ASTM F983-86(2018)
(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 practice 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 does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
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.
General Information
Relations
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: F983 − 86 (Reapproved 2018)
Standard Practice for
Permanent Marking of Orthopaedic Implant Components
ThisstandardisissuedunderthefixeddesignationF983;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3. Methods of Marking
3.1 For metallic implants, the procedures described in
1.1 It is common practice for orthopaedic implant manufac-
Practice F86 should be followed.
turers to apply permanent identification to implant compo-
nents. In this regard, Practice F86 describes recommended
3.2 For nonmetallic implants, other methods should be
locations and methods of marking for metallic implants.
devised and utilized.
1.2 The purpose of this practice is to (1) recommend that
3.3 In any case, however, the marking method should (a)
orthopaedic implants be permanently marked, and (2) recom-
not compromise implant performance significantly, and (b)
mend practical amounts of information that should be included
provide legibility over the anticipated service life of the
in the marking. It is recognized, however, that marking is not
implant.
practical in some cases (see 4.1).
4. Information Included in Permanent Marking
1.3 This standard does not purport to address all of the
4.1 Orthopaedic implants vary widely in size (for example,
safety concerns, if any, associated with its use. It is the
from wire to total joint prostheses), and the amount of
responsibility of the user of this standard to establish appro-
information that practically can be included in marking varies
priate safety, health, and environmental practices and deter-
accordingly.Someimplants,suchasthreadedpinsandcerclage
mine the applicability of regulatory limitations prior to use.
wire and very small bone screws, do not provide any surfaces
1.4 This international standard was developed in accor-
which can be marked practically.
dance with internationally recognized principles on standard-
4.2 Standard Information—Where implant size and shape
ization established in the Decision on Principles for the
allow, it is recommended that the following information be
Development of International Standards, Guides and Recom-
included in permanent marking:
mendations issued by the World Trade Organization Technical
4.2.1 Manufacturer:
Barriers to Trade (TBT) Committee.
4.2.2 Material—The use of generic names or ASTM
2. Referenced Documents standards, or both, in addition to or in place of trade names is
2 recommended, where applicable.
2.1 ASTM Standards:
4.2.3 Implant component catalog number or model number.
F86 Practice for Surface Preparation and Marking of Metal-
4.2.4 Implant component serial number or lot number.
lic Surgical Implants
4.3 Minimum Information—Where implant size and shape
allow, it is recommended that the manufacturer mark smaller
1 implants with symbols or letters selected by the manufacturer
This practice is under the jurisdicti
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