ISO 15374 pdf download.Implants for surgery — Requirements for production of forgings
1 Scope
This International Standard specifies requirements for the production of forgings of stainless steel, unalloyed titanium, titanium alloy or cobalt-based alloys intended to be used as semifinished products in the manufacturing of surgical implants. NOTE An International Standard giving requirements for forgings is under preparation.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 5832-1 :1 997, Implants for surgery — Metallic materials — Part 1 : Wrought stainless steel. ISO 5832-2:1 996, Implants for surgery — Metallic materials — Part 2: Unalloyed titanium . ISO 5832-3:1 996, Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy. ISO 5832-5:1 993, Implants for surgery — Metallic materials — Part 5: Wrought cobalt-chromium-tungsten-nickel alloy. ISO 5832-6:1 997, Implants for surgery — Metallic materials — Part 6: Wrought cobalt-nickel-chromium- molybdenum alloy. ISO 5832-7:1 994, Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium- nickel-molybdenum iron alloy . ISO 5832-8:1 997, Implants for surgery — Metallic materials — Part 8: Wrought cobalt-nickel-chromium- molybdenum-tungsten-iron alloy. ISO 5832-9:1 992, Implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel . ISO 5832-1 0:1 993, Implants for surgery — Metallic materials — Part 1 0: Wrought titanium 5-aluminum 2,5-iron alloy.ISO 5832-1 1 :1 994, Implants for surgery — Metallic materials — Part 1 1 : Wrought titanium 6-aluminium 7-niobium alloy. ISO 5832-1 2:1 996, Implants for surgery — Metallic materials — Part 1 2: Wrought cobalt-chromium-molybdenum alloy. ISO 6892:1 984, Metallic materials — Tensile testing . EN 1 0204:1 991 , Metallic products — Types of inspection documents . ETTC 2:1 995 1 ) , Microstructural standards for alpha + beta titanium alloy bars. NOTE The above reference will be replaced by references to appropriate International Standards when the latter become available.
3 Definitions
For the purposes of this International Standard, the following definitions apply. 3.1 closed-die forging metallic article formed by pressing or hammering a metal into a closed die 3.2 batch lot forgings to the same pattern produced from material from the same heat during one production run and, if subsequent heat treatment is required, heat-treated together 3.3 open-die forging half-finished product shaped by impact or pressure, without a cutting operation 3.4 forging semifinished product or implant component produced by one or more forging operations
4 Composition of forging stock
Forgings shall be made from forging stock of stainless steel, unalloyed titanium, titanium alloy or cobalt-based alloys that comply with the relevant parts of ISO 5832 (see clause 2).
5 Process control
5.1 Temperature The heating temperature before forging shall be controlled. For unalloyed titanium and titanium alloys, heating of the forging shall be carried out in such a manner as to minimize pick-up of hydrogen.
5.2 Shear banding
If shear bands are present in the material, they shall not impair the application of the product. 5.3 Surface 5.3.1 General All products produced by hot forgings shall be descaled by suitable techniques and pickled if necessary. 5.3.2 Forgings made of unalloyed titanium or of titanium alloy All oxide scale and oxygen-enriched material, including a case, shall be removed from the surface of unalloyed titanium and titanium alloy forgings. 5.4 Hydrogen content of forgings made of unalloyed titanium or of titanium alloy When determined upon a cross-section taken from the smallest cross-sectional area of the forging, the hydrogen content shall not exceed 0,01 5 % (mass fraction). 5.5 Heat treatment Any heat treatment after the forging operation shall be agreed between the supplier of the forgings and the customer. NOTE To achieve specific properties in the finished product, alternative conditions may be specified such as hot-forging, warm-working or cold-forging,