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Orthopaedic instruments. Drive connections. Part 2: Screwdrives for single slot head screw, screws with cruciate slot and cross-recessed head screws
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Basic data
| Standard ID | YY/T 0957.2-2014 (YY/T0957.2-2014) |
| Description (Translated English) | Orthopaedic instruments. Drive connections. Part 2: Screwdrives for single slot head screw, screws with cruciate slot and cross-recessed head screws |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C35 |
| Classification of International Standard | 11.040.40 |
| Word Count Estimation | 10,171 |
| Date of Issue | 6/17/2014 |
| Date of Implementation | 7/1/2015 |
| Quoted Standard | GB/T 230.1; YY/T 0294.1; YY/T 0605.5; ISO 2380; ISO 9268 |
| Adopted Standard | ISO 8319.2-1986, IDT |
| 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 slotted, cross slot and Phillips screws with a screwdriver. This Standard specifies the technical requirements for a spin in and out with a slotted surgical implants, cross slot or Phillips head screwdriver bone screw. Screwdriver |
YY/T 0957.2-2014: Orthopaedic instruments. Drive connections. Part 2: Screwdrives for single slot head screw, screws with cruciate slot and cross-recessed head screws
---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.
Orthopaedic instruments.Drive connections.Part 2. Screwdrives for single slot head screw, screws with cruciate slot and cross-recessed head screws
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Orthopedic tools twist fittings - Part 2. word
Slot, cross slot and Phillips screws with a screwdriver
Orthopaedicinstruments-Driveconnections-Part 2. Screwdriversforsingle
slotheadscrews, screwswithcruciateslotandcross-recessedheadscrews
(ISO 8319-2. 1986, IDT)
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
YY/T 0957 "joint orthopedic tool twist" is divided into two parts.
--- Part 1. socket head cap screws with a wrench;
--- Part 2. slotted, Phillips slot and Phillips screws with a screwdriver.
This section YY/T Section 20957 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This part identical with ISO 8319-2. 1986 "orthopedic tools twist fittings - Part 2. slotted, Phillips and Phillips head screw groove
Nail with a screwdriver. "
This part of ISO 8319-2. 1986 technical differences are as follows.
--- Chapter 2 normative references, with YY/T 0294.1 replace the defunct ISO 683-13;
--- ISO 2380-1 instead of ISO 2380;
--- Appendix A added references ISO 9585.
Consistency correspondence between this part of international documents and normative references of our files are as follows.
YY/T 0294.1-2005 surgical instrument metallic materials - Part 1. Stainless steel (ISO 7153-1.1991, MOD)
GB/T 230.1-2009 metallic materials - Rockwell hardness test - Part 1. Test methods (A, B, C, D, E, F, G, H, K,
N, T scale) (ISO 6508-1.2005, MOD)
YY/T 0606.5-2007 tissue-engineered medical products - Part 5. Matrix and stent performance and testing (ISO 5853-5.
2005, IDT)
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 Medical Device Quality Supervision and Inspection Center, Changzhou Comfort Medical Devices Co., Ltd., the State Food and Drug
Goods Administration Medical Device Evaluation Center.
The main drafters of this section. Li Nan, King Ming, Liu Bin, Liu Yinghui, makin bamboo, Ding Wei, Jiang Kai.
Introduction
Various screwdrivers basic requirements are as follows.
--- Working end should be able to accurately fit the screw nail head;
--- Material for spin-rod should be able to meet all clinical requirements;
--- Screwdriver should be of sufficient strength;
YY/T 0957 aimed at this section does not affect the design attributes screwdriver prerequisite to ensure the above requirements can be achieved.
Orthopedic tools twist fittings - Part 2. word
Slot, cross slot and Phillips screws with a screwdriver
1 Scope
YY/T 0957 provisions of this part of the threads in and out of a surgical implant with slotted, cross slot or Phillips head screw for bone screws
Wire cutter technical requirements. Screwdriver set forth in this section applies to comply with the requirements of ISO 9268 screws.
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 230.1 metallic materials - Rockwell hardness test - Part 1. Test methods (A, B, C, D, E, F, G, H, K, N, T standard
Feet) (GB/T 230.1-2009, ISO 6508-1.2005, MOD)
YY/T 0294.1 surgical instrument metallic materials - Part 1. Stainless steel (YY/T 0294.1-2005, ISO 7153-1.1991,
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)
ISO 2380 Assembly tools for screws and nuts slotted screwdriver Part 1. manual and electric screwdriver working end
(Assemblytoolsforscrewsandnuts-Screwdriversforslotted-headscrews-Part 1. Tipsforhand-
andmachine-operatedscrewdrivers)
ISO 9268 Implants for surgery - Metal bone screws nail head lower tapered surface dimensions (Implantsforsurgery-Metal
bonescrewswithconicalunder-surfaceofhead-Dimensions)
3 Design and dimensions
3.1 slotted screw with a screwdriver
3.1.1 Manual screwdriver
Slotted screw with a screwdriver should be as shown in the manual screwdriver head screwdriver head size and shown in Table 1 should be consistent with the provisions of or compliance with 3.1.2
Provisions screwdriver head.
3.1.2 Electric Screwdriver
Slotted screws with an electric screwdriver should contain head screwdriver as shown in Figure 2, and the screwdriver head size should be consistent with the provisions in Table 1.
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