01 - Plaquette Me dic. 13.En_02 - Plaquette mÈdicale

Metallic materials for Implants,
Ancillaries and Instruments
Supporting
High-tech industries
since 1928
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Responsiveness, reactivity, proficiency
Customised inventory enabling ex-stock delivery
Technical advice service,
supporting innovation and material
selection at our customers
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Logistics organisation
offering secure and fast delivery worldwide
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has been supplying the medical industry since the mid
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Quality of
suppliers
Quality of products and
systems
We consider our
suppliers to be our
partners, all being
approved by the
major players of the
medical industry, thus
guaranteeing their
high quality fully integrated production
and manufacturing
systems.
Certified ISO 9001 : 2008 and
ISO 13485 : 2003, STAINLESS
attaches particular importance
to quality assurance and
product traceability, both for
implants and surgical instruments.
On top of a control on any
incoming batch, a mill certificate is systematically supplied
with every shipment.
Corrosion of surgical instruments: still an issue?
Within the framework of NFS 94090, our partner
Aubert & Duval has successfully developed high
performance materials which combine elevated
tensile strength and hardness while maintaining or
even improving corrosion resistance.
These results have been achieved despite,
Corrosion resistance: salt spray exposure
test according to ISO 9227
X15TN
Thermal
cycle for
HRC ≥ 58
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highly corrosive cleaning and decontamination
environments:
chemically active decontamination solutions,
cleaning detergents under pulsed waterjet,
high temperature and high pressure sterilization.
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x 20
x1
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human body fluid corrosion, blood in particular.
XDBD
Temper
140°C /
285°F
without
rust
%%
dearea
surface
non oxydée
For example, MX466, one of the precipitation
hardening stainless steels, combines a UTS of
1750MPa/253ksi with a hardness ≥ 50HRC in
the H900 condition.
Also consider X15TN, a martensitic stainless
steel where carbon has been replaced by nitrogen thus avoiding coarse carbide formation,
which is so detrimental to corrosion resistance,
and which displays an outstanding hardness of
59 HRC.
100
90
80
70
60
50
40
30
20
10
24 h
96 h
264 h
Exposure
time
Temps
d'exposition
X15TN thermal cycle for HRC ≥ 58
MX455 - H900
d 1980’s, our credo being based on three main principles:
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Quality of service
Like all our clients who have chosen to put
their trust in us, you may rest assured that we
are fully committed to high quality service.
Amongst our customers we include:
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Stryker Group
Groupe Marle
SMB
Greatbatch
Tornier
Minitubes
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Mathys
Zimmer
DePuy
Symmetry
Lisi Medical
…
and their many subcontractors.
ST4542 - H900
XDBD
GRADES FOR IMPLANTS
Stainless
grades
Common designations
ISO 5832
ASTM
AISI
M25W*
X2CrNiMo18.14.3
316 L
1
F 138 - F 139
316 L
ST4441VM
X2CrNiMo18.14.3
316 L
1
F 138 - F 139
316 L
M30NW*
X4CrNiMnMoN21.9.4
9
F 1586
NONICM2*
X8MnCrMoN23.21.1
-
F 2229
M64BC*
CoCr28 Mo
Allow 21 (Low Carbon)
12
F 799
F 1537 alloy 1
XSH*
CoCr20W15Ni
5
F 90
Phynox®**
Elgiloy®***
CoCr20Ni15Mo7
UNS R 30003
7
F 1058
MP35N®****
UNS R 30035
6
F 562
Stainless
steels
ST 955
UNS C95510
Cobalt
base alloys
Titanium
and
Titanium alloys
Non alloyed
Titanium
Titanium Grade 2
2
F 67 grade 2
Ti-6Al4V ELI
TA6V ELI
Titanium Grade 5
3
F 136
Tantalum
TANTALUM
UNS R 05200
-
F 560
* Aubert & Duval registered trademark
** Aperam Alloys Imphy registered trademark
*** Elgiloy Specialty Metals registered trademark
**** SPS Technologies, Inc. registered trademark
Galling problems
with your implants ?
M30NW specially
recommended for highly-stressed
surgical implants
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Very low level of inclusions
Homogeneous fine grain
Select M64BC
a cobalt base material
= fatigue
strength
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Highly non-magnetic, recommended for
MRI without deflection
> High mobility hip prostheses
> Very thin-gauge screws
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Highly polishable
High yield strength allowing high
fatigue strength
Closed-die forging ability
Excellent friction properties
Typical chemical analysis
C
Cr
Ni
Mo
Mn
N
W
Al
Others
V
Properties
Balance
0.02
17
14
3
Fe
Austenitic stainless steel for orthopaedic application.
0.02
17
14
3
Fe
Austenitic stainless steel for trauma and orthopaedic
implants.
≤ 0.06
21
9
2.5
4
0.4
≤ 0.08
21
0.1
0.7
23
0.9
Nb 0.3
Improved mechanical properties and corrosion resistance.
Non-magnetic.
Fe
Tube obtained
by continuous
casting.
Nickel-free
austenitic
grade, non-allergenic, non-magnetic.
Good mechanical properties and resistance to wear.
Fe
Easy to work-harden. 50 HRC hardness for O.D. ≤ 30 mm.
28
0.5
≤ 0.1
20
10
< 0,15
20
15
7
< 0,025
20
35
10
0.15
6
15
Fe 15
≤ 0.08
0.02
≤ 0.08
0.04
4
6
Co
High strength and corrosion resistance.
Co
High X-Ray opacity.
Stents.
Co
Excellent corrosion resistance combined
with very high yield strength. Orthodontics, stents.
Co
Outstanding corrosion resistance and ultra high
mechanical properties (varies with work strengthening).
Orthopaedic cables.
Ti
Excellent biocompatibility.
Ti
Excellent biocompatibility.
Good combination of strength and density.
99.95
min.
Ta
At least double vacuum arc remelted
≤ 0.14
Metal is vacuum melted
and remelted
Bushings, spherical bearings.
Very high X-Ray opacity.
Markers for plastic implants.
All the above data are typical figures only.
Please contact us for any specific requirements.
Process of all grades includes a consumable electrode remelting phase.
Typical mechanical properties
1600
1400
N / mm2
1200
UTS
1000
YS
800
Fatigue
600
400
200
0
Solution
treated
Coldworked
M25W
Solution
treated
Coldworked
M30NW
Solution
treated
Coldworked
NONIC M2
Thermomechanical
Annealed
M64BC
TA6V ELI
GRADES FOR SURGICAL INSTRUMENTS
Austenitic
Stainless
Steel
Martensitic
Stainless
Steels
Stainless
grades
Common designations
EN +
NFS 94090
ASTM
AISI
MBC
alias X18MBC*
X2CrNiMo17.12.2
316 L
1.4404
ST4028
X30Cr13
ST80
alias APX*
APX4*
C
Cr
Ni
F 899
316 L
0.02
17
12
1.4028
F 899
420 B
0.3
13
X17CrNi16.2
1.4057
F 899
431
0.16
17
2
X4CrNiMo16.5.1
1.4418
-
0.06
16
5
X15TN*
X40CrMoVN16.2
1.4123
F 899
420 MOD
0.4
15.5
2
XDBD*
X105CrMo17
1.4125
F 899
440 C
1
17
0.5
ST4542
X5CrNiCuNb16.4
1.4542
F 899
630
0.06
16.5
4
X2CrNiCuTiNb12.9
1.4543
F 899
XM 16
0.02
12
8.5
-
F 899
< 0.02
12
11
2
(1)
Precipitation
hardening
Stainless
Steels
(1)
MX455*
(1)
NEW
MX466*
X1CrNiMoAlTi12.11.2
UNS S 11100
* Aubert & Duval registered trademark
(1)
Typical chemical analy
Mo
2.5
1
When selecting a steel for instruments, it is necessary to consider its corrosion resistance
and mechanical properties in relation to its conditions of service - wear, friction,
cutting parameters, sterilization and washing conditions…
Process includes a consumable electrode
remelting phase
MX466
A new martensitic precipitation hardening
stainless steel for surgical instruments
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Easy ageing with virtually no distortion
Excellent corrosion resistance
Higher strength than other ''PH'' grades
for stronger, lighter and better-designed surgical instruments:
lower tendency to tip hexagon damage of the long thin screwdrivers
● longer periods between two grinding operations for drills, gouges and reamers
● dedicated ta small instruments (O.D. ≤ 2mm) which easily distort
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Typical mechanical properties
ysis
Others
Balance
Δ HRC
Fe
-
550
200
Fe
52
1750
Fe
32
Fe
32
V : 0.3
N : 0.2
UTS N/mm2 YS N/mm2
Properties / Applications
Condition
Solution
treated
Excellent corrosion resistance.
Can be hardened by cold-working.
For highly corrosion-resistant instruments.
1500
Quenched &
tempered
Basic grade for high strength instruments.
1000
750
Quenched &
tempered
1000
750
Quenched &
tempered
-
Quenched,
sub-zero
cooled
& tempered
Very high hardness and corrosion resistance.
Instruments for cutting, guides and assemblies e.g.
milling cutters, drills, taps, broaches, cutting and drilling
guides, screwdrivers,…
Note : must be heat treated with care to optimise properties.
Quenched &
tempered
Same as above, but with limited corrosion resistance.
Excellent combination of corrosion resistance and
mechanical strength.
APX can be hardened up to 47 HRC.
Delivered in the heat treated condition with
UTS ~ 1000 N/mm².
Fe
58
Fe
59
Cu : 4
Nb : 0.3 + Ta
Fe
42
1350
1200
Solution
annealed
& aged
Cu : 2
Ti : 1.2
Nb : 0.4 + Ta
Fe
48
1600
1500
Solution
annealed
& aged
Good combination of strength, toughness and
corrosion resistance.
For highly stressed instruments such as impactors,
screwdrivers and rasps.
Easy to heat treat.
MX455 = metal is vacuum induction melted and remelted.
Al : 1.5
Ti : 0.3
Fe
50
1750
1600
Solution
annealed
& aged
Metal is vacuum induction melted and remelted.
Biopsy and navigation needles.
Screwdrivers, drills.
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As well as austenitic steels, the other two types of steel appropriate for these applications are:
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Martensitic steels which are capable of higher hardness, but which must be quenched and tempered before use.
Precipitation hardening stainless steels which are easy to put into service due to their simple heat treatment.
Relative
Properties
ed stock
Dedicaat l market
ic
ed
for the m
Corrosion resistance
X18 MBC
APX 4
ST4542
APX
MX 455
MX466
APX
X15TN
HRC 47
ST4028
XDBD
Mechanical properties
FRANCE
Wherever you are,
BRAZIL
we are never very far away
CHINA
DEUTSCHLAND
INDIA
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ITALY
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SWITZERLAND
TURKEY
UNITED KINGDOM
Innovative Metal Solutions
STAINLESS is also well-known in the Aerospace,
Connector and Micro-Electronic sectors.
It also has logistics organised around several storage bases
able to offer secure and fast supply
throughout Europe, the USA, China and India.
2, rue Thalès - 25410 Dannemarie-sur-Crète - France
Tél. 33 (0)3 81 48 57 40 - Fax 33 (0)3 81 48 57 52
SUISSE SA
STAINLESS SUISSE SA
STAINLESS AMERICA, Inc.
Bürenstrasse 32 - CH-2542 Pieterlen
Tel. +41 (0)32 377 37 20 - Fax +41 (0)32 377 37 21
3735 W. Belmont - 60618 Chicago IL - USA
Tel. +1(708) 667 7898 - Fax +1(773) 539 9328
www.stainless.eu
ISO 9001:2008
ISO 13485:2003
Photos STAINLESS, DIXI - October 2013
USA