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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.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42320000(Orthopedic surgical implants)