YY/T 0958.1-2014 English PDF

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YY/T 0958.1-2014: Orthopaedic drilling instruments. Part 1: Drill bits, taps and countersink cutters
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0958.1-2014	154	Add to Cart	3 days	Orthopaedic drilling instruments. Part 1: Drill bits, taps and countersink cutters	Valid

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Basic data

Standard ID: YY/T 0958.1-2014 (YY/T0958.1-2014)
Description (Translated English): Orthopaedic drilling instruments. Part 1: Drill bits, taps and countersink cutters
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 8,880
Date of Issue: 6/17/2014
Date of Implementation: 7/1/2015
Quoted Standard: ISO 7153.1; ISO 5835
Adopted Standard: ISO 9714.1-1991, 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 the use of stainless steel orthopedic surgical drills, taps and countersink cutters. This standard specifies the orthopedic surgical drills, taps and countersink cutter materials, mechanical properties, size and marking requiremen

YY/T 0958.1-2014: Orthopaedic drilling instruments. Part 1: Drill bits, taps and countersink cutters

---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 drilling instruments.Part 1. Drill bits, taps and countersink cutters ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Orthopedic drill class devices - Part 1. Drill, Taps and Shen head cutter Orthopaedicdrilinginstruments-Part 1. Drilbits, (ISO 9714-1.1991, IDT) Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released

Foreword

YY/T 0958 "drill class orthopedic devices" intended to divide part of the publication, currently plans to release the following components. --- Part 1. drills, taps and countersink cutters. This section YY/T Section 10958 of. This section drafted in accordance with GB/T 1.1-2009 given rules. This section uses the translation method identical with ISO 9714-1.1991 "drill class orthopedic devices - Part 1. drills, taps and milling countersunk head Knife". 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) Correspondence between the consistency of the international section of the file referenced in Appendix A country with the following documents. --- YY/T 0662-2008 surgical implants asymmetric surface of the metal bone screw thread and mechanical performance requirements spherical And test methods (ISO 6475. 1989, IDT) --- YY/T 0957.1-2014 orthopedic tools twist fittings - Part 1. socket head cap screws with a wrench (ISO 8319-1. 1996, IDT) --- YY/T 0957.2-2014 orthopedic tools twist fittings - Part 2. slotted, Phillips slot and Phillips head screws Screwdriver (ISO 8319-2. 1986, IDT) Determination of strength and stiffness --- YY/T 0342-2002 surgical implant plate bending (ISO 9585.1990, IDT) 1991, 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, the State Food and Drug Administration Medical Device Review Evaluation Center, Changzhou City, Kang Hui Medical Devices Co., Ltd. The main drafters of this section. Li Nan, Jing Ming blue Weng Chi, Liu Bin, Tony Sun, Peng Hao. Orthopedic drill class devices - Part 1. Drill, Taps and Shen head cutter

1 Scope

YY/T 0958 This section provides the orthopedic surgical drills, taps and countersink cutter, mechanical properties, dimensions and marking to Demand, the drill, taps and countersink cutters made of stainless steel, in orthopedic surgery and ISO 5835 with the provisions of the bone screw use. Note 1. relates to bone screws, bone plates and the corresponding international standard tools of relationship listed in Appendix A for reference. Note 2. At present, only stainless steel has been recognized as a material for producing the device in future revisions may include other materials and coating materials.

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. ISO 7153-1 surgical instrument metallic materials - Part 1. Stainless steel (Surgicalinstruments-Metalic materials-Part 1. Stainlesssteel) ISO 5835 Hexagon drive surgical implants under the spherical surface of asymmetrical thread connecting metal bone screw size (Implants forsurgery-Metalbonescrewswithhexagonaldriveconnection, sphericalunder-surfaceofhead, asymmetricalthread-Dimensions)

3 Materials and Mechanical Properties

Drill bits, taps and countersink cutter manufacturing materials should be used in line with the provisions of ISO 7153-1, grade of steel letter code. D, H, I, and R.

4 Dimensions

4.1 Drill Drill diameter should be in accordance with Table 1, the point angle should be 80 ° ~ 100 °. 4.2 Taps Tap the bottom diameter and the outer diameter shall be in accordance with Table 1, thread form and pitch and ISO 5835 should provide a corresponding screw thread shape The same type and pitch. 4.3 Shen head cutter The pin and the cutter head diameter should be in accordance with Table 1 and Figure 1, the cutter should be 90 ° conical or spherical. ......

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