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 outlines the recommended procedures for permanently marking both metallic and nonmetallic orthopaedic implant components. Developed by ASTM International, this standard ensures orthopaedic implants are traceable and easily identifiable throughout their lifecycle, supporting patient safety, regulatory compliance, and effective device management. The practice also details the information that should be included in the marking, depending on the size and shape of the implant.

Key Topics

• Permanent Identification: The standard promotes the permanent marking of implant components to enable positive identification. This is crucial both before surgical placement and when implants are removed, facilitating patient care and research into implant performance.
• Recommended Information:
  • For implants where space permits, the marking should include:
    • Manufacturer identification
    • Material type (preferably using generic or ASTM standard names)
    • Catalog or model number
    • Serial or lot number
  • For smaller implants, at minimum, symbols or letters identifying the manufacturer and material are recommended. These should be explained in product literature.
• Marking Methods:
  • For metallic implants, marking should follow methods in ASTM F86.
  • For nonmetallic implants, manufacturers should devise suitable marking methods.
  • Any marking approach must not compromise the performance of the implant or its legibility over its service life.
• Optional Information: Manufacturers may include additional details such as implant size or whether the device is designed for right or left limb application.
• Exception Cases: The standard recognizes that not all orthopaedic implants can be practically marked, such as very small components like wire or tiny screws.

Applications

ASTM F983-86(2018) is essential for:

• Orthopaedic Implant Manufacturers: Ensures consistency in the marking of a wide variety of implant types, helping to meet regulatory requirements and quality assurance goals.
• Healthcare Providers and Surgeons: Facilitates traceability of implants, supporting patient safety, recall management, and post-implantation research.
• Device Tracking and Compliance: Enables seamless tracking and traceability through the supply chain and patient care continuum, supporting best practices in medical device management.
• Device Retrieval and Analysis: Aids in the identification of retrieved implants, contributing to research on implant longevity and performance.
• Preparation for Surgery: Assists medical staff in maintaining clear identification when implants are removed from packaging and sterilized before surgery.

Related Standards

For comprehensive marking and preparation guidance, the following standards are directly referenced and relevant:

• ASTM F86: Practice for Surface Preparation and Marking of Metallic Surgical Implants, which provides detailed methods and locations for marking metallic components.
• WTO TBT Principles: The standard aligns with international principles for standardization as established by the World Trade Organization’s Technical Barriers to Trade Committee.

Practical Value

Adhering to ASTM F983-86(2018) helps:

• Promote Global Market Access by following internationally recognized practices.
• Minimize Errors and Enhance Safety through clear, permanent identification of implant components.
• Support Regulatory and Quality Compliance with clearly documented practices for identification, tracking, and recall of orthopaedic implants.

By implementing the recommendations in ASTM F983, manufacturers and healthcare providers reinforce the integrity and traceability of orthopaedic implants, leading to improved healthcare outcomes and device management.

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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