ASTM F1089-10

Standard Test Method for Corrosion of Surgical Instruments

SIGNIFICANCE AND USE
This test method provides a test methodology and means of evaluation consistent to both producers and users alike. The corrosion tests serve as an indicator of proper material processing selection by the manufacturers and proper care by the user.
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 fabricated from stainless steel such as, but not limited to, those listed in Specification F899.
1.2 Austenitic (Class 3), martensitic (Class 4), precipitation hardenable (Class 5), and ferritic (Class 6) materials shall use the boil test.
1.3 Ferritic (Class 6) materials with a minimum 16 % chromium content, austenitic (Class 3), and precipitation hardenable (Class 5) materials shall use the boil test and the copper sulfate test.
1.4 The copper sulfate test is used to detect the presence of metallic iron and iron oxide on the surface of materials.
1.5 The copper sulfate test is not recommended for martensitic materials. (See Note X1.1.)
1.6 The boil test is applicable to martensitic, austenitic, ferritic, and precipitation hardenable materials to detect 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.
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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 31-Aug-2010
• 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 F1089-02 - Standard Test Method for Corrosion of Surgical Instruments
• Effective Date: 01-Sep-2010
• Replaced By: ASTM F1089-18 - Standard Test Method for Corrosion of Surgical Instruments
• Effective Date: 01-Feb-2018
• Referred By: ASTM F1079-87(2022) - Standard Specification for Inserted and Noninserted Surgical Scissors
• Effective Date: 01-Sep-2010
• Referred By: ASTM B883-19 - Standard Specification for Metal Injection Molded (MIM) Materials
• Effective Date: 01-Sep-2010
• Referred By: ASTM F1613-95(2023) - Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
• Effective Date: 01-Sep-2010
• Referred By: ASTM F1744-96(2016) - Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
• Effective Date: 01-Sep-2010
• Referred By: ASTM F1325-91(2023) - Standard Specification for Stainless Steel Suture Needle Holders—General Workmanship Requirements and Corresponding Test Methods
• Effective Date: 01-Sep-2010

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F1089 − 10
Standard Test Method for
1
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* 2. Referenced Documents
2
1.1 This test method covers general test procedures and 2.1 ASTM Standards:
evaluation criteria for the corrosion resistance of surgical A380 Practice for Cleaning, Descaling, and Passivation of
instruments intended for reuse in surgery and fabricated from Stainless Steel Parts, Equipment, and Systems
stainless steel such as, but not limited to, those listed in A967 Specification for Chemical Passivation Treatments for
Specification F899. Stainless Steel Parts
F899 Specification for Wrought Stainless Steels for Surgical
1.2 Austenitic (Class 3), martensitic (Class 4), precipitation
Instruments
hardenable (Class 5), and ferritic (Class 6) materials shall use
the boil test.
3. Significance and Use
1.3 Ferritic (Class 6) materials with a minimum 16 %
3.1 Thistestmethodprovidesatestmethodologyandmeans
chromium content, austenitic (Class 3), and precipitation
of evaluation consistent to both producers and users alike. The
hardenable (Class 5) materials shall use the boil test and the
corrosion tests serve as an indicator of proper material pro-
copper sulfate test.
cessing selection by the manufacturers and proper care by the
1.4 The copper sulfate test is used to detect the presence of user.
metallic iron and iron oxide on the surface of materials.
4. Reagents and Materials
1.5 The copper sulfate test is not recommended for marten-
4.1 Copper Sulfate—Copper sulfate pentahydrate
sitic materials. (See Note X1.1.)
(CuSO ·5H O).
4 2
1.6 The boil test is applicable to martensitic, austenitic,
4.2 Sulfuric Acid—Sulfuric acid AR (H SO ), sp gr 1.84.
2 4
ferritic, and precipitation hardenable materials to detect free
iron or any other anodic surface contaminants on stainless 4.3 Distilled Water.
steel.
4.4 Isopropyl Alcohol or 95% Ethyl Alcohol.
1.7 Values in either inch-pound or SI are to be regarded
4.5 NonreactiveVessel, such as a glass or ceramic container.
separately as standard. The values stated in each system may
not be exact equivalents; therefore each system shall be used
5. Specimen Preparation
independent of the other. Combining values from the two
5.1 Boil Test:
systems may result in non-conformance with the specification.
5.1.1 Wash the instrument(s) with mild soap using a non-
1.8 This standard does not purport to address all of the
metallic hard bristle brush and warm tap water, 26 to 51°C (80
safety concerns, if any, associated with its use. It is the
to 125°F).
responsibility of the user of this standard to establish appro-
5.1.2 Rinse the instruments thoroughly at room temperature
priate safety and health practices and determine the applica-
in distilled water, 95 % ethyl alcohol, or isopropyl alcohol.
bility of regulatory limitations prior to use.
5.1.3 Dry using paper towel or soft cloth.
5.2 Copper Sulfate Corrosion Test:
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.15 on Material Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Sept. 1, 2010. Published September 2010. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 1987. Last previous edition approved in 2002 as F1089 – 02. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F1089-10. 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

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F1089 − 10
5.2.1 Wash the instrument(s) with mild soap using a non- 6.2.2.1 The test solution is swabbed on the surface of the
metallic hard bristle brush and warm, 26 to 51°C (80 to 125°F) sample representing the lot of passivated parts.
tap water. 6.2.2.2 Apply additional solution as needed to keep the
5.2.2 Rinse the instruments thoroughly at room temperature surface wet for a period of at least 6 min.
in distilled water followed by rinsing in 95 % ethyl alcohol or 6.2.2.3 Rinse the instrument(s) thoroughly with distilled
isopropyl alcohol. water and dry with care not to disturb copper deposits if
5.2.3 Air dry (ambient air). present.
5.3 Passivation:
7. Interpretation of Results
5.3.1 Instruments shall be chemi
...

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:F1089–02 Designation: F1089 – 10
Standard Test Method for
1
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 fabricated from stainless steel such as, but not limited to, those listed in Specification F899.
1.2Austenitic (Class 3), martensitic (Class 4), and precipitation hardening (Class 5) materials shall use the boil test and the
copper sulfate test.
1.3Ferritic (Class 6) materials shall use the copper sulfate test.
1.4The copper sulfate test is used to detect chromium depletion at the grain boundaries caused by improper heat treatment or
improper cold working of austenitic materials.
1.5The copper sulfate test is used to detect improper heat treatment of martensitic materials.
1.6The boil test is applicable to martensitic, austenitic, and precipitation hardened materials to detect surface imperfections.
1.7The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
1.2 Austenitic (Class 3), martensitic (Class 4), precipitation hardenable (Class 5), and ferritic (Class 6) materials shall use the
boil test.
1.3 Ferritic (Class 6) materials with a minimum 16 % chromium content, austenitic (Class 3), and precipitation hardenable
(Class 5) materials shall use the boil test and the copper sulfate test.
1.4 The copper sulfate test is used to detect the presence of metallic iron and iron oxide on the surface of materials.
1.5 The copper sulfate test is not recommended for martensitic materials. (See Note X1.1.)
1.6 The boil test is applicable to martensitic, austenitic, ferritic, and precipitation hardenable materials to detect 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
exactequivalents;thereforeeachsystemshallbeusedindependentoftheother.Combiningvaluesfromthetwosystemsmayresult
in non-conformance with the specification.
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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
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
F899 Specification for Wrought Stainless Steels for Surgical Instruments
3. Significance and Use
3.1 This test method provides a test methodology and means of evaluation consistent to both producers and users alike. The
corrosion tests serve as an indicator of proper material processing selection by the manufacturers and proper care by the user.
4. Reagents and Materials
4.1 Cupric Sulfate—Cupric sulfate crystals (CuSO ·5H O), 1 g. O).
Copper Sulfate—Copper sulfate pentahydrate (CuSO 2
4
1
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.
´1
Current edition approved Dec. 10, 2002. Published February 2003. Originally approved in 1987. Last previous edition approved in 1987 as F1089–87 (1994) . DOI:
10.1520/F1089-02.on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Sept. 1, 2010. Published September 2010. Originally approved in 1987. Last previous edition approved in 2002 as F1089 – 02. DOI:
10.1520/F1089-10.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. ForAnnualBookofASTMStandards
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 Consh
...