ASTM F1089-02

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F1089–02
Standard Test Method for
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Corrosion of Surgical Instruments
This standard is issued under the fixed designation F1089; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F899 SpecificationforWroughtStainlessSteelsforSurgical
Instruments
1.1 This test method covers general test procedures and
evaluation criteria for the corrosion resistance of surgical
3. Significance and Use
instruments intended for reuse in surgery and fabricated from
3.1 Thistestmethodprovidesatestmethodologyandmeans
stainless steel such as, but not limited to, those listed in
of evaluation consistent to both producers and users alike. The
Specification F899.
corrosion tests serve as an indicator of proper material pro-
1.2 Austenitic (Class 3), martensitic (Class 4), and precipi-
cessing selection by the manufacturers and proper care by the
tation hardening (Class 5) materials shall use the boil test and
user.
the copper sulfate test.
1.3 Ferritic (Class 6) materials shall use the copper sulfate
4. Reagents and Materials
test.
4.1 CupricSulfate—Cupric sulfate crystals (CuSO ·5H O),
4 2
1.4 The copper sulfate test is used to detect chromium
1g.
depletion at the grain boundaries caused by improper heat
4.2 Sulfuric Acid—Sulfuric acid AR (H SO ), sp gr 1.84,
2 4
treatment or improper cold working of austenitic materials.
2.5 g.
1.5 The copper sulfate test is used to detect improper heat
4.3 Distilled Water.
treatment of martensitic materials.
4.4 Isopropyl Alcohol or 95% Ethyl Alcohol.
1.6 The boil test is applicable to martensitic, austenitic, and
4.5 NonreactiveVessel, such as a glass or ceramic container.
precipitation hardened materials to detect surface imperfec-
tions.
5. Specimen Preparation
1.7 The values stated in SI units are to be regarded as the
5.1 Boil Test:
standard. The values given in parentheses are for information
5.1.1 Wash the instrument(s) with mild soap using a non-
only.
metallic hard bristle brush and warm tap water, 26 to 51°C (80
1.8 This standard does not purport to address all of the
to 125 °F).
safety concerns, if any, associated with its use. It is the
5.1.2 Rinse the instruments thoroughly at room temperature
responsibility of the user of this standard to establish appro-
in distilled water, 95 % ethyl alcohol, or isopropyl alcohol.
priate safety and health practices and determine the applica-
5.1.3 Dry using paper towel or soft cloth.
bility of regulatory limitations prior to use.
5.2 Copper Sulfate Corrosion Test:
5.2.1 Wash the instrument(s) with mild soap using a non-
2. Referenced Documents
metallichardbristlebrushandwarm,26to51°C(80to125 °F)
2
2.1 ASTM Standards:
tap water.
A380 Practice for Cleaning, Descaling, and Passivation of
5.2.2 Rinse the instruments thoroughly at room temperature
Stainless Steel Parts, Equipment, and Systems
in distilled water followed by rinsing in 95 % ethyl alcohol or
isopropyl alcohol.
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This test method is under the jurisdiction ofASTM Committee F04 on Medical
5.2.3 Air dry (ambient air).
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
6. Procedure
Current edition approved Dec. 10, 2002. Published February 2003. Originally
´1
6.1 Boil Test:
approved in 1987. Last previous edition approved in 1987 as F1089 – 87 (1994) .
DOI: 10.1520/F1089-02.
6.1.1 Immerse the instrument(s) into a nonreactive con-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
tainer of distilled water.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
6.1.2 Bring the water to a boil.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. 6.1.3 Maintain boiling temperature for 30 6 1 min.
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F1089–02
6.1.4 Ensure that the instrument(s) remains immersed. 6.2.2.4 Rinse the instrument(s) thoroughly with tap water
6.1.5 Removetheheatsourceandlettheinstrument(s)stand and vigorously clean with cloth or nonmetallic soft bristle
for3h 6 15 min. brush to remove any nonadherent copper plating.
6.1.6 Remove the instrument(s) from the water and set on a
towel to air dry (ambient air) for 2 h 6 10 min.
7. Interpretation of Results
6.1.7 It is recommended that the pH level of test water is
7.1 Boil Test:
recorded before discarding. If the pH is outside the 6.5 to 7.0
7.1.1 All surfaces shall show no signs of corrosion (without
range, the instrument was not
...