ASTM F983-86(2005)
(Practice)Standard Practice for Permanent Marking of Orthopaedic Implant Components
Standard Practice for Permanent Marking of Orthopaedic Implant Components
ABSTRACT
This practice covers recommendations on permanent marking of metallic and nonmetallic orthopaedic implant components. The practical amounts of information that should be included in the marking are specified. Where implant size and shape allow, it is recommended that the following standard information be included in the permanent marking: (1) manufacturer, (2) material, (3) implant component catalog number or model number, and (4) implant component serial number or lot number. For smaller implants, it is recommended that the following minimum information be included in the permanent marking: symbols or letters selected by the manufacturer which identify (1) the manufacturer and (2) the material from which the component is made. The system of symbols or letters shall be described in the manufacturer's product literature. Optional information may be included in the permanent marking, such as implant size and whether an implant is intended for right limb or left limb reconstruction.
SCOPE
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 standard 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 may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety problems associated with its use. It is the responsibility of whoever uses this standard to consult and establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Standards Content (Sample)
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Designation:F983–86 (Reapproved 2005)
Standard Practice for
Permanent Marking of Orthopaedic Implant Components
This standard is issued under the fixed designation F 983; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2 For nonmetallic implants, other methods should be
devised and utilized.
1.1 It is common practice for orthopaedic implant manufac-
3.3 In any case, however, the marking method should (a)
turers to apply permanent identification to implant compo-
not compromise implant performance significantly, and (b)
nents. In this regard, Practice F86 describes recommended
provide legibility over the anticipated service life of the
locations and methods of marking for metallic implants.
implant.
1.2 The purpose of this practice is to (1) recommend that
orthopaedic implants be permanently marked, and (2) recom-
4. Information Included in Permanent Marking
mend practical amounts of information that should be included
4.1 Orthopaedic implants vary widely in size (for example,
in the marking. It is recognized, however, that marking is not
from wire to total joint prostheses), and the amount of
practical in some cases (see 4.1).
information that practically can be included in marking varies
1.3 This standard does not purport to address all of the
accordingly.Someimplants,suchasthreadedpinsandcerclage
safety concerns, if any, associated with its use. It is the
wire and very small bone screws, do not provide any surfaces
responsibility of the user of this standard to establish appro-
which can be marked practically.
priate safety and health practices and determine the applica-
4.2 Standard Information—Where implant size and shape
bility of regulatory limitations prior to use.
allow, it is recommended that the following information be
2. Referenced Documents included in permanent marking:
4.2.1 Manufacturer:
2.1 ASTM Standards:
4.2.2 Material—The use of generic names or ASTM stan-
F86 Practice for Surface Preparation and Marking of Me-
dards, or both, in addition to or in place of trade names is
tallic Surgical Implants
recommended, where applicable.
3. Methods of Marking 4.2.3 Implant component catalog number or model number.
4.2.4 Implant component serial number or lot number.
3.1 For metallic implants, the procedures described in
4.3 Minimum Information—Where implant size and shape
PracticeF86 should be followed.
allow, it is recommended that the manufacturer mark smaller
implants with symbols or letters selected by the manufacturer
This practice is under the jurisdiction ofASTM Committee F04 on Medical and
which identify (a) the manufacturer and (b) the material from
Surgical Materials and Device
...
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