ASTM_F_1089_-_18.pdf

Designation:F108918Standard Test Method forCorrosion of Surgical Instruments1This standard is issued under the fixed designation F1089;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope*1.1 This test method covers general test procedures andevaluation criteria for the corrosion resistance of new andreusable surgical instruments fabricated from stainless steelalloys,such as,but not limited to,those listed in SpecificationF899.1.2 Instruments containing stainless steel materials that areexclusive to the following shall use the boil test and the coppersulfate test:austenitic materials(Class 3),precipitation hard-ening materials(Class 5),and ferritic materials(Class 6)containing equal or greater than 16%chromium.1.3 Instruments containing any of the following stainlesssteel materials shall use the boil test:martensitic materials(Class 4)and ferritic materials(Class 6)containing less than16%chromium.1.4 The copper sulfate test is used to detect the presence offree iron on the surface of materials.1.5 The copper sulfate test as described in 6.2 is notrecommended for martensitic materials or for ferritic materialscontaining less than 16%chromium because these steels maygive a positive indication irrespective of the presence orabsence of anodic surface contaminants(see X1.5).1.6 The boil test is applicable to martensitic,austenitic,ferritic,and precipitation hardening materials to detect surfaceimperfections,free iron,or other anodic surface contaminantson stainless steel.1.7 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.8 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.9 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2A380 Practice for Cleaning,Descaling,and Passivation ofStainless Steel Parts,Equipment,and SystemsA967 Specification for Chemical Passivation Treatments forStainless Steel PartsB912 Specification for Passivation of Stainless Steels UsingElectropolishingD1193 Specification for Reagent WaterE122 Practice for Calculating Sample Size to Estimate,WithSpecified Precision,the Average for a Characteristic of aLot or ProcessE1402 Guide for Sampling DesignF899 Specification for Wrought Stainless Steels for SurgicalInstrumentsF1744 Guide for Care and Handling of Stainless SteelSurgical Instruments2.2 Federal Specifications3MIL-STD-753 Corrosion-Resistant Steel Parts:Sampling,Inspection and Testing for Surface Passivation3.Significance and Use3.1 This test method provides corrosion test methodologiesand means of evaluation that serve as indicators of propermaterial selection and proper processing by the manufacturer.NOTE1It is recommended that instruments be chemically passivatedaccording to one of the treatments in Specification A967,electropolishedaccording to Specification B912,or both,prior to evaluating the corrosionresistance according to this test method.The likelihood of failure may behigher for non-passivated instruments.1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved Feb.1,2018.Published March 2018.Originallyapproved in 1987.Last previous edition approved in 2010 as F1089 10.DOI:10.1520/F1089-18.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from Superintendent of Documents,U.S.Government PrintingOffice,Washington,DC 20402.*A Summary of Changes section appears at the end of this standardCopyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 4.Reagents and Materials4.1 CopperSulfateCoppersulfatepentahydrate(CuSO45H2O).4