ASTM_F_1089_-_10.pdf

Designation:F108910Standard 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 surgicalinstruments intended for reuse in surgery and fabricated fromstainless steel such as,but not limited to,those listed inSpecification F899.1.2 Austenitic(Class 3),martensitic(Class 4),precipitationhardenable(Class 5),and ferritic(Class 6)materials shall usethe boil test.1.3 Ferritic(Class 6)materials with a minimum 16%chromium content,austenitic(Class 3),and precipitationhardenable(Class 5)materials shall use the boil test and thecopper sulfate test.1.4 The copper sulfate test is used to detect the presence ofmetallic iron and iron oxide on the surface of materials.1.5 The copper sulfate test is not recommended for marten-sitic materials.(See Note X1.1.)1.6 The boil test is applicable to martensitic,austenitic,ferritic,and precipitation hardenable materials to detect freeiron or any other anodic surface contaminants on stainlesssteel.1.7 Values in either inch-pound or SI are to be regardedseparately as standard.The values stated in each system maynot be exact equivalents;therefore each system shall be usedindependent of the other.Combining values from the twosystems may result in non-conformance with the specification.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 and health practices and determine the applica-bility of regulatory limitations prior to use.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 PartsF899 Specification for Wrought Stainless Steels for SurgicalInstruments3.Significance and Use3.1 This test method provides a test methodology and meansof evaluation consistent to both producers and users alike.Thecorrosion tests serve as an indicator of proper material pro-cessing selection by the manufacturers and proper care by theuser.4.Reagents and Materials4.1 CopperSulfateCoppersulfatepentahydrate(CuSO45H2O).4.2 Sulfuric AcidSulfuric acid AR(H2SO4),sp gr 1.84.4.3 Distilled Water.4.4 Isopropyl Alcohol or 95%Ethyl Alcohol.4.5 Nonreactive Vessel,such as a glass or ceramic container.5.Specimen Preparation5.1 Boil Test:5.1.1 Wash the instrument(s)with mild soap using a non-metallic hard bristle brush and warm tap water,26 to 51C(80to 125F).5.1.2 Rinse the instruments thoroughly at room temperaturein distilled water,95%ethyl alcohol,or isopropyl alcohol.5.1.3 Dry using paper towel or soft cloth.5.2 Copper Sulfate Corrosion Test:1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved Sept.1,2010.Published September 2010.Originallyapproved in 1987.Last previous edition approved in 2002 as F1089 02.DOI:10.1520/F1089-10.2For 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.*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 States1 5.2.1 Wash the instrument(s)with mild soap using a non-metallic hard bristle brush and warm,26 to 51C(80 to 125F)tap water.5.2.2 Rinse the instruments thoroughly at room temperaturein distilled water followed by rinsing in 95%ethyl alcohol orisopropyl alcohol.5.2.3 Air dry(ambient air).5.3 Passivation:5.3.1 Instruments shall be chemically passivated or elec-tropolished according to the passivation treatments specified inSpecification A967 prior to evaluating the corrosion resistanceaccording to this test method.5.3.2 Passivated parts shall exhibit a chemically cleansurface 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 thefinal surface treatment,it must be evaluated whether a second-ary passivation treatment is necessary or not.6.Procedure6.1 Boil Test:6.1.1 Immerse the instrument(s)into a nonreactive con-tainer of distilled water.6.1.2 Bring the water to a boil.6.1.3 Maintain boiling temperature for 30 6 1 min.6.1.4 E