ASTM F983-86(2000)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F983–86 (Reapproved 2000)
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 3.3 In any case, however, the marking method should (a)
not compromise implant performance significantly, and (b)
1.1 It is common practice for orthopaedic implant manufac-
provide legibility over the anticipated service life of the
turers to apply permanent identification to implant compo-
implant.
nents. In this regard, Practice F 86 describes recommended
locations and methods of marking for metallic implants.
4. Information Included in Permanent Marking
1.2 The purpose of this practice is to ( 1) recommend that
4.1 Orthopaedic implants vary widely in size (for example,
orthopaedic implants be permanently marked, and (2) recom-
from wire to total joint prostheses), and the amount of
mend practical amounts of information that should be included
information that practically can be included in marking varies
in the marking. It is recognized, however, that marking is not
accordingly.Someimplants,suchasthreadedpinsandcerclage
practical in some cases (see 4.1).
wire and very small bone screws, do not provide any surfaces
1.3 This standard does not purport to address all of the
which can be marked practically.
safety concerns, if any, associated with its use. It is the
4.2 Standard Information—Where implant size and shape
responsibility of the user of this standard to establish appro-
allow, it is recommended that the following information be
priate safety and health practices and determine the applica-
included in permanent marking:
bility of regulatory limitations prior to use.
4.2.1 Manufacturer:
2. Referenced Documents 4.2.2 Material—The use of generic names or ASTM stan-
dards, or both, in addition to or in place of trade names is
2.1 ASTM Standards:
recommended, where applicable.
F 86 Practice for Surface Preparation and Marking of Me-
4.2.3 Implant component catalog number or model number.
tallic Surgical Implants
4.2.4 Implant component serial number or lot number.
3. Methods of Marking 4.3 Minimum Information—Where implant size and shape
allow, it is recommended that the manufacturer mark smaller
3.1 For metallic implants, the procedures described in
implants with symbols or letters selected by the manufacturer
Practice F 86 should be followed.
which identify (a) the manufacturer and ( b) the material from
3.2 For nonmetallic impla
...