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है”ह”ह

IS 14239 (1995): Orthopaedic Drilling Instruments - DrillBits, Taps and Countersink Cutters [MHD 2: OrthopaedicInstruments, Implants and Accessories]

IS 18239 : 1995 ISO’9714-1 : 1991

Indian Standard

ORTHOPAEDIC DRILLING INSTRUMENTS - DRliL BITS,

TAPS AN-D COUNTERSINK CUTTERS

UDC 616-069.6 : 615.472.3

@ BIS 1995

BUREAU OF INDIAN STANDARDS MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG

NEW DELHI 110002

February 1995 Price Group 3

)li

Otthopaedic Instruments and AccessoriesSectionafCommittee, MHD 2

NATIONAL FOREWORD

This Indian Standard which is identical with IS0 9714-l : 1991 ‘Orthopaedic drilling instruments - Pan 1 Drilfbiis, taps and countersink cutters’, issued by the International Organization for Stand- ardization (ISO), was adopted by theBureau of Indian Standards on the recommendation of the Orthopaedic Instruments and Access&es Sectional Committee and approval of the Medical Equip- ment and Hospital Planning Division Council.

The text of above mentioned IS0 standardhas been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention is particularly drawn to thefollowing:

a)

9

Wherever the words ‘International Standard’ appear referring to this 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 appoint (.) as the decimal marker.

In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which areto be substituted in their place are listed below along with their degree of equivalence for the editions indicated:

International Corresponding Indian Degree of Standard Standard Equivalence

IS0 5835 : 1991 IS 9829 (Part 1) : 1981 Metal bone screws : Technically Pan 1 Screws with asymmetric~thread, variable equivalent fitting (spherical) and IS 9829 (Part 2) : 1981 Metal bone screws : Part 2 Screws with asym- metric thread, conical under surfaces

The concerned technical committee has reviewed the provisions of IS0 7153-l : 1983 referred in this-adopted standard and has decided that this is acceptable for use in conjunction with this standard.

For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2 : 1960 ‘Rules for rounding off numerical values (revised)‘. The number of significant places retained in the rounded off value should be the same as that of the specified value’ in this standard.

Indian Stand&@ .

ORTHOPAEDIC DRILLING INSTRUMENTS - DRILL BITS,

TAPS AND COUNTERSINK; ti#TTERS m.., “”

1 Scope

This part of IS0 9714 specifies materials and me- chanical properties, dimensions and marking re- quirements for drill bits, taps and countersink cutters made of stainless steel for use in orthopaedic surgery with bone screws as specified in IS0 5835.

NOTES

1 The interrelationship of 4nternational Standards deal- ing with bone screws, bone plates and relevant tools is shown for information in annex A.

2 At present only stainless steel has been considered as a material for manufacturing these instruments. Other materials and coatings may be included at a later re- vision.

2 Normative references

The following standards contain provisions which, through reference ini this text, constitute provisions of this part of IS0 91714. At the time of publication, the editions indicated were valid. All standards are subject to revision, aind parties to agreements based on this part of IS0 9714 are encouraged to investt- gate the possibility of applying the most recent edi- tions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards.

IS0 5835:1881, implants for surgery - Metal bone screws wJth heq~#@ *dr&e connection, spherical under-surface of head, asymmetrical thread - Di- mensions.

IS0 7153-1:1883, instruments for surgery - Metallic materials - Part 1: Stalhless steel.

3 Materialb and mechanical properties

Drill bits, taps%~I~&~nt~rsink cutters shall be made from metal complyiQg with the requirements given in IS0 7153-1, irefere@ze letter of steel grade: D, H, I and R.

4 Dlmenribn8

4.1 Drill bits

The diameter of the drill bit shall be as -given in table 1. The potmangle shall be in the range 80° to 1000.

4.2 laps

The core diameter and outside diameter shall be as given In table 1. The thread form and pitch shall be that of, the appropriate screw as specffied in IS0 5835.

1

IS 14@% : 1

:7 IS0 9714 1

, I

4.3 Couriters)hk cutters 5 Mark!-

The diameter of the pin and cutter head shall be as given in table 1 ‘and figure 1. The cutter shall be ei- ther of colnical~ form with an angle of BY or of spherical form.

5.1 Drill blts

Drill bits shall be marked with the diameter of the bit, expressed In millimetres.

Figure 1 - Countersink cutter

5.2 laps

Taps shall be marked with the code and nominal size of the screw, as specified in IS0 5835, with which they are Intended to be used.

5.3 Counterslnk cutters

Countersink cutters shall be marked with the nomi- nal sizes of the screw, as specified in IS0 5835, with which they are Intended to be used.

Table I - Dlmenslons of drill bits, taps and countersink cutters Dimensions in mlllimetres

Screws

(These data are extracted from IS0 5835 and are glven here for Informatlon.)

Drill bits Taps’) Countersink cutters

Diameter Mameter

of drill of drill

Intended Intended

Cutter Outslde Core

Pin head

IS0 5835 Nominal Core for drlllfng dlameter dlameter

Pitch dlameter dlameter

code dlameter diameter Pitch for drllllng

clearance ptlot - dt

d2 hole tapping

hots A.02 -0.01 0 -0.15 0 -0.15 0 -0.1 0

-. .-

Screws wlth shallow thread:

HA 1;s 195 1.1 095 1,s 1,l 1.5 191 0.5 1.1 4

HA2 2 1,3 096 2 185 2 193 0,6 1.1 4

HA 2,7 287 199 1 2,7 2 2,7 f,6 1 2,5 6

HA 33 3.5 294 1,25 395 25 385 24 1,25 2.5 6

HA4 4 299 I,5 4 3 4 2,6 185 25 6

HA 4,6 495 3 1,75 4,5 3,2 4,5 3 1,75 4,s 8

HA5 5 395 1,75 5 3,7 5 335 1,75 4,5 8

Screws with deep thread:

HB4 4 1.6 1,75 Not appll- 2 4 1.6 1,75 Not requlred for HS

HB 6,s 6-5 3 2,75 cable to HB screws

3,2 6,s 3 2,75 screws

1) It is recommended that the maxlmum varlatlon from the theoretlcal profile at any point on thread form should not exceed:

- 0,050 mm for HA 1,s and HA 2

- 6,075 mm for HA 2,7 to HA 5

- 0,075 mm for HEt 4 and HB 6,s

Interrelationship

Annex A (informative)

of International Standards dealing and relevant tools

IS 14229 : 1995 IS0 9714 : 1991

with bone screws, bone plates

It has be n decided that the set of International Standards dealing with bone screws, bone plates and relevant tools sh uld be divided into two parallel series. The basis of the division into two series Is the essentially dif- ferent de igns of the screw threads of the bone screws (HA and HEI type screws as opposed to HC and HD type screws).

A simpli ed schematic guide illustrating the interrelationship between screws, plates and tools covered by the parallet f eries of International Standards is given on the following page.

3

IS 14mo:1QQs Is0 9714:1991

Screw8 Heed under-rurface

Thread

Drive connection

HA HB

u s-1

0 \“““/ \‘““/

conical

ec30 Single

slot

1 Combined dr*Ne connectiona

Single slot and cross- recessed

head

Cruciete slot and uo!8s- recessed

head

In preparation

-

Mechanical requirements IS0 6475

Breaking torque/ angle of rotation

Plates IS0 9269

/ =-..1-- Is09585----

Driving toolr

Keys and screwdrivers

IS0 83192 t I

1 Screwdrhfers

IS0 9714-1 -I_ In preparation

4

Cl1

PI

C33

c41

IS 14239’: 199s IS0 9714 : 1991

Annex B (informative)

Biblihgraphy: International Standards referred -to in table in annex A

IS0 5835:1991, implants for surgery - Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread - Dbnensions.

c53

ISO-5836119 8, bone plate with~asym %

implants for surgery - Metal - Holes corresponding to screws

,etrical thread and spherical under-

[61

surface.

c71 IS0 6475:1989, Implants for surgery - Metal bone screws with asymmetrical thread and spherical under-surface - Mechanical require- ments and test methods. VI

IS0 8319-1:1986. Orthopaedic instruments - Drive connections - Part I: Keys for use with screws with hexagon socket heads. C91

IS0 8319-2:1986, Orthopaedic instruments - Drive connections - Part 2: Screwdrivers for sing/e slot head screws, screws with cruciate slot and cross-recessed head screws.

IS0 9268:1988, fmplants for surgery - Metal bone screws with conical under-surface of head - Dimensions.

!SO 9269:1988, implants for surgery - Metal bone plates - Holes and slots corresponding to screws with conical under-surface.

IS0 9585:1990, implants for surgery - Determi- nation of bending strength and stiffness of bone p/&es.

IS0 9714-l:lBBl, Orthopaedic drilling instru- ments - Part 1: Drill bits, taps and countersink cutters.

. .

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