ASTM F1744-96(2016)

Standard Guide for Care and Handling of Stainless Steel Surgical Instruments

ABSTRACT
This guide is intended to provide a better understanding of the care of stainless steel surgical instruments intended for reuse. This guide is not intended for use with electrical, pneumatic, or other powered surgical instruments. The stainless steels most used are martensitic and austenitic types. The instruments shall be used only for their intended purpose, such as cutting, holding, clamping, retracting, and so forth. Undue stress or strain should be avoided when handling and cleaning. The guide includes care in particular for hemostatic forceps, needle holders, scissors, microsurgical instruments, instrument kits, and other sharp instruments. The instrument care specified includes cleaning, lubrication, and inspection. Testing, repair and restoration, and sterilization are specified.
SCOPE
1.1 This guide is intended to provide a better understanding of the care of stainless steel surgical instruments intended for reuse. This guide is not intended for use with electrical, pneumatic or other powered surgical instruments.

General Information

• Status: Published
• Publication Date: 30-Sep-2016
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.33 - Medical/Surgical Instruments

Relations

• Refers: ASTM F921-10(2018) - Standard Terminology Relating to Hemostatic Forceps
• Effective Date: 01-Oct-2018
• Refers: ASTM F1078-10(2018) - Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades
• Effective Date: 01-Oct-2018
• Refers: ASTM F899-19 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 15-Sep-2019
• Refers: ASTM F899-20 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Feb-2020
• Referred By: ASTM F116-12(2021) - Standard Specification for Medical Screwdriver Bits
• Effective Date: 01-Oct-2016
• Referred By: ASTM F1089-18 - Standard Test Method for Corrosion of Surgical Instruments
• Effective Date: 01-Oct-2016

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F1744 − 96 (Reapproved 2016)
Standard Guide for
1
Care and Handling of Stainless Steel Surgical Instruments
This standard is issued under the fixed designation F1744; 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 create a protective chromium oxide surface layer while remov-
ing surface carbon and iron. This is accomplished in the
1.1 This guide is intended to provide a better understanding
atmosphere slowly or through immersion in oxidizing solution
of the care of stainless steel surgical instruments intended for
or through an electro-polish process. Through repeated pro-
reuse. This guide is not intended for use with electrical,
cessing the passivation layer will thicken until a good protec-
pneumatic or other powered surgical instruments.
tive film is formed.
2. Referenced Documents 3.2.1 Never expose instruments to strong acids such as
2
hydrochloric, aqua regia, dilute sulphuric, carbonic, and tar-
2.1 ASTM Standards:
taric.
F899 Specification for Wrought Stainless Steels for Surgical
3.2.2 Avoid contact with salt solutions such as aluminum
Instruments
chloride, mercury salts, and stannous chloride. Also avoid
F921 Terminology Relating to Hemostatic Forceps
contact with potassium thiocyanate and potassium permangan-
F1026 Specification for General Workmanship and Perfor-
ate and limit contact with iodine solutions to periods of less
mance Measurements of Hemostatic Forceps
than 1 h.
F1078 Terminology for Surgical Scissors—Inserted and
Non-Inserted Blades 3.2.3 Chloride-bearing solutions such as blood and saline
F1079 Specification for Inserted and Noninserted Surgical can cause localized corrosion.Avoid prolonged exposure to or
Scissors rinsing in saline solutions or corrosion and pitting will occur.
F1089 Test Method for Corrosion of Surgical Instruments Use demineralized or distilled water instead. Place instruments
F1325 Specification for Stainless Steel Suture Needle into water, an enzymatic solution, or a disinfectant bath
Holders-General Workmanship Requirements and Corre- immediately after use so the blood or other material will not
sponding Test Methods dry on them prior to transport to the designated cleaning/
reprocessing area.
3. General
4. General Care of Instruments
3.1 StainlessSteelTypes—The stainless steels most used are
martensitic and austenitic types such as those in Specification
4.1 General—Use instruments only for their intended
F899. Martensitic stainless steel contains iron, chromium, and
purpose, such as cutting, holding, clamping, retracting, and so
sufficient carbon so that when it is hardened by heat treatment,
forth.Avoid undue stress or strain when handling and cleaning.
a substantial martensitic structure is the result. Austenitic
Standard terminology relating to Hemostatic Forceps and
stainless steel has better corrosion resistance and contains iron,
Surgical Scissors are found in Terminology F921 and Termi-
chromium, and nickel. It has a substantial austenitic structure
nology F1078.
and a lower carbon content.Although it cannot be hardened by
4.1.1 Hemostatic Forceps—These forceps are designed to
heat treatment, it can be work-hardened.
clamp blood vessels.They should not be used to clamp towels,
3.2 Passivation—Stainlesssteelcanspot,stain,andcorrode.
suction tubing, or as needle holders or pliers. Misuse generally
This is minimized by passivation which is a process used to
results in misalignment and even cracked box locks.
4.1.2 Needle Holders—Although designed to withstand
1
someforce,theyarenottobeusedaspliers,jawmisalignments
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
being the result. Select a needle holder matching the size
F04.33 on Medical/Surgical Instruments.
needle being used.
Current edition approved Oct. 1, 2016. Published October 2016. Originally
ε1
4.1.3 Scissors—Do not use scissors for the wrong job,
approved in 1997. Last previous edition approved in 2008 as F1744 – 96 (2008)
DOI: 10.1520/F1744-96R16.
otherwise, the tips will become misaligned and the blades will
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
dull or chip. Delicate scissors should be particularly guarded
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
against misuses. Use tissue scissors for tissue dissections only,
Standards volume informatio
...