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YY/T 0957.2-2014Orthopaedic instruments - Drive connections - Part 2: Screwdrivers for single slot, cross recess and cross recess head screws (English PDF)

矫形工具拧动接头 第2部分:一字槽、十字槽和十字槽头螺钉用螺丝刀

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 17, 2014

Implementation date

July 1, 2015

Scope

YY/T 0957.2-2014 is the English-translated version of 矫形工具拧动接头 第2部分:一字槽、十字槽和十字槽头螺钉用螺丝刀.

YY/T 0957.2 standardises the screwdriver end of an orthopaedic drive connection, for single slot, cross recess and cross recess head screws. It is Part 2 of the Chinese series on orthopaedic instrument drive connections, the companion to Part 1 on hexagon socket keys. The interface between a driver and an implant screw sounds trivial until it fails: a driver that cams out or rounds a recess in the depth of a wound leaves a screw that can be neither advanced nor removed, with the patient open on the table. Dimensional standardisation is what keeps drivers and screws interchangeable across sets and suppliers. For a manufacturer of orthopaedic instrument sets serving the Chinese market, this is the governing dimensional standard.

Document preview — YY/T 0957.2-2014

National Standard of the People's Republic of China

ICS
11.040.40
Classification
C35

Issued by: National Medical Products Administration

Contents

  • 1 Scope
  • 2 Normative references
  • 3 Design and dimensions
  • 3.1 Slotted screw with a screwdriver

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.

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 0957.2 standardises the screwdriver end of an orthopaedic drive connection, for single slot, cross recess and cross recess head screws. It is Part 2 of the Chinese series on orthopaedic instrument drive connections, the companion to Part 1 on hexagon socket keys. The interface between a driver and an implant screw sounds trivial until it fails: a driver that cams out or rounds a recess in the depth of a wound leaves a screw that can be neither advanced nor removed, with the patient open on the table. Dimensional standardisation is what keeps drivers and screws interchangeable across sets and suppliers. For a manufacturer of orthopaedic instrument sets serving the Chinese market, this is the governing dimensional standard.

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)

3.1 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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 6508 · YY/T 0294.1-2005 · ISO 7153 · YY/T 0605.5-2007 · ISO 5832 · ISO 2380 · ISO 9268

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