ISO 5838-1:1983

Implants for surgery — Skeletal pins and wires — Part 1: Material and mechanical requirements

Implants chirurgicaux — Fils et broches pour os — Partie 1: Matériaux et propriétés mécaniques

General Information

• Status: Withdrawn
• Publication Date: 31-Jul-1983
• Withdrawal Date: 31-Jul-1983
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 5 - Osteosynthesis and spinal devices
• Drafting Committee: ISO/TC 150/SC 5 - Osteosynthesis and spinal devices
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 16-Nov-1995

Relations

• Revised: ISO 5838-1:1995 - Implants for surgery — Skeletal pins and wires — Part 1: Material and mechanical requirements
• Effective Date: 15-Apr-2008
• Consolidated By: ISO 13000-2:1997 - Plastics — Polytetrafluoroethylene (PTFE) semi-finished products — Part 2: Preparation of test specimens and determination of properties
• Effective Date: 06-Jun-2022

Standards Content (Sample)

International Standard 58381 1
INTE RNATIONAC ORGANIZATION FOR STANDARDIZATION.MEXAYHAPOAHAR OPrAHM3AUMR Il0 CTAHAAPTM3AUMMKlRGANlSATlON INTERNATIONALE DE NORMALISATION
Implants for surgery - Skeletal pins and wires -
Part 1 : Material and mechanical requirements
Implants chirurgicaux - Fis et broches pour os - Partie 1 : Matériaux et propriétés mécaniques
First edition - 1983-ûû-O1
UDC 615.465 : 621.886.1 : 669-426 Ref. No. IS0 5838/1-1983 (El
Descriptors : surgical implants, pins, wire, mechanical properties, specifications.
Price based on 2 pages

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Foreword
IS0 (the International Organization for Standardization) is a worldwide federation of
national standards institutes (IS0 member bodies). The work of developing Inter-
national Standards is carried out through IS0 technical committees. Every member
body interested in a subject for which a technical committee has been set up has the
right to be represented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also takepart in the work.
Draft International Standards adopted by the technical committees are circulated to
the member bodies for approval before their acceptance as International Standards by
the IS0 Council.
International Standard IS0 5838/ 1 was developed by Technical Committee
ISO/TC 150, lmplanfs for surgery, and was circulated to the member bodies in May
1982.
It has been approved by the member bodies of the following countries :
Spain
Australia Ireland
Canada Korea, Rep. of Switzerland
China Mexico United Kingdom
Egypt, Arab Rep. of New Zealand USA
France Poland USSR
Germany, F.R. Romania
India South Africa, Rep. of
The member body of the following country expressed disapproval of the document on
technical grounds :
Austria
O International Organization for Standardization, 1983
Printed in Switzerland
I

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INTERNATIONAL STANDARD IS0 !B38/1-1983 (E)
Implants for surgery - Skeletal pins and wires -
Part 1 : Material and mechanical requirements
1 Scope and field of application 3.1 Austenitic stainless steel
The stainless steel used in making skeletal pins and wires shall
This part of IS0 5838 specifies material and mechanical re-
quirements for skeletal pins and wires for use in bone surgery, be in accordance with IS0 583211, composition A or B, and
shall meet the requirements of the intergranular corrosion test
excluding wires for binding.
specified in clause 8 of IS0 =/I.
3.2 Wrought titanium 6-aluminium 4-vanadium
2 References
alloy
IS0 82, Steel - Tensile testing.
Wire made of titanium alloy shall be in accordance with the re-
quirements specified for composition in IS0 5832/3, excluding
IS0 89, Steel - Tensile testing of wire.
requirements for tensile strength and elongation which are
specified in clause 4 of this International Standard.
IS0 5832, Implants for surgery - Metallic materials
- Part I : Wrought stainless steel.
3.3 Wrought cobalt-chromium-tungaten-nickel
- Part 3: Wrought titanium &aluminium 4-vanadium
all0 y. alloy
- Part 5: Wrought cobalt-chromium-tungsten-nicke~a~loY.
Cobalt-chromium-tungsten-nickel alloy used in making skeletal
pins and wires shall be in accordance with IS0 583215.
ASTM E8, Methods of tension testing of metallic materials.
NOTE - The above reference will be replaced by a reference to the ap-
4 Mechanical properties
propriate International Standard when the latter becomes available.
The mechanical properties, determined as specified in clause 5,
shall be in accordance with the requirements given in the table.
3 Material
5 Methods of test
Skeletal pins and wires shall be made of materials in actor-
dance with 3.1, 3.2 and 3.3.
The methods of test to be used in determining compliance with
8C-
the requirements Of this International Standard shall be in
Upon request, the supplier of the pins and wires shall produce
cordance with IS0 82 or IS0 89 or ASTM E8 depending on the
evidence that the pins have been manufactured from material
form of the product.
complying with the relevant International Standards.
1

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2

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Norme internationale
INTERNATIONAL ORGANIZATION FOR STANDARDIZATIONoMEXI(LIYHAPOI(LIHAR OPrAHM3AUHR il0 CTAHllAPTH3AUMHoORGANlSATlON INTERNATIONALE DE NORMALISATION
Implants chirurgicaux - Fils et broches pour os -
Partie 1 : Matériaux et propriétés mécaniques
Implants for surgery - Skeletal pins and wires - Part 1 : Material and mechanical requirements
Première édition - 1983-08-01
Réf. no : IS0 5838/1-1983 (FI
CDU 615.465 : 621.886.1 : 669-426
Descripteurs : implant chirurgical, épingle, fil métallique, propriété mécanique, spécification.
Prix basé sur 2 pages

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Avant-propos
L'ISO (Organisation internatio
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