GOST R ISO 5838-1-2011

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  ГОСТ Р ИСО 5838-1-2011

GOST R ISO 5838−1-2011 Implants for surgery. Rods, pins and wire for skeletal traction. Part 1. Materials and mechanical properties

GOST R ISO 5838−1-2011

Group В32
В73
В74

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

IMPLANTS FOR SURGERY. RODS, PINS AND WIRE FOR SKELETAL TRACTION

Part 1

Materials and mechanical properties

Implants for surgery. Spokes, skelet pins and wires. Part 1. Material and mechanical requirements

OKS 11.040.40
OKP 93 9800

Date of introduction 2012−10−01

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 from September 28, 2011 No. 409-St

4 this standard is identical to international standard ISO 5838−1:1995* «Implants for surgery. Needles and wire for skeletal traction. Part 1. Materials and mechanical properties» (ISO 5838−1:1995 «Implants for surgery — Skelet pins and wires — Part 1: Material and mechanical requirements»).
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* Access to international and foreign documents mentioned here and below, you can get a link on the website shop.cntd.ru. — 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 requirements for materials, mechanical properties of rods, spokes and wire (fixing small bone fragments) for skeletal traction, to be applied in bone surgery, excluding wires for ligatures (ligation) and cerclage (contraction).

2 Normative references

This standard uses the regulatory references to the following standards:

ISO 5832−1:1987* Implants for surgery. The metallic materials. Part 1. Wrought stainless steel
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* Replaced by ISO 5832−1:2007.


ISO 5832−2:1993* Implants for surgery. The metallic materials. Part 2. Non-alloy titanium
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* Replaced by ISO 5832−2:1999.


ISO 5832−3 Implants for surgery. The metallic materials. Part 3. Alloys based on titanium containing 6% aluminum and 4% vanadium

ISO 5832−5:1993* Implants for surgery. The metallic materials. Part 5. Alloys based on cobalt, chromium, tungsten and Nickel
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* Replaced by ISO 5832−5:2005.


ISO 5832−6:1980* Implants for surgery. The metallic materials. Part 6. Alloys based on cobalt, Nickel, chromium and molybdenum
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* Replaced by ISO 5832−6:1997.


ISO 5832−7:1994 Implants for surgery. The metallic materials. Part 7. The alloy is ductile and cold-deformed cobalt, chromium, Nickel, molybdenum and iron

ISO 5832−8 Implants for surgery. The metallic materials. Part 8. Alloys based on cobalt, Nickel, chromium, molybdenum, tungsten and iron

ISO 5832−11:1994 Implants for surgery. The metallic materials. Part 11. Alloys based on titanium containing 6% aluminum and 7% niobium

ISO 6892:1984 Metallic materials. Tensile test
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* Replaced with ISO 6892−1:2009.

3 Material

Rods, pins and wire for skeletal traction should be made of deformable materials in accordance with the requirements of the relevant parts of ISO 5832.

4 Mechanical properties

The mechanical properties, determined in accordance with section 5, shall meet the requirements given in table 1.


Table 1 — Mechanical properties

5 test Methods

Test methods for determining compliance with the requirements of this standard must comply with ISO 6892.

App YES (reference). Information about the compliance of the referenced international standards reference the national standards of the Russian Federation (and acting in this capacity inter-state standards)

App YES
(reference)

Table YES.1