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Basic data
| Standard ID | YY/T 0957.1-2014 (YY/T0957.1-2014) |
| Description (Translated English) | rthopaedic instruments. Drive connections. Part 1: Keys for use with screws with hexagon socket heads |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C35 |
| Classification of International Standard | 11.040.40 |
| Word Count Estimation | 9,987 |
| 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 5835 |
| Adopted Standard | ISO 8319-1-1996, 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 Allen screw with a wrench. This Standard provides for screwed or unscrewed Surgical Implant size wrench working end of the Allen metal bone screws, tolerances, mechanical properties, and performance requirements. Wrench specif |
YY/T 0957.1-2014: rthopaedic instruments. Drive connections. Part 1: Keys for use with screws with hexagon socket heads
---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.
rthopaedic instruments Drive connections Part 1. Keys for use with screws with hexagon socket heads
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Orthopedic tools twist fittings
Part 1. socket head cap screws with a wrench
Part 1. Keysforusewithscrewswithhexagonsocketheads
(ISO 8319-1.1996, 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 10957 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
Consistency correspondence between this part of international documents and normative references of our files are as follows.
--- GB/T 230.1 metallic materials - Rockwell hardness test - Part 1. Test methods (A, B, C, D, E, F, G, H, K, N, T
Ruler) (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)
This section uses the translation method identical with ISO 8319-1.1996 "orthopedic tools twist fittings - Part 1. socket head cap screws with a wrench
hand".
This part of ISO 8319-1.1996 technical differences are as follows. Appendix A to add a reference to the ISO 9585.
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, King Ming, Ma bamboo, Liu Bin, Liu Yinghui, Yin Zhuo, Bao Yifu.
Introduction
Various screw wrench basic requirements are as follows.
Working end --- screw wrench should be able to accurately fit the screw nail head;
--- Material for the manufacture of screw wrench shall meet all clinical requirements;
--- Screw wrench should be of sufficient strength;
This part of ISO 8319 is intended to screw wrench design without affecting the properties of the premise to ensure that the above requirements can be achieved.
Orthopedic tools twist fittings
Part 1. socket head cap screws with a wrench
1 Scope
YY/T 0957 provisions of this part of the working end wrench for screwed into or out of the surgical implant metal bone screws with a hex of
Dimensions, tolerances, mechanical properties and performance requirements. Has a working end of this Part apply to screw wrench in line with ISO 5835
With 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 5835 Hexagon drive surgical implants under the spherical surface of asymmetrical thread connecting metal bone screw size (Implantsfor
surgery-Metalbonescrewswithhexagonaldriveconnection, sphericalunder-surfaceofhead, asymmetrical
thread-Dimensions)
3 Dimensions and tolerances
Dimensions and tolerances shall comply with Figure 1 and Table 1 provisions.
Explanation.
e --- diagonal diameter;
s --- on the edge width;
l --- Hexagon length portion.
1 screw wrench size label
...
