ASTM F1089-87(1994)e1

Standard Test Method for Corrosion of Surgical Instruments

SCOPE
1.1 This test method covers general test procedures and evaluation criteria for the corrosion resistance of surgical instruments fabricated from stainless steel and intended for reuse in surgery.
1.2 Austenitic (Class 3), martensitic (Class 4), and precipitation hardening (Class 5) materials are to use the boil test and the copper sulfate test.
1.3 Ferritic (Class 6) materials are to use the copper sulfate tests.
1.4 The copper sulfate test is used in austenitic materials to detect chromium depletion at the grain boundaries caused by improper heat treatment or improper cold working.
1.5 For martensitic steels, the copper sulfate test is used to detect improper heat treatment.
1.6 The boil test is applicable to martensitic, austenitic, and precipitation hardened materials to detect surface imperfections.
1.7This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 31-Dec-1993
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaced By: ASTM F1089-02 - Standard Test Method for Corrosion of Surgical Instruments
• Effective Date: 10-Dec-2002
• Referred By: ASTM F1079-87(2022) - Standard Specification for Inserted and Noninserted Surgical Scissors
• Effective Date: 01-Jan-1994
• Referred By: ASTM F1744-96(2016) - Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
• Effective Date: 01-Jan-1994
• Referred By: ASTM F1325-91(2023) - Standard Specification for Stainless Steel Suture Needle Holders—General Workmanship Requirements and Corresponding Test Methods
• Effective Date: 01-Jan-1994
• Referred By: ASTM F1613-95(2023) - Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
• Effective Date: 01-Jan-1994
• Referred By: ASTM B883-19 - Standard Specification for Metal Injection Molded (MIM) Materials
• Effective Date: 01-Jan-1994

Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
e1
Designation: F 1089 – 87 (Reapproved 1994)
Standard Test Method for
Corrosion of Surgical Instruments
This standard is issued under the fixed designation F 1089; 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 (e) indicates an editorial change since the last revision or reapproval.
e NOTE—Section 8 was added editorially in April 1994.
1. Scope cessing selection by the manufacturers and proper care by the
user.
1.1 This test method covers general test procedures and
evaluation criteria for the corrosion resistance of surgical
4. Reagents and Materials
instruments fabricated from stainless steel and intended for
4.1 Cupric Sulfate—Cupric sulfate crystals (CuSO ·5H O),
4 2
reuse in surgery.
1g.
1.2 Austenitic (Class 3), martensitic (Class 4), and precipi-
4.2 Sulfuric Acid—Sulfuric acid AR (H SO ), sp gr 1.84,
2 4
tation hardening (Class 5) materials are to use the boil test and
2.5 g.
the copper sulfate test.
4.3 Distilled Water.
1.3 Ferritic (Class 6) materials are to use the copper sulfate
4.4 Isopropyl Alcohol or 95 % Ethyl Alcohol.
tests.
4.5 Nonreactive Vessel, such as a glass or ceramic container.
1.4 The copper sulfate test is used in austenitic materials to
detect chromium depletion at the grain boundaries caused by
5. Specimen Preparation
improper heat treatment or improper cold working.
5.1 Boil Test:
1.5 For martensitic steels, the copper sulfate test is used to
5.1.1 Wash the instrument(s) with mild soap using a non-
detect improper heat treatment.
metallic hard bristle brush and warm tap water (80 to 125 °F).
1.6 The boil test is applicable to martensitic, austenitic, and
5.1.2 Rinse the instruments thoroughly at room temperature
precipitation hardened materials to detect surface imperfec-
in distilled water, 95 % ethyl alcohol, or isopropyl alcohol.
tions.
5.1.3 Dry using paper towel or soft cloth.
1.7 This standard does not purport to address all of the
5.2 Copper Sulfate Corrosion Test:
safety concerns, if any, associated with its use. It is the
5.2.1 Wash the instrument(s) with mild soap using a non-
responsibility of the user of this standard to establish appro-
metallic hard bristle brush and warm (80 to 125 °F) tap water.
priate safety and health practices and determine the applica-
5.2.2 Rinse the instruments thoroughly at room temperature
bility of regulatory limitations prior to use.
in distilled water followed by rinsing in 95 % ethyl alcohol or
isopropyl alcohol.
2. Referenced Documents
5.2.3 Air dry (ambient air).
2.1 ASTM Standards:
A 380 Practice for Cleaning and Descaling Stainless Steel
6. Procedure
Parts, Equipment, and Systems
6.1 Boil Test:
F 899 Specification for Stainless Steel Billet, Bar, and Wire
3 6.1.1 Immerse the instrument(s) into a nonreactive con-
for Surgical Instruments
tainer of distilled water.
F 921 Definitions of Terms Relating to Hemostatic Forceps
6.1.2 Bring the water to a boil.
6.1.3 Maintain boiling temperature for 30 6 1 min.
3. Significance and Use
6.1.4 Ensure that the instrument(s) remains immersed.
3.1 This test method provides a test methodology and means
6.1.5 Remove the heat source and let the instrument(s) stand
of evaluation consistent to both producers and users alike. The
for3h6 15 min.
corrosion tests serve as an indicator of proper material pro-
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.
This test method is under the jurisdiction of ASTM Committee F04 on Medical
6.1.7 It is recommended that the pH level of test water is
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
recorded before discarding. If the pH is outside the 6.5 to 7.0
F04.33 on Medical/Surgical Instruments.
range, the instrument was not cleaned thoroughly and should
Current edition approved Oct. 30, 1987. Published December 1987.
Annual Book of ASTM Standards, Vol 01.03. be retested accordingly.
Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 1089
6.2 Copper Sulfate Corrosion Test: 7.1.1 All surfaces are to show no signs of corrosion (without
6.2.1 Copper Sulfate Solution Preparation:
magnification).
6.2.1.1 Fill a nonreactive container with 22.5 mL of warm
7.1.2 A slight evidence of rust (ferrous oxide) in serrations,
distilled water (80 to 125 °F).
teeth, locks, ratchets, inserts (brazed or soldered junctions),
6.2.1.2 Add1gof cupric sulfate crystals and stir until the
etc., shall not be cause for rejection.
crystals are completely dissolved.
7.2 Copper Sulfate Corrosion Test:
...