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GOST R 50328.1-92

GOST 30208−94 (ISO 7153−1-88)/GOST R 50328.1−92 (ISO 7153−1-88) Instruments. The metallic materials. Part 1. Stainless steel


GOST 30208−94 (ISO 7153−1-88)
GOST R 50328.1−92 (ISO 7153−1-88)

Group P21

INTERSTATE STANDARD

Surgical instruments

METALLIC MATERIALS

Part 1

Stainless steel

Surgical instruments. Metallic materials. Part 1. Stainless steel

ISS 11.040.30
11.060.20
77.140. 20
OKP 94 3000

Date of introduction 1994−01−01*
_________________
* For more information about the introduction
force see the label «notes». -
Note the manufacturer’s database.

INFORMATION DATA

1 PREPARED by the Technical Committee for standardization TC 14 «Medical instruments"

2 Adopted by the Interstate Council for standardization, Metrology and certification (Protocol No. 5 of 20 may 1994)

This standard is prepared by the direct application of international standard ISO 7153−1-88 «Instruments. The metallic materials. Part 1. Stainless steel» with additional requirements that reflect the needs of the economy

By the resolution of Gosstandart of Russia from March 12, 1996 N 164 GOST 30208−94 (ISO 7153−1-88) promulgated as the national standard of the Russian Federation from the date of adoption of this resolution and recognized as having equal force with GOST R 50328.1−92 (ISO 7153−1-88) on the territory of the Russian Federation in connection with the full authenticity of their content

3 INTRODUCED FOR THE FIRST TIME

4 REFERENCE NORMATIVE AND TECHNICAL DOCUMENTS

     
Designation of the domestic normative referenced Designation international standard
The partition number, apps
-
ISO 683−13−86 2; 4
-
ISO 4957−80 2; 4
GOST 5632−72
- App

5 REISSUE

1 Scope

This standard applies to stainless steel used for making surgical and dental tools and special tools for orthopaedic surgery.

Note — When selecting the steel grade, shape, size and condition for supply of tools must take into account factors such as tool design and manufacturing capabilities of the manufacturer is not covered by this standard.


This standard does not exclude the possibility of using steels other brands in the manufacture of tools, such as carbon steels for cutting tools.

The requirements of section 4 are mandatory, other requirements are recommended.

Compliance steels set this standard, grades of steel used in the economy, given in the Appendix.

2 Normative references


The present standard features references to the following standards:

ISO 683−13−86 Steel heat-treated. Alloy and high speed. Part 13. Steel forged stainless steel*

ISO 4957−80 Tool steel*
_______________
* See informational data.

3 Selection of steel grades


Examples of the use of steel for the manufacture of tools for various purposes is given in table 1.


Table 1

       
Refer to
the increase of steel grades
(see table.2)
Cutting tools Preferably used for narezushi tools Mounting parts and other accessories
And - Forceps for removal of tissue; surgical forceps; retractors; probe; forceps-forceps; dental (small)
Axis; solid handle; dowel pins; screws; nuts
In Bone pliers; wire cutters; conchotomy; chisels and drill bits fluted; bone curette; cutters with plates of hard alloy Clamps; clamps with curved handles; the tongs to separate; retractors; probes; dental forceps to remove the teeth.

Probes dental; root elevators; kangalanatolian; dental forceps-tweezers small
Coil springs; integral handles; screws; nuts
With Bone nippers; cutters; tools for removing dental calculus; dental instruments; dental drill bits Laboratory and orthopedic forceps; dental probe; tweezers-dental forceps (small); dental forceps for tooth extractions; root elevators; kangalanatolian
-
D Scissors; rongeur; bone cutting forceps; conchotomy; scalpels; knives; drill bits and drill bit fluted; bone curette; wire cutters; tools for removing dental calculus; dental instruments; dental drill bits
Root elevators; dental probes; kangalanatolian -
E, F
Scalpels - -
G Scalpels; chisels and drill bits fluted; scissors large
- -
N Scissors; rongeur; conchotomy; chisels and drill bits fluted; bone curette; wire cutter for wire
- -
I Scissors; rongeur; conchotomy; scalpels; knives; drill bits and drill bit fluted; bone curette; wire cutter for wire
- -
K Chisels and drill bits fluted; bone curette
- -
L - - Solid handle; the guide pins, axles, screws, nuts
M - Retractors; bath for prints Hollow handle; the guide pins, rivets, screws
N Chisels; bone curette Probes One-piece handle; guide pins; rivets; axis; screws; nuts
On - Probes dental Spring; nut; rivet
R
- - Screws; rivet
R Tools for removing Tartar; drill bits; dental curette Kangalanatolian; dental probes; laboratory and orthodontic pliers
-

4 Chemical composition


The chemical composition of the steel must correspond to that specified in table

2. The chemical composition of the steels referred to in ISO 683−13 and ISO 4957, are given for information only.


Table 2

                         
Steel grade
Mass fraction of elements, %
  Class
               
Train-
the beginning
nie

ISO
4957
at
ISO
683−13
Carbon

Cream
tions,
no more
Marga-
finally,
no more
Foz
the odds, nothing more
Sulfur

Chrome

Moth
bden

Nickel

Other ele-
cops

Martensitic steel
And - 3 0,09
to 0.15
1,0 1,0 0,040 Not more than 0,030 11,5
to 13.5
- Not more than 1.0 -
In 27 4 0,16
to 0.25








12,0
to 14.0




 
With 28 5 0,26
to 0.35
















D - - 0,42
to 0.50








12,5
14.5






E



0,47
to 0.57
0,50

0,030 0.025 13,7
to 15.2


Not more than 0,50


F     0,60
to 0.70
        12,0
to 13.5
   
G



0,65
to 0.75
1,0

0,040 Not more than 0,030
12,0
to 14.0
0,50 Not more than 1.0  
H



0,35
to 0.40




0,045

14,0
to 15.0
0,40
to 0.60
- Vanadium:
0,10
to 0.15
I     0,42
to 0.56
        12,0
to 15.0
0,45
to 0.90
 
K 30

0,33
to 0.43




0,030

15,0
to 17.0
1,0
to 1.5
Not more than 1.0
-
R  

0,85
to 0.95




0,045

17,0
to 19.0
0,9
to 1.3
- Vanadium: 0,07
to 0.12
Ferritic steels
L - 8A Not more than 0.08
1,0 1,5 0,060 0,15
to 0.35
16,0
to 18.0
Not more than 0,60 Not more than 1.0 -
Austenitic steel
M - 11 Not more than 0.07
1,0 2,0 0,045 Not more than 0,030 17,0
to 19.0
- 8,0
to 11.0
-
N

17 Not more than 0.12




0,060 0,15
to 0.35




8,0
to 10.0


On

14 Not more than 0.15




0,045 Not more than 0,030 16,0
to 18.0


6,0
to 8.0


P

20 Not more than 0.07








16,5
to 18.5
2,0
to 2.5
10,5
to 13.5


Notes

1 Not allowed to enter in the steel alloying elements not provided for in table 2, without the consent of the customer, except use them to complete the melting process. Do not allow any of the scrap or other charge material elements affect the hardenability, mechanical properties and applicability.

2 Letter grades used in this standard only for reference in tables 1 and 2.

3 Rooms steel grades are preliminary and can be changed when you publish an international standard.

4, the Manufacturer may add molybdenum to 0.7%.

Application (reference). Table of compliance of steel grades stated in this standard, grades of steel used in the economy

APP
(reference)



Table 3

       
  Analogue steel for the country’s economy
 
The designation of the steel grade

Steel grade Designation of the normative document
The degree of conformity of the chemical composition of the steel according to ISO 7153−1-88
The possibility of application of domestic industry
And 12X13
GOST 5632−72 The match is full, the application may
In 20X13    
With 30X13    
D 45X14    
E -
- -
F 65X13 THAT 14−1-4105−86 Full compliance (upper limit for chromium more — 14%); the use is possible
G, N - - -
I 50Х14МФ THAT 14−1-3909 Compliance complete (the upper limit for molybdenum — 0,8%); use is possible
K - - -
R 90Х18МФ THAT 14−1-4628−89 The match is full, the application may
L - - -
M 12KH18N9 GOST 5632−72 Compliance complete (the upper limit on carbon and 0.12%); application possible (up to the creation of new steel)
N, O, P - - -




The electronic text of the document
prepared by JSC «Code» and checked by:
the official publication of the
High quality steel: a Collection of Standards. -

M.: IPK Publishing house of standards, 2002