GOST R 51397-99
GOST R 51397−99
STATE STANDARD OF THE RUSSIAN FEDERATION
STRIP AND WIRE
OF SPECIAL ALLOYS
FOR CONNECTING AND IMPLANTED
MEMBERS OF PRODUCTS FOR CARDIOVASCULAR
SURGERY
GENERAL SPECIFICATIONS
GOSSTANDART OF RUSSIA
Moscow
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 № 523-St
3 Standard developed on the basis of international standards ISO 5832−5-93 «Implants for surgery. The metallic materials. Part 5. Cobaltcontaining wrought alloy» and 5832−7-94 ISO, «Implants for surgery. The metallic materials. Кобальтохромоникелевомолибденожелезный cold forging alloy» in terms of chemical composition, grain size, evaluation of non-metallic inclusions and mechanical properties
4 INTRODUCED FOR THE FIRST TIME
GOST R 51397−99
STATE STANDARD OF THE RUSSIAN FEDERATION
STRIP AND WIRE MADE OF SPECIAL ALLOYS FOR CONNECTING
AND IMPLANTED ELEMENTS PRODUCTS FOR CARDIOVASCULAR SURGERY
General specifications
Special alloy strip and wire for connecting and implanted members of products for cardiovascular surgery.
General specifications
Date of introduction 2000−07−01
1 Scope
This standard applies to cold rolled strip thickness 0,10 — 2,0 mm and cold drawn wire diameter 0.1 — 6.0 mm special alloy 40KKHNM and 48КХВН for the manufacture of connecting elements (brackets for suturing blood vessels, frames, artificial heart valves) cardiovascular and other implantable items used in surgery (brackets for overlapping mechanical joints on organs and tissues, implants, etc.).
Mandatory requirements for the quality of the products set out in 4.2, 4.4 (except norms relative elongation), 5.2, 6.1, 6.7, 6.8.
2 Normative references
The present standard features references to the following standards:
GOST 166−89 Calipers. Specifications
GOST 427−75 Rulers measuring metal. Specifications
GOST 1778−70 Steel. Metallographic methods of determination of nonmetallic inclusions
GOST 2771−81 cold-drawn round Wire. Assortment
GOST 2789−73 surface Roughness. Parameters and characteristics
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 4381−87 Micrometers lever. General 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
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 11701−84 Metals. Methods tensile tests of thin sheets and strips
GOST 12344−88 Steel alloyed and high alloy. Methods for determination of carbon
GOST 12345−88 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 14117−85 Tape from precision alloys for elastic elements. Specifications
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 19300−86 means of measuring the surface roughness profile method. The profiling-contact profilometers. Types and basic parameters
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. Main parameters and size
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 By type of products is divided into:
tape cold-rolled made of alloy 40KKHNM;
the wire cold-drawn from alloys of 40KKHNM and 48КХВН.
3.2 as a material steel is subdivided:
— polonaruwa — PN;
— heat-treated.
Note — the recommended degree of strain-hardening: polonikova — 20 — 30%.
3.3 produce a Tape thickness 0.10 — 2.0 mm width 20 — 250 mm; wire — diameter 0.1 — 6.0 mm.
3.4 Tape is manufactured in coils or lengths. Pieces of tape are manufactured with the length of 1000 — 1200 mm of tape thickness to 1.7 mm inclusive and a length of 500 — 1200 mm strip thickness greater than 1.7 mm.
3.5 the Shape, dimensions and limit deviations of the dimensions must conform to the requirements of GOST and GOST 14117 14118.
Examples of symbols:
Tape with a thickness of 0.20 mm, a width of 100 mm alloy grade 40KKHNM, polonikova (MON), edged (On), normalized camber (C):
The alloy wire 40KKHNM, polonikova (PN), with a diameter of 0.5 mm, quality h9 according to GOST 2771−81:
The alloy wire 48КХВН, thermally treated (THAT), with a diameter of 1.20 mm
Wire 48КХВН-1,20-GOST R 51397−99
4 Technical requirements
4.1 Method of making alloys
Alloys should be smelted with the use of special methods: smelting (vacuum induction), remelting (vacuum arc, electroslag) 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.
Note — Alloys are obtained by special methods, is further denoted by a dash at the end of the brand names of the letters:
VI — vacuum induction smelting;
VD — vacuum arc remelting;
W — electroslag remelting.
4.2 Chemical composition of alloys 40KKHNM and 48КХВН shall be those specified in table 1.
Table 1 — Chemical composition of alloys 40KKHNM and 48КХВН
| Designation grade alloy | Mass fraction of elements, % | |||||||||||
| Carbon | Silicon | Manganese | Phosphorus | Sulfur | Cobalt | Chrome | Tungsten | Nickel | Iron | Molybdenum | ||
| no more | ||||||||||||
| 40KKHNM | 0,15 | 1,0 | 1,0 — 2,5 | 0,015 | 0,015 | 39,0 — 42,0 | 18,5 — 21,5 | - | 14,0 — 18,0 | The rest | 6,5 — 8,0 | |
| 48КХВН | 0,15 | 1,0 | 2,0 | 0,015 | 0,015 | 47,0 — 49,0 | 19,0 — 21,0 | 14,0 — 16,0 | 9,0 — 11,0 | Not more than 3.0 | - | |
Note — by agreement with the health authorities allowed small deviations in the mass fraction of the elements specified in table 1, not entailing changes in the structure and mechanical properties.
4.3 Tape and wire produced in the heat-treated and polonikeman States.
4.4 Mechanical properties of the steel products in delivery condition shall comply with the standards listed in table 2.
4.5 the quality of the surface of the heat-treated or polonikova tape shall conform to the requirements of GOST 14117, polonikova wire — 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 5-th numbers according to GOST 5639.
Tape the grain size is determined after heat treatment. Optional standards, before
4.7 Pollution steel non-metallic inclusions in the evaluation by the maximum score should not exceed the limits specified in table 3.
Table 2 — Mechanical properties of ribbon and wire alloys 40KKHNM and 48КХВН on delivery
| Designation grade alloy | Assortment | Delivery condition | Mechanical properties at room temperature | ||
| The tensile strength σin N/mm2 | The yield strength σof 0.2 N/mm2 | Relative elongation δ, % | |||
| not less than | |||||
| 40KKHNM | Tape, wire | Heat-treated | 950 | 450 | 65 |
| Tape, wire | Polonikeman | 1450 | 1300 | 8 | |
| 48КХВН | Wire | Heat-treated | 860 | 310 | 10 |
| Wire | Polonikeman | 1370 | - | 5 | |
Notes 1 heat treatment Regime chosen by the manufacturer to achieve the required properties. 2, With the supply of steel products (strip, wire) in polonikeman mechanical properties determined on samples after the heat treatment (tempering). 3, the yield strength of the wire and the ribbon thickness is less than 0.5 mm is determined by the requirement of the user. 4 standards of elongation of the optional before | |||||
Table 3 — Assessment of contamination of the tape non-metallic inclusions and wire alloys 40KKHNM and 48КХВН
| View inclusions | Non-metallic inclusion, points, no more |
| The Sulphides (A) | 1 |
| Aluminates (In) | 3 |
| Silicates (C) | 1 |
| Globular oxides (d) | 3 |
Note — regulations on the content of nonmetallic inclusions optional before | |
4.8 Marking, packaging
4.8.1 Labeling and packaging — according to GOST 7566.
4.8.2 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.
4.8.3 In agreement with the consumer to protect the wire from corrosion is allowed to apply the oiling of industrial oils 45, 20,-20A and-40A, tape — AND-20A and 40A according to GOST 20799.
4.8.4 the Rolls of tape thickness of 0.3 mm or less, the bundles of strands, and coils, the coil and mandrel should be wrapped in one or more layers of waterproof paper GOST 9569, 10396 GOST, GOST 8828 or other regulatory documents and laid in serried ranks in boxes of types I or II according to GOST 2991 or other normative documents.
4.8.5 the Rolls of tape with the thickness more than 0.3 mm and coils of wire with a diameter of 2.0 mm or more wrapped in one or more layers of paper according to GOST 9569, GOST 8828, GOST 10396 or other regulatory documents, the film according to GOST 10354, 16272 GOST or other regulations or container holstoproshivny cloth 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.
Packed rolls of barbed wire shall be tied with wire according to GOST 3282 or other regulatory documents or some other way to protect the packs from unwinding.
4.8.6 Outer diameter rolls of tape with the thickness more than 0.3 mm and the coil wire should be no more than 1200 mm, internal — not less than 180 mm.
4.8.7 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 the Products take parties. The party must consist of one of metal products of alloy grades, one melting, one the thickness of the strips or of the same diameter wire, 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 steel products taken from the party:
— for chemical analysis — one sample from the melt;
— for quality control of surfaces and sizes — all metal products;
— to determine the amount of the actual grain, non-metallic inclusions, surface roughness, mechanical properties of the two roll or two cut to ribbons, two winding (mandrel, coil) wire;
— to determine camber — three rolls or three pieces.
In the party the tape, obtained by cutting one coil to the specified width, such as one roll.
5.3 Determination of roughness and camber of the tape is carried out periodically, but not less than once per quarter.
5.4 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 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 28473, GOST 29095, or other methods providing the required accuracy of the analysis.
6.2 Quality of the surface and the edges of the belt checked visually, without the use of magnifying devices on the 2 — 5th round coil wire visually. At customer’s request, surface quality check on the coils on the outer layer of wire wound on a spool.
6.3 the Thickness of the tape is checked using micrometer according to GOST 6507 or GOST 4381 or other means of measuring the respective accuracy. The tape width is measured by caliper according to GOST 166 or metal ruler according to GOST 427.
Tape sizes in coils checked at a distance of not less than the length of the coil from end of the roll, the thickness of the strip is checked at a distance of at least 5 mm from the edge.
Wire diameter is measured in two mutually perpendicular directions of the same section, not less than in three places with a micrometer according to GOST 6507, GOST 11358 or other measuring tools that provide required accuracy.
6.4 To check the tape to check the camber portion of the tape length 1 — 3 m is laid on a flat surface and to the concave side of the strip, apply a line length of 1 m, then determine the metal ruler according to GOST 427 distance between the most remote point of the arc of the tape from the line.
6.5 surface Roughness check the profilers, profiling according to GOST 19300, optical devices or work samples in accordance with the requirements of GOST 2789.
6.6 the Amount of the actual grain is determined on two samples taken, one from the coil, or coil cut, according to GOST 5639.
6.7 Sampling for mechanical tests carried out according to GOST 7564.
6.8 the Mechanical properties of the tape define in two short longitudinal specimens (type I or II according to GOST 11701), taken one by one from the roll or cut.
Mechanical properties of the wire determined according to GOST 10446 four samples taken, two from each roll.
6.9 Monitoring and sampling to assess the contamination of the alloys with non-metallic inclusions is carried out in the churchyard 1778.
Control of non-metallic inclusions is carried out in the intermediate blank of any convenient thickness after heat treatment.
By agreement between manufacturer and consumer control of non-metallic inclusions may be performed in the finished product.
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.
7.3 Tape and wire transporterowych all types of transport in covered vehicles in accordance with the rules of carriage valid for this mode of transport.
Allowed transportation on open rolling stock.
7.4 Tape and 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.
