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Implants for neurosurgery. Preformed cranioplasty plates that can be altered
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Basic data
| Standard ID | YY/T 0917-2014 (YY/T0917-2014) |
| Description (Translated English) | Implants for neurosurgery. Preformed cranioplasty plates that can be altered |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C35 |
| Classification of International Standard | 11.040.40 |
| Word Count Estimation | 5,580 |
| Date of Issue | 6/17/2014 |
| Date of Implementation | 7/1/2015 |
| Quoted Standard | GB/T 13810; YY/T 0605.5; YY/T 0640; ISO 5832.2; ISO 5832.3; ISO 5832.5; ASTM F 86 |
| Adopted Standard | ASTM F622-1979(2002), 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 cover the skull defect can be plastic prefabricated metal skull plate. This standard specifies the requirements can be prefabricated plastic skull plate materials, dimensions and tolerances, surface treatment and labeling, packagi |
YY/T 0917-2014: Implants for neurosurgery. Preformed cranioplasty plates that can be altered
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Implants for neurosurgery.Preformed cranioplasty plates that can be altered
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Neurosurgical implants may be preformed plastic 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 Amendment uses ASTMF622-1979 (2002) "cranioplasty can use plastic panels standard gauge
Fan. "
Technical differences between this standard and ASTMF622-2002 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 ASTMF67 and ASTMF136;
● YY/T 0605.5 substitute ASTMF90;
● ISO 5832-2 replaced ASTMF67;
● ISO 5832-3 replaced ASTMF136;
● ISO 5832-5 replaced ASTMF90;
● increase YY/T 0640;
--- Remove ASTMF622-1979 (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.
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 of this standard. Li Nan, Zhang Lu, Fan platinum, Liu Bin, Terence Chang.
Neurosurgical implants may be preformed plastic skull plate
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)
ASTMF86 metal surgical implant surface treatment and marking (StandardPracticeforSurfacePreparationand
MarkingofMetalicSurgicalImplants)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Skull plate cranioplastyplate
For covering or repair skull defects or holes in implantable devices.
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.
...
