ASTM F1089-2018 Standard Test Method for Corrosion of Surgical Instruments《外科器械腐蚀的标准试验方法》.pdf

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1、Designation: F1089 18Standard 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 new andreusable surgical instruments fabricated

3、 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 (

4、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

5、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 o

6、f 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

7、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

8、 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 S

9、tandards, 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 Pas

10、sivation 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

11、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. Signific

12、ance 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.NOTE 1It is recommended that instruments be chemically passivatedaccording to one of the treatments in Specific

13、ation 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 of ASTM Committee F04 on Medicaland Surgic

14、al 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, v

15、isit 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 20

16、402.*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

17、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.14. Reagents and Materials4.1 Copper SulfateCopper sulfate pentahydrate(CuSO45H2O).4.2 Sulfuric AcidS

18、ulfuric acid AR (H2SO4), sp gr 1.84.4.3 Distilled Water or Reagent Water conforming to Speci-fication D1193, Type IV.4.4 Isopropyl Alcohol or 95 % Ethyl Alcohol.4.5 Nonreactive Vessel, such as a glass or ceramic container.5. Specimen Preparation5.1 Wash the instrument(s) with mild soap using an appr

19、o-priate nonmetallic bristle brush and warm (25 to 50C) tapwater.5.2 Rinse the instrument(s) thoroughly at room temperaturein distilled water, reagent water, 95 % ethyl alcohol, orisopropyl alcohol.5.3 Dry using a paper towel or soft cloth.5.4 Use plastic tongs and gloves during cleaning and han-dli

20、ng. Avoid contact with steel or stainless steel tongs or othermetallic items that may damage or contaminate the surfaceafter cleaning.6. Procedure6.1 Boil Test:6.1.1 Immerse the instrument(s) into a nonreactive con-tainer of distilled or reagent water.6.1.2 Bring the water to a boil.6.1.3 Maintain a

21、t boiling temperature for 30 6 1 min.6.1.4 Ensure 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 t

22、he pH level of the test waterbe recorded immediately at the conclusion of the test. If the pHis outside the range of 6.5 to 7.0, the instrument was notcleaned thoroughly and should be retested accordingly.6.2 Copper Sulfate Test:6.2.1 Copper Sulfate Solution Preparation:6.2.1.1 Fill a nonreactive co

23、ntainer with 250 mL of distilledor reagent water.6.2.1.2 Add 1 mL of sulfuric acid (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 Apply the test solution onto the surface of theinstrument(s).6

24、.2.2.2 Apply additional solution as needed to keep thesurface wet for a period of at least 6 min.6.2.2.3 Rinse the instrument(s) thoroughly with distilled orreagent water and dry, with care taken to not disturb copperdeposits if present.7. Interpretation of Results7.1 Boil Test:7.1.1 Surfaces shall

25、show no signs of corrosion (withoutmagnification) with the following exceptions:7.1.1.1 Rust (ferrous oxide) on serrations, teeth, locks,ratchets, inserts, brazed junctions, soldered junctions, etchedareas, engravings, or laser marks shall not be cause forrejection.7.2 Copper Sulfate Test:7.2.1 Surf

26、aces shall show no signs of copper plating (with-out magnification) with the following exceptions:7.2.1.1 Copper plating on serrations, teeth, locks, ratchets,brazed junctions, soldered junctions, etched areas, engravings,laser marks, or dulling of polished surfaces shall not be causefor rejection.7

27、.2.1.2 Copper plating at the periphery of the copper sulfatesolution drops caused by concentration of the solution due toevaporation shall not be cause for rejection.NOTE 2See Guide F1744 for discussion on the higher susceptibility ofserrations, teeth, locks, ratchets, inserts, etc. to corrosion.8.

28、Sampling Plan8.1 Each instrument manufacturer shall define an appropri-ate sampling plan for ensuring instrument safety and quality.8.2 Rejected lots are often re-passivated and retested, typi-cally using an increased sample size of instruments. If the lotis rejected a second time, it is recommended

29、 that the cause ofthe repeat failure be evaluated before proceeding.NOTE 3Practice E122 and Guide E1402 may be useful in thedevelopment of the sampling plan.9. Part Disposition9.1 Instruments that were tested with copper sulfate solutionshall be discarded.NOTE 4Instruments that fail the boil test ma

30、y be discarded orremediated (see 8.2).10. Precision and Bias10.1 No statement is made concerning either the precisionor bias of the boil test and the copper sulfate test because theresults state merely whether there is conformance to the criteriafor success specified in the procedure.11. Keywords11.

31、1 boil test; copper sulfate test; corrosion tests; immersiontest; surgical instrumentsF1089 182APPENDIX(Nonmandatory Information)X1. ADDITIONAL INFORMATIONX1.1 Specific instrument design/manufacturing processeswill influence corrosion test results. Accumulated testing ex-perience is an important fac

32、tor in determining the significanceof corrosion results obtained for stainless steel.X1.2 The results of these tests may be improved if theinstrument has been allowed several hours dwell time in airbetween the completion of the passivation treatment (see Note1) and the start of the test methods.X1.3

33、 Testing of Reusable Instruments in Active UseX1.3.1 Though the primary use of this test method is forinstruments in their initial condition, it is recognized that itmay be desirable to use it to monitor the condition of reusableinstruments on a periodic basis. This is due to frequentexposure to cor

34、rosive materials such as bodily fluids, cleaningsolutions, and sterilization methods, and also surface contami-nation that may occur due to incidental contact with steelsurfaces.X1.3.2 General recommendations for the care of stainlesssteel surgical instruments are contained in Guide F1744.X1.3.3 Per

35、iodic repassivation of the instruments accordingto one of the treatments in Specification A967 can be used tohelp increase the life span of the stainless surfaces. Care maybe needed to avoid damage to features such as laser marks.X1.3.4 Testing of instruments in active use shall use the boiltest onl

36、y, regardless of the type of stainless steel.X1.3.5 Instruments with corrosion, either as a result ofnormal use, or as a failure state of the boil test, may beremediated using an appropriate rust removal method, pro-vided that they are then repassivated and retested.X1.4 The boil test as described i

37、n 6.1 was developed for thisstandard. The copper sulfate test as described in 6.2 wasadapted from Specification A967, Practice A380, and MIL-STD-753. The martensitic grade adherent copper sulfate test asdescribed in X1.5 was adapted from Practice A380 and waspreviously used in the main body of this

38、standard.X1.5 Martensitic Grade Adherent Copper Sulfate TestX1.5.1 This test is used on instruments made of hardenedmartensitic stainless steel for the purpose of detecting free iron.X1.5.2 Solution PreparationAdd 5.4 mL of sulfuric acid(H2SO4, sp. gr 1.84) to 90 mL of distilled or reagent water and

39、then add4gofcopper sulfate pentahydrate (CuSO45H2O) andstir until the crystals are completely dissolved.X1.5.3 Test ProcedureApply the test solution to the sur-face of the instrument(s). This may be done by submerging theinstrument in the test solution, if desired. Apply additionalsolution as needed

40、 to keep the surface wet for a period of atleast 6 min. Rinse the instrument(s) thoroughly with distilled orreagent water and wipe with moderate vigor to determine if anycopper present is adherent or nonadherent.X1.5.4 Interpretation of ResultsInstruments with nonad-herent copper are considered acce

41、ptable. Copper plating inserrations, teeth, locks, ratchets, brazed junctions, solderedjunctions, etched areas, engravings, laser marks, or dulling ofpolished surfaces shall not be cause for rejection.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard si

42、nce the last issue (F1089 10)that may impact the use of this standard. (Approved Feb. 1, 2018)(1) Updated several parts of Sections 1, 3, 6, 7, and 11 forimproved clarity and correctness.(2) Replaced 5.3 with Note 1.(3) Combined 5.1 and 5.2.(4) Revised Section 8.(5) Disposition of boil test failures

43、 moved from 9.1 to Note 4.(6) Added Section 10.(7) Note X1.1 to X1.5.(8) Removed X1.1, X1.2, and X1.3; added new X1.2, X1.3,and X1.4.F1089 183ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of thi

44、s standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five yea

45、rs andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical commit

46、tee, 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 Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 1942

47、8-2959,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 Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 184