इंटरनेट मानक

Disclosure to Promote the Right To Information

Whereas the Parliament of India has set out to provide a practical regime of right to
information for citizens to secure access to information under the control of public authorities,
in order to promote transparency and accountability in the working of every public authority,
and whereas the attached publication of the Bureau of Indian Standards is of particular interest
to the public, particularly disadvantaged communities and those engaged in the pursuit of
education and knowledge, the attached public safety standard is made available to promote the
timely dissemination of this information in an accurate manner to the public.

“जान1 का अ+धकार, जी1 का अ+धकार” “प0रा1 को छोड न' 5 तरफ”

Mazdoor Kisan Shakti Sangathan Jawaharlal Nehru
“The Right to Information, The Right to Live” “Step Out From the Old to the New”

IS 11640-7 (1987): Retractor, Part 7: Abdominal and Liver,

Mikulicz's Pattern [MHD 1: Surgical Instruments]

“!ान $ एक न' भारत का +नम-ण”

Satyanarayan Gangaram Pitroda
“Invent a New India Using Knowledge”

“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता ह”

है”
ह
Bhartṛhari—Nītiśatakam
“Knowledge is such a treasure which cannot be stolen”
 UDC 618’472:617’55:616’36 IS:1164d(Part7)-IQ87 .

( Reaffirmed 1998 )
Indian Standard

SPECIFICATION FOR RETRACTOR 13

PART 7 ABDOMINAL AND LIVER, MIKULICZ’S PATTERN

I. scope- Specifies dimensional and other requirements of abdominal and liver, Mikulicz’s patterr
:urved retractor used in general surgery.

2. Shape and Dimensions - As shown in Fig. 1.

I 4 b 4 ha Mr
+5 +5 f2 = P CI

i
240 95 35 10 45 230
7
‘
.:
7 60 280
250 129 5O 15

255 165 50 18 75 320

I
All dimensions in millimetres.

FIG. 1 RETRACTOR, ABDOMINAL AND LIVER, CURVED TYPE, MIKULICZ’S PATTERN

3. Material -Stainless steel conforming to Designation 20Crl3 or 30Cr13 of IS : 6603-1972 ‘Spec

fication for stainless steel bars and flats’.

Adopted 6 March 1987 I 0 January 1988, BIS I Or 2

BUREAU OF INDIAN STANDARDS

MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
WEW DELHI 110002
IS : 11640 ( Part 7 ) - 1987

4. Requirements

4.1 Heat Treatment and Hardness-The retractor shall be heat treated to give a hardness of 390-485
HV when tested in accordance with IS : 1501-I 968 ‘Method for Vickers hardness test for steel ( first
revision )‘.

4 .~2 Workmanship - The retractor shall be free from burrs, pits, cracks and other surface defects. The
edges of the blade shall be properly rounded.

4.3 Surface Condition - All surfaces shall be free from pores, crevices and grinding marks. The
retractor shall be supplied free from residual scale, acid, grease and grinding and polishing materials.
Compliance with these requirements shall be checked by inspection using normal vision (corrected,
if necessary).

4.4 Surface Finish -The surface finish shall be one of or a combination of the following:

a) Mirror polished;
b) Reflection-reducing, for example, satin finish or matt black finish; and
c) An applied surface coating, for example, for insulation purposes,
Note -The satin finish should be effected bv an appropriate procedure, such as grinding, brushing, electropolishing
and, in addition, satin finishing (glass beading or satin brushing ). The finish should be uniform and smooth and It
should reduce glare. Instrumentof mirror finish should be adequately ground to remove all surface imperfections and
polished to remove grinding marks, resulting in a mirror finish. The mirror finish shouid be effected by an appropriate
procedure such as polishing, brushing, electropolishing, and mirror buffing.

4.5 Passivation and Final Treatment - The retractor shall be treated by a suitable passivation process.
Note 1 - Examples of methods of passivation are by efectropolishing or by treating with 10 percent (v/v) nitric acid
solution for not less than 30 minutes at a temperature of not less than 10°C and not exceeding 60°C. The retractor
should then be rinsed in water and dried in hot air.

Note 2 - If the joints are lubricated, the lubricant should be non-corrosive and suitable for medical application
according to the Indian Pharmacopoeia.

5. Tests

5.1 Rigidity Test

5.1.1 The retracting part of the blade shall be applied to the edge of a chair or table. It shall be
pulled manually by exerting a maximum force along the axis of the handle. The retractor shall show
no sign of damage or permanent set.

5.1.2 A force of 300 N shall be applied at the top of the turned end of the retracti.ng blade. The
maximum force shall_ be gradual!y_atta/ned and maintained for two minutes. On completion of the
test the retractor shall show no sign of damage.

5.2 Corrosion Resistance -Test the retractor in accordance with IS : 7531-1975 ‘Method for boiling
and autoclaving test for corrosion resistance of stainless steel surgical instruments’. The retractor shall
show no sign of corrosion after the test.

6. Marking - Each retractor shall be -marked with the following:

a) Manufacturer’s name initials or recognized trade-mark; and
b) The words ‘Stainless Steel’.

6.1 Certification Marking - Details available with the Bureau of Indian Standards,

7. Packing - Each retractor may be wrapped in a moisture-proof paper or put in a polyethylene bag
and packed in cardboard cartons. The retractor may also be packed as agreed to between the purchaser
and the supplier.

6. Sampling - Sampling procedure and acceptance criteria for conformity shall be as agreed to bet-
ween the purchaser and the supplier. A recommended scheme for the same is given in Appendix A.
 IS:11640( Part7) -1987

APPENDIX A
( Clause 8 )

SAMPLING PLAN AND CRITERIA FOR CONFORMITY

A-l Lot

A-l.1 In a consignment, all the retractors of the same pattern and dimensions shall be grouped toge-
ther to constitute a lot not exceeding 50 items. Each lot shall be tested for the requirements of this
specification.

A-2. Scale of Sampling and Criteria for Conformity

A-2.1 Eight retractors shall be selected at random from each lot by using random number tables (see
IS : 4905-l 968 ‘Methods for random sampling’ ). Each retractor in the sample shall be individually
tested for the requirements of shape and dimensions ( 2 ), material ( 3 ), workmanship and finish ( 4.2
to 4.4 ), and marking ( 6 ). Any retractor failing to meet one or more of the above requirements shall
be termed defective. No defective retractor in the sample shall be permitted if the lot is to be accep-
ted in this clause.

A-2.2 The lot which has been found satisfactory according to A-2.1 shall be tested for hardness ( 4.1 ),
rigidity ( 5.1 ), and corrosion resistance test ( 5.2 ). For this purpose, one retractor shall be sampled at
random and be tested for the above requirements. If need be, more retractors may be drawn for con-
ducting the relevant tests.

A-2.2.1 No failure shall occur if the lot is to be declared acceptable under this clause.

EXPLANATORY NOTE

This standard is one of the series of Indian Standards on retractors.

In the preparation of this standard assistance has been derived from DIN 58289-1983, Abdominal
and liver retractor Mikulicz, blade curved issued by Deutsches Institut fiir Normung, West Germany.
3

Printed at Printrade, New Delhi, India