ASTM F983-86(2018)

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

• Status: Published
• Publication Date: 31-Jan-2018
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.21 - Osteosynthesis

Relations

• Replaces: ASTM F983-86(2013) - Standard Practice for Permanent Marking of Orthopaedic Implant Components
• Effective Date: 01-Feb-2018
• Refers: ASTM F86-12a - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 01-Dec-2012
• Refers: ASTM F86-12 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 15-May-2012
• Refers: ASTM F86-04(2009) - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 01-Dec-2009
• Refers: ASTM F86-04 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 01-Oct-2004
• Refers: ASTM F86-01 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 10-Jan-2001
• Refers: ASTM F86-00 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 10-Jan-2001
• Referred By: ASTM F3437-23 - Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation
• Effective Date: 01-Feb-2018
• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 01-Feb-2018
• Referred By: ASTM F86-21 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 01-Feb-2018
• Referred By: ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
• Effective Date: 01-Feb-2018
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 01-Feb-2018
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 01-Feb-2018
• Referred By: ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
• Effective Date: 01-Feb-2018
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
• Effective Date: 01-Feb-2018

Overview

ASTM F983-86(2018): Standard Practice for Permanent Marking of Orthopaedic Implant Components provides essential guidelines for the permanent identification marking of orthopedic implant components. Issued by ASTM International, this standard applies to both metallic and nonmetallic implants and recommends practical information that should be included in the markings to ensure traceability, patient safety, and quality control throughout the implant’s lifecycle. These recommendations assist manufacturers, healthcare providers, and regulatory bodies in identifying and managing orthopaedic implants before, during, and after surgery.

Key Topics

• Marking Requirements
  The standard defines both the recommended and minimum content for permanent marking on implants, depending on the size and characteristics of each implant component.

  • Recommended standard information:
    • Manufacturer’s name or identifier
    • Material from which the component is made
    • Implant catalog or model number
    • Serial number or lot number
  • For small implants:
    • At minimum, symbols or letters identifying the manufacturer and material

• Marking Methods

  • For metallic implants, markings should follow the procedures specified in ASTM F86.
  • For nonmetallic implants, suitable alternative marking methods should be used, provided they:
    • Do not compromise implant function
    • Ensure legibility for the device’s intended lifespan

• Optional Additional Information

  • Manufacturers may also include details such as implant size or whether the component is intended for left or right limb reconstruction.

• Usability Considerations

  • Marking should not adversely affect implant performance or patient safety.
  • In cases where marking is impractical (e.g., extremely small components), exceptions are acknowledged.

Applications

Implementation of ASTM F983-86(2018) is essential across several stages in the orthopaedic implant supply chain:

• Manufacturers

  • Ensure traceability of each component through standardized permanent markings
  • Facilitate post-market surveillance and product recalls
  • Promote international market acceptance through compliance with globally recognized standards

• Healthcare Providers

  • Aid in the identification of implants during surgical procedures and postoperative management
  • Provide reliable information for patient records and follow-up care
  • Enable accurate tracking of implants in case of adverse events or required removals

• Regulatory Bodies

  • Assess compliance with marking regulations and ensure public safety
  • Standardize practices for medical device identification across regional and international markets

Related Standards

• ASTM F86 - Practice for Surface Preparation and Marking of Metallic Surgical Implants: Provides specific methods for marking metallic components, referenced by ASTM F983.
• ISO 13485 - Quality management systems for medical devices: Addresses requirements for consistent design, production, and traceability, complementing permanent marking requirements.
• ISO 10993 - Biological evaluation of medical devices: Ensures that marking processes do not compromise biocompatibility.

Practical Value

Complying with ASTM F983-86(2018) offers several advantages:

• Enhances implant traceability and accountability
• Facilitates clinical research into implant performance and utilization trends
• Reduces risks associated with misidentification
• Supports efficient implant recalls and corrective actions when necessary

By following this standard, organizations ensure that orthopaedic implant components are unmistakably identified, promoting patient safety and supporting effective medical device management in healthcare settings worldwide.

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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