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है”ह”ह

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

Buream of Indian Standards

RIS is ;I ;tltutory institution established under the Bureau of Indian Standards Act, 1986 to promote harmor&Jr;.: tiG:velopment of the activities of standardization, marking and quality certification of goods and attending to connected matters in the country.

Copyright

BZS has the copyr;ght of all its publications. No part of these publications may be reproduced in any form without the prior permission in writing of BIS. This ,does not preclude the free use, in the course of implementing the standard, of necessary details, such as symbols and sizes, type or grade designations. Enquiries relating to copyright be adressed to the Director ( Publications ), BIS.

Revision~of Indian Standards

Indian Standards are reviewed periodically and revised, when necessary and amendments, if any, are issued from time to time. Users of Indian Standards should ascertain that they are in possession of the’ latest amendments or, edition. Comments on this Indian Standard may be sent to BIS giving the following reference:

Dot. No. MHD 2 (2135)

Amendments Issued Since Publication

Amend No. Date of Issue Text Affected

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