Search result: YY/T 0956-2014
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Implane for surgury. Staples with parallel legs for orthopaedic use. General requirements
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YY/T 0956-2014
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| Standard ID | YY/T 0956-2014 (YY/T0956-2014) | | Description (Translated English) | Implane for surgury. Staples with parallel legs for orthopaedic use. General requirements | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 9,996 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Older Standard (superseded by this standard) | YY 0119-2002 | | Quoted Standard | GB/T 228.1; GB 4234; YY/T 0605.5; YY/T 0640; ISO 5832.3; ISO 5832.4 | | Adopted Standard | ISO 8827-1988, IDT | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to orthopedic U-shaped nails. This Standard specifies the orthopedic U-shaped nails design, dimensions, tolerances, materials, surfaces, packaging and labeling requirements. |
YY/T 0956-2014
Implane for surgury.Staples with parallel legs for orthopaedic use.General requirements
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Partially replaced YY 0119-2002
Orthopedic surgical implants with U-shaped nails General requirements
(ISO 8827. 1988, IDT)
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 the translation method identical with ISO 8827 "orthopedic surgical implants with U-shaped staples General requirements."
Correspondence between the consistency of the standards of international documents and normative references of the following documents.
--- GB 4234-2003 surgical implants made of stainless steel (ISO 5823-1.1997, MOD)
--- YY/T 0605.5-2007 surgical implants of metallic materials - Part 5. Wrought cobalt - chromium - tungsten - nickel alloys (ISO 5832-5.
2005, IDT)
--- GB/T 228.1-2010 tensile testing of metallic materials - Part 1. room temperature test methods (ISO 6892-1.2009,
MOD)
--- YY/T 0640-2008 active surgical implants General requirements (ISO 14630.2005, IDT)
This standard and ISO 8827. 1988 as compared, differences are as follows.
Normative documents with YY/T 0640 instead of ISO 6018.
Note. ISO 6018 has been annulled, the content is covered by ISO 14630, YY/T 0640 equivalent conversion ISO 14630.
This standard replaces YY 0119-2002 "metal orthopedic implants osteosynthesis with nails" on the part of the U-shaped staples.
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 was proposed by the China Food and Drug Administration.
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 Medical Device Quality Supervision and Inspection Center, Changzhou City, Kang Hui Medical Devices Co., Ltd.
The main drafters of this standard. Makin bamboo, Jiang Xi, Li Libin, Wang Aiping, Zhao Dan, Zhang Wenhui.
Orthopedic surgical implants with U-shaped nails General requirements
1 Scope
This standard specifies the Orthopedic U-shaped staples General requirements and dimensions and tolerancing.
Note. Appendix A gives the U-shaped staples selection and use of guidelines, but do not form an integral part of this standard.
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 228.1 tensile testing of metallic materials - Part 1. room temperature test methods (GB/T 228.1-2010, ISO 6892-1.
2009, MOD)
GB 4234 stainless steel surgical implants (GB 4234-2003, ISO 5832-1.1997, MOD)
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 5832-3 Implants for surgery - Metallic materials - Part 3. Forged Titanium 6Al vanadium alloy (Implantsforsurgery-
Metalicmaterials-Part 3. Wroughttitanium6-aluminium4-vanadiumaloy)
ISO 5832-4 Implants for surgery - Metallic materials - Part 4. Cast cobalt - chromium - molybdenum alloy (Implantsforsurgery-
Metalicmaterials-Part 4. Cobalt-chromium-molybdenumcastingaloy)
3 Design
3.1 radius of curvature
U-shaped staples selected wire manufacturing, within a radius of curvature of not less than 2mm and not smaller than the diameter of the wire, bend shape should be smooth.
3.2 tip
U-shaped nail tip may be conical, three prism, spear-shaped or a flat shape.
3.3 nail leg
Nail the legs should be parallel.
Note 1. Orthopedic shown in Figure 1 with the typical form of U-shaped nails. Figure 1 shows a U-shaped staples names and dimensions, its purpose is not specified U-shaped
Nail design requirements, this standard does not constitute a U-shaped staple Requirements section.
Note 2. Although there are other forms of cross-section of U-shaped nails, but generally circular, oval and rectangular cross-section class. If the manufacturer U-shaped nails with wire, general mining
Wire with a diameter of 2.5mm. Elliptical cross section can achieve greater strength, generally specifications for 4mm × 2mm, or by strengthening the curved screen angle
Song at the strength [Fig. 1b)]. Nail the legs may be flat, barbed or other forms.
4 Dimension
U-shaped nail size should be the effective length (l), the effective width (b), the diameter (d) are labeled (Figure 1), in millimeters, for example,
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