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ALLOYS
FOR SURGICAL INSTRUMENTS

Proper selection of alloys for


tubular components in surgical
instruments is critical to the
development of
cost-effective instruments that
function as intended and can be
fabricated in an economical manner.
However, the optimum material is
seldom the least expensive.
William Fender*
Carpenter Special Products Corporation
El Cajon, California

Robert Brown*
RSB Alloy Applications LLC
Leesport, Pennsylvania

tainless steel alloys such as enhancedstrength UNS S30400 (AISI Type 304)
have been the material of choice for the
tubular components in dental and surgical instruments. Although this alloy has worked
well for the first generation of instruments designed for confined spaces, it has some drawbacks
that limit its usefulness for instruments in todays
more aggressive surgical procedures. These drawbacks include loss of strength during welding,
poor edge retention, poor wear resistance, and
poor galling resistance.
Stainless steel alloy development has yielded
a number of stainless steels with properties that
make them worthy candidates for medical instrument tubing. Each of these alloys exhibits enhanced properties over those provided by UNS
S30400. This article reviews beneficial material
properties and the alloys that offer them.
Stainless steel alloy properties
Corrosion resistance: In the past, the inherent
corrosion resistance of stainless steel has been
deemed adequate for surgical instruments, but
not so today. It is crucial to consider not only body
fluids, but also pre- and post- surgical instrument
cleaning techniques when determining the level
of corrosion resistance required. Table 1 shows
the relative corrosion resistance of alloys that are
*Member of ASM International

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considered to have acceptable biocompatibility


for medical instruments. When more corrosion
resistance is required because of cleaning or sterilizing solutions, an alloy further to the right
should be considered.
Strength and toughness: Medical instruments designed today frequently are required to
be thinner and longer, which requires materials
with higher toughness, fatigue strength, and tensile strength. All of these properties are interrelated. Generally, as the strength and hardness
increase, the ductility and toughness decrease.
The degree to which this holds true differs among
the alloy families and to some degree within a
family. Table 2 illustrates the combinations of properties and the alloys available to achieve them.
Edge retention, wear, and galling: Edge retention becomes one of the critical material properties for cutting or shaping instruments. If a cutting edge becomes dull prematurely, the
instrument becomes difficult and potentially dangerous to handle.
Wear and galling resistance are crucial when
metallic parts move in relation to each other in an
instrument. If wear or galling develops in service,
not only will the instrument stop performing
properly, but also it may introduce metallic debris into the wound.
Edge retention or wear resistance is determined
by both hardness and the hardening method.
Generally, as the hardness of a metal increases,
so do the edge retention, wear resistance, and
galling resistance.
However, the method by which the hardness
is developed is also critical. Table 3 shows the relationship between relative edge retention, wear
resistance, and galling resistance; how these properties are achieved; and a ranking of selected alloys. The edge retention of a martensitic stainless
is better than that of a precipitation-hardening
stainless or an austenitic stainless at the same
hardness because of the wear resistance of the
hard carbides in the martensitic stainless.
Welding effects
It is frequently necessary to weld one or more
components during the fabrication of a medical
instrument. Consider the effect of the welding
operation on the materials properties and the
processing necessary to overcome any negative
results during the instrument design and original material selection phases.
The heat generated when a metal is welded
causes metallurgical changes that differ with each

ADVANCED MATERIALS & PROCESSES/APRIL 2005

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Table 1 Corrosion resistance of alloys with acceptable biocompatibility


Improved corrosion resistance
UNS S45000
(Carpenter Custom 455 stainless)

UNS S 46500
(Carpenter Custom 465 stainless)

UNS S42010
(Carpenter BioDur TrimRite stainless)

UNS S31603
(Type 316/316L)

UNS S45000
(Carpenter Custom 450 stainless)

UNS S63000
Carpenter Custom 630 (17-4PH)

UNS S304003
(Type 304/304L)

Table 2 Steel property combinations and the alloys available


to achieve specified toughness and fatigue strength
Toughness and
fatigue strength

Tensile strength,
MPa (ksi)

Method of strengthening

Family/Alloy

Excellent

to 1794 (260)

Age 900F (482C) to 1150F (621C)

Precipitation hardening
UNS S46500

Good

to 1689 (245)

Age 900F (482C) to 1150F (621C)

Precipitation hardening
UNS S45500

Good

to 1351 (196)

Age 900F (482C) to 1150F (621C)

Precipitation hardening
UNS S45000
UNS S63000

Poor to fair

to 1620 (235)

Harden at 1850/1900F (1010/1066C),


quench and temper in the range of
350-700F (177-371C)

Martensitic
UNS S42010 UNS S42000

Good

to 1385 (200)

Cold deformation, cold rolling


or cold drawing. Not hardenable by
heat treatment.

Austenitic
UNS S30403
UNS S31603

Table 3 Effects of hardening methods on selected properties, with alloy rankings


Relative
edge
retention

Relative
resistance
to galling and wear

Very good

Very good

Good

Excellent

Fair to poor

Method of hardening

Alloy family

Very good

Heat treatment (aging) causes the formation of


fine intragranular precipitates, which strain the
molecular structure and harden the material.
The precipitates are not particularly hard.

Precipitation
hardening
UNS S46500

Very good

Heat treatment (aging) causes the formation of


fine intragranular precipitates, which strain the
molecular structure and harden the material.
The precipitates are not particularly hard.

Precipitation
hardening
UNS S45500

Good

Heat treatment (aging) causes the formation of


fine intragranular precipitates, which strain the
molecular structure and harden the material.
The precipitates are not particularly hard.

Precipitation
hardening
UNS 45000
UNS 63000

Excellent

Formation of hard, carbon rich particles (carbides)


through heat treatment (harden and temper).

Martensitic
UNS S42010
UNS S42000

Fair to poor

Cold working causes deformation of the metals


structure, which results in an increase in hardness.
Heat treating will generally not cause an increase
in hardness.

Austenitic
UNS S30403
UNS 31603

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Table 4 Welding efffects on stainless steel and post-weld corrective heat


Alloy family

Weld area metallurgical changes

Post-weld heat treatment

Precipitation Hardening
UNS 46500

Base metal exhibits both aged and annealed


properties. Grain growth will occur. Toughness
may be reduced.

Requires solution anneal + age to recover


maximum properties.

Precipitation Hardening
UNS S45000
UNS S45000
UNS S63000

Base metal exhibits both aged and annealed


properties. Grain growth will occur. Toughness
may be reduced.

Most PH alloys require solution anneal + age to


recover properties. UNS S45000 may be aged
directly after welding, without solution
annealing.

Martensitic
UNS S42010
UNS S42000

Base metal in high-temperature heat-affected


zone and weld deposit becomes hard and brittle.
Rapid grain growth occurs in these areas.
Severity increases as carbon content in the alloy
increases.

Material must be properly cooled from the


welding temperature, annealed, hardened, and
tempered. Lower carbon grades such as 420 and
TrimRite may usually be hardened and tempered
without solution annealing.

Austenitic
UNS S30403
UNS S31603

Base metal is annealed and softened in the


high-temperature heat-affected zone. Potential
significant loss of corrosion resistance in
heat-affected zone.

Cannot regain original strength if material had


been cold worked. Corrosion resistance regained
by annealing.

alloy family. These changes range from softening


the metal, to making it very hard and brittle.
While the welding method can influence these
changes, all fusion welding processes (Metal Inert
Gas - MIG, Tungsten Inert Gas -TIG, Laser, and
Electron Beam - EB) cause them. These effects tend
to be less severe with Laser and EB welding than
with MIG and TIG welding. Resistance and inertia welding minimize these changes. These
changes and corrective heat treatments are summarized in Table 4.

Alloy selection
In general, as the demands placed on an instrument by the procedure and surgeon increase, so
do the demands placed on the material.
Low stress: Some instruments, such as trocars, which are not subjected to high stress or torsional loads, and are not used for shaping, frequently may be made from UNS S30403 (Type
304L) stainless steel.
High stress: Long slender instruments, such
as drivers or arthroscopic instruments, are likely
to have high demands placed on them. The increased strength and toughness of UNS S46500
(Carpenters Custom 465 stainless) are put to
good use in these types of instruments. The alloys
high hardness and resulting edge retention, while
not as good as a martensitic stainless of similar
hardness, is more than adequate for many cutting and shaping applications.
Cutting and shaping: Cutting and shaping
instruments, such as shavers or samplers, require
an alloy such as UNS S42010 (BioDur TrimRite)
or UNS S42000 (Type 420), which are hard and
have good edge retention. The wear and galling
resistance of these alloys is beneficial for smooth
operation when the instruments contain parts
that move in relation to each other.
The information discussed above is intended
to assist the instrument design engineer in identifying alloys to be consider for a particular application. A qualified metallurgist or materials
engineer should be contacted for detailed information about material properties as they relate
to the specific instrument being designed.

For more information: William Fender, Medical Application Engineer, Carpenter Special Products Corporation, 1717 Cuyamaca St., El Cajon, CA 92020; tel: 619/
596-4314; fax: 619/562-5776.

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