ASTM F86-21 PDF

Full title and description

ASTM F86-21 — Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants. This practice describes surface characteristics, recommended surface-preparation methods (for example cleaning, passivation and electropolishing), and marking approaches intended to improve corrosion resistance and preserve implant surface integrity and traceability.

Abstract

ASTM F86-21 provides guidance on the acceptable surface conditions and preparation techniques for metallic surgical implants and on methods for marking implants so that markings and surface treatments do not compromise corrosion resistance or biocompatibility. The practice highlights surface-preparation options, inspection points, and where implant-specific specifications should take precedence. It is intended as a practical reference for manufacturers, suppliers and regulatory/quality personnel involved in implant production and handling.

General information

• Status: Active (current practice)
• Publication date: January 6, 2021
• Publisher: ASTM International
• ICS / categories: Implants for surgery; medical and surgical materials and devices (ICS code generally associated with implants for surgery: 11.040.40)
• Edition / version: F86-21 (2021 edition)
• Number of pages: 5 pages (typical published length for this practice)

Scope

This practice provides descriptions of surface characteristics, surface-preparation techniques, and marking recommendations applicable to metallic surgical implants with the primary objective of improving corrosion resistance of implant surfaces and any surface markings. It does not prescribe marking nomenclature, neutralization of endotoxin, or replace implant-specific specifications; where an implant specification exists, that specification takes precedence. Values are provided in SI or inch-pound units (each system to be used independently).

Key topics and requirements

• Definitions of common surface conditions and finishes relevant to implants.
• Recommended surface-preparation methods (cleaning, degreasing, passivation, electropolishing) to minimize corrosion risk.
• Guidance on marking implants so markings remain legible while avoiding damage to corrosion-resistant layers.
• Inspection and final-check considerations for surface quality and marking integrity.
• Priority of implant-specific specifications over general practice where conflicts arise.
• Notes on units (SI and inch-pound) and responsibility for safety/environmental practices during implementation.

Typical use and users

Used by medical device and implant manufacturers, implant component suppliers, quality and regulatory affairs personnel, sterilization and finishing service providers, design engineers, and contract manufacturers to establish or verify processes for finishing and marking metallic implants. Also used by auditors and regulatory reviewers as a reference practice for surface and marking expectations.

Related standards

Commonly referenced alongside other implant and surgical-device standards, for example ASTM F983 (permanent marking of orthopedic implant components), ASTM F565 (care and handling of orthopedic implants and instruments), ASTM specifications for implant alloys and material standards (for example titanium and cobalt‑chromium implant material specifications), and relevant ISO standards on surgical implant materials and surgical instruments (e.g., ISO standards addressing metallic implant materials and surgical instrument metallurgy). Users should consult implant-specific specifications and recognized regulatory consensus lists for applicable cross-references.

Keywords

metallic surgical implants; surface preparation; passivation; electropolishing; cleaning; implant marking; corrosion resistance; surface finish; inspection; ASTM F86-21

FAQ

Q: What is this standard?

A: ASTM F86-21 is a practice that describes acceptable surface characteristics, surface-preparation methods, and marking recommendations for metallic surgical implants, with the goal of maintaining corrosion resistance and implant surface integrity.

Q: What does it cover?

A: It covers descriptions of surface conditions, recommended cleaning and finishing techniques (including passivation and electropolishing), considerations for marking implants so markings do not compromise corrosion resistance, inspection points, and the relationship between this practice and implant-specific specifications.

Q: Who typically uses it?

A: Implant manufacturers, component suppliers, finishing and passivation service providers, quality and regulatory staff, design engineers, contract manufacturers, and auditors use this practice to guide surface finishing and marking decisions for metallic implants.

Q: Is it current or superseded?

A: The F86-21 edition (published January 6, 2021) is the current practice edition. Users should verify if a newer revision has been issued by ASTM or if regulatory recognition lists have been updated since publication.

Q: Is it part of a series?

A: It is one practice within the body of ASTM standards relating to surgical implants and devices (developed under ASTM committees covering medical and surgical materials and devices) and is commonly used alongside other ASTM and ISO standards addressing implant materials, marking, handling, and performance.

Q: What are the key keywords?

A: Surface preparation, passivation, electropolishing, cleaning, implant marking, corrosion resistance, metallic surgical implants, surface finish.