YY/T 0928-2014 English PDF

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YY/T 0928-2014: Implants for neurosurgery. Preformed cranioplasty plates
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0928-2014	149	Add to Cart	2 days	Implants for neurosurgery. Preformed cranioplasty plates	Valid

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Basic data

Standard ID: YY/T 0928-2014 (YY/T0928-2014)
Description (Translated English): Implants for neurosurgery. Preformed cranioplasty plates
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 5,516
Date of Issue: 6/17/2014
Date of Implementation: 7/1/2015
Quoted Standard: GB 4234; YY/T 0640; ISO 5832-4; ASTM F 86; ISO 5832-1
Adopted Standard: ASTM F452-2008, MOD
Regulation (derived from): China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies): State Food and Drug Administration
Summary: This Standard applies to no longer be covered by shaping skull defects prefabricated metal skull plate. This Standard specifies the materials, dimensions and tolerances, surface treatment and labeling, packaging and labeling, but does not include requirem

YY/T 0928-2014: Implants for neurosurgery. Preformed cranioplasty plates

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Implants for neurosurgery.Preformed cranioplasty plates ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Neurosurgical implants prefabricated skull plate Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard uses redrafted law revision adopted ASTMF452-2008 "Neurosurgical implants prefabricated skull plate." Technical differences between this standard and ASTMF452-2008 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 ASTMF139; Instead of using the ISO 5832-1 ASTMF139; Instead of using the ISO 5832-4 ASTMF75; Remove ASTMF56; Increase YY/T 0640. --- Remove ASTMF452-2008 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. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard by the national surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Technical Committee (SAC/TC110/SC1) centralized. This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, the State Food and Drug Pipe Authority for Medical Device Evaluation Center. The main drafters. Zhang Lu, Li Nan, King Ming, Song Duo, Liu Bin, Dong Wenxing. Neurosurgical implants prefabricated skull plate

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) ASTMF86 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. 4.2 preformed shape of the skull should be able in the corresponding defect (such as. the parietal ridge, eminence occipital, frontal, temporal lines, etc.) are the reconstruction of the skull Often the structure and symmetry. 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. ......

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