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ISO 5838-1-2013 pdf free download
ISO 5838-1-2013 pdf free download.Implants for surgery Metallic skeletal pins and wires Part 1:General requirements
Implants chirurgicaux — Fils et broches pour os — Partie 1: Matériaux et pro priétés mécaniques.
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 ol 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 583 2-5, Implants forsurgery — Metallic materials — PartS: Wrought cobalt-chromium-tuqsten-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 cobalt- chromium-nickel-molybdenum-i ron alloy
ISO 5832-8, Implants for surgery — Metallic materials — Part 8: Wrought cobalt-nukel-chromiummolybdenum- 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
8 Packaging
The requirements of ISO 14630:2012, Clause 10, shall apply.
9 Information supplied by the manufacturer
9.1 General
The requirements of ISO 14630:2012, Clause I 1,apply together with the following particular requirement.
9.2 Instructions for use
The requirements of ISO 14630:2012, 11.3. apply, and shall include the following details when relevant:
a) the product name,
b) characteristic sizes.
c) material specification, and
d) the appropriate drill bit dimensional characteristics.
9.3 Marking on implant
The requirements of ISO 14630:2012, 11.5, apply. and shall include the following details when the dimensions permit:
— the manufacturer’s name or trademark, and
— the batch code.
Additional markings could include length and diameter or cross-sectional size for skeletal pins.ISO 5838-1-2013 pdf free download.
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