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YY/T 0727.1-2009: Implants for surgery. Metal intramedullary nailing systems. Part 1: Intramedullary nails
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Implants for surgery. Metal intramedullary nailing systems. Part 1: Intramedullary nails
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YY/T 0727.1-2009
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Basic data | Standard ID | YY/T 0727.1-2009 (YY/T0727.1-2009) | | Description (Translated English) | Implants for surgery. Metal intramedullary nailing systems. Part 1: Intramedullary nails | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 15,115 | | Date of Issue | 2009-11-15 | | Date of Implementation | 2010-12-01 | | Quoted Standard | GB/T 12417.1; GB 23102; YY/T 0605.5; YY/T 0605.6; YY/T 0605.7; YY/T 0605.8; YY/T 0640; YY/T 0727.3; ISO 965-1; ISO 965-2; ISO 5832-1; ISO 5832-2; ISO 5832-3; ISO 5832-4; ISO 5832-9; ISO 5832-10; ISO 5832-12 | | Adopted Standard | ISO 15142-1-2003, IDT | | Regulation (derived from) | Industry standard filing Notice 2010 No. 2 (No. 122 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies: by way of surgical implants for the long bone temporarily fixed metal medical equipment, gives the intramedullary nail definitions and requirements. This standard applies to all human temporary fixation of long bone intramedullary fixation with metal. | YY/T 0727.1-2009: Implants for surgery. Metal intramedullary nailing systems. Part 1: Intramedullary nails
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Implants for surgery.Metal intramedullary nailing systems.Part 1. Intramedullary nails
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
YY/T 0727.1-2009/ISO 15142-1.2003
Implants for surgery - Metal intramedullary nail system
Part 1. intramedullary nail
(ISO 15142-1.2003, IDT)
Posted 2009-11-15
2010-12-01 implementation
State Food and Drug Administration issued
Foreword
YY/T 0727 "surgical implants metal intramedullary nail system" is divided into three parts.
--- Part 1. intramedullary nail;
--- Part 2. locking member;
--- Part 3. Connect the instrument to expand the canal and diameter measurements.
This section YY/T Section 10727 of.
This part identical with ISO 15142-1.2003 "surgical implants metal intramedullary nail system - Part 1. intramedullary nail."
For ease of use, this section made the following editorial changes.
a) "this International Standard" be replaced by "this section";
b) use a decimal point instead of a decimal comma ",". ",";
c) the normative references have been converted to equivalent national standards or industry standards with international standards with national standards or industry standards
instead;
d) Remove the foreword and introduction of international standards.
Appendix A of this section is an informative annex.
This part of the National Surgical implants and orthopedic instruments Standardization Technical Committee (SAC/TC110) centralized.
This section is drafted. Tianjin State Food and Drug Administration Medical Device Quality Supervision and Inspection Center.
The main drafters of this section. Dongshuang Peng, Zuo Xiao Wang, Li Nan, Qi Baofen.
YY/T 0727.1-2009/ISO 15142-1.2003
Implants for surgery - Metal intramedullary nail system
Part 1. intramedullary nail
1 Scope
YY/T 0727 provisions of this part of the way by a surgical implant for temporary fixation within the bone marrow long metal medical devices, given marrow
Nail definitions and requirements.
This section applies to all human long bone intramedullary temporary fixing metal fixation devices.
2 Normative references
The following documents contain provisions which, through reference YY/T 0727 to the present, constitute provisions of this section. For dated reference documents
Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section
Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this
section.
GB/T 12417.1 active surgical implants bone and joint replacement implants - Part 1. Particular requirements for osteosynthesis implants
(GB/T 12417.1-2008, ISO 14602.1998, IDT)
GB 23102 Implants for surgery metallic materials Ti-6Al-7Nb alloy processing material (GB 23102-2008, ISO 5832-11.1994,
IDT)
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 0605.6 surgical implants of metallic materials - Part 6. Wrought cobalt - nickel - chromium - molybdenum alloy (YY/T 0605.6-2007,
ISO 5832-6.1997, IDT)
YY/T 0605.7 surgical implants of metallic materials - Part 7. malleable and cold cobalt - chromium - nickel - molybdenum - iron alloy
(YY/T 0605.7-2007, ISO 5832-7.1994, IDT)
YY/T 0605.8 surgical implants of metallic materials - Part 8. Wrought cobalt - nickel - chromium - molybdenum - tungsten - iron alloy (YY/T 0605.8-
2007, ISO 5832-8.1997, IDT)
YY/T 0640 General requirements for passive surgical implants (YY/T 0640-2008, ISO 14630.2005, IDT)
Part 3 YY/T 0727.3 metal surgical implant intramedullary nail system. measuring instruments and connections to expand the diameter of the canal
(YY/T 0727.3-2009, ISO 15142-3.2003, IDT)
ISO 965-1 ISO general metric screw threads - Tolerances - Part 1. Principles and basic data
ISO 965-2 ISO general metric screw threads - Tolerances - Part 2. Limits of sizes for general internal and external threads of medium quality
ISO 5832-1 Implants for surgery - Metallic materials - Part 1. Forged steel
ISO 5832-2 Implants for surgery - Metallic materials - Part 2. Titanium
ISO 5832-3 Implants for surgery - Metallic materials - Part 3. Forged Titanium 6Al vanadium alloy
ISO 5832-4 Implants for surgery metallic materials - Part 4. Cast cobalt - chromium - molybdenum alloy
Part 9 ISO 5832-9 Implants for surgery metallic materials. Forged high nitrogen stainless steel
ISO 5832-10 Implants for surgery metallic materials - Part 10. -5 forged titanium alloy aluminum -2.5
ISO 5832-12 Implants for surgery - Metallic materials - Part 12. Wrought cobalt - chromium - molybdenum alloy
3 Terms and Definitions
The following terms and definitions apply YY/T 0727 to the present section. Figures 1 to 4 shows examples of various types of intramedullary nail.
YY/T 0727.1-2009/ISO 15142-1.2003
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