is 5395-1 (1989): surgical implants - intramedullary ... · .d -. surgical implants-intramedullary...
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IS 5395-1 (1989): Surgical Implants - IntramedullaryNailing Systems for Bone Surgery, Part 1: IntramedullaryNails with Cloverleaf or V-Shaped Cross-Section [MHD 2:Orthopaedic Instruments, Implants and Accessories]
IS 5395 (Part 1) : 1989
IS0 583711 : 1985
Indian Standard
r- )
SPECIFICATION F-OR .d -. SURGICAL IMPLANTS-INTRAMEDULLARY NAILING
SYSTEMS FOR BONE SUR-GERY PART 1 INTRAMEDULLARY NAILS WITH CLOVERLEAF
OR V-SHAPED CROSS-SECTION
(Second Revision)
UDC 61.5.465:621.886.2:616.71-089-74
0 BIS 1990 -\
I
M’ BUREAU OF 4NDIAN STANDARDS MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002
August 1990 Price Group 4
IS 5395 (Part 1) : 1989 5837/l : 1985
Indian Standard
SPECIFICATION IfOR
SURGICAL IMPLANTS-INTRAMEDULLARY NAI-LING SYSTEMS; FOR BONE SURGERY
PART 1 INTRAMEDULLARY NAILS WITH CLOVERLEAF
OR V-SHAPED CROSS-SECTION
(Second Revision)
NATIONAL FOREWORD
This Indian Standard (Part 1) (Second Revisron), which is identical with ISOm5837/1 .1985 ‘Implants
for surgery -1ntramedullary nailing systems -Part 1 : lntramedullary nails with cloverleaf or V-
shaped cross-section: issued by the International Organization for Standardization (ISO) has been
adopted by the Bureau of Indian Standard, on 26 June 1989 on the recommendations of. the
Orthopaedic Instruments and Accessories Sectional Committee (MHDb2) and approval of the Medical
Equipment and Hospital Planning Division Council.
Whereverthe words ‘International Standard’ appear referring tothis,standard, they should be read as
‘Indian Standard’.
Comma (,) has been used as a decimal marker while in Indian standards, the current practice is to use a
point (.) as the decimal marker,.
CROSS REFERENCES
In this Indian Standard, the following International standards are referred to. Read in their respective
places the following,
internatronai Standard Indian Standard Degree of
Correspondence
IS0 583211 : 1987 Implants for surger&Part 1 :Wrought stainleSs
IS 5347 (Part 2) : 1984 Require- Identical ments for orthopaedic implants
steel Part 2 Wrought starnless steel
IS0 5832/5 : 1978 Implants for
.surgery-‘Part,5,: Wrought cobalt- chromium-tungsten-nickel alloy
IS 5347 (Part 6) : 1984 Require- Identical ments for drthopaedic implants : Part 6 Wrought cobalt-chromium- tungsten-nickel alloy
ADDITIONAL INFORMATION
Drthopaedic Instruments and Accessories Sectional Committee felt that na-ils and extracting hooks mey also be provided with the following additional requirements:
Foi\m A, lntramedullary nailswith cloverleaf cross-section, straight (s&3) may be provided iwith eYeof :the same size as given in Fig. 1, on the other end also.
Extracting hooks C&e, 7, may also be provided with dimension
1 ’
‘g’as 4 mini, Min
As in the Original Standard, this Page is Intentionally Left Blank
IS 5395 (Part 1) : 1989 IS0 5837/l : 1985
\ 1 Scope and field of application 2 References
This part of IS0 5857 specifies the main and fitting dimensions IS0 5832, implants for surgey - Metallic materials
for i&ramedullary nails with cloverleaf dr V-shaped cross-
section for use in bone surgery. It also specifies extracting
hooks and recommends the diameters of the guide wires to be
used with the nails.
- Part 1 I Wrought stainless steel.
- Part 5: Wrought cobalt-chromium-tungsten-nickel
al/o y.
NOTE - All dimnsmrrs are given in millimetres
3
IS 5396 (Part 3) : 1983 IS0 5837/-l : 1985
.
3 Form A
lntrameduilary nails with cloverleaf cross-section, straight.
Figure 1
l b3 can continue throughout the length of the nail. For functional reasons it is to be borne in mind that in this case bg shall not exceed the diameter of the relevant guide wire (see clause 81.
r ‘
L
1
1
1
Table 1
6 7 1 8 9 10 11 12 13 14 15 16 -
I1 0 - 0 0
-0.18 0.22 - 0.27
‘2 min. 27 3 1 3.3. 1 3.8 ( 45 - 5,3 8.3
19 I 2.5 -T--T- ‘1 I ,- I _P_L-
+ 0.45 + 0.7
I 0 I 0
‘2 min. 2.2 3.2 .--
53 + 0.7
0 2.5 ‘3,3
_______.
r Wrcught cobalt- chromknn- tungsten-nickel alloy,
IS0 5832/5
(In all ranges steps of ’ 10 mm)
0,80 0.90 to to
1.15 1,25
1 1.15 to 1,30 to 1.55
I.50 , ----- 0,79 0,97 0% 1’77 1,27 to 1.47
--- 140 2M) 240 290
4E 5% zl to
!xN
4
IS 6395 (Part 1) : 1989 ISO5837/1:1985
4 form B
lntramedullary nails with cloverleaf cross-section, curved. =60
L---1
This end may be straight or curved at the discretion of the purchaser
This end may be fluted discretion of the purchaser
Figure 2
Table 2
bz
I to I to I to I 1.30 to 1.65
s -.-. Wrought cobalt- chromium- tungsten-nickel alloy, IS0 6632/5
(In all ranges steps of ’ 10 mm)
___.__--.--
1.27 to 1.47
-- -- -- 240 I 290
I ! 4% &I
.5
IS 5395 (Part 1) : q 989 IS0 5837/l : 1985
6 Form C
Intramedullary nails with V-shaped cross-section.
I
~.___--...-_.._.---~_-__ --I --_-
Figure 3
Table 3
----.__ --0.18 -0.22 ______I___.
b2 min. 1,3 -l__:_‘i:9__~_” ’
Stainless steel type 6, IS0 583211 \
___I____- I,10 to 1.40 _._-L 1,35 to 1.65
a 4 50 350 _~___~ __._____-
~--__71_53”.’
I lln all ranges steps of 10 mm) 126 t@ 300
6 Form D
lntramedullaty nails Jvith ulove’rleaf crosxection, double-ended.
t
25min _I ‘\
___. ---I_----___ ..- .--------------~ /
Figure 4
l bs can continue throughout the length-of the nail. For functional reasons it is to be borne in mind that in this case h3 shall not exceed the diameter of the relevant guide wire (see clause 8).
The ends may be fiat or tapered in an asymmetric curved manner at the discretion of the purchaser.
The dimensions of the form D nails are given in table 1, as far form A.
IS 5395 (Part 1) : 1989
IS0 5837/l : 1985
7 Extracting hooks
T?E dimensiors of the r?xtracting hooks are given in tables 4 and 5.
Figure 5
Table 4
r- For cloverleaf naiis
range of diameter d,
t-- - I
g mm. 2 I
8 Recommended diameters of guide wires
Table 6 ,
Diameter of nails 6 / 7 8 -___
for nails
Diameter ofoguide Form A and D i 2.5 .3
, __._- ~---- wires, _oo5 for nails
I Form B Z.6 3 3,5 1 4
7
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Amendments Issued Since Publication
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