GOST R ISO 5832-1-2010

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  ГОСТ Р ИСО 5832-1-2010

GOST R ISO 5832−1-2010 Implants for surgery. The metallic materials. Part 1. Corrosion-resistant (stainless) wrought

GOST R ISO 5832−1-2010

Group В32
B33
B34
В74

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

IMPLANTS FOR SURGERY. METALLIC MATERIALS

Part 1

Corrosion-resistant (stainless) wrought

Implants for surgery. Metallic materials. Part 1. Wrought stainless steel

OKS 11.040.40
OKP 93 9800

Date of introduction 2011−11−01

Preface

The objectives and principles of standardization in the Russian Federation established by the Federal law of 27 December 2002 N 184-FZ «On technical regulation», and rules for the application of national standards of the Russian Federation — GOST R 1.0−2004 «Standardization in the Russian Federation. The main provisions"

Data on standard

1 PREPARED by Federal State unitary enterprise «Central research Institute of ferrous metallurgy them. I. P. Bardin» (FSUE «tsniichermet im. I. P. Bardina») on the basis of their own authentic translation into the Russian language of the standard referred to in paragraph 4

2 SUBMITTED by the Technical Committee for standardization TC 453 «Implants in surgery"

3 APPROVED AND put INTO EFFECT by the Federal Agency for technical regulation and Metrology dated November 12, 2010 N 393-St

4 this standard is identical to international standard ISO 5832−1:2007* «Implants for surgery. The metallic materials. Part 1. Wrought stainless steel» (ISO 5832−1:2007 «Implants for surgery — Metallic materials — Part 1: Wrought stainless steel»).
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* Access to international and foreign documents referred to here and hereinafter, can be obtained by clicking on the link. — Note the manufacturer’s database.

In applying this standard it is recommended to use instead of the referenced international standards corresponding national standards of the Russian Federation, details of which are given in Appendix YES

5 INTRODUCED FOR THE FIRST TIME


Information about the changes to this standard is published in the annually issued reference index «National standards», and the text changes and amendments — in monthly indexes published information «National standards». In case of revision (replacement) or cancellation of this standard a notification will be published in a monthly information index «National standards». Relevant information, notification and lyrics are also posted in the information system of General use — on the official website of the Federal Agency for technical regulation and Metrology on the Internet

1 Scope

This standard specifies performance requirements and test methods of rolled deformed corrosion resistant (stainless) steel for the manufacture of surgical implants.

Notes

1 Mechanical properties of steel, obtained on samples of finished products may differ from those specified in this standard.

2 Steel presented in this standard, corresponds to UNS S31673 ASTM F 138 [1], ASTM F 139 [2], and a number 1.4441 to DIN 17443 [3].

2 Normative references

The present standard features references to the following standards*. For undated references, use the latest valid edition.
_______________
* The table of conformity of national standards international see the link. — Note the manufacturer’s database.

ISO 377 Steel and steel products. Location and preparation of test specimens for specific mechanical tests

ISO 404 Steel and steel products. General technical delivery conditions

ISO 437 Steel and cast iron. Determination of total carbon content. Gravimetric method-combustion of the sample

ISO 439 Steel and iron. Determination of total silicon content. Gravimetric method

ISO 629 Steel and cast iron. Determination of manganese. Spectrophotometric method

ISO 643 Steel. Metallographic method of determination of the apparent grain size

ISO 671 Steel and cast iron. The determination of the sulfur content. Titrimetric method with combustion of the sample

ISO 4967:1998 Steel. Determination of content of nonmetallic inclusions. Metallographic method using standard diagrams

ISO 6892 Metallic materials. Tensile test at ambient temperature

ISO 10714 Steel and iron. The determination of phosphorus. Spectrophotometric method with the use of molybdate of postanawia

3 Chemical composition

3.1 Samples for research

Selection of samples for analyses should be carried out in accordance with the requirements of ISO 377.

3.2 the composition of the steel according plavonia analysis

The chemical composition of the steel at plavonia analysis, determined in accordance with section 6 shall conform to the composition given in table 1.

Table 1 — Chemical composition

Item	Mass fraction of elements, %
Carbon	Not more than 0,030
Silicon	Not more than 1.0
Manganese	Not more than 1.0
Phosphorus	0.025
Sulfur	Not more than 0,010
Nitrogen	Not more than 0.10
Chrome	17,0−19,0
Molybdenum	2,25−3,0/2,25−3,00*
Nickel	13,0−15,0
Copper	Not more than 0,50
Iron	Basis
* In the denominator of the given entry, adopted on the territory of the Russian Federation.

The contents of chromium and molybdenum in the steel should satisfy the following condition:

,

where  — mass fraction of molybdenum, in percent;

 — mass fraction of chromium, in percent.

4 Microstructure in the heat treated condition

________________

* Heat treatment method chosen by the manufacturer to achieve the required properties.

4.1 grain Size

Austenitic grain, as determined in accordance with section 6, must not be larger than 5-th number.

4.2 Microstructure

The microstructure of the steel should not contain Delta ferrite, Chi-() or Sigma-phase in the study in accordance with section 6.

4.3 non-metallic inclusions

Pollution steel non-metallic inclusions, determined in accordance with section 6, the target size of hot-rolled steel shall not exceed the values given in table 2.

Note — Possible to use the vacuum or electroslag remelting steel production that meets the specified requirements for cleanliness.

Table 2 — Norms of pollution steel non-metallic inclusions

View inclusions	Non-metallic inclusions, score
	thin series	thick series*
	no more
The Sulphides (A)	1,5	1/1,0
Aluminates (In)	1,5	1/1,0
Silicates (C)	1,5	1/1,0
Globular oxides (D)	1,5	1/1,0
* In the denominator of the given entry, adopted on the territory of the Russian Federation.

5 Mechanical properties

5.1 Samples for testing

The selection and preparation of samples for tensile tests carried out in accordance with the requirements of ISO 377.

5.2 tensile Test

The properties of steel depending on type of steel products: long products, wire, sheet or tape when a tensile test in accordance with section 6 shall conform to the values given in tables 3, 5 and 6, respectively.

If one of the test specimens does not meet the requirements or is destroyed beyond the estimated length of the specimen, repeat tests are carried out in accordance with the requirements of ISO 404.

5.3 the Calculated length

The estimated length should be of 5.65mm or 50 mm depending on the thickness and diameter of the specimen and the initial cross-sectional area profile, in square millimetres (see tables 4 and 7).

Table 3 — Mechanical properties of rolled products

Condition	Diameter or thickness , mm	Tensile strength , MPa	Yield strength , MPa	Elongation , %
			not less than
Heat-treated*	All sizes	490−690	190	40
Cold	Not more than 22	860−1100	690	12
High hardness	No more than 8	No more than 1400	-	-
* Heat treatment method chosen by the manufacturer to achieve the required properties.

Table 4 — calculated Dependence of sample length from the range of steel products

Steel products	The estimated length
	50 mm	5,65
Round bars, wire	More than 5 mm	Not more than 5 mm
Profiles	40 mm	40 mm

Table 5 — Mechanical properties of the wire

Condition	Diameter , mm	Tensile strength , MPa	Elongation , %
			not less than
Heat-treated*	0,0250,13	1000	30
	0,130,23	No more than 930	30
	0,230,38	Not more than 890	35
	0,380,5	Not more than 860	40
	0,50,65	No more than 820	40
	More than 0.65	Not more than 800	40
Cold drawn**	0,20,7	1600−1850	-
	0,71	1500−1750	-
	11,5	1400−1650	-
	1,52	1350−1600	-
* Heat treatment method chosen by the manufacturer to achieve the required properties. ** According to the customer’s requirement cold drawn wire can be supplied with higher strength.

Table 6 — Mechanical properties of tapes and sheets

Condition	Tensile strength , MPa	Yield strength , MPa	Elongation , %
		not less than
Heat-treated*	490−690	190	40
Cold	860−1100	690	10
* Heat treatment method chosen by the manufacturer to achieve the required properties.

Table 7 — the calculated Dependence of sample length to thickness of metal

Steel products	The estimated length
	50 mm	5,65
Strip, sheet	More than 1.5 mm	Not more than 1.5 mm

6 test Methods

Test methods for determination of the requirements of this standard are given in table 8.

Table 8 — test Methods

Requirement	Section or subsection of the standard	Test method
Chemical composition:	3
carbon		ISO 437
silicon		ISO 439
manganese		ISO 629
sulfur		ISO 671
phosphorus		ISO 10714
other items		Accepted analytical methodologies (ISO methods, if any)
Grain size	4.1	ISO 643*
Microstructure	4.2	a) metallographic method to prepare the samples heat-treated** condition with longitudinal and transverse sections; b) using known methods the samples considered in the hundredfold increase of the presence or absence of Delta-ferrite and carbides
Evaluation of inclusions	4.3	ISO 4967:1998, method A, plate II
Mechanical properties: — tensile strength; — yield strength; — elongation	6	ISO 6892, for the relevant steel products
* It is preferable to take samples to determine the grain size after the last heat treatment before the final cold deformation operation. If the samples taken after final operations of cold deformation, the samples must be prepared with transverse sections. ** Method heat treatment chosen by the manufacturer to achieve the required properties.

App YES (reference). Information about the compliance of the referenced international standards national standards of the Russian Federation

App YES
(reference)

Table YES.1

Marking the reference international standard	The degree of compliance	Designation and name of the relevant national standard
ISO 377	-	*
ISO 404	-	*
ISO 437	-	*
ISO 439	MOD	GOST 12346−78 (ISO 439−82) Steel alloyed and high alloy. Methods for determination of silicon content
ISO 629	MOD	GOST 12348−78 (ISO 629−82) Steel alloyed and high alloy. Methods for determination of manganese GOST 22536.5−87 (ISO 629−82) carbon Steel and unalloyed cast iron. Methods for determination of manganese
ISO 643	-	*
ISO 671	MOD	GOST 12345−2001 (ISO 671−82) Steel alloyed and high alloy. Methods for determination of sulfur content
ISO 4967:1998	MOD	GOST 1778−70 (ISO 4967−79) Steel. Metallographic methods of determination of nonmetallic inclusions
ISO 6892	MOD	GOST 1497−84 (ISO 6892−84) Metals. Test methods tensile GOST 10006−80 (ISO 6892−84) of the Pipe metal. Test method tensile GOST 10446−80 (ISO 6892−84) Wire. Test method tensile
ISO 10714	-	*
ISO 14284	-	*
* The corresponding national standard is missing. Prior to its adoption, it is recommended to use the translation into Russian language of this international standard. The translation of this international standard is the Federal information Fund regulations and standards. Note — In this table used the symbol of compliance of the standards: — MOD — modified standard.

Bibliography

[1]	ASTM F 138−03 Technical conditions for the hire wire of wrought corrosion-resisting steel 18 chromium — 14 Nickel — 2.5 molybdenum for surgical implants (UNS S31673)
[2]	ASTM F 139−03 specifications for thin sheet and strip of wrought corrosion-resisting steel 18 chromium — 14 Nickel — 2.5 molybdenum for surgical implants (UNS S31673)
[3]	DIN 17443 corrosion-resistant Steel for surgical implants. Technical delivery conditions