International Standard

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION*MEXfiYHA?O~HAR OPrAHM3AUMR ll0 CTAHCIAPTM3ALWWORGANlSATlON INTERNATIONALE DE NORMALISAT~ON

Foreword
IS0 (the International Organization for Standardization) is a worldwide federation of
national standards bodies (IS0 member bodies). The work of preparing International
Standards is normally carried out through IS0 technical committees. Each member
body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, govern-
mental and non-governmental, in liaison with ISO, also take part in the work.

Draft International Standards adopted by the technical committees are circulated to

the member bodies for approval before their acceptance as International Standards by
the IS0 Council. They are approved in accordance with IS0 procedures requiring at
least 75 % approval by the member bodies voting.
iTeh STANDARD PREVIEW
International Standard
Surgical instruments.
IS0 7741 was prepared
(standards.iteh.ai)
by Technical Committee ISO/TC 170,

Users should note that all International

ISO 7741:1986
Standards undergo revision from time to time
https://standards.iteh.ai/catalog/standards/sist/d018b022-c3ce-4738-9cc9-
and that any reference made herein to any other International Standard implies its
latest edition, unless otherwise stated. 6964b967755f/iso-7741-1986

0 International Organization for Standardization, 1986

Printed in Switzerland
INTERNATIONAL STANDARD IS0 7741-1986 (E)

Instruments for surgery - Scissors and shears -

General requirements and test methods

1 Scope and field of application 3.2 Rivet or screw

This International Standard specifies general requirements and The rivet or screw shall be made of stainless steel chosen, at
corresponding routine test methods for scissors and shears the discretion of the manufacturer, from the grades specified in
which are used in surgery. IS0 683/13.

2 References 4 Requirements

IS0 683113, Heat-treated steels, alloy steels and free-cutting 4.1 Heat treatment and hardness for component
s tee/s - Part 73: Wrought stainless steels. parts, excluding rivets and screws
IS0 4957, Tool steels.

IS 0 6507 / 1, Metallic materials iTeh STANDARD4.1PREVIEW

- Hardness
.I Heat treatment
test - Vickers test
The component parts of the instruments shall be heat treated
- Part 7: HV 5 to HV 100.

IS0 6508, Metallic materials - Hardness

(standards.iteh.ai)
test - Rockwell test
under suitable conditions to ensure compliance
requirements of 4.1.2 and 4.1.3 for the material used.
with the
- Scales A, B, C, E, F, G, H. 1)

ISO 715311, Instruments for surgery

ISO 7741:19864.1.2 Hardness for instruments
- Metallic materials - without tungsten
Part 7: Stainless steel. https://standards.iteh.ai/catalog/standards/sist/d018b022-c3ce-4738-9cc9-
carbide or stellite inserts
6964b967755f/iso-7741-1986
The Rockwell hardness of the finished instruments shall be
3 Material within the range from 50 HRC to 58 HRC (approximately
equivalent to Vickers hardness range from 530 HV to 670 HV)
3.1 Component parts when tested in accordance with IS0 6508 and IS0 6507/l,
respectively. Opposite blades shall not vary in hardness by
The component parts of the instruments, excluding the rivet or more than 4 units on the Rockwell C hardness scale.
screw, shall be made of stainless steel in accordance with
table I. 4.1.3 Hardness for instruments with tungsten carbide
or stellite inserts
Table 1 - Material - Steel grades
The Vickers hardness of the tungsten carbide or stellite inserts
I Steel grade
shall be at least 710 HV 10 when tested in accordance with
Reference letter Grade No. according to IS0 6507/l. The inserts of opposite blades shall not vary in hard-
according to ness by more than 50 units on the Vickers HV 10 hardness scale
IS0 7153/l IS0 4957 IS0 683/13

I B" I 27" ~ 1 4" I

The Rockwell hardness of the body of the instruments
tungsten carbide or stellite inserts shall be 40 HRC min.
with
C ** 28 5
D - -
H - - 4.2 Corrosion resistance
I - -

* Only for scissors and shears with tungsten carbide or stellite

4.2.1 Scissors and shears made of steel grade C
inserts.
Two test methods are specified for determining corrosion
** Special attention should be given to meeting the requirements resistance !see 4.2.3 and 4.2.4). Both of these tests shall be car-
of 4.1.2. ried out.

1) At present at the stage of draft. (Revision of ISO/R 80-1968 and IS0 2713-1973.)
 IS0 7741-1986 (El

4.2.2 Scissors and s made of steel grades B, D, l-l 2 Instruments with a mirror finish should be adequately ground to
and I remove all surface imperfections and polished to remove grinding
marks in order to achieve a mirror finish. This should be achieved using
Two test rnethods are specified for determining corrosion an appropriate procedure, for example polishing, brushing, electro-
polishing and mirror buffing.
resistance (see 4.2.3 and 42.4).
3 Attention is drawn to the fact that some surface coatings applied to
NOTE - When placing an order, the purchaser should state whether surgical instruments can be detrimentally affected if the instrument is
both tests are to be carried out or, if not, which of the tests is to be car- cleaned in a solvent-cleaning machine. Such incompatibilities should
ried out. If the purchaser does not provide such a statement, the be anticipated and avoided or minimized.
choice is left to the discretion of the manufacturer.
4.4.3 Passivation and final treatment
4.2.3 Test for resistance to copper sulfate
The instruments shall, unless the metallurgical characteristics
of the instrument (for example the presence of brazed or
Except as specified below, there shall be no plating of copper
soldered junctions) renders it inappropriate, be treated by a
on the instruments, when tested as specified in 5.1. Copper
suitable passivation process.
plating at the edges of the drops of the copper sulfate solution,
or at soldered or brazed junctions, or dulling of polished NOTES
surfaces caused by the copper sulfate solution, shall be
1 Examples of methods of passivation are by electropolishing or by
disregarded. A slight plating of copper in small areas of the treatment with 10 % ( V/V) nitric acid solution for not less than 30 min
joints shall be disregarded. at a temperature of not less than IO OC and not exceeding 60 OC. The
instruments should then be rinsed in water and dried in hot air.

4.2.4 Test for resistance to boiling water 2 If the joints are lubricated, the lubricant should be non-corrosive
and suitable for medical application in accordance with the relevant
When tested as specified in 5.2, there shall be no visible signs national pharmacopoeia.
of corrosion.
4.5 Cutting ability
4.3 Workmanship
iTeh STANDARD PREVIEW
The cutting ability of the instruments shall be tested in ac-

The instruments shall be manufactured

(standards.iteh.ai)
in accordance with the
cordance with clause 5.3.

recognized standards of workmanship. The testing material shall be cut cleanly without tearing.
ISO 7741:1986
The instruments shall have joints https://standards.iteh.ai/catalog/standards/sist/d018b022-c3ce-4738-9cc9-
which move smoothly and After the test, no distortion, cracks or any other permane nt
shall be neither too loose nor too tight; it shall be possible to modifications
6964b967755f/iso-7741-1986 of the instrument shall be visible.
close and reopen the instrument easily with two fingers.

5 Test methods
4.4 Surface condition
5.1 Copper sulfate test
4.4.1 General
5.1 .l Test solution
All surfaces shall be free from pores, crevices and grinding
marks. The instrument shall be supplied free from residual Copper (II) sulfate pentahydrate
scale, acid, grease and grinding and polishing materials. Com- (CuSO,=5H,O) 4,og
pliance with these requirements shall be checked by inspection
under normal vision, corrected, if necessary.
Sulfuric acid CQ(H2S04) = I ,&I g/ml] w g
Distilled water 90,O ml

4.4.2 Surface finish

5.1.2 Apparatus
The surface finish shall be one of, or a combination of, the
Glass or ceramic beaker.
following :

a) mirror polished ; 5.1.3 Preparation

b) reflection-reducing, for example satin finish, matt black
Scrub the instrument using soap and warm water, rinse
finish; ’
thoroughly in distilled water, dip in 95 % (V/V) ethanol and dry.
c) an applied surface coating, for for electrical in-
sulation purposes.
5.1.4 Procedure

NOTES Immerse the instrument in the test solution contained in the

1 The satin finish should be achieved using an appropriate procedure, beaker at room temperature for 6 min. Remove the instrument
for example grinding, brushing, electropolishing and, in addition, satin and wash it with distilled water or water of equivalent quality,
finishing (glass beading or satin brushing). The finish should be or wipe it with wet cotton wool. Examine the instrument for
uniform and smooth and it should reduce glare. evidence of copper deposits.

2
 IS0 7741-1986 (E)

5.2 Boiling water test Then remove the instrument from the water and leave it
exposed to the air for 2 h. Rub the instrument vigorously with a
dry cloth and examine it. Record the presence of blemishes.
5.2.1 Reagent

Distilled or de-ionized water. 5.3 Cutting ability

5.2.2 Apparatus The instrument shall be cleaned, as specified in 5.2.3, before

testing.
Glass or ceramic beaker or suitable corrosion-resisting,
stainless steel vessel. The testing material in accordance with table 2 shall be cut .lon-
stop three times along two-thirds of the blade without lateral
pressure.
5.2.3 Preparation of sample

Scrub the instrument using soap and warm water, rinse

6 Marking
thoroughly in water (5.2.1) and dry.

6.1 The instrument shall be marked with at least the trade

5.2.4 Procedure mark of the manufacturer or supplier.

Immerse the instrument in boiling water (5.2.1) in the beaker or

vessel for at least 30 min. Subsequently, allow the instrument 6.2 Instruments not having tungsten carbide inserts shall not
to cool for at least 1 h in the water used for the test. have gold-coloured handles.

Table 2 - Testing materials

Testing
iTeh STANDARD Number
PREVIEW Category Examples

Wetted
material
tissue
(standards.iteh.ai)
of layers
1
of instrument
Micro-spring Barraquer scissors
paper I ridectomy scissors
ISO 7741:1986 De Wecker scissors
--
Gauze https://standards.iteh.ai/catalog/standards/sist/d018b022-c3ce-4738-9cc9-
No. 181) 2 Lightweight Iris scissors
6964b967755f/iso-7741-1986
Bow-handled Strabismus scissors
Stevens tendon scissors
Kilner dissecting scissors
Potts-de-Mar-tell scissors
Joseph scissors

5 Medium weight Mayo scissors

Bow-handled Metzenbaum scissors
Nail scissors
Sims uterine scissors
Dauphine dressing scissors
Tonsil scissors

8 Heavyweight Lister bandage scissors

Smith bandage scissors
Bowel scissors
Doyen flesh scissors

1) In accordance with the European pharmacopoeia.

3
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ISO 7741:1986
https://standards.iteh.ai/catalog/standards/sist/d018b022-c3ce-4738-9cc9-
6964b967755f/iso-7741-1986
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ISO 7741:1986
https://standards.iteh.ai/catalog/standards/sist/d018b022-c3ce-4738-9cc9-
6964b967755f/iso-7741-1986
 iTeh STANDARD PREVIEW
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ISO 7741:1986
https://standards.iteh.ai/catalog/standards/sist/d018b022-c3ce-4738-9cc9-
6964b967755f/iso-7741-1986