YY/T 0928-2014Implants for neurosurgery—Preformed cranioplasty plates (English PDF)

Foreword

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

This standard uses redrafted law revision adopted ASTM F452-2008 "Neurosurgical implants prefabricated skull plate." Technical differences between this standard and ASTM F452-2008 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. With GB 4234 instead of ASTM F139; Instead of using the ISO 5832-1 ASTM F139; Instead of using the ISO 5832-4 ASTM F75; Remove ASTM F56; Increase YY/T 0640.

--- Remove ASTM F452-2008 in Chapters 8 and 9.

This standard only specifies the skull plate prefabricated materials, dimensions and tolerances, surface treatment and marking, enterprises should be based on this standard and reference Content ISO 14630 combined performance of all enterprise product development registered product standards.

1 Scope

This standard specifies the neurosurgical implants skull plate prefabricated materials, dimensions and tolerances, surface treatment and marking, and labeling and packaging Notes, but it does not include requirements for biocompatibility and toxicity of materials.

This standard applies without remodeling to cover cranial defects prefabricated metal skull plate.

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 4234 stainless steel surgical implants (GB 4234-2003, ISO 5832-1:1997, MOD)

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-Metalicma-terials-Part 1. Wroughtstainlesssteel)

ISO 5832-4 Implants for surgery - Metallic materials - Part 4. cast cobalt-chromium-molybdenum alloy (Implantsforsurgery- Metalicmaterials-Part 4. Cobalt-chromium-molybdenum) ASTM F86 metal surgical implant surface treatment and marking (StandardPracticeforSurfacePreparationand MarkingofMetalicSurgicalImplants)

3 Materials

Prefabricated skull plate can be used in line with GB 4234 or ISO 5832-1, ISO 5832-4 and found acceptable in its neurosurgery He manufactured materials. Material shall be marked with delivery status (eg. annealed, cold, etc.).

4 Dimensions and tolerances

4.1 prefabricated panels without remodeling the skull should be able to make a variety of sizes to accommodate different sizes of skull defects.

4.3 prefabricated skull plate should have several vias (Figure 1).

Skull shape and thickness of 4.4 prefabricated panels should be able to meet the different needs of the thickness tolerances shall comply with the requirements in Table 1.