ISO 5838-1-2013 pdf free.Implants for surgery- Metallic skeletal pins and wires – Part 1: General requirements.
This part of ISO 5838 specifies general requirements for metallic skeletal pins and wires for use in bone surgery, excluding wires for binding and twisting.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 3651-2, Determination of resistance to intergranular corrosion of stainless steels — Part 2:
Ferritic,austenitic and ferritic-austenitic (duplex) stainless steels — Corrosion test in media containing sulfuric acid
ISO 5832-1, Implants for surgery — Metallic materials — Part 1: Wrought stainless steel ISO 5832-2, Implants for surgery — Metallic materials — Part 2: Unalloyed titanium ISO 5832-3, Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
ISO 5832-5, Implants for surgery — Metallic materials — Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
ISO 5832-6, Implants for surgery — Metallic materials — Part 6: Wrought cobalt-nickel-chromium- molybdenum alloy
ISO 5832-7, implants for surgery — Metallic materials — Part 7; Forgeable and cold-formed cobaltchromium -nickel-molybdenum-iron alloy
ISO 5832-8, Implants for surgery Metallic materials — Part 8: Wrought cobalt-nickel-chromium- molybdenum- tungsten-iron alloy
ISO 5832-9, implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel
ISO 5832-11, implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy
ISO 5832-12, implants for surgery — Metallic materials — Part 12: Wrought cobalt-chromium- molybdenum alloy
ISO 5832-14, Implants for surgery — Metallic materials — Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy
ISO 6892-1, Metallic materials — Tensile testing — Part 1: Method of test at room temperature ISO 14630:2012, Non-active surgical implants — General requirements
3 Material
Skeletal pins and wires shall be made of wrought materials in accordance with ISO 5832-1, ISO 5832-2, ISO 5832-3, ISO 5832-5, ISO 5832-6, ISO 5832-7, ISO 5832-8, ISO 5832-9, ISO 5832-11, ISO 5832-12
and ISO 5832-14.
4 Mechanical properties
The mechanical properties shall be in accordance with the requirements given in Table 1. The test methods in ISO 6892-1 shall be used in determining compliance with the tensile requirements.
5 Method of manufacture
Skeletal pins and wires shall be manufactured by a cold drawing or a cold working process. Welds are not permissible. If local heating is needed for re-shaping points made of stainless steel, this can only be permitted provided that the whole of the final product can be shown to satisfy the intergranular corrosion test according to ISO 3651-2.
6 Finish
The external surface finish shall be free from burs, scratches and other defects visible to the naked eye. The products shall be appropriately treated to provide surface passivation.
Special attention should be paid to screw threads, if applicable.
7 Sterilization
The requirements of ISO 14630:2012, Clause 9, shall apply.ISO 5838-1 pdf download.
Tags: Implants for surgery
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