GOST 31622-2012
GOST 31622−2012 rental of corrosion-resistant steel for surgical implants. Technical specifications (with Amendment)
GOST 31622−2012
INTERSTATE STANDARD
RENTAL OF CORROSION-RESISTANT STEEL FOR SURGICAL IMPLANTS
Specifications
Wrought stainless steel for surgical implants. Specifications
ISS 77.140.20
11.040.70
Date of introduction 2015−01−01
Preface
Goals, basic principles and procedure of works on interstate standardization have been established in GOST 1.0−92 «interstate standardization system. Basic provisions» and GOST 1.2−2009 «interstate standardization system. Interstate standards, rules and recommendations on interstate standardization. Rules of development, adoption, application, renewal and cancellation"
Data on standard
1 PREPARED by the Federal state unitary enterprise «all-Russian research Institute of standardization and certification in engineering» (VNIINMASH)
2 as AMENDED by the Federal Agency for technical regulation and Metrology (Rosstandart)
3 ACCEPTED by the Interstate Council for standardization, Metrology and certification (Protocol of may 24, 2012 No. 41)
The adoption voted:
| Short name of the country on MK (ISO 3166) 004−97 | Country code MK (ISO 3166) 004−97 |
Abbreviated name of the national authority for standardization |
| Azerbaijan | AZ |
Azstandart |
| Belarus | BY |
Gosstandart Of The Republic Of Belarus |
| Kazakhstan | KZ |
Gosstandart Of The Republic Of Kazakhstan |
| Kyrgyzstan | KG |
Kyrgyzstandard |
| Russia | EN |
Rosstandart |
| Uzbekistan |
UZ | Uzstandard |
| Ukraine | UA |
The Ministry Of Economic Development Of Ukraine |
(Amendment. ICS N 7−2016).
4 by Order of the Federal Agency for technical regulation and Metrology dated 1 November 2012 N 673-St inter-state standard GOST 31622−2012 introduced as a national standard of the Russian Federation from 1 January 2015.
5 this standard corresponds to international standard ISO 5832−1:1987* Implants for surgery — Metallic materials — Part 1: Wrought stainless steel (Implants for surgery. The metallic materials. Part 1. Wrought stainless steel) in terms of requirements to chemical composition, mechanical properties, austenite grain size, presence of alpha-phase, the purity of the metal non-metallic inclusions and resistance to intergranular corrosion.
________________
* Access to international and foreign documents referred to here and hereinafter, can be obtained by clicking on the link to the site shop.cntd.ru. — Note the manufacturer’s database.
Translation from English (en)
The degree of compliance — non-equivalent (NEQ).
The standard is based on the application of GOST R 51394−99.
6 INTRODUCED FOR THE FIRST TIME
Information about the changes to this standard is published in the annual reference index «National standards», and the text changes and amendments — in monthly information index «National standards.» In case of revision (replacement) or cancellation of this standard a notification will be published in the 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
AMENDED, published in the IUS N 7, 2016
An amendment made by the manufacturer of the database
1 Scope
This standard applies to the rental of corrosion-resistant steel, intended for the manufacture of surgical implants:
— sheet cold-rolled steel with a thickness of 0.8−3.9 mm;
— rolled steel with special surface finish (wire diameter 4.0−6.0 mm). Mandatory requirements for the quality of the products set out in 4.2, 4.5, 5.2, 6.3, 6.7.
2 Normative references
The present standard features references to the following standards:
GOST 166−89 Calipers. Specifications
GOST 1497−84 Metals. Test methods tensile
GOST 1778−70 Steel. Metallographic methods of determination of nonmetallic inclusions
GOST 2789−73 surface Roughness. Parameters and characteristics
GOST 5582−75 rolled sheet corrosion-resistant, heatresistant and heat-proof. Specifications
GOST 5632−72 high-alloy Steels and alloys corrosion-resistant, heatresistant and heat-proof. Brand
GOST 5639−82 of Steel and alloys. Methods of detection and determination of grain size
GOST 6032−2003 Steels and alloys corrosion-resistant. Methods of test for resistance to intergranular corrosion
GOST 6507−90 Micrometers. Specifications
GOST 7502−98 metallic measuring tape. Specifications
GOST 7564−97 hire. General rules of sample, blanks collection for mechanical and technological tests
GOST 7565−81 Iron, steel and alloys. Sampling method for mechanical composition
GOST 7566−94 metal Products. Acceptance, marking, packing, transportation and storage
GOST 10446−80 Wire. Test method tensile
GOST 11701−84 Metals. Methods tensile tests of thin sheets and strips
GOST 12344−2003 Steel alloyed and high alloy. Methods for determination of carbon
GOST 12345−2001 Steel alloyed and high alloy. Methods of determining sulphur
GOST 12346−78 Steel alloyed and high alloy. Methods for determination of silicon
GOST 12347−77 Steel alloyed and high alloy. Methods for determination of phosphorus
GOST 12348−78 Steel alloyed and high alloy. Methods for determination of manganese
GOST 12350−78 Steel alloyed and high alloy. Methods for determination of chromium
GOST 12352−81 Steel alloyed and high alloy. Methods for determination of Nickel
GOST 12354−81 Steel alloyed and high alloy. Methods for determination of molybdenum
GOST 12359−99 carbon Steel alloyed and high alloy. Methods for determination of nitrogen
GOST 14192−96 Marking of cargo
GOST 14955−77 quality round Steel with special surface finish. Specifications
GOST 19904−90 cold-rolled steel sheets. Assortment
GOST 21650−76 means of fastening of package cargoes in transport packages. General requirements
GOST 24597−81 the packaged goods. Basic parameters and dimensions
GOST 26663−85 transport Packs. Formation with the use of packaging. General technical requirements
GOST 26877−2008 metal Products. Methods of measuring form deviations of
Note — When using this standard appropriate to test the effect of reference standards in the information system of General use — on the official website of the Federal Agency for technical regulation and Metrology on the Internet or in the annual information index «National standards» published as on January 1 of the current year, and the editions of the monthly information index «National standards» for the current year. If the reference standard is replaced (changed), when using this standard should be guided by replacing (amended) standard. If the reference standard is cancelled without replacement, then the situation in which the given link applies to the extent that does not affect this link.
3 Classification, basic parameters and dimensions
3.1 According to the type of production of rolled corrosion-resistant steel grade 03Х18Н16МЗ are divided into:
cold — rolled sheet;
a rod with special surface finish.
3.2 as of the material rolled is divided into:
— annealed (sheet metal and wire);
— full hard — N (rod).
3.3 the surface quality of rolled sheet must meet the requirements of GOST 5582, group M2a and M3A.
The quality of the surface finish of the bars shall conform to the requirements of GOST 14955, b and G.
3.4 type of production, the purpose and as indicated in the order.
3.5 the Shape, dimensions, tolerances for size and deviation from flatness of sheets shall conform to the requirements of GOST 19904, rods with special surface finish GOST 14955.
The length and width of leaves, in agreement with the consumer.
Examples of symbols
Sheets cold-rolled normal accuracy: thickness (BT), high flatness (PV), with cut edges (O), heat treated (THAT) and the quality of the surface M3A, size 2,0·1000·2000 mm, of steel grade 03Х18Н16М3:
Bars with a diameter of 5.0 mm, a quality of surface finish of group b, class h10, thermally treated (THAT), of steel grade 03Х18Н16М3:
Bars with a diameter of 4.0 mm, quality surface finishes group, class h10, cold-worked (H), of steel grade 03Х18Н16М3:
4 Technical requirements
4.1 the Method of manufacture of steel
Steel is smelted with the use of special methods of refining, such as vacuum arc.
Method of melting defined by the manufacturer.
4.2 Chemical composition
4.2.1 Chemical composition of corrosion-resistant steel 03Х18Н16М3 for feeding the sample shall be those specified in table 1.
Table 1 — Chemical composition of corrosion resistant steel stamps 03Х18Н16М3 for feeding the sample
| Chemical composition |
Carbon | Silicon | Manganese | Chrome | Nickel | Molybdenum | Nitrogen | Sulfur | Phosphorus | Copper |
| Mass fraction of elements, % |
Not more than 0,030 | Not more than 0.4 | Not more than 2.0 | 17,0−18,5 | 14,5−16,5 | 2,6−3,1 | Not more than 0.10 | Not more than 0,010 | 0.025 | Not more than 0.30 |
Notes | ||||||||||
4.2.2 the Permissible deviation of chemical composition of corrosion-resistant steel 03Х18Н16М3 between the values listed in table 1, and the results of analysis of the finished steel shall conform to the requirements of GOST 5632.
4.3 Mechanical properties of the rolled products should conform to the standards given in table 2.
Table 2 — Mechanical properties of rolled corrosion-resistant steel 03Х18Н16М3
| Assortment | Delivery condition | Temporary resistance |
The yield strength |
Elongation |
| not less than | ||||
| Sheet | Heat-treated | 490−690 | 190 | 40* |
| Rod | Heat-treated | 490−690 | 190 | 40 |
| Negativnoe | 860−1100 | 690 | 12 | |
| * For sheets with thickness less than 3.0 mm — 38%. Notes 1 heat treatment Method chosen by the manufacturer to achieve the required properties. 2 Mechanical properties of heat-treated bars is determined on samples after quenching, hardened rods and heat-treated sheets in the delivery condition. 3 Norms of mechanical properties optional before | ||||
(4.4 the macro-structure of hire should not have residues of shrinkage, delamination, foreign metal and non-metallic inclusions, cracks and bubbles that are visible without using the magnifying devices. The sections of the sheets should be free of cracks, splits and delamination.
4.5 rental in the state of delivery must be resistant to intergranular corrosion.
4.6 In the microstructure of steel long products should not be ferritic phase.
The content of ferritic phase in the microstructure of steel sheet metal should not exceed the point 1.
4.7 Pollution steel non-metallic inclusions shall not exceed the values given in table 3.
Table 3 — Norms of pollution steel non-metallic inclusions (point)
| View inclusions | Non-metallic inclusion, points, not less | |
| Thin series | Thick series | |
| The Sulphides (A) | 1,5 | 1,0 |
| Aluminates (In) |
||
| Silicates (C) |
||
| Globular oxides (D) |
||
4.8 Norms of contamination of non-metallic inclusions and the content of ferrite phase in the steel sheet and rolled steel optional before 01.01.2005.
4.9 Austenitic grain should not be larger than 4-th number.
4.10 Labeling, packaging
4.10.1 Labeling and packaging — according to GOST 5582 and GOST 14955.
4.10.2 Transport marking under GOST 14192 with main, additional and informational inscriptions performed by waterproof paint on the cargo or labels securely attached to the load.
5 acceptance Rules
5.1 rental take parties. The party must consist of one rolled steel grades, one melting, one the thickness of the sheets or of the same diameter rods, one state deliveries, one mode of heat treatment, one group of surface finishes.
Each batch of rental must be accompanied by a document of quality according to GOST 7566.
5.2 To check the quality of hire from the party taken:
— for chemical analysis — one sample from melting GOST 7565;
— to control the quality of the surface and the dimensions of the rental;
for tensile testing, size of austenitic grain, the tendency to intergranular corrosion of sheet metal, one sheet, rolled sections — two rods;
— to determine the ferritic phase two rods or sheet melt;
— to determine the surface roughness of bars — five samples from different bars of the party;
— for definition of non-metallic inclusions or six samples.
5.3 If unsatisfactory test results of at least one of the indicators, repeat tests carried out according to GOST 7566.
6 Methods to control
6.1 surface Quality of rolled checked visually without the use of magnifying devices.
6.2 control of the deviation from flatness, camber, skew cutting of the rolled carried out according to GOST 26877.
Sheet thickness checked with a micrometer according to GOST 6507, the length and width of roulette graveyard 7502.
The diameter and shape of the test bars according to GOST 14955 in two mutually perpendicular directions in at least three places a caliper according to GOST 166, micrometer churchyard 6507.
6.3 Sampling for the determination of chemical composition is carried out according to GOST 7565. Chemical analysis were carried out according to GOST 12344 — GOST 12348, 12350 GOST, GOST 12352, 12354 series GOST, GOST 12359 or other methods providing the required accuracy of the analysis. If there are differences in used methods established by this standard.
6.4 For testing in tension, susceptibility to intercrystalline corrosion, determination of austenitic grain size selected one sample from each test sheet or rod. Sampling for mechanical tests carried out according to GOST 7564.
Sampling for testing of sheet metal is carried out across the direction of rolling, long products — along the direction of rolling.
6.5 tensile Test bars is carried out according to GOST 10446 two samples; sheets according to GOST 1497, GOST 11701 on a single sample.
6.6 surface Roughness of bars check profiling, optical devices or working samples five samples taken from different bars of the party according to GOST 2789.
6.7 susceptibility to intercrystalline corrosion is determined according to GOST 6032 on a single sample for sheets and two samples for bar method AM within 24 h without provoking heat.
6.8-Size of austenitic grains for the rolled section is determined according to GOST 5639 on two samples taken after annealing before the last cold-forming operation.
Size of austenitic grain of the rolled metal sheets is determined according to GOST 5639 two samples in the delivery condition of the metal.
6.9 Sampling for the control of non-metallic inclusions is carried out according to GOST 1778.
6.10 Assessment of pollution steel non-metallic inclusions is carried out by increasing a hundred times the diameter of the field of view of 0.8 mm by comparison with the drawings of the scale (Appendix a). In the evaluation scan the entire area of the cone. Assessment of contamination of non-metallic inclusions is carried out on the very dusty field sections.
The area of the cone shall be 200 mm(20·10 mm). To determine the content of non-metallic inclusions are selected six samples from a sheet or two of bars. In the Protocol write the form of inclusions, their score, corresponding to the standard thin or thick series.
Control of non-metallic inclusions is carried out with a sliding tackle after thermal treatment.
By agreement between the consumer and the manufacturer the control of non-metallic inclusions may be performed in the finished product.
6.11 the Content of the ferritic phase is determined at a magnification of 100 times on two longitudinal and two transverse thin sections made from samples taken from the sheet or rolled sections, or pieces of them. Scan the entire area of the cone. The etched micro-sections is recommended in a Marble’s reagent (4 g of copper sulphate, 100 ml of ethanol, 50 ml of hydrochloric acid), electrolytic method in 10% aqueous solution of oxalic acid or by other methods.
Control of the ferritic phase is carried out with a sliding tackle after thermal treatment.
By agreement between the consumer and the manufacturer control of the ferritic phase may be performed in the finished product.
6.12 monitoring of the content of the ferritic phase and the assessment of pollution steel non-metallic inclusions for the sheet metal is carried out at the consumer or customer (as agreed).
7 Transportation and storage
7.1 Transportation and storage — by GOST 7566.
7.2 When you ship two or more packages to one user should enlarge the cargo space in accordance with the requirements of GOST 21650, GOST 24597, GOST 26663.
Annex a (mandatory). Scale for assessment of non-metallic inclusions
Appendix A
(required)
Figure A. 1. Sulfide type
| Sulfide type | ||
| Thin series (thickness ~4 µm) |
Thick series (thickness ~6 µm) | |
| Total length |
Figure A. 1
Figure A. 2. Alumina type
| Alumina type | ||
| Thin series (thickness ~ 9 µm) |
Thick series (thickness ~15 µm) | |
| Total length |
Figure A. 2
Figure A. 3. Silicate type
| Silicate type |
||
| Thin series (thickness up to ~5 µm) |
Thick series (thickness ~9 µm) | |
| Total length |
Figure A. 3
Figure A. 4. Globular oxides
| Globular oxides | ||
| Thin series (thickness up to ~8 µm) |
Thick series (thickness ~12 µm) |
Figure A. 4
_________________________________________________________________________________________
UDC 615.465:006.354 ISS 77.140.20 NEQ
11.040.70
Key words: corrosion-resistant steel, rolled sheet. black bars, surgical implants, macrostructure, mechanical properties, ferrite phase, non-metallic inclusions, grain autentyczne, surface quality
