ASTM F86-21

Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

SIGNIFICANCE AND USE
3.1 The objective of surface treatments as documented in this practice is to improve the corrosion resistance of metallic surgical implants including, but not limited to, those manufactured from iron, cobalt, nickel, titanium, and tantalum base materials.  
3.2 Iron particles, ceramic media, and other foreign particles may become smeared over or embedded into the surface of implants during processing operations such as forming, machining, tumbling, media blasting, marking, and so forth. These particles should be removed to minimize localized corrosion and superficial blemishes.  
3.3 The various chemical and electrochemical surface treatments specified by this practice are used to remove objectionable surface contaminants and to restore maximum corrosion resistance to, or promote the creation of, an inert or passive surface, such as a metal oxide film, as is applicable to the specific material. Some of these treatments are referred to as passivation treatments. The preferred surface treatment for a given application varies depending on the implant material and the nature of the surface contaminants.  
3.4 Depending on the implant, its material, and the type of marking method and procedure, the marking may be applied before or after a chemical or electrochemical surface treatment. When marking is performed after the surface treatment, the localized implant surface shall be evaluated to determine if there is a need for additional surface treatment.
Note 1: The need for additional surface treatment is likely for stainless steel with all marking methods, and for nonferrous alloys when the marking method involves direct or second-hand contact with iron-based or other material that would be considered an objectionable surface contaminant.  
3.5 The selection of procedures to be applied to the implants, and additional requirements which are not covered by this practice, may be included in the implant production specification.
SCOPE
1.1 This practice provides descriptions of surface characteristics, surface preparation, and marking for metallic surgical implants, with the purpose of improving the corrosion resistance of the implant surfaces and markings.  
1.2 Marking nomenclature and neutralization of endotoxin are not specified in this practice (see X1.4).  
1.3 Surface requirements and marking methods included in the implant specification shall take precedence over requirements listed in this practice, where appropriate.  
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
1.5 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.  
1.6 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-May-2021
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

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: F86 − 21
Standard Practice for
Surface Preparation and Marking of Metallic Surgical
1
Implants
This standard is issued under the fixed designation F86; the number immediately following the designation indicates the year of original
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* vation of Stainless Steel Parts, Equipment, and Systems
A967/A967M Specification for Chemical Passivation Treat-
1.1 This practice provides descriptions of surface
ments for Stainless Steel Parts
characteristics, surface preparation, and marking for metallic
B600 Guide for Descaling and Cleaning Titanium and Tita-
surgical implants, with the purpose of improving the corrosion
nium Alloy Surfaces
resistance of the implant surfaces and markings.
B912 Specification for Passivation of Stainless Steels Using
1.2 Marking nomenclature and neutralization of endotoxin
Electropolishing
are not specified in this practice (see X1.4).
E2148 GuideforUsingDocumentsRelatedtoMetalworking
1.3 Surface requirements and marking methods included in or Metal Removal Fluid Health and Safety
E2275 Practice for Evaluating Water-Miscible Metalwork-
the implant specification shall take precedence over require-
ments listed in this practice, where appropriate. ing Fluid Bioresistance and Antimicrobial Pesticide Per-
formance
1.4 The values stated in either SI units or inch-pound units
E2657 Practice for Determination of Endotoxin Concentra-
are to be regarded separately as standard. The values stated in
tions in Water-Miscible Metalworking Fluids
each system may not be exact equivalents; therefore, each
F748 PracticeforSelectingGenericBiologicalTestMethods
system shall be used independently of the other. Combining
for Materials and Devices
values from the two systems may result in nonconformance
F983 Practice for Permanent Marking of Orthopaedic Im-
with the standard.
plant Components
1.5 This standard does not purport to address all of the 3
2.2 ISO Standard:
safety concerns, if any, associated with its use. It is the
ISO 10993-11:2017 Biological Evaluation of Medical
responsibility of the user of this standard to establish appro-
Devices—Part 11: Tests for Systemic Toxicity, Annex G
priate safety, health, and environmental practices and deter-
4
2.3 USP Standard:
mine the applicability of regulatory limitations prior to use.
USP General Chapter <161> Medical Devices—Bacterial
1.6 This international standard was developed in accor-
Endotoxin and Pyrogen Tests (2019)
dance with internationally recognized principles on standard-
5
2.4 FDA Document:
ization established in the Decision on Principles for the
FDA Guidance for Industry: Pyrogens and Endotoxins
Development of International Standards, Guides and Recom-
Testing: Questions and Answers, 2012 (updated in 2019)
mendations issued by the World Trade Organization Technical
6
2.5 AAMI Standard:
Barriers to Trade (TBT) Committee.
AAMIST72:2019 Bacterialendotoxins—Testmethods,rou-
tine monitoring, and alternatives to batch testing
2. Referenced Documents
2
3. Significance and Use
2.1 ASTM Standards:
A380/A380M Practice for Cleaning, Descaling, and Passi-
3.1 The objective of surface treatments as documented in
this practice is to improve the corrosion resistance of metallic
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
3
Surgical Materials and Devices and is the direct responsibility of Subcommittee Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F04.12 on Metallurgical Materials. 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Current edition approved June 1, 2021. Published June 2021. Originally Available from U.S. Pharmacopeial Convention (USP), 12601 Twinbrook
approved in 1984. Last previous edition approved in 2013 as F86 – 13. DOI: Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
5
10.1520/F0086-21. Available from U.S. Food and Drug Administration (FDA), 10903 New
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Hampshire Ave., Silver Spring, MD 20993, http://www.fda.gov.
6
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Available from Association for the Advancement of Medical Instrumentation
Standards volume information, refer to the standard’s Document Summary page on (AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633, http://
the ASTM website. www.aami.org.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F86 − 13 F86 − 21
Standard Practice for
Surface Preparation and Marking of Metallic Surgical
1
Implants
This standard is issued under the fixed designation F86; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope*
1.1 This practice provides descriptions of surface characteristics, surface preparation, and marking for metallic surgical implants,
with the purpose of improving the corrosion resistance of the implant surfaces and markings.
1.2 Marking nomenclature and neutralization of endotoxin are not specified in this practice (see X1.4).
1.3 This practice provides a description of surface characteristics, methods of surface preparation, and methods of marking for
metallic surgical implants. Marking nomenclature and neutralization of endotoxin are not specified in this practice (see X1.3).
Surface requirements and marking methods included in the implant specification shall take precedence over requirements listed
in this practice, where appropriate.
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values given in
parentheses are mathematical conversions to SI units that are provided for information only and are not considered stated in each
system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the
two systems may result in nonconformance with the standard.
1.5 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.6 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.
2. Referenced Documents
2
2.1 ASTM Standards:
A380A380/A380M Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems
A967A967/A967M Specification for Chemical Passivation Treatments for Stainless Steel Parts
B600 Guide for Descaling and Cleaning Titanium and Titanium Alloy Surfaces
B912 Specification for Passivation of Stainless Steels Using Electropolishing
E2148 Guide for Using Documents Related to Metalworking or Metal Removal Fluid Health and Safety
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.12
on Metallurgical Materials.
Current edition approved June 1, 2013June 1, 2021. Published July 2013June 2021. Originally approved in 1984. Last previous edition approved in 20122013 as
F86 – 12a.F86 – 13. DOI: 10.1520/F0086-13.10.1520/F0086-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F86 − 21
E2275 Practice for Evaluating Water-Miscible Metalworking Fluid Bioresistance and Antimicrobial Pesticide Performance
E2657 Practice for Determination of Endotoxin Concentrations in Water-Miscible Metalworking Fluids
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F983 Practice for Permanent Marking of Orthopaedic Implant Components
3
2.2 ISO Standard:
ISO 10993-11:2017 Biological Evaluation of Medical Devices—Part 11: Tests for Systemic Toxicity, Annex G
4
2.3 USP Standard:
USP General Chapter <161> Medical Devices—Bacterial Endotoxin and Pyrogen Tests (2019)
5
2.4 FDA Document:
FDA Guidance for Industry: Pyrogens and Endotoxins Testing: Questions and Answers, 2012 (updated in 2019)
6
2.5 AAMI Standard:
AAMI ST72:2019 Bacterial endotoxins—Test methods, routine monitoring, and alternatives t
...