IS 14228: Implants for Surgery-staples with Parallel Legs for Orthopedic Use - General Requirements

11 Pages·1996·1.2 MB·English

by  Bureau of Indian Standards

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“The Right to Information, The Right to Live” “Step Out From the Old to the New”
IS 14228 (1996): Implants for Surgery-staples with Parallel
Legs for Orthopedic Use - General Requirements [MHD 2:
Orthopaedic Instruments, Implants and Accessories]
“!ान $ एक न’ भारत का +नम-ण”
Satyanarayan Gangaram Pitroda
““IInnvveenntt aa NNeeww IInnddiiaa UUssiinngg KKnnoowwlleeddggee””
“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता हहहहै””ै”
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“Knowledge is such a treasure which cannot be stolen”

SI 82241 : 1996
IS0 7288 : 1988

Indian Standard
STNALPMI ROF SELPATS-YREGRUS WITH
LELLARAP SGEL ROF CIDEAPOHTRO ESU -
LARENEG STNEMERIUQER
SCI 3.688.126:32.980-616

_I SIB 6991
@
BUREAU OF INDIAN STANDARDS
KANAM ,NAVAHB 9 RUDAHAB HAHS RAFAZ GRAM
NEW IHLED 200011

March 6991 Price Group 3
cideapohtrO stnemurtsnl dna seirosseccA lanoitceS ,eettimmoC DHM 2
LANOITAN FOREWORD
sihT naidnI dradnatS hcihw si lacitnedi ittiw 0SI 7288 : 8891 stnalpmI‘ for yregrus - selpatS htiw
lellarap sgel for cideapohtro esu - lareneG ,’stnemeriuqer deussi yb eht lanoitanretnI noitazinagrO
for noitazidradnatS ,)OSI( saw detpoda yb eht uaeruB of naidnI sdradnatS no eht noitadnemmocer
of eht cideapohtrO stnemurtsnI dna seirosseccA lanoitceS eettimmoC dna lavorppa of eht lacideM
tnempiuqE dna latipsoH gninnalP noisiviD .licnuoC
ehT txet of evoba denoitnem 0SI dradnats sah neeb devorppa sa elbatius for noitacilbup sa naidnI
dradnatS tuohtiw .snoitaived niatreC snoitnevnoc ,era ,revewoh ton lacitnedi ot esoht desu ni naidnI
.sdradnatS noitnettA si ylralucitrap nward ot eht :gniwollof
)a reverehW eht sdrow lanoitanretnI‘ ’dradnatS raeppa gnirrefer ot siht ,dradnats yeht dluohs
eb daer sa naidnI‘ .’dradnatS
)b Comma ),( sah neeb desu sa a lamiced rekram elihw ni naidnI ,sdradnatS eht tnerruc ecitcarp
si ot esu a tniop ).( sa eht lamiced .rekram
nI siht detpoda ,dradnats ecnerefer sraeppa ot niatrec lanoitanretnI sdradnatS for hcihw naidnI
sdradnatS osla .tsixe
ehT gnidnopserroc naidnI sdradnatS hcihw era ot eb detutitsbus ni rieht ecalp era detsil woleb gnola
htiw rieht eerged of ecnelaviuqe for snoitide :detacidni
International Standard Corresponding Indian Standard Degree of
Equivalence
0SI 5832-i : 7891 SI 7435 traP( )2 : 3991 stnemeriuqeR for lacitnedI
cideapohtro :stnalpmi traP 2 thguorW sselniats
leets (first revision)
0SI 3-2385 : 8791 SI 7435 traP( )4 : 4891 stnemeriuqeR for lacitnedI
cideapohtro :stnalpmi traP 4 thguorW muinatit
muinimula-6 muidanav-4 yolla
0SI 4-2385 : 8791 SI 7435 traP( )5 : 4891 stnemeriuqeR for lacitnedI
cideapohtro :stnalpmi traP 5 -muimorhc-tlaboC
munedbylom gnitsac syolla
0SI 5-2385 : 8791 SI 7435 traP( )6 : 4891 stnemeriuqeR for lacitnedI
cideapohtro :stnalpmi traP 6 -tlaboc-thguorW
netsgnut-muimorhc lekcin yolla
0SI 8106 : 7891 SI 04241 : 5991 cideapohtrO stnalpmi - lareneG lacitnedI
stnemeriuqer for ,gnikram gnigakcap dna -llebal
gni
0SI 2986 : 4891 SI 8061 : 2791 dohteM for elisnet gnitset of leets yllacinhceT
stcudorp tnelaviuqe
(first revision)
roF eht esoprup of gnidiced rehtehw a ralucitrap tnemeriuqer of siht dradnats si deilpmoc ,htiw eht
lanif ,eulav devresbo ro ,detaluclac gnisserpxe eht tluser of a tset ro ,sisylana llahs eb dednuor off
ni ecnadrocca htiw SI 2 : 0691 seluR‘ for gnidnuor off laciremun seulav (revised)‘. ehT rebmun of
tnacifingis secalp deniater ni eht dednuor off eulav dluohs eb eht emas sa taht of eht deificeps eulav
ni siht .dradnats ’
IS 14228 : 1996
IS0 8827 : 1988
Indian Standard
STNALPMI ROF SELPATS-YREGRUS WITH
LELLARAP SGEL ROF CIDEAPOHTRO ESU - ,
LARENEG STNEMERIUQER
1 Scope and field of application 3 Design
This International Standard covers general requirements and 3.1 Radius of curvature
the designation of dimensions and tolerances of staples with
parallel legs intended for use in orthopaedic surgery. The internal radius of curvature of staples made from wire shall
be,not less than 2 mm or the diameter of the wire, whkhever is
NOTE - The annex gives guidance on the selection and use of staples the greater. The curve shall have a smooth contour.
and does not form an integral part of this International Standard.

3.2 Points

Points of staples shall be conical, trocar-shaped, spear-shaped
or flattened (i.e tapered in one plane).
2 References
3.3 Legs
IS0 5832, Implants for surgery - Metallic materials -
The legs shall be parallel.
Part :1 Wrought stainless steel.
NOTES
1 Examples of typical forms of,staples used in orthopaedic surgery
Part 3: Wrought titanium 5aluminium 4-vanadium alloy.
are illustrated in figure 1. Figure 1 shows the designation of dimensions
and gives nomenclature; it does not purport to specify design
Part 4: Cobalt-chromium-molybdenum casting alloy. requirements and does not otherwise form part of the requirements for
staples as laid down in this International Standard.
_ Part 5: Wrought cobalt-chromium-tungsten-nickel alloy. 2 Staples are commonly of circular, oval or modified rectangular
cross-section, although other forms may be used. If staples are made
IS0 6018, Implants for surgery - General requirements for from wire, wire 2,5.mm in diameter is ‘commonly used. Greater
strength may be achieved by usingan oval cross-section, generally of
marking, packaging and labelling.
the order of 4 mm x 2 mm, or by reinforcing the bend area with webs
[see figure lb)]. The legs may be plain, or have barbs or other surface
IS0 6892, Metallic materials - Tensile testing. features or treatments.

1
IS l&228:1998
IS0 8827 : 1988
Internal radius, Corner with
stiffening web
a) Standard staple b) Webbed staple
Barb Barb
T=l!l U
b

c) Barbed staple d) Barbed and webbed staple
1
Step (offset)
2 -
1
LLlv~
e) Stepped (offset) staple f) Tapered staple
Figurd 1 -. Examples of typical forms of staples for use in orthopaedic surgery
2
IS 14228: 1998
IS0 8827 : 1988
Internal radius-,
l-4
b
g) Common staple hl Oblique staple
r-f?
0
1 o 0 + ~yf;;tissue ingrowth
i) Table staple
NOTE - The figures illustrate various types of staple for the purpose of defining the relevant dimensions and features, but the illustrations do not
otherwise form part of the requirements for staples as laid down in this International Standard.
Figure 1 - Examples of typical forms of staples for use in orihopaedic surgery (concluded)

4 Size designation In the case of table staples [see figure li)]; the parallelism
?olerances shall apply to each and every pair of legs.
The size of staples shall be designated by effective length, I,
effective width, b, and diameter, d, respectively (see figure I),
6 Materials
expressed in millimetres, as follows:
25 x 20 x i 8.1 General
Staples with legs of unequal length shall have the effective Staples shall be made from austenitic stainless steel, cast
length of each leg stated. cobalt-chromium-molybdenum alloy, wrought cobalt-
chromium-tungsten-nickel alloy, or wrought titanium alloy.
Staples of oval or modified rectangular cross-section shall have When produced from wire or by casting, the material shall
the major and minor cross-sectional dimensions stated. satisfy the requirements laid down in 6.2, 6.3, 6.4 and 6.5.
5 Tolerances 6.2 Austenitic stainless steel wire
The effective length and effective width of staples shall be in 62.1 Composition
accordance with the nominal dimensions f 1 mm.
Wire used in the manufacture of staples shall be made from
The axis of one lag of the staple shall be parallel, with respect to austenitic stainless steal in accordance with IS0 5632-l and
the axis of the other: leg, within a cylindrical tolerance zone shall comply with the requirements of the corrosion resistance
0,5 mm in diameter (see figure 2). test specified in IS0 5832-l.

3
IS 14228 : 1998
IS0 8827 : 1988
Tolerance in millimetres
Figure 2 - Parallelism of legs
6.22 Tensile properties 700 N/mm2, the proof stress of non-proportional elongation
I?@,, shall be not less than 500 N/mm2 and the percentage
When tested in accordance with IS0 6892, the tensile prop- elongation after fracture shall be not less than 8 %.
erties of the wire in the as-drawn (coiled) condition and after
straightening shal! be as given in the table.
6.4 Wrought cobalt-chromium-tungsten-nickel
alloy
Table - Tensile properties of wire made ~~om
austenitic stainless steel
6.4.1 Composition
Minimum tensile
strength Percentage Wrought cobalt-chromium-tungsten-nickel alloy used in the
Diameter elongation manufacture of staples shall comply with the requirements laid
after fracture
down in IS0 5832-5, except for the tensile properties of the
min. material which shall comply with the requirements laid down in

mm -_- N/mm2 I1 N/mm2 - % 6.4.2.
1 _1550 L1400
1.5 1550 1400 6.4.2 Tensile properties
2 1550 1400
2.5 1550 1400 When tested in accordance with IS0 6892, the tensile strength
3.15 1400 1325 of the cold drawn wire used for staples shall be not less than
4 1400 1240 1 280 N/mm2 and the percentage elongation after fracture shall
be not less than 7 %.
NOTE - The wire may have been subjected to B stress-relieving heat
treatment at a temperature not exceeding 450 OC.
6.5 Wrought titanium alloy
6.3 Cast cobalt-chromium-molybdenum alloy
6.5.1 Composition
6.3.1 Composition Wire made of wrought titanium 6-aluminium 4-vanadium alloy
shall comply with the requirements laid down in IS0 5832-3,
Cast cobalt-chromium-molybdenum alloy used in the manufac- except for the tensile properties of the material which shall
ture of staples shall comply with the requirements laid down in comply with the requirements laid down in 6.5.2.
IS0 5632-4, except for the tensile properties of the material
which shall comply with the requirements laid down in 6.3.2.
6.5.2 Tensile properties
6.3.2 Tensile properties When tested in accordance with IS0 6892, the tensile strength
of the wires used for staples shall be within the range from
When tested in accordance with IS0 6892, the tensile strkgth 1 150 N/mm2 to 1 400 N/mm2 and the percentage elongation
of the staples in the as-cast condition shall be not less than after fracture shall be not less than 3 %.
4
IS 14228:1998
Iso 8827:1988
7 Finish 8 Packaging
The surface finish shall be free from burrs, scratches and other Packaging shall be in accordance with IS0 6018.
defects visible to the naked eye.
NOTE - Particular care should be taken with regard to the quality of 9 Marking of packages
the surface finish of the curved portions of staples.
Packages shall be marked in accordance with IS0 6018. Thp
size of the staples shall be marked in accordance with clause 4
of this International Standard.
Annex
Guidance on use and selection of staples
(This annex does not form an integral part of the Standard.)
In clinical practice; these devices may be found to break or open out under load. This tendency may be reduced by selecting staples
a) of larger cross-sectional area;
b) with webs as illustrated in figures lb) and Id);

c) made by casting in cobalt-chromium-molybdenum alloy or by forging in other suitable alloys.
Extra strength is most important when staples are used for epiphyseal arrest, when the number 2nd location of the staples needs
special consideration in order to distribute the load. The staples should be inserted with the legs of the staple parallel to the epiphyseal
cartilage plate; oblique or stepped (offset) staples are intended to facilitate this where the bone surface is flared.
In order to obtain improved holding, optional surface features, such as barbs or coatings, may be added. The legs of the staple should
not be weakened by incorporating these features which may themselves cause problems when the staples are removed at a later
stage.

5