ASTM F1089-18

Standard Test Method for Corrosion of Surgical Instruments

SIGNIFICANCE AND USE
3.1 This test method provides corrosion test methodologies and means of evaluation that serve as indicators of proper material selection and proper processing by the manufacturer.  
Note 1: It is recommended that instruments be chemically passivated according to one of the treatments in Specification A967, electropolished according to Specification B912, or both, prior to evaluating the corrosion resistance according to this test method. The likelihood of failure may be higher for non-passivated instruments.
SCOPE
1.1 This test method covers general test procedures and evaluation criteria for the corrosion resistance of new and reusable surgical instruments fabricated from stainless steel alloys, such as, but not limited to, those listed in Specification F899.  
1.2 Instruments containing stainless steel materials that are exclusive to the following shall use the boil test and the copper sulfate test: austenitic materials (Class 3), precipitation hardening materials (Class 5), and ferritic materials (Class 6) containing equal or greater than 16 % chromium.  
1.3 Instruments containing any of the following stainless steel materials shall use the boil test: martensitic materials (Class 4) and ferritic materials (Class 6) containing less than 16 % chromium.  
1.4 The copper sulfate test is used to detect the presence of free iron on the surface of materials.  
1.5 The copper sulfate test as described in 6.2 is not recommended for martensitic materials or for ferritic materials containing less than 16% chromium because these steels may give a positive indication irrespective of the presence or absence of anodic surface contaminants (see X1.5).  
1.6 The boil test is applicable to martensitic, austenitic, ferritic, and precipitation hardening materials to detect surface imperfections, free iron, or other anodic surface contaminants on stainless steel.  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.8 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.  
1.9 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: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.15 - Material Test Methods

Relations

• Replaces: ASTM F1089-10 - Standard Test Method for Corrosion of Surgical Instruments
• Effective Date: 01-Feb-2018
• Refers: ASTM F899-23 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Nov-2023
• Refers: ASTM E1402-13(2023) - Standard Guide for Sampling Design
• Effective Date: 01-Nov-2023
• Refers: ASTM F899-20 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Feb-2020
• Refers: ASTM F899-19 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 15-Sep-2019
• Refers: ASTM E1402-13(2018) - Standard Guide for Sampling Design
• Effective Date: 01-Nov-2018
• Refers: ASTM B912-02(2018) - Standard Specification for Passivation of Stainless Steels Using Electropolishing
• Effective Date: 01-Oct-2018
• Refers: ASTM F1744-96(2016) - Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
• Effective Date: 01-Oct-2016
• Refers: ASTM E1402-13 - Standard Guide for Sampling Design
• Effective Date: 01-Aug-2013
• Refers: ASTM B912-02(2013) - Standard Specification for Passivation of Stainless Steels Using Electropolishing
• Effective Date: 01-May-2013
• Refers: ASTM F899-12b - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Dec-2012
• Refers: ASTM F899-12a - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Nov-2012
• Refers: ASTM F899-12 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Jun-2012
• Refers: ASTM E122-09e1 - Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process
• Effective Date: 01-Aug-2011
• Refers: ASTM F899-11 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Mar-2011

Overview

ASTM F1089-18: Standard Test Method for Corrosion of Surgical Instruments is an internationally recognized standard developed by ASTM International. It provides standardized test procedures and evaluation criteria to assess the corrosion resistance of new and reusable surgical instruments fabricated from stainless steel alloys. This standard ensures that surgical instruments meet strict material and processing requirements, supporting patient safety and extending instrument life.

ASTM F1089-18 specifies two primary corrosion test methods - the boil test and the copper sulfate test - for detecting surface imperfections, free iron, and other contaminants in surgical instruments. These tests serve as indicators of material selection, proper processing by the manufacturer, and ongoing instrument quality during reuse.

Key Topics

• Test Methods: The standard includes the boil test and copper sulfate test for evaluating corrosion resistance of different stainless steel classes used in surgical instruments.
  • The boil test applies to martensitic, austenitic, ferritic, and precipitation-hardening stainless steels.
  • The copper sulfate test is used mainly for austenitic, ferritic (with at least 16% chromium), and precipitation-hardening steels to detect free iron on surfaces.
• Material and Processing Requirements: ASTM F1089-18 references material specifications, including passivation (A967), electropolishing (B912), and proper instrument preparation to minimize corrosion susceptibility.
• Evaluation Criteria: The standard outlines objective criteria for passing or failing corrosion tests, specifying locations and surface features where minor corrosion may be acceptable or not cause for rejection.
• Sampling and Retesting: Guidance is provided for sampling plans, retesting rejected lots, and appropriate actions for instruments that fail the corrosion tests.
• Safety and Compliance: Users are responsible for ensuring appropriate safety, health, and environmental practices when applying the standard.

Applications

ASTM F1089-18 plays a critical role across the medical device and surgical instrument industries:

• Manufacturing Quality Assurance: Instrument manufacturers use this standard to verify that new products have been fabricated and processed properly to resist corrosion.
• Regulatory Compliance: By following ASTM F1089-18, manufacturers and healthcare providers can demonstrate compliance with international regulations and quality requirements for medical devices.
• Instrument Reprocessing: Healthcare facilities use the test methods in periodic checks to monitor the ongoing corrosion resistance of reusable instruments, ensuring long-term safety and performance.
• Maintenance and Remediation: The standard assists users in identifying and remedying corrosion issues, including recommendations for passivation and retesting of instruments in active use.

Related Standards

ASTM F1089-18 references and complements several other key industry standards:

• ASTM F899: Specification for Wrought Stainless Steels for Surgical Instruments
• ASTM A967: Specification for Chemical Passivation Treatments for Stainless Steel Parts
• ASTM B912: Specification for Passivation of Stainless Steels Using Electropolishing
• ASTM A380: Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems
• ASTM D1193: Specification for Reagent Water
• ASTM E122/E1402: Practices and guides for sampling design and precision calculation
• ASTM F1744: Guide for Care and Handling of Stainless Steel Surgical Instruments

By following ASTM F1089-18 in conjunction with these related standards, manufacturers and users ensure rigorous, consistent, and effective processes for corrosion testing and prevention in surgical instruments, enhancing patient safety and compliance with international best practices.

Keywords: ASTM F1089-18, corrosion resistance, surgical instruments, stainless steel, boil test, copper sulfate test, material passivation, medical device quality, reusable instruments, international standards.

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: F1089 − 18
Standard Test Method for
Corrosion of Surgical Instruments
This standard is issued under the fixed designation F1089; 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* 1.9 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 This test method covers general test procedures and
ization established in the Decision on Principles for the
evaluation criteria for the corrosion resistance of new and
Development of International Standards, Guides and Recom-
reusable surgical instruments fabricated from stainless steel
mendations issued by the World Trade Organization Technical
alloys, such as, but not limited to, those listed in Specification
Barriers to Trade (TBT) Committee.
F899.
1.2 Instruments containing stainless steel materials that are
2. Referenced Documents
exclusive to the following shall use the boil test and the copper
2.1 ASTM Standards:
sulfate test: austenitic materials (Class 3), precipitation hard-
A380 Practice for Cleaning, Descaling, and Passivation of
ening materials (Class 5), and ferritic materials (Class 6)
Stainless Steel Parts, Equipment, and Systems
containing equal or greater than 16 % chromium.
A967 Specification for Chemical Passivation Treatments for
1.3 Instruments containing any of the following stainless
Stainless Steel Parts
steel materials shall use the boil test: martensitic materials
B912 Specification for Passivation of Stainless Steels Using
(Class 4) and ferritic materials (Class 6) containing less than
Electropolishing
16 % chromium.
D1193 Specification for Reagent Water
E122 Practice for Calculating Sample Size to Estimate,With
1.4 The copper sulfate test is used to detect the presence of
Specified Precision, the Average for a Characteristic of a
free iron on the surface of materials.
Lot or Process
1.5 The copper sulfate test as described in 6.2 is not
E1402 Guide for Sampling Design
recommended for martensitic materials or for ferritic materials
F899 Specification for Wrought Stainless Steels for Surgical
containing less than 16% chromium because these steels may
Instruments
give a positive indication irrespective of the presence or
F1744 Guide for Care and Handling of Stainless Steel
absence of anodic surface contaminants (see X1.5).
Surgical Instruments
1.6 The boil test is applicable to martensitic, austenitic,
2.2 Federal Specifications
ferritic, and precipitation hardening materials to detect surface
MIL-STD-753 Corrosion-Resistant Steel Parts: Sampling,
imperfections, free iron, or other anodic surface contaminants
Inspection and Testing for Surface Passivation
on stainless steel.
3. Significance and Use
1.7 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this 3.1 This test method provides corrosion test methodologies
and means of evaluation that serve as indicators of proper
standard.
material selection and proper processing by the manufacturer.
1.8 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
NOTE 1—It is recommended that instruments be chemically passivated
responsibility of the user of this standard to establish appro- according to one of the treatments in Specification A967, electropolished
according to Specification B912, or both, prior to evaluating the corrosion
priate safety, health, and environmental practices and deter-
resistance according to this test method. The likelihood of failure may be
mine the applicability of regulatory limitations prior to use.
higher for non-passivated instruments.
1 2
This test method is under the jurisdiction ofASTM Committee F04 on Medical For referenced ASTM standards, visit the ASTM website, www.astm.org, or
and Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
F04.15 on Material Test Methods. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Feb. 1, 2018. Published March 2018. Originally the ASTM website.
approved in 1987. Last previous edition approved in 2010 as F1089 – 10. DOI: Available from Superintendent of Documents, U.S. Government Printing
10.1520/F1089-18. Office, Washington, DC 20402.
*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
F1089 − 18
4. Reagents and Materials 6.2.2.3 Rinse the instrument(s) thoroughly with distilled or
reagent water and dry, with care taken to not disturb copper
4.1 Copper Sulfate—Copper sulfate pentahydrate
deposits if present.
(CuSO ·5H O).
4 2
4.2 Sulfuric Acid—Sulfuric acid AR (H SO ), sp gr 1.84.
2 4
7. Interpretation of Results
4.3 Distilled Water or Reagent Water conforming to Speci-
7.1 Boil Test:
fication D1193, Type IV.
7.1.1 Surfaces shall show no signs of corrosion (without
4.4 Isopropyl Alcohol or 95 % Ethyl Alcohol. magnification) with the following exceptions:
7.1.1.1 Rust (ferrous oxide) on serrations, teeth, locks,
4.5 Nonreactive Vessel, such as a glass or ceramic container.
ratchets, inserts, brazed junctions, soldered junctions, etched
5. Specimen Preparation areas, engravings, or laser marks shall not be cause for
rejection.
5.1 Wash the instrument(s) with mild soap using an appro-
7.2 Copper Sulfate Test:
priate nonmetallic bristle brush and warm (25 to 50°C) tap
water. 7.2.1 Surfaces shall show no signs of copper plating (with-
out magnification) with the following exceptions:
5.2 Rinse the instrument(s) thoroughly at room temperature
7.2.1.1 Copper plating on serrations, teeth, locks, ratchets,
in distilled water, reagent water, 95 % ethyl alcohol, or
brazed junctions, soldered junctions, etched areas, engravings,
isopropyl alcohol.
laser marks, or dulling of polished surfaces shall not be cause
5.3 Dry using a paper towel or soft cloth.
for rejection.
7.2.1.2 Copper plating at the periphery of the copper sulfate
5.4 Use plastic tongs and gloves during cleaning and han-
solution drops caused by concentration of the solution due to
dling.Avoid contact with steel or stainless steel tongs or other
evaporation shall not be cause for rejection.
metallic items that may damage or contaminate the surface
after cleaning.
NOTE2—SeeGuideF1744fordiscussiononthehighersusceptibilityof
serrations, teeth, locks, ratchets, inserts, etc. to corrosion.
6. Procedure
6.1 Boil Test:
8. Sampling Plan
6.1.1 Immerse the instrument(s) into a nonreactive con-
8.1 Each instrument manufacturer shall define an appropri-
tainer of distilled or reagent wate
...

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: F1089 − 10 F1089 − 18
Standard Test Method for
Corrosion of Surgical Instruments
This standard is issued under the fixed designation F1089; 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 test method covers general test procedures and evaluation criteria for the corrosion resistance of surgical instruments
intended for reuse in surgery and new and reusable surgical instruments fabricated from stainless steel alloys, such as, but not
limited to, those listed in Specification F899.
1.2 Austenitic (Class 3), martensitic (Class 4), precipitation hardenable Instruments containing stainless steel materials that are
exclusive to the following shall use the boil test and the copper sulfate test: austenitic materials (Class 3), precipitation hardening
materials (Class 5), and ferritic (Class 6) materials shall use the boil test.materials (Class 6) containing equal or greater than 16 %
chromium.
1.3 Ferritic (Class 6) materials with a minimum 16 % chromium content, austenitic (Class 3), and precipitation hardenable
(Class 5) materials Instruments containing any of the following stainless steel materials shall use the boil test and the copper sulfate
test.test: martensitic materials (Class 4) and ferritic materials (Class 6) containing less than 16 % chromium.
1.4 The copper sulfate test is used to detect the presence of metallic iron and iron oxide free iron on the surface of materials.
1.5 The copper sulfate test as described in 6.2 is not recommended for martensitic materials. (Seematerials or Note X1.1.)for
ferritic materials containing less than 16% chromium because these steels may give a positive indication irrespective of the
presence or absence of anodic surface contaminants (see X1.5).
1.6 The boil test is applicable to martensitic, austenitic, ferritic, and precipitation hardenablehardening materials to detect
surface imperfections, free iron, or any other anodic surface contaminants on stainless steel.
1.7 Values in either inch-pound or SI are to be regarded separately as standard. The values stated in each system may not be
exact equivalents; therefore each system shall be used independent of the other. Combining values from the two systems may result
in non-conformance with the specification.SI units are to be regarded as standard. No other units of measurement are included in
this standard.
1.8 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.
1.9 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
2.1 ASTM Standards:
A380 Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems
A967 Specification for Chemical Passivation Treatments for Stainless Steel Parts
B912 Specification for Passivation of Stainless Steels Using Electropolishing
D1193 Specification for Reagent Water
E122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or
Process
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved Sept. 1, 2010Feb. 1, 2018. Published September 2010March 2018. Originally approved in 1987. Last previous edition approved in 20022010
as F1089 – 02.F1089 – 10. DOI: 10.1520/F1089-10.10.1520/F1089-18.
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
F1089 − 18
E1402 Guide for Sampling Design
F899 Specification for Wrought Stainless Steels for Surgical Instruments
F1744 Guide for Care and Handling of Stainless Steel Surgical Instruments
2.2 Federal Specifications
MIL-STD-753 Corrosion-Resistant Steel Parts: Sampling, Inspection and Testing for Surface Passivation
3. Significance and Use
3.1 This test method provides acorrosion test methodologymethodologies and means of evaluation consistent to both producers
and users alike. The corrosion tests serve as an indicator that serve as indicators of proper material processing selection by the
manufacturers selection and proper careprocessing by the user.manufacturer.
NOTE 1—It is recommended that instruments be chemically passivated according to one of the treatments in Specification A967, electropolished
according to Specification B912, or both, prior to evaluating the corrosion resistance according to this test method. The likelihood of failure may be higher
for non-passivated instruments.
4. Reagents and Materials
4.1 Copper Sulfate—Copper sulfate pentahydrate (CuSO ·5H O).
4 2
4.2 Sulfuric Acid—Sulfuric acid AR (H SO ), sp gr 1.84.
2 4
4.3 Distilled Water. Water or Reagent Water conforming to Specification D1193, Type IV.
4.4 Isopropyl Alcohol or 95 % Ethyl Alcohol.
4.5 Nonreactive Vessel, such as a glass or ceramic container.
5. Specimen Preparation
5.1 Wash the instrument(s) with mild soap using an appropriate nonmetallic bristle brush and warm (25 to 50°C) tap water.
5.2 Boil Test: Rinse the instrument(s) thoroughly at room temperature in distilled water, reagent water, 95 % ethyl alcohol, or
isopropyl alcohol.
5.1.1 Wash the instrument(s) with mild soap using a nonmetallic hard bristle brush and warm tap water, 26 to 51°C (80 to
125°F).
5.1.2 Rinse the instruments thoroughly at room temperature in distilled water, 95 % ethyl alcohol, or isopropyl alcohol.
5.1.3 Dry using paper towel or soft cloth.
5.3 Copper Sulfate Corrosion Test: Dry using a paper towel or soft cloth.
5.2.1 Wash the instrument(s) with mild soap using a nonmetallic hard bristle brush and warm, 26 to 51°C (80 to 125°F) tap
water.
5.2.2 Rinse the instruments thoroughly at room temperature in distilled water followed by rinsing in 95 % ethyl alcohol or
isopropyl alcohol.
5.2.3 Air dry (ambient air).
5.4 Passivation: Use plastic tongs and gloves during cleaning and handling. Avoid contact with steel or stainless steel tongs or
other metallic items that may damage or contaminate the surface after cleaning.
5.3.1 Instruments shall be chemically passivated or electropolished according to the passivation treatments specified in
Specification A967 prior to evaluating the corrosion resistance according to this test method.
5.3.2 Passivated parts shall exhibit a chemically clean surface and shall, on visual inspection, show no etching, pitting, or
frosting resulting from the passivation procedures.
5.3.3 Passivated parts shall be marked by vibratory, impact, chemical, or laser methods. If marking is performed after the final
surface treatment, it must be evaluated whether a secondary passivation treatment is necessary or not.
6. Procedure
6.1 Boil Test:
6.1.1 Immerse the instrument(s) into a nonreactive container of distilled or reagent water.
6.1.2 Bring the water to a boil.
6.1.3 Maintain at boiling temperature for 30 6 1 min.
6.1.4 Ensure that the instrument(s) remains immersed.
6.1.5 Remove the heat source and let the instrument(s) stand for 3 h 6 15 min.
6.1.6 Remove the instrument(s) from the water and set on a towel to air dry (ambient air) for 2 h 6 10 min.
Available from Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.
F1089 − 18
6.1.7 It is recommended that the pH level of the test water is recorded before discarding. be recorded immediately at the
conclusion of the test. If the pH is outside the range of 6.5 to 7.0 range, 7.0, the instrument was not cleaned thoroughly and should
be retested accordingly.
6.2 Copper Sulfate Corrosion Test:
6.2.1 Copper Sulfate Solution Preparation:
6.2.1.1 Fill a nonreactive container with 250 mL of distilled or reagent water.
6.2.1.2 Add 1 mL of sulfuric acid (H SO , sp gr 1.84).
2 4
6.2.1.3 Add 4 g of copper sulfate pentahydrate (CuSO ·5H O) and stir until the crystals are completely dissolved.
4 2
6.2.2 Test Procedure:
6.2.2.1 The Apply the test solution is swabbed on onto the surface of the sample representing the lot of passivated
parts.instrument(s).
6.2.2.2 Apply additional solution as needed to keep the surface wet for a period of at least 6 min.
6.2.2.3 Rinse the instrument(s) thoroughly with distilled or reagent water and dry, with care nottaken to not disturb copper
deposits if present.
7. Interpretation of Results
7.1 Boil Test:
7.1.1 All surfaces shall show no signs of corrosion (without magnification).
7.1.1 A slight evidence of
...