YY/T 1141-2017 English PDF (YY/T1141-2017)

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YY/T 1141-2017: General technique requirements for osteotome
YY/T 1141-2017
General technique requirements for osteotome
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 91141-1999, YY 91071~91073-1999
General technical conditions for osteotome
Published on.2017-09-25
2018-10-01 implementation
State Food and Drug Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
5 Test method 2
6 logo 3
Reference 4
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 91141-1999 "General technical conditions for orthopedic chisels" and YY 91071-1999 "flat bone chisel",
YY 91072-1999 "round bone chisel" and YY 91073-1999 "medical chisel cutting performance test method". And YY/T 91141-1999,
Compared with YY 91071-1999, YY 91072-1999 and YY 91073-1999, the main technical changes are as follows.
--- Modify the requirements of the osteotome material;
--- Modify the hardness requirements;
--- Remove the surface finish requirements of the osteotome, and change to the surface roughness requirements;
--- Modify the performance method of the osteotome;
--- Removed the requirements for inspection rules, packaging, transportation and storage.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110).
This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Fule Technology Development Co., Ltd., Beijing Natong Medical
Science and Technology Research Institute Co., Ltd.
The main drafters of this standard. Zhang Zhenghui, Zhang Wenhui, Qiu Wanyu, Guo Zixue, Jiang Yao, Li Renyao.
This standard replaces YY/T 91141-1999, YY 91071~91073-1999.
The previous versions of YY/T 91141-1999 were released as follows.
---WS2-302-1983, YY/T 91141-1999.
The previous versions of YY 91071~91073-1999 are released as follows.
---ZBC35001~35003-1984, YY 91071~91073-1999.
General technical conditions for osteotome
1 Scope
This standard specifies the type and basic dimensions, materials, requirements, test methods and markings of the osteotome.
This standard applies to surgical instruments used in orthopedics.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 230.1-2004 Metallic Rockwell hardness test - Part 1. Test methods (A, B, C, D, E, F, G, H, K, N, T
ruler)
GB/T 1220 stainless steel rod
GB/T 4340.1 Vickers hardness test for metallic materials - Part 1. Test methods
GB/T 10610 Product Geometrical Specification (GPS) Surface structure profiling method and method for assessing surface structure
YY/T 0149-2006 Test method for corrosion resistance of stainless steel medical instruments
YY/T 0294.1 Surgical instruments, metallic materials - Part 1. Stainless steel
YY/T 1052 surgical instrument sign
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Osteotomy osteotome
A chisel tool used to cut bones in orthopedic surgery.
4 requirements
4.1 Materials
The heads of orthopedic chisel can be selected from the materials specified in GB/T 1220, YY/T 0294.1 and ASTMF899, etc.
Manufacture of quality materials.
4.2 Surface quality
4.2.1 Appearance
The shape of the osteotome should be flat and symmetrical. Except for the cutting edge, there should be no defects such as sharp edges, burrs and cracks.
4.2.2 Surface roughness
The outer surface of the cutting edge of the osteotome is Ra≤0.4μm.
4.3 Performance
4.3.1 The sharpness of the osteotome
4.3.1.1 The sharpness of the flat bone chisel
When the width of the bone chisel edge is ≤6mm, it is applied to the test piece with a force of 6600N (hardness is not less than 28HV1 or higher hardness)
The test material, such as a 3mm diameter fuse, should have a cutting depth of ≥1.8mm.
When the width of the bone chisel edge is >6mm, it is applied to the test piece with a force of 14000N (hardness is not less than 28HV1 or higher hardness)
The test material, such as a 3mm diameter fuse, should have a cutting depth of ≥2.7mm.
4.3.1.2 The sharpness of the round bone chisel
4.3.1.2.1 Straight round bone chisel
When the head diameter is 6mm or 8mm, it is applied to the test piece with a force of 14000N (hardness is not less than 28HV1 or hardness)
Higher test materials, such as 40mm × 15mm × 3.2mm flat fuses, should have a cutting depth of ≥ 2.1mm.
When the head diameter is 10mm or 12mm, apply the test piece with a force of 14000N (hardness is not less than 28HV1 or hard)
Higher test materials, such as flat fuses of 40mm × 15mm × 3.2mm), the cutting depth should be ≥1.8mm.
4.3.1.2.2 Elbow round chisel
When the head diameter is 6mm or 8mm, it is applied to the test piece with a force of 14000N (hardness is not less than 28HV1 or hardness)
Higher test materials, such as flat fuses of 40mm × 15mm × 3.2mm), the cutting depth should be ≥ 1.9mm.
When the head diameter is 10mm or 12mm, apply the test piece with a force of 14000N (hardness is not less than 28HV1 or hard)
Higher test materials, such as flat fuses of 40mm × 15mm × 3.2mm), the cutting depth should be ≥ 1.7mm.
4.3.2 Osteon strength
The cutting edge of the osteotome should have good cutting performance. It should be dropped from the height of 260mm with a drop hammer of 1180g, hammered by the bone for 10 times, after cutting.
Should not be curled or chipped.
4.4 Hardness
The hardness of the head of the osteotome is. not less than 35HRC or 350HV10, the enterprise should also specify the maximum hardness.
4.5 size
Should meet the requirements of product technical requirements.
4.6 Corrosion resistance
It should not be lower than the requirement of grade b of the boiling water test method for corrosion resistance of stainless steel medical instruments in YY/T 0149-2006.
5 Test methods
5.1 Materials
The chemical composition shall be sampled on the final product and the test shall be carried out in accordance with the method specified in the selected material standard and shall comply with the provisions of 4.1.
5.2 Surface quality
5.2.1 Observed by eyesight or by hand, it shall comply with the provisions of 4.4.1.
5.2.2 Surface roughness test, in accordance with the method of GB/T 10610.
5.3 Performance
5.3.1 Use the testing machine to clamp the handle of the osteotome and cut the test specimen with the blade, which shall comply with the provisions of 4.2.1.
5.3.2 Depending on the application, a simulated bone material sample (eg, a specific grade of rigid polyurethane foam as specified in ASTM F1839) is selected.
Samples), cut according to the angle specified by the enterprise, in accordance with the provisions of 4.3.2.
5.4 Hardness
Hardness test, in accordance with the method specified in GB/T 230.1-2004 or GB/T 4340.1.
5.5 size
Measure with a universal gauge or a dedicated gauge.
5.6 Corrosion resistance
Test according to the method specified in YY 0149-2006.
6 signs
Product markings shall comply with the requirements of YY/T 1052.
references
[1] ASTM F899 Standard Specification for Forged Stainless Steel for Surgical Instruments (StandardSpecification forWrought
StainlessSteelsforSurgicalInstruments)
[2] ASTMF1839 Standard Specification for Standard Specification for Rigid Polyurethane Foam for Orthopedic Instruments and Tools (StandardSpeci-
ficationforRigidPolyurethaneFoamforUseasaStandardMaterialforTestingOrthopedicDevices
andInstruments)