alloysforsurg.
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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
S
tainless steel alloys such as enhanced-
strength UNS S30400 (AISI Type 304)
have been the material of choice for the
tubular components in dental and sur-
gical instruments. Although this alloy has worked
well for the first generation of instruments de-
signed for confined spaces, it has some drawbacks
that limit its usefulness for instruments in today’s
more aggressive surgical procedures. These draw-
backs 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 instru-
ment tubing. Each of these alloys exhibits en-
hanced 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
36 ADVANCED MATERIALS & PROCESSES/APRIL 2005
considered to have acceptable biocompatibility
for medical instruments. When more corrosion
resistance is required because of cleaning or ster-
ilizing solutions, an alloy further to the right
should be considered.
• Strength and toughness: Medical instru-
ments designed today frequently are required to
be thinner and longer, which requires materials
with higher toughness, fatigue strength, and ten-
sile strength. All of these properties are inter-
related. 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 prop-
erties and the alloys available to achieve them.
• Edge retention, wear, and galling: Edge re-
tention becomes one of the critical material prop-
erties for cutting or shaping instruments. If a cut-
ting edge becomes dull prematurely, the
instrument becomes difficult and potentially dan-
gerous 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 de-
bris 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 re-
lationship between relative edge retention, wear
resistance, and galling resistance; how these prop-
erties are achieved; and a ranking of selected al-
loys. 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 material’s properties and the
processing necessary to overcome any negative
results during the instrument design and orig-
inal material selection phases.
The heat generated when a metal is welded
causes metallurgical changes that differ with each
alloysforsurg.qxp 3/17/2005 10:38 AM Page 3

Table 1 — Corrosion resistance of alloys with acceptable biocompatibility

Improved corrosion resistance →
UNS S45000 UNS S 46500 UNS S31603
(Carpenter Custom 455 stainless) (Carpenter Custom 465 stainless) (Type 316/316L)
UNS S42010 UNS S45000 —
(Carpenter BioDur TrimRite stainless) (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 Tensile strength,
fatigue strength MPa (ksi) Method of strengthening Family/Alloy
Excellent to 1794 (260) Age 900ºF (482ºC) to 1150ºF (621ºC) Precipitation hardening
UNS S46500
Good to 1689 (245) Age 900ºF (482ºC) to 1150ºF (621ºC) Precipitation hardening
UNS S45500
Good to 1351 (196) Age 900ºF (482ºC) to 1150ºF (621ºC) Precipitation hardening
UNS S45000 UNS S63000
Poor to fair to 1620 (235) Harden at 1850/1900ºF (1010/1066ºC), Martensitic
quench and temper in the range of UNS S42010 UNS S42000
350-700ºF (177-371ºC)
Good to 1385 (200) Cold deformation, cold rolling Austenitic
or cold drawing. Not hardenable by UNS S30403 UNS S31603
heat treatment.

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

Relative Relative
edge resistance
retention to galling and wear Method of hardening Alloy family
Very good Very good Heat treatment (aging) causes the formation of Precipitation
fine intragranular precipitates, which strain the hardening
molecular structure and harden the material. UNS S46500
The precipitates are not particularly hard.
Very good Very good Heat treatment (aging) causes the formation of Precipitation
fine intragranular precipitates, which strain the hardening
molecular structure and harden the material. UNS S45500
The precipitates are not particularly hard.
Good Good Heat treatment (aging) causes the formation of Precipitation
fine intragranular precipitates, which strain the hardening
molecular structure and harden the material. UNS 45000
The precipitates are not particularly hard. UNS 63000
Excellent Excellent Formation of hard, carbon rich particles (carbides) Martensitic
through heat treatment (harden and temper). UNS S42010
UNS S42000
Fair to poor Fair to poor Cold working causes deformation of the metal’s Austenitic
structure, which results in an increase in hardness. UNS S30403
Heat treating will generally not cause an increase UNS 31603
in hardness.

ADVANCED MATERIALS & PROCESSES/APRIL 2005 37

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

Alloy family Weld area metallurgical changes
Precipitation Hardening Base metal exhibits both aged and annealed
UNS 46500 properties. Grain growth will occur. Toughness
may be reduced.
Precipitation Hardening Base metal exhibits both aged and annealed
UNS S45000 properties. Grain growth will occur. Toughness
UNS S45000 may be reduced.
UNS S63000
Martensitic Base metal in high-temperature heat-affected
UNS S42010 zone and weld deposit becomes hard and brittle.
UNS S42000 Rapid grain growth occurs in these areas.
Severity increases as carbon content in the alloy
increases.
Austenitic Base metal is annealed and softened in the
UNS S30403 high-temperature heat-affected zone. Potential
UNS S31603 significant loss of corrosion resistance in
heat-affected zone.
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 in-
ertia welding minimize these changes. These
changes and corrective heat treatments are sum-
marized in Table 4.
Post-weld heat treatment
Requires solution anneal + age to recover
maximum properties.
Most PH alloys require solution anneal + age to
recover properties. UNS S45000 may be aged
directly after welding, without solution
annealing.
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.
Cannot regain original strength if material had
been cold worked. Corrosion resistance regained
by annealing.
Alloy selection
In general, as the demands placed on an instru-
ment by the procedure and surgeon increase, so
do the demands placed on the material.
• Low stress: Some instruments, such as tro-
cars, which are not subjected to high stress or tor-
sional loads, and are not used for shaping, fre-
quently 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 in-
creased strength and toughness of UNS S46500
(Carpenter’s Custom 465 stainless) are put to
good use in these types of instruments. The alloy’s
high hardness and resulting edge retention, while
not as good as a martensitic stainless of similar
hardness, is more than adequate for many cut-
ting 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 iden-
tifying alloys to be consider for a particular ap-
plication. A qualified metallurgist or materials
engineer should be contacted for detailed infor-
mation about material properties as they relate
to the specific instrument being designed.

For more information: William Fender, Medical Ap-

plication Engineer, Carpenter Special Products Corpo-
ration, 1717 Cuyamaca St., El Cajon, CA 92020; tel: 619/
596-4314; fax: 619/562-5776.

38 Circle 16 or visit www.adinfo.cc ADVANCED MATERIALS & PROCESSES/APRIL 2005