YY/T 0345.3-2014Implants for surgery - Skeletal pins and wires - Part 3: Kirschner skeletal wires (English PDF)

Foreword

YY/T 0345 "metal surgical implants bone needles" is divided into three sections.

--- Part 1. Material and mechanical performance requirements;

--- Part 2. Steinmann pin size;

--- Part 3. Kirschner. This section YY/T Section 30345 of. This section drafted in accordance with GB/T 1.1-2009 given rules.

This Part replaces YY 0345-2002 "osteosynthesis implant metal spicules." The main difference between "surgical implant metal bone needle" and YY 0345-2002 of.

--- YY 0345-2002 metal spicules only stainless steel material, and this standard also includes titanium, titanium and cobalt-based materials, Therefore, a wider scope of application of the new standards;

--- YY 0345-2002 metal spicules more general type, but this standard is divided into specific Steinmann pin and Kirschner, distinguish more To clarify;

--- YY 0345-2002 only provides the tensile strength of the metal bone needles, and in accordance with this standard material, different sizes refined Mechanical properties of metal spicules requirements, and increased requirements fractured elongation;

--- YY 0345-2002 only provides metal bone needles size range of the standard size is more detailed, and increased tolerance.

This section uses the translation method to modify the use of ISO 5838-3:1993 "spicules metal surgical implants - Part 3. Kirschner." This part of ISO 5838-3:1993 as compared to only normative references have been adjusted to technical differences, in order to adapt to China Technical conditions, the consistency of the correspondence section of the international normative documents referenced in our country with the following documents.

--- YY/T 0345.1-2011 metal surgical implant bone needles - Part 1. Material and mechanical performance requirements (ISO 5838-1:1995, IDT)

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

--- Original standard references ISO 6018. 1987 has been abolished, and did not reprint, so the standard is adopted covering content

ISO 6018 of YY/T 0640 be replaced.

Since the implementation of this section, instead of YY 0345-2002 "osteosynthesis implant metal bone needle" in the appropriate section.

1 Scope

YY/T 0345 provisions of this part of the Kirschner features. Materials and mechanical performance requirements see YY/T 0345.1.

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.

YY/T 0345.1 surgical implant metal bone pins - Part 1. Material and mechanical performance requirements

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

3 Dimensions

Size should be consistent with Figure 1, the provisions of Figure 2 and Table 1.

4 Ends

Kirschner should tip at one end or both ends of the tip.

If the Kirschner wire tip cone-shaped blade, constitutes the angle between the plane of the tip should be shown in Figure 2.

Note: Appendix A lists the different tip and a blunt end may be used.

5 Marking and packaging

Kirschner packaging and labeling shall comply with YY/T 0640's.

Should indicate the length, diameter Kirschner packaging (Unit. mm) Type and ends.