GOST R 51396-99

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  ГОСТ Р 51396-99

GOST R 51396−99 Wire from special alloys for connecting power and implanted members of products for organism’s bones. General specifications

GOST R 51396−99

Group В73

STATE STANDARD OF THE RUSSIAN FEDERATION

WIRE FROM SPECIAL ALLOYS FOR CONNECTING POWER AND IMPLANTED MEMBERS OF PRODUCTS FOR ORGANISM’S BONES

General specifications

Special alloy wire for connecting load-bearing and implanted members of products for organism''s bones. General specifications

OKS 77.140.20*
OKP 12 6100
93 9135
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* In the index «National standards» 2010 ACS 11.040.40, 77.140.20. -
Note the manufacturer’s database.

Date of introduction 2000−07−01

Preface

1 DEVELOPED AND SUBMITTED by the Technical Committee for standardization TC 375 «steel Products from ferrous metals and alloys"

2 ADOPTED AND put INTO EFFECT by the Resolution of Gosstandart of Russia from December 16, 1999 N 522-St

3 Standard meets the requirements of international standards ISO 5832−6-97 «Implants for surgery. The metallic materials. Part 6. Кобальтоникелевохромомолибденовый wrought alloy» and 5832−8-97 ISO, «Implants for surgery. The metallic materials. Part 8. Кобальтоникелевохромомолибденотитановый wrought alloy» in terms of chemical composition, grain size and mechanical properties

4 INTRODUCED FOR THE FIRST TIME

5 REISSUE

1 Scope

This standard applies to cold drawn wire with diameter 0.1−6.0 mm special alloy grades 35Н32КХМ and 45КХНМВТ for the manufacture of connecting power elements (nails, etc.) skeletal systems, as well as other elements of medical devices (implants, frames, etc.).

Mandatory requirements for the quality of the products set out in 4.2, 4.4, 5.2, 6.1, 6.5, 6.6.

2 Normative references

The present standard features references to the following standards:

GOST 2771−81 cold-drawn round Wire. Assortment

GOST 2991−85 wooden disposable Boxes for loads up to 500 kg. General specifications

The Wire GOST 3282−74 General purpose low carbon steel. Specifications

GOST 5639−82 of Steel and alloys. Methods of detection and determination of grain size

GOST 6507−90 Micrometers. Specifications

GOST 7564−97 hire. General rules of sample, blanks collection for mechanical and technological tests

GOST 7565−81 Iron, steel and alloys. Method of sampling for chemical composition

GOST 7566−94 metal Products. Acceptance, marking, packing, transportation and storage

GOST 8828−89 base Paper and paper double-layer waterproof packaging. Specifications

GOST 9569−79* waxed Paper. Specifications
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* On the territory of the Russian Federation GOST 9569−2006, here and hereafter. — Note the manufacturer’s database.

GOST 10354−82 polyethylene Film. Specifications

GOST 10396−84 crepe cable Paper. Specifications

GOST 10446−80 Wire. Test method tensile

GOST 11358−89 Thickness and stenkomer indicator with a scale division of 0.01 and 0.1 mm. specifications

GOST 12344−88* Steel alloyed and high alloy. Methods for determination of carbon
______________
* On the territory of the Russian Federation GOST 12344−2003, here and hereafter. — Note the manufacturer’s database.

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 12349−83 Steel alloyed and high alloy. Methods for determination of tungsten

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 12353−78 Steel alloyed and high alloy. Methods for determination of cobalt

GOST 12354−81 Steel alloyed and high alloy. Methods for determination of molybdenum

GOST 12356−81 Steel alloyed and high alloy. Methods for determination of titanium

GOST 14118−85 Wire from precision alloys for elastic elements. Specifications

GOST 14192−96 Marking of cargo

GOST 14253−83 Paintings holstoproshivny cleaning. Specifications

GOST 16272−79 plasticized polyvinyl chloride Film technical. Specifications

GOST 20799−88 Oils. Specifications

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 28473−90 Iron, steel, ferroalloys, chromium and manganese metal. General requirements for methods of analysis

GOST 29095−91 Alloys and powders heat-resistant, corrosion-resistant, precision Nickel-based. Methods of iron determination

3 Classification, basic parameters and dimensions

3.1 the condition of the material the wire is divided into:

— pawnagetool — PN;

— nagarebana — N;

— vysokolegirovannye — VN;

— heat-treated.

Note — the recommended degree of autofrettage, percent:

— polonaruwa — 20−30;

— nagarebana — 35−55;

— vysokokachestvennoj — 60−80.

3.2 the Wire is manufactured diameter 0.1−6.0 mm.

3.3 the Shape, dimensions and limit deviations of the dimensions must conform to the requirements of GOST 14118.

Examples of symbols

Wire of alloy grade 45КХНМВТ, nagarebana (N), with a diameter of 1.10 mm, quality h9 according to GOST 2771:

Wire

Wire of alloy grade 35Н32КХМ, polonikova (PN), with a diameter of 2.80 mm, tolerance Js9:

Wire

Wire of alloy grade 45КХНМВТ, thermally treated (THAT), with a diameter of 1.40 mm

Wire 45 CHNNGC-1,40-GOST R 51396−99

4 Technical requirements

4.1 Method of making alloys

Alloys should be smelted with the use of special methods: smelting (vacuum-induction — VI), remelting (vacuum arc — VD, electroslag — W) or their combination.

Method of smelting and remelting defined by the manufacturer.

At the request of the consumer, the manufacturer specifies the method of smelting in the document about quality.

4.2 Chemical composition of the alloys 35Н32КХМ and 45КХНМВТ shall be those specified in table 1.


Table 1 — Chemical composition of alloys 35Н32КХМ and 45КХНМВТ

4.3 Wire produced in thermally processed polonikova, cold-worked and vysokochastotnom States.

4.4 Mechanical properties of the wire as supplied must conform to the standards given in table 2.


Table 2 — Mechanical properties of the wire from the alloys of 35Н32КХМ and 45КХНМВТ on delivery

4.5 the quality of the surface polonikova, Nagarjuna and vysokokachestvennoj wire shall conform to the requirements of GOST 14118. The quality of the surface of the heat-treated wire — by agreement between the consumer and the manufacturer.

4.6 the Size of the actual grain should not be larger than 4, the numbers for the alloy grade 35Н32КХМ and 5th numbers for grade 45КХНМВТ.

Optional standards, before 01.01.2005. Inspection results are entered into the document of quality.

4.7 Labeling, packaging

4.7.1 Labeling and packaging — according to GOST 7566.

4.7.2 the Wire should be wound on the spool (mandrel) separatornyi rows, providing free spooling, with reliable fixation of the free end.

Each coil (coil mandrel) consists of a single segment wire. Allowed winding on a spool (mandrel) no more than three pieces of wire. Sections of wire shall be separated by spacers, thus preventing wire entanglement.

4.7.3 To protect the wire from corrosion is allowed to apply the oiling of industrial oils 45, 20,-20A and 40A according to GOST 20799.

4.7.4 Coils, coil and mandrel should be wrapped in one or more layers of waterproof paper GOST 8828, 10396 GOST, GOST 9569 or other regulatory documents and laid in serried ranks in boxes, made according to GOST 2991 (boxes type I or II) or other boxes of regulatory documents.

Allowed coils of wire with a diameter of 2 mm and more packaging in single or multiple layers of paper according to GOST 9569, GOST 8828, GOST 10396, then, in the film according to GOST 10354, GOST 16272 holstoproshivny or tare the fabric according to GOST of 14,253, non-woven cloth, stitched the flap of waste textile industry or other types of packaging materials according to the normative documents, with the exception of cotton and linen fabrics. Packaging the skeins must be tied with wire according to GOST 3282 or other regulatory documents or some other way to protect the packs from unwinding.

The outer diameter of a coil should be no more than 1200 mm, internal — not less than 180 mm.

4.7.5 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 Wire take parties. Each party must consist of one wire of alloy grades, one melting, one diameter, one state deliveries, one mode of heat treatment.

Each batch must be accompanied by a document of quality according to GOST 7566.

5.2 To verify the quality of wire taken from the party:

— for chemical analysis — one sample from the melt;

— for quality control of surfaces and sizes — 100% skeins (coils, bars);

— to determine the amount of the actual grain and mechanical properties of two winding (mandrel, coil).

5.3 If unsatisfactory test results of at least one of the indicators, repeat tests according to GOST 7566.

6 Methods to control

6.1 Sampling for the determination of chemical composition is carried out according to GOST 7565. Chemical composition of alloys determined according to GOST 12344−12350 GOST, GOST 12352−12354 series GOST, GOST 12356, 28473 GOST, GOST 29095, or other methods providing the required accuracy of the analysis.

6.2 surface Quality of the wire is checked visually without the use of magnifying devices.

At customer’s request, surface quality check on the coils on the outer layer of wire wound on a spool.

6.3 wire Diameter measure in two mutually perpendicular directions of the same section, not less than three rolls, micrometer according to GOST 6507, instruments according to the GOST 11358или other measuring tools that provide required accuracy.

6.4 the Size of the actual grain is determined on two samples, one from a coil (coil mandrels) according to GOST 5639.

6.5 Sampling for mechanical tests carried out according to GOST 7564.

6.6 Mechanical properties of the wire determined according to GOST 10446 four samples taken, two from each winding (mandrel, coil).

7 Transportation and storage

7.1 Transportation and storage — by GOST 7566.

7.2 Wire with the diameter more than 0.45 mm transporterowych in coils with a diameter of 0.45 mm and less coils or bars.

By agreement between manufacturer and consumer nagaremono and vysokolegirovannye wire diameter of 0.45 mm and less transporterowych in reels.

7.3 Wire are transported in the covered vehicles of all types in accordance with the rules of cargo transportation applicable to transportation of this species.

Allowed transportation on open rolling stock.

When you ship two or more packages to one user should amalgamate in accordance with the requirements of GOST 21650, GOST 24597, GOST 26663.

7.4 Weight of cargo space with mechanized loading and unloading in open vehicles shall not exceed 5 tonnes in indoor — 1250 kg With manual loading and unloading weight of the package (package) must not exceed 80 kg.

7.5 Wire should be stored in a dry place at temperature from 5 to 40 °C, relative humidity of 80%, in the absence of air in alkaline, acidic and other aggressive contaminants.

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

M.: IPK Publishing house of standards, 2002