the
maximum and minimum diameters sh
...

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