ASTM F1089-2010 Standard Test Method for Corrosion of Surgical Instruments《外科仪器腐蚀的标准试验方法》.pdf

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1、Designation: F1089 10Standard 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 parent

2、heses 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 surge

3、ry 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 %chromiu

4、m 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

5、 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 sta

6、ndard. 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,

7、 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 Passivati

8、on ofStainless Steel Parts, Equipment, and SystemsA967 Specification for Chemical Passivation Treatmentsfor Stainless Steel PartsF899 Specification for Wrought Stainless Steels for SurgicalInstruments3. Significance and Use3.1 This test method provides a test methodology and meansof evaluation consi

9、stent 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 Copper SulfateCopper sulfate pentahydrate(CuSO45H2O).4.2 Sulfuric AcidSulfuric acid AR (H2SO4), sp g

10、r 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

11、 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:5.2.1 Wash the instrument(s) with mild soap using a non-metallic hard bristle brush and warm, 26 to 51C (80 to

12、 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 tre

13、atments specified inSpecification A967 prior to evaluating the corrosion resistanceaccording to this test method.1This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Mate

14、rials.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 A

15、nnual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1*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.5.3.2 P

16、assivated 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 surfa

17、ce 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 Ensure

18、that the instrument(s) remains immersed.6.1.5 Remove the heat source and let the instrument(s) standfor3h6 15 min.6.1.6 Remove the instrument(s) from the water and set on atowel to air dry (ambient air) for 2 h 6 10 min.6.1.7 It is recommended that the pH level of test water isrecorded before discar

19、ding. If the pH is outside the 6.5 to 7.0range, the instrument was not cleaned thoroughly and shouldbe retested accordingly.6.2 Copper Sulfate Corrosion Test:6.2.1 Copper Sulfate Solution Preparation:6.2.1.1 Fill a nonreactive container with 250 mL of distilledwater.6.2.1.2 Add 1 mL of sulfuric acid

20、 (H2SO4, sp gr 1.84).6.2.1.3 Add4gofcopper sulfate pentahydrate(CuSO45H2O) and stir until the crystals are completelydissolved.6.2.2 Test Procedure:6.2.2.1 The test solution is swabbed on the surface of thesample representing the lot of passivated parts.6.2.2.2 Apply additional solution as needed to

21、 keep thesurface wet for a period of at least 6 min.6.2.2.3 Rinse the instrument(s) thoroughly with distilledwater and dry with care not to disturb copper deposits ifpresent.7. Interpretation of Results7.1 Boil Test:7.1.1 All surfaces shall show no signs of corrosion (withoutmagnification).7.1.2 A s

22、light evidence of rust (ferrous oxide) in serrations,teeth, locks, ratchets, inserts (brazed or soldered junctions), andso forth, shall not be cause for rejection.7.2 Copper Sulfate Corrosion Test:7.2.1 All surfaces shall show no visual signs of copperplating (without magnification) with the followi

23、ng exceptions:7.2.1.1 Copper plating in serrations, teeth, locks, ratchets,braze junctions, solder junctions, or dulling of polished sur-faces shall not be cause for rejection.7.2.1.2 Copper plating at the periphery of the copper sulfatesolution drops caused by concentration of the solution due toev

24、aporation shall not be cause for rejection.8. Rejection and Retest8.1 Any lot failing to meet the specified test requirements ofthe purchase order shall be rejected.8.1.1 A rejected lot may, at the option of the processor, bere-passivated, with or without re-pretreatment, and then beretested.8.2 The

25、 number of samples tested from a lot subject to retestshall be twice the original specified test frequency, to the limitof the number of pieces in the lot.8.2.1 All samples must pass the specified acceptance crite-rion for the specified test for the retested lot to be accepted.9. Part Disposition9.1

26、 Instruments that were tested in copper sulfate solutionand instruments that failed the boil test shall be discarded.10. Keywords10.1 boil test; copper sulfate corrosion test; corrosion-surgical implants; immersionAPPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The function of this test method i

27、s to provide, bothproducers and users alike, a consistent test methodology andmeans of evaluating test results.NOTE X1.1Practice A380 states that a specialized copper sulfate testis used extensively on surgical and dental instruments made of hardenablemartensitic stainless steel for the purpose of d

28、etecting free iron anddetermining overall good manufacturing practice.X1.1.1 Solution PreparationAdd 5.4 mL of sulfuric acid(H2SO4, sp. gr 1.84) to 90 mL of distilled water and then add4 g of copper sulfate pentahydrate (CuSO45H2O) and stir untilthe crystals are completely dissolved.X1.1.2 Test Proc

29、edureThe test solution is swabbed on thesurface of the sample representing the lot of passivated parts.Apply additional solution as needed to keep the surface wet fora period of at least 6 min. Rinse the instruments thoroughlywith distilled water and wipe with moderate vigor to determineif the coppe

30、r is adherent or nonadherent.X1.1.3 Interpretation of ResultsInstruments with nonad-herent copper are considered acceptable. Copper plating inserrations, teeth, locks, ratchets, braze junctions, solder junc-tions, or dulling of polished surfaces shall not be cause forrejection.F1089 102X1.2 The corr

31、osion tests serve as indicator of propermaterial processing selection by the manufacturers and propercare by the user.X1.3 Both the boil test and copper sulfate test serve as anindicator that the surface has achieved a passive state as well asdetecting the presence of free iron or any other anodic s

32、urfacecontaminants. Heat treatment has an important effect oncorrosion resistance of martensitic stainless steel.X1.4 Specific instrument design/manufacturing processeswill influence corrosion test results. Accumulated testing ex-perience is an important factor in determining the significanceof corr

33、osion results obtained for stainless steel.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F1089 02)that may impact the use of this standard. (Approved Sept. 1, 2010.)Changes from the previous document include:(1) Updating the sc

34、ope to agree with the latest information inSpecification A967,(2) Adding Specification A967 as a Referenced Document,(3) Adding 5.3 instrument passivation information,(4) Updating 6.2 and 7.2.1.2 Copper Sulfate Corrosion Test,(5) Adding new Sections 8, Rejection and Retest, and 9, PartDisposition,(6

35、) Adding information in X1.1.1, X1.1.2, and X1.1.3 todescribe the specialized copper sulfate test used for martensiticstainless steels (nonmandatory information), and(7) Deleting X1.5 grain boundary chromium depletion infor-mation, which involves a different type of copper sulfate testmethod.ASTM In

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37、ly their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand s

38、hould be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on S

39、tandards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F1089 103