YY/T 0816-2010Implants for surgery—Malleable wires for use as sutures and other surgical applications (English PDF)

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

This standard uses redrafted Law Amendment uses ISO 10334:1994 "surgical sutures and other surgical implants with a flexible wire." This standard and ISO 10334:1994 in comparison, only normative references have been adjusted to technical differences, in order to adapt to China Technical conditions, adjust the focus reflected in Chapter 2, "Normative references", the specific adjustments are as follows.

--- Instead of using the ISO 5832-1 ISO 5832-1. 1987;

--- Instead of using the ISO 5832-2 ISO 5832-2:1993;

--- With YY/T 0605.5 replaces ISO 5832-5:1993;

--- Instead of using the ISO 5832-9 ISO 5832-9:1992;

--- With YY/T 0640 instead of ISO 6018. 1987;

--- With GB/T 228 instead of ISO 6892. 1984;

--- With GB/T 239 instead of ISO 7800. 1984;

--- With GB/T 238 instead of ISO 7801. 1984;

--- With ASTM F86 instead ASTM F86-91.

1 Scope

This standard specifies the surgical sutures or for other forms of organization and implant fixation with flexible wire sizes and machinery Performance and test methods. Mechanical properties, including tensile strength, elongation, bending and torsion capability damaged. This standard does not involve surface finish.

Note 1. In the case of wire twisting and knotting should not be broken, the surface should not appear fracturing, cracks or cracks.

Note 2. The wire may be used simultaneously with other implants. In this case, the composition of the D and E of stainless steel wire (see ISO 5832-1) only And the corresponding stainless steel implants used in common; similarly, the use of high nitrogen stainless steel wire and other high nitrogen stainless steel can only co-implant With use. This is done to reduce that may arise between the wire and the other implant galvanic corrosion.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 228 metal materials at room temperature tensile test method (GB/T 228-2002, eqvISO 6892.1998)

GB/T 238 metal material wire repeated bending test method (GB/T 238-2002, ISO 7801. 1984, IDT)

GB/T 239 metal wire torsion test method (GB/T 239-1999, eqvISO 7800. 1984)

YY/T 0605.5 surgical implants of metallic materials - Part 5. Wrought cobalt - chromium - tungsten - nickel alloy (YY/T 0605.5-2007, ISO 5832-5:2005, IDT)

YY/T 0640 General requirements for passive surgical implants (YY/T 0640-2008, ISO 14630:2005, IDT)

ISO 5832-1 Implants for surgery - Metallic materials - Part 1. Forged Stainless Steel (Implantsforsurgery-Metalic materials-Part 1. Wroughtstainlesssteel)

ISO 5832-2 Implants for surgery - Metallic materials - Part 2. Titanium (Implantsforsurgery-Metalic materials-Part 2. Unaloyedtitanium)

ISO 5832-9 Implants for surgery - Metallic materials - Part 9. Forged high nitrogen stainless steel (Implantsforsurgery- Metalicmaterials-Part 9. Wroughthighnitrogenstainlesssteel) ASTM F86 metal surgical implant surface treatment and marking (StandardPracticeforSurfacePreparationand MarkingofMetalicSurgicalImplants)

3 Materials

Flexible wire material can be in line with the requirements of ISO 5832-1 forged stainless steel, titanium comply with the requirements of ISO 5832-2, consistent with Forging high nitrogen requirements of ISO 5832-9 stainless steel, in line with forged cobalt-chromium tungsten nickel YY/T 0605.5 requirements.

4 Surface Treatment

When the customer needs, it can be wire passivation, passivation procedures based ASTM F86.