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YY/T 0345.3-2014: Implants for surgery. Skeletal pins and wires. Part 3: kirschner skeletal wires
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0345.3-2014 | English | 139 |
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Implants for surgery. Skeletal pins and wires. Part 3: kirschner skeletal wires
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YY/T 0345.3-2014
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PDF similar to YY/T 0345.3-2014
Standard similar to YY/T 0345.3-2014 YY/T 0346 YY 0341.2 YY 0341.1 YY/T 0345.2 Basic data | Standard ID | YY/T 0345.3-2014 (YY/T0345.3-2014) | | Description (Translated English) | Implants for surgery. Skeletal pins and wires. Part 3: kirschner skeletal wires | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 6,627 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Older Standard (superseded by this standard) | YY 0345-2002 | | Quoted Standard | YY/T 0345.1; YY/T 0640 | | Adopted Standard | ISO 5838.3-1993, MOD | | Regulation (derived from) | China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 Kirschner. This Standard specifies the Kirschner wire length, diameter size requirements, as well as the cone-shaped tip of the blade angle between the plane of the requirements, and cited various blunt end tip and may be used in | YY/T 0345.3-2014: Implants for surgery. Skeletal pins and wires. Part 3: kirschner skeletal wires---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 surgery Skeletal pins and wires Part 3. Kirschner skeletal wires
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Partially replaced YY 0345-2002
Implants for surgery - Metal bone needle
Part 3. Kirschner
(ISO 5838-3.1993, MOD)
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
YY/T 0345 "metal surgical implants bone needles" is divided into three sections.
--- Part 1. Material and mechanical performance requirements;
--- Part 2. Steinmann pin size;
--- Part 3. Kirschner.
This section YY/T Section 30345 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This Part replaces YY 0345-2002 "osteosynthesis implant metal spicules."
The main difference between "surgical implant metal bone needle" and YY 0345-2002 of.
--- YY 0345-2002 metal spicules only stainless steel material, and this standard also includes titanium, titanium and cobalt-based materials,
Therefore, a wider scope of application of the new standards;
--- YY 0345-2002 metal spicules more general type, but this standard is divided into specific Steinmann pin and Kirschner, distinguish more
To clarify;
--- YY 0345-2002 only provides the tensile strength of the metal bone needles, and in accordance with this standard material, different sizes refined
Mechanical properties of metal spicules requirements, and increased requirements fractured elongation;
--- YY 0345-2002 only provides metal bone needles size range of the standard size is more detailed, and increased tolerance.
This section uses the translation method to modify the use of ISO 5838-3.1993 "spicules metal surgical implants - Part 3. Kirschner."
This part of ISO 5838-3.1993 as compared to only normative references have been adjusted to technical differences, in order to adapt to China
Technical conditions, the consistency of the correspondence section of the international normative documents referenced in our country with the following documents.
--- YY/T 0345.1-2011 metal surgical implant bone needles - Part 1. Material and mechanical performance requirements (ISO 5838-
1.1995, IDT)
--- YY/T 0640-2008 active surgical implants General requirements (ISO 14630.2005, IDT)
--- Original standard references ISO 6018. 1987 has been abolished, and did not reprint, so the standard is adopted covering content
ISO 6018 of YY/T 0640 be replaced.
Since the implementation of this section, instead of YY 0345-2002 "osteosynthesis implant metal bone needle" in the appropriate section.
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 part is proposed by the China Food and Drug Administration.
This part of the National Surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Technical Committee (SAC /
TC110/SC1) centralized.
This section is drafted. Tianjin 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 section. Zhang Chen, Ma Chun Bao, Liu Yinghui, Guo Xiaolei.
Implants for surgery - Metal bone needle
Part 3. Kirschner
1 Scope
YY/T 0345 provisions of this part of the Kirschner features.
Materials and mechanical performance requirements see YY/T 0345.1.
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.
YY/T 0345.1 surgical implant metal bone pins - Part 1. Material and mechanical performance requirements
YY/T 0640 General requirements for passive surgical implants (YY/T 0640-2008, ISO 14630.2005, IDT)
3 Dimensions
Size should be consistent with Figure 1, the provisions of Figure 2 and Table 1.
4 ends
Kirschner should tip at one end or both ends of the tip.
If the Kirschner wire tip cone-shaped blade, constitutes the angle between the plane of the tip should be shown in Figure 2.
Note. Appendix A lists the different tip and a blunt end may be used.
5 marking and packaging
Kirschner packaging and labeling shall comply with YY/T 0640's.
Should indicate the length, diameter Kirschner packaging (Unit. mm) Type and ends.
Figure 1 Kirschner main dimensions
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