YY/T 0917-2014Implants for neurosurgery—Preformed cranioplasty plates that can be altered (English PDF)

Foreword

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

This standard uses redrafted Law Amendment uses ASTM F622-1979 (2002) "cranioplasty can use plastic panels standard gauge Fan. " Technical differences between this standard and ASTM F622-2002 follows.

--- On normative references, this standard has been adjusted technical differences, in order to adapt our technical conditions, the adjusted situation Focus is reflected in the status of Chapter 2, "Normative references", the specific adjustments are as follows.

- GB/T 13810 instead of ASTM F67 and ASTM F136;

- YY/T 0605.5 substitute ASTM F90;

- ISO 5832-2 replaced ASTM F67;

- ISO 5832-3 replaced ASTM F136;

- ISO 5832-5 replaced ASTM F90;

- increase YY/T 0640;

--- Remove ASTM F622-1979 (2002) 6.3, Chapter 9, Chapter 10.

This standard only specifies the skull plate can be prefabricated plastic materials, dimensions and tolerances, surface treatment and marking, enterprises should be based on this standard and reference Content test YY/T 0640 combined performance of all enterprise product development registered product standards.

1 Scope

This standard applies to cover the skull defect may be plastic prefabricated metal skull plate, the provisions of the skull plate can be prefabricated plastic material, Dimensions and tolerances, surface treatment and marking, packaging and labeling requirements.

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 13810 surgical implants of titanium and titanium alloy materials

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 5832-2 Implants for surgery metallic materials - Part 2. Titanium (Implantsforsurgery-Metalicmaterials- Part 2. Unaloyedtitanium)

ISO 5832-3 Implants for surgery - Metallic materials - Part 3. Forged titanium 6 aluminum 4 - vanadium alloy (Implantsforsurgery- Metalicmaterials-Part 3. Wroughttitanium6-aluminium4-vanadiumaloy)

ISO 5832-5 Implants for surgery - Metallic materials - Part 5. Wrought cobalt - chromium - tungsten - nickel alloy (Implantsforsurgery- Metalicmaterials-Part 5. Wroughtcobalt-chromium-tungsten-nickelaloy) ASTM F86 metal surgical implant surface treatment and marking (StandardPracticeforSurfacePreparationand MarkingofMetalicSurgicalImplants)

3 Terms and Definitions

The following terms and definitions apply to this document.

4 Materials

Prefabricated plastic skull plate can be used in line with GB/T 13810, YY/T 0605.5 or ISO 5832-2, ISO 5832-3, ISO 5832-5 Manufacturing and neurosurgery acceptable other materials.

5 Dimensions and Tolerances

5.1 can be prefabricated plastic skull plate can be made into a variety of sizes to accommodate different sizes of skull defects. Doctors in plastic surgery to plate To suit a particular type of skull defects.