GOST 31625-2012
INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (EASC)
INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC)
GOST
INTERSTATE 31625−2012 STANDARD
STRIP AND WIRE MADE OF SPECIAL ALLOYS FOR THE CONNECTING AND IMPLANTED ELEMENTS PRODUCTS FOR CARDIOVASCULAR SURGERY
General specifications
Edition official
Moscow
STANDARTINFORM
Preface
Goals, basic principles and procedure of works on interstate standardization established GOST 1.0−92 «interstate system
standardization. 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 (Gosstandart)
3 ACCEPTED by the Interstate Council for standardization, Metrology and certification (Protocol No. 41−2012 of may 24, 2012)
The standard was accepted by voting:
| Short name of the country on MK (ИС0 3166) 004−97 | Country code MK (ИС0 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 |
| Russian Federation | EN | Rosstandart |
| Tajikistan | TJ | Tajikstandart |
| Uzbekistan | UZ | Uzstandart |
4 by Order of the Federal Agency for technical regulation and Metrology dated November 01, 2012, No. 670-St interstate standard GOST 31625−2012 introduced as a national standard of the Russian Federation from 1 January 2015.
5. The standard is based on the application of GOST R 51397−99
6 INTRODUCED FOR THE FIRST TIME
Information about introduction in action (termination) hereof shall be published in the monthly published index «National standards».
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 published information index
«National standards». In case of revision or cancellation of this standard the appropriate information will be published in a monthly information index «National standards»
In the Russian Federation this standard may be fully or partially reproduced, replicated and distributed as an official publication without the permission of the Federal Agency for technical regulation and Metrology.
31625−2012 GOST INTERSTATE STANDARD
STRIP AND WIRE MADE OF SPECIAL ALLOYS FOR THE 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 -2015−01−01
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 grades 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
Edition official
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 technical conditions GOST 5639−82 of Steel and alloys. Methods of detection and determination of grain size
GOST 6507−90 Micrometers. Technical conditions 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 Paper-base and two-layer paper
waterproof packing. Specifications
GOST 9569−2006 waxed Paper. Specifications GOST 10354−82 polyethylene Film. Technical conditions 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 12344−2003 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 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 the 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. 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
Note — When using this standard appropriate to test the effect of reference standards for the sign «National standards» drawn up as of January 1 of the current year and related information signs, published in 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, the position in which reference is made to it is applied in the part not affecting this link
3 Classification, basic parameters and dimensions
3.1 In mind, the products are divided into:
— cold-rolled strips of alloy grade 40KKHNM;
the wire cold-drawn from alloys of 40KXIIM and 48КХВН.
3.2 the condition of the material the products are divided into:
— pawnagetool — PN;
— heat-treated.
Note — the recommended degree of jakartovice: poluapartmana — 20−30%.
3.3 produce a Tape thickness 0.10−2.0 mm, a width of 20−250 mm; wire — diameter 0.1−6.0 mm.
3.4 Tape is manufactured in coils or lengths. Segments of the tape are manufactured with a length of 1000−1200 mm of tape thickness to 1.7 mm incl. length 500−1200 mm tape thickness St of 1.7 mm.
3.5 the Shape, dimensions and limit deviations of the dimensions must meet the requirements of GOST 14117 and 14118 GOST.
Examples of symbols
Tape with a thickness of 0.20 mm, a width of 100 mm alloy grade 40KKHNM, polonikova (MON), edged (On), normalized with the camber
(C):
0,20 x 100 — On- GOST 14117−85
Tape-----------------------------------------------
40KKHNM — PN GOST 31625 — -2012
Wire of alloy grade 40KKHNM, polonikova (PN), with a diameter of 0.5 mm, quality h9 according to GOST 2771:
0,5 — И9 GOST 2771−81
Wire -------------------------------------------
40KKHNM — PN GOST 31625 — -2012
Wire of alloy grade 48КХВН, thermally treated (THAT), with a diameter of 1.20 mm
Wire 48КХВН-1,20- GOST 31625−2012 4 Technical requirements 4.1 the 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 the alloys 40KKHNM and 48КХВН shall be those specified in table 1.
Table! — Chemical composition of alloys 40KKHNM and 48КХВН
| Mass fraction | elements. % | ||||||||||
Mark with LLP local ka |
From|lsro | Cream tions |
Marga Heff |
Phosphorus | Sulfur | To belt |
Chrome | Wolf RAM |
Nickel | Iron | Molyb den |
| COP more | |||||||||||
| 40KKHNM | 0.15 | 1,0 | 1.0- 2.5 |
0.015 | 0.015 | 39,0- 42.0 |
18.5 in 21,5 |
- | 14.0-lb 0 | The rest Noah |
6.5- 8,0 |
| 48КХВН | 2.0 | 47.0- 49.0 |
19.0- 21.0 |
14.0- 16,0 |
9.0- 11.0 |
Not bass 3,0 |
- | ||||
| Note — by agreement with the health authorities allowed small deviations in the mass fraction of the elements specified in the table, not plakuchie a change of structure and mechanical properties. | |||||||||||
4.3 Tape' and wire to produce thermally 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 must meet 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 number, but GOST 5639.
Tape the grain size is determined after heat treatment. Inspection results are entered into the document of quality.
4.7 Pollution steel non-metallic inclusions in the evaluation by the maximum score should not exceed the limits specified in table 3.
Table?- Mechanical properties of ribbon and wire alloys ICH 40KXIIM and 48KXBII on delivery
| Mark l alloy | CopraueiiT | Condition phlegm | Mechanical properties at room temperature | ||
| Temporary resistance to the «estate of a,. N/mm2 | The yield strength <\, d, N/mm1 |
Relative elongation &, $ | |||
| not msmse | |||||
| 40KXIIM | Summer. wire |
Termopress properly | 950 | 450 | 65 |
| 11ол>, nagaremono | 1450 | 1300 | 8 | ||
| 48KXBII | Wire | Term obrab SP EN ing | 860 | 310 | 10 |
| 11олунагарто bath | 1370 | - | 5 | ||
Note 1 heat treatment Regime chosen by the manufacturer to achieve the required svaiste 2, With the supply of steel products 3, the yield strength of the wire and tape caraway, mens 0.5 mm is determined by the requirement of the user. 4 standards of elongation of the optional before | |||||
Tabletas — Assessment of pollution of the ribbon and wire alloys 40KXIIM and 48KXUIImetallic inclusions
| View inclusions | Sskmdemm inclusion score (the glue |
| The Sulphides (A) | 1 |
| Aluminates (In) | 3 |
| Silicates (C) | 1 |
| Globular oxides (D) | 3 |
Note — regulations on the content of non-metallic inclusion 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 type I or type 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 at 9569 GOST, GOST 8828, GOST 10396 or other regulatory documents, the film according to GOST 10354, 16272 GOST or other regulations or container holstoproshivny fabric at a 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
4.8.7 Transport marking — according to 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 — -
GOST 12350, 12352 GOST — — — GOST 12354 series, 28473 GOST, 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 2−5-th turn of the 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, devices according to 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 of 1−3 m are placed on a flat surface and to the concave side of the strip, apply a line length of 1 m, and then determine 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 according to GOST 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 are transported in the covered vehicles of all types in accordance with the transportation rules on the transportation of the species.
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, at a relative humidity of 80%, in the absence of air in alkaline, acidic and other aggressive contaminants.
UDC 615.465:006.354 ISS 77.140.20 MOD
Key words: special composition, cold drawn wire, cold drawn strip, the connecting member, the cardiovascular system, mechanical properties, size of the actual grains, nonmetallic inclusions, surface quality, vacation, chemical composition
