This standard specifies the classification, requirements, test methods, inspection rules, instructions, standards, packaging, transportation and storage requirements of metal orthopedic nails, which are bone-jointing implants. This standard applies to metal orthopedic nails, which are used for internal fixation of fractures during orthopedic surgery. YY 0119-2002 Bone-jointing implants Metal orthopedic nails YY0119-2002 Standard download decompression password: www.bzxz.net

s_11.040.45
Pharmaceutical Industry Standard of the People's Republic of China
YY0119-2002
Generation Y0l191993
Implants for osteosynthesis
Metal orthopedic nails
Implants for osteosynthesis- Metal correctinnal naif2002-09-24 Issued
State Food and Drug Administration Issued
2003-04-01 Implementation
YY 0119 2002
Non-standard small documents
Test signing and approval
Tight regulations
Instructions for use number
Operation confirmation and storage
Monthly requirements·
Yy 0119—2002
This standard is subject to the basic requirements of the use of YY03112 active metal contact materials containing cardboard and metal release agent color damage standard YY!—1! The standard will be revised in January.
The implementation of this standard is from the original standard Y13-1003 metal orthopedic use. This standard is approved by the National Drug Administration. This standard is issued by the National Association of Orthopedic Equipment (1S110). The unit of this confirmation is Jiangsu Hongbao Group Medical Technology Co., Ltd. This standard is mainly drafted by Yiping,
1Fan Guo
Osteosynthesis implants
Metal orthopedic nails
YY01192002
This standard specifies the classification, requirements, test methods, inspection rules, operating instructions, marking, packaging, transportation and storage requirements of metal orthopedic nails. This standard applies to orthopedic nails (hereinafter referred to as orthopedic nails). This product is used for internal fixation during surgery. 2 Normative referenced documents
The clauses in the following documents are the references to the standard. For any referenced document with a date later, all its accompanying amendments (excluding the contents of the reference) or downgrades are not applicable to this standard. However, the latest versions of these documents can be used according to the research results of this standard. The following are undated referenced documents, and their latest versions are applicable to the following international standards: G1/T125 New stainless steel nails for surgical implants
GB/T13:0 Test method for thickness of titanium implants G/138 Titanium and lock materials for surgical implants G/1811997.c91505532-21993) YY0345 Concept of surgical implants YY0311 General technical conditions for non-active surgical nails 3 Classification
3.1 Product model number of orthopedic nails
Product type serial number (Type 1)
Product code (orthopedic nail)
3.2 Product type code of orthopedic nails
Product type code of orthopedic nails in accordance with the provisions of the product type code table of orthopedic products. Table 1 3.3 Types and sizes of products of various types: The figure shows the specifications of the special series or special goods. 3.3.1 The basic type and size of the product are as shown in the figure 2? The basic type and size of the product are as shown in the figure 2? The basic type and size of the product are as shown in the figure 3? The basic type and size of the product are as shown in the figure 3? The basic type and size of the product are as shown in the figure 4? The basic type and size of the product are as shown in the figure 3? The basic type and size of the product are as shown in the figure 4? The basic type and size of the product are as shown in the figure 4? The basic type and size of the product are as shown in the figure 3? The basic type and size of the product are as shown in the figure 4? The basic type and size of the product are as shown in the figure 4? The basic type and size of the product are as shown in the figure 4? The basic type and size of the product are as shown in the figure 4? 01192002
Price in mm
Unit in m
YY01192002
Figure 4)
3.3.5 Other types and basic dimensions are specified in Figure 6
Within mm
3.3.6 The hook type shall be in accordance with the provisions of Figure 6,
4 Requirements
r0119—2002
The new shape package shall be made of the non-travel material specified in 544 or (made of bonding alloy material specified in 5/1133) 4.2 Hardness
The hardness of the orthopedic nail shall be 210V1G. The hardness of the orthopedic nail shall be 2RHV1 04.3 Corrosion resistance
The corrosion resistance of the stainless steel material should meet the requirements of YY04:-20024.8.1, -8.4.4 Surface quality
4.2.1 The surface quality of the orthopedic needle should not be any defects. 4.4.? The surface quality of the main surface of the orthopedic needle should be as specified in the table 6
The effect, the edge, the surface quality of the stainless steel material ... Size
The D and M dimensions of the shape should be checked during acceptance. 5 Test methods
5.1 Materials
The chemical composition and quality of the straightening nail products shall meet the requirements of GB/T4234 and GB:3510, and meet the requirements of 1.1.
5.2 Hardness control test
According to GB/T1310, the arithmetic mean of the different points on the needle surface shall be used, and the standard shall be 1.5.3 Corrosion resistance test
According to 5.3.1 and 5.3.2 of YY0341-22, the test shall meet the requirements of 4.3.1. 5. 4 Surface quality
5.4.1 Defect inspection shall be carried out according to the general provisions of YYT0] in accordance with the provisions of 1.4.[. 5.4.2 The relative armor connection monitoring degree exceeds the supply comparison operation (or the test reaches the parallel: in accordance with the provisions of 4..2 YY0*19—2002
5.4.3 External requirements: The daytime visual system seat meets the current provisions of 1.4. 5.5 Performance of the equipment
Anti-action: The bottom meets the provisions of 1.5. 5. 6 Size
General measuring tools, shall comply with the provisions of 1.6
6 Inspection rules
The inspection rules for orthopedic nails shall comply with the provisions of YY0441-22. Note: 45 According to this specification,
Instructions for use
Orthopedic nail instructions shall comply with the provisions of YY11202, Section ? B Marking
New orthopedic nails shall comply with the provisions of Chapter 8 of YY112002: 9 Packaging
The packaging of orthopedic needles shall comply with the provisions of Section 9 of YY141-2. 10 Transportation and storage Www.bzxZ.net
Orthopedic nails shall comply with the provisions of Section 10 of Y10341202. 11 Quick use requirements
The use requirements of broken nails shall comply with the provisions of Chapter 11 of YY31-C2.
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