YY/T 0816-2010 Implants for surgery - Malleable wires for use as sutures and other surgical applications
1 Scope
This standard specifies the dimensions and mechanical properties of malleable wires for use as sutures and other forms of tissue and implant fixation in surgery, and gives test methods. The mechanical properties specified are tensile strength, elongation, and resistance to damage in bending and in torsion.
Surface finish is not covered by this standard.
Note 1: The wires shall neither fracture while being twisted or knotted, nor develop cracks or crevices on its surface.
Note 2: The wires may be used together with other implants. In these circumstances, the stainless steel wire of compositions D and E (see ISO 5832-1) should only be used in relation to implants made of corresponding stainless steel, and wires made of high-nitrogen stainless steel should only be used in relation to implants of high-nitrogen stainless steel. This will reduce the possibility of galvanic corrosion occurring between the wires and implant.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 228 Metallic materials - Tensile testing at ambient temperature (GB/T 228-2002, eqv ISO 6892: 1998)
GB/T 238 Metallic materials - Wire -Reverse bend test (GB/T 238-2002, ISO 7801:1984, IDT)
GB/T 239 Metallic materials wire torsion test (GB/T 239-1999, eqv ISO 7800:1984)
YY/T 0605.5 Implants for surgery - Metallic materials - Part 5: Wrought cobalt-chromium-tungsten-nickel alloy (YY/T 0605.5-2007, ISO 5832-5:2005, IDT)
YY/T 0640 Non-active surgical implants - General requirements (YY/T 0640-2008, ISO 14630:2005, IDT)
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 5832-9 Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
ASTM F 86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
3 Materials
Malleable wire shall be made from wrought stainless steel complying with ISO 5832-1, from unalloyed titanium complying with ISO 5832-2, from wrought high-nitrogen stainless steel complying with ISO 5832-9, or from wrought cobalt-chromium-tungsten-nickel alloy complying with YY/T 0605.5.
4 Surface preparation
The wire may be subjected to a passivation process if requested by the customer. Such passivation process shall be performed in accordance with ASTM F 86.
5 Dimensions
The nominal diameter of the wire shall be stated by the manufacturer (see clause 8). The tolerances for the nominal diameter of the wire are given in Table 1 to Table 4.
6 Mechanical properties
YY/T 0816-2010 Implants for surgery - Malleable wires for use as sutures and other surgical applications
1 Scope
This standard specifies the dimensions and mechanical properties of malleable wires for use as sutures and other forms of tissue and implant fixation in surgery, and gives test methods. The mechanical properties specified are tensile strength, elongation, and resistance to damage in bending and in torsion.
Surface finish is not covered by this standard.
Note 1: The wires shall neither fracture while being twisted or knotted, nor develop cracks or crevices on its surface.
Note 2: The wires may be used together with other implants. In these circumstances, the stainless steel wire of compositions D and E (see ISO 5832-1) should only be used in relation to implants made of corresponding stainless steel, and wires made of high-nitrogen stainless steel should only be used in relation to implants of high-nitrogen stainless steel. This will reduce the possibility of galvanic corrosion occurring between the wires and implant.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 228 Metallic materials - Tensile testing at ambient temperature (GB/T 228-2002, eqv ISO 6892: 1998)
GB/T 238 Metallic materials - Wire -Reverse bend test (GB/T 238-2002, ISO 7801:1984, IDT)
GB/T 239 Metallic materials wire torsion test (GB/T 239-1999, eqv ISO 7800:1984)
YY/T 0605.5 Implants for surgery - Metallic materials - Part 5: Wrought cobalt-chromium-tungsten-nickel alloy (YY/T 0605.5-2007, ISO 5832-5:2005, IDT)
YY/T 0640 Non-active surgical implants - General requirements (YY/T 0640-2008, ISO 14630:2005, IDT)
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 5832-9 Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
ASTM F 86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
3 Materials
Malleable wire shall be made from wrought stainless steel complying with ISO 5832-1, from unalloyed titanium complying with ISO 5832-2, from wrought high-nitrogen stainless steel complying with ISO 5832-9, or from wrought cobalt-chromium-tungsten-nickel alloy complying with YY/T 0605.5.
4 Surface preparation
The wire may be subjected to a passivation process if requested by the customer. Such passivation process shall be performed in accordance with ASTM F 86.
5 Dimensions
The nominal diameter of the wire shall be stated by the manufacturer (see clause 8). The tolerances for the nominal diameter of the wire are given in Table 1 to Table 4.
6 Mechanical properties
