ASTM F1089-2002 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: F 1089 02Standard Test Method forCorrosion of Surgical Instruments1This standard is issued under the fixed designation F 1089; 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 pare

2、ntheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This test method covers general test procedures andevaluation criteria for the corrosion resistance of surgicalinstruments intended for reuse in sur

3、gery and fabricated fromstainless steel such as, but not limited to, those listed inSpecification F 899.1.2 Austenitic (Class 3), martensitic (Class 4), and precipi-tation hardening (Class 5) materials shall use the boil test andthe copper sulfate test.1.3 Ferritic (Class 6) materials shall use the

4、copper sulfatetest.1.4 The copper sulfate test is used to detect chromiumdepletion at the grain boundaries caused by improper heattreatment or improper cold working of austenitic materials.1.5 The copper sulfate test is used to detect improper heattreatment of martensitic materials.1.6 The boil test

5、 is applicable to martensitic, austenitic, andprecipitation hardened materials to detect surface imperfec-tions.1.7 The values stated in SI units are to be regarded as thestandard. The values given in parentheses are for informationonly.1.8 This standard does not purport to address all of thesafety

6、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:A 380 Practice for Cleaning, Descali

7、ng, and Passivation ofStainless Steel Parts, Equipment, and Systems2F 899 Specification for Stainless Steel for Surgical Instru-ments33. Significance and Use3.1 This test method provides a test methodology and meansof evaluation consistent to both producers and users alike. Thecorrosion tests serve

8、as an indicator of proper material pro-cessing selection by the manufacturers and proper care by theuser.4. Reagents and Materials4.1 Cupric SulfateCupric sulfate crystals (CuSO45H2O),1g.4.2 Sulfuric AcidSulfuric acid AR (H2SO4), sp gr 1.84,2.5 g.4.3 Distilled Water.4.4 Isopropyl Alcohol or 95 % Eth

9、yl 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 125 F).5.1.2 Rinse the instruments thoroughly at room temperaturein dis

10、tilled 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 125 F)tap water.5.2.2 Rinse the instruments thoroughly at

11、room temperaturein distilled water followed by rinsing in 95 % ethyl alcohol orisopropyl alcohol.5.2.3 Air dry (ambient air).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 f

12、or 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.1This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of Subcommittee

13、F04.33 on Medical/Surgical Instruments.Current edition approved Dec. 10, 2002. Published February 2003. Originallyapproved in 1987. Last previous edition approved in 1987 as F 1089 87 (1994)e1.2Annual Book of ASTM Standards, Vol 01.03.3Annual Book of ASTM Standards, Vol 13.01.1Copyright ASTM Interna

14、tional, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.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 discarding. If the pH is out

15、side 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 22.5 mL of warmdistilled water, 26 to 51C (80 to 125 F).6.2.1.2 Add1gofcupric su

16、lfate crystals and stir until thecrystals are completely dissolved.6.2.1.3 Add 2.5 g of sulfuric acid and mix thoroughly.6.2.2 Test Procedure:6.2.2.1 Submerge the instrument(s) in a nonreactive con-tainer containing copper sulfate solution at a temperature of 17to 20C (63 to 67 F).6.2.2.2 Instrument

17、s too large for complete immersion shallhave partial immersion or test by drops of the solution.6.2.2.3 The copper sulfate solution shall be allowed toremain in contact with the instrument for 6 min 6 30 s.6.2.2.4 Rinse the instrument(s) thoroughly with tap waterand vigorously clean with cloth or no

18、nmetallic soft bristlebrush to remove any nonadherent copper plating.7. Interpretation of Results7.1 Boil Test:7.1.1 All surfaces shall show no signs of corrosion (withoutmagnification).7.1.2 A slight evidence of rust (ferrous oxide) in serrations,teeth, locks, ratchets, inserts (brazed or soldered

19、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 following exceptions:7.2.1.1 Copper plating in serrations, teeth, locks, ratchets,braze junctions, solder juncti

20、ons, 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 shall not be cause for rejection.8. Keywords8.1 boil test; copper sulfate corrosion test; corrosion-surgical implants; immersionAPPENDIX(Nonmandatory Inf

21、ormation)X1. RATIONALEX1.1 The function of this test method is to provide, bothproducers and users alike, a consistent test methodology andmeans of evaluating test results.NOTE X1.1Practice A 380 states that a specialized copper sulfate testis used extensively on surgical and dental instruments made

22、 of hardenablemartensitic stainless steel.X1.2 The corrosion 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 asre

23、move chemical and free iron contaminants. Heat treatmenthas an important effect on corrosion resistance in martensiticstainless steel. The boil test is applicable to martensitic,austenitic, and precipitation hardened materials to detect sur-face imperfections.X1.4 Specific instrument design/manufact

24、uring processeswill influence corrosion test results. Accumulated testing ex-perience is an important factor in determining the significanceof corrosion results obtained for stainless steel.X1.5 The copper sulfate test was developed to detectchromium depletion at the grain boundaries of austeniticma

25、terial due to improper heat treatment (in the 900 to 1100 Frange) or improper cold working. The boil test would notreadily show these defects, but would show cracks and pitting.The austenitic materials should be subjected to both tests.Improper heat treatment can result in carbide formation in thema

26、rtensitic materials It is recognized in 7.2.1.1 that plating ofunpolished surfaces may occur, and trouble areas are specifi-cally excluded. This exclusion would negate the phenomena ofplating in these areas with Type 410. The boil test is importantfor these materials for surface imperfections. The c

27、oppersulfate test is important to detect improper heat treatment. Theprecipitation hardening steels are included for the same ratio-nale as the austenitics.F1089022ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this

28、standard. Users of this 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 r

29、eviewed every five years 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 therespon

30、sible 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 Standards, 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).F1089023