ASTM F1089 - 18

    Standard Test Method for Corrosion of Surgical Instruments

    Active Standard ASTM F1089 | Developed by Subcommittee: F04.15

    Book of Standards Volume: 13.01


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    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.

    1. 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.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    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

    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

    Federal Specifications

    MIL-STD-753


    ICS Code

    ICS Number Code 11.040.30 (Surgical instruments and materials)

    UNSPSC Code

    UNSPSC Code 42295139(Instrument rolls for surgical instruments or accessories)


    Referencing This Standard
    Link Here
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    DOI: 10.1520/F1089-18

    Citation Format

    ASTM F1089-18, Standard Test Method for Corrosion of Surgical Instruments, ASTM International, West Conshohocken, PA, 2018, www.astm.org

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