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

• Refers: ASTM E1402-13(2018) - Standard Guide for Sampling Design
• Effective Date: 01-Nov-2018
• Refers: ASTM F1744-96(2016) - Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
• Effective Date: 01-Oct-2016
• Refers: ASTM B912-02(2018) - Standard Specification for Passivation of Stainless Steels Using Electropolishing
• Effective Date: 01-Oct-2018
• Refers: ASTM F899-19 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 15-Sep-2019
• Refers: ASTM F899-20 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Feb-2020
• Referred By: ASTM F1079-87(2022) - Standard Specification for Inserted and Noninserted Surgical Scissors
• Effective Date: 01-Feb-2018
• Referred By: ASTM F1325-91(2023) - Standard Specification for Stainless Steel Suture Needle Holders—General Workmanship Requirements and Corresponding Test Methods
• Effective Date: 01-Feb-2018
• Referred By: ASTM B883-19 - Standard Specification for Metal Injection Molded (MIM) Materials
• Effective Date: 01-Feb-2018
• Referred By: ASTM F1613-95(2023) - Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
• Effective Date: 01-Feb-2018

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
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* 1.9 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
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
3
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.
3
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 Inter
...

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
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 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
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
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.
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.
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, P
...