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YY/T 1133-2020 English PDF

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YY/T 1133-2020: (Passive surgical implant combination instrument metal bone drill)
Status: Valid
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YY/T 1133-2020English119 Add to Cart 3 days [Need to translate] (Passive surgical implant combination instrument metal bone drill) Valid YY/T 1133-2020

PDF similar to YY/T 1133-2020


Standard similar to YY/T 1133-2020

YY/T 1122   YY 0989.7   YY/T 1141   

Basic data

Standard ID YY/T 1133-2020 (YY/T1133-2020)
Description (Translated English) (Passive surgical implant combination instrument metal bone drill)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Word Count Estimation 6,632
Date of Issue 2020-06-30
Date of Implementation 2021-06-01
Older Standard (superseded by this standard) YY/T 91133-1999
Regulation (derived from) Announcement No. 76 (2020) of the National Medical Products Administration
Issuing agency(ies) State Drug Administration

YY/T 1133-2020: (Passive surgical implant combination instrument metal bone drill)

---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.
People's Republic of China Pharmaceutical Industry Standards YY/T 1133-2020 replaces YY/T 91133-1999 Released on 2020-06-30 Implementation of 2021-06-01 Issued by the National Medical Products Administration

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 91133-1999 "Pistol Hand Bone Drill". Compared with YY/T 91133-1999, the main changes are as follows. ---Modified the standard name; ---Modified and adjusted the overall structure and format of the standard; --- Delete the "type" (see the first part of YY/T 91133-1999) and the "acceptance rules" (see the first part of YY/T 91133-1999) three parts); ---The technical requirements and test methods have been modified as necessary, and some unsuitable requirements and methods have been deleted (see YY/T 91133- Second, 4, 7-16, Fourth, 26, 27 of.1999), the "materials" (see YY/T 91133-1999, second, 5 and 3.1) and "foreign "View" (see YY/T 91133-1999 in the second, 6 and 3.6) requirements, add "breaking torque" (3.2), "hardness" (3.3), "resistance Corrosion performance" (3.4), "Surface roughness" (3.5), "Dimensions" (3.7), "Radial runout" (3.8), "Cutting performance" (3.9) of Claim. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Standardization Technical Committee for Surgical Implants and Orthopaedic Devices (SAC/TC110). Drafting organizations of this standard. Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Natong Technology Group Co., Ltd., Beijing Fuleke Technology Development Co., Ltd. The main drafters of this standard. Li Nan, Wang Tao, Zhang Lu, Li Renyao, Zhao Wenwen, Liu Zhenhai, Li Hongyan. The previous editions of the standard replaced by this standard are as follows. ---WS2-181-74; ---YY/T 91133-1999. Passive surgical implant combined instrument metal bone drill

1 Scope

This standard specifies the requirements, test methods and markings for metal bone drills. This standard applies to metal bone drills used in conjunction with passive surgical implants. This standard does not include metal bone drills with surface coating treatment.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 230.1 Rockwell Hardness Test of Metallic Materials Part 1.Test Method GB/T 4340.1 Vickers Hardness Test of Metallic Materials Part 1.Test Method GB/T 10610 Product Geometric Technical Specification (GPS) Surface structure profile method to evaluate the rules and methods of surface structure YY/T 0149-2006 Stainless steel medical equipment corrosion resistance test method YY/T 0294.1 Metallic materials for surgical instruments Part 1.Stainless steel YY/T 1052 Surgical instrument mark

3 requirements

3.1 Materials Metal bone drills can be selected from materials specified in YY/T 0294.1 or ASTM F899, or materials that have been proven to be acceptable for clinical use manufacture. 3.2 Breaking torque The manufacturer shall specify the minimum breaking torque of the metal bone drill according to the size, cutting edge form, material and other indicators of the metal bone drill. 3.3 Hardness The manufacturer shall specify the hardness of the metal bone drill according to the material and processing technology. 3.4 Corrosion resistance The corrosion resistance of the outer surface of the metal bone drill made of stainless steel should not be lower than the requirements of YY/T 0149-2006 in the boiling water method class b. Requirement, or the manufacturer according to YY/T 0149-2006 in other test methods for metal bone drills. 3.5 Surface roughness The manufacturer shall specify the roughness Ra value of the main surface of the metal bone drill. 3.6 Appearance The outer surface of the metal bone drill should be free of defects such as small nicks, scratches, cracks, depressions, sharp edges (except for the cutting edge), burrs, etc., and no inlays or final additions. Industrial sediments and other pollutants. 3.7 Dimensions The manufacturer shall specify the length, diameter, point angle (vertex angle, tip angle) and other important part dimensions of the working part of the metal bone drill. 3.8 Radial circular runout The manufacturer shall specify the radial runout of the metal bone drill. 3.9 Cutting performance The manufacturer shall specify the cutting performance of metal bone drills (applicable to bone drills used with power tools).

4 Test method

4.1 Materials The chemical composition inspection of metal materials for metal bone drills should be sampled from the final product, and carried out in accordance with the method specified in the selected material standard test. Note. The test of materials should be sampled on the final product. If the final product cannot be sampled due to structure or size, the same batch of raw materials can also be used for the same addition. The sample of the craftsmanship. 4.2 Breaking torque The manufacturer should work out the test method for the fracture torque of the bone drill according to the characteristics of the metal bone drill. The number of samples required for the test should be based on the selected test method. Test method standards to determine. 4.3 Hardness The hardness of the metal bone drill shall be carried out according to the method of GB/T 230.1 or GB/T 4340.1. Note. The test of materials should be sampled on the final product. If the final product cannot be sampled due to structure or size, the same batch of raw materials can also be used for the same addition. The sample of the craftsmanship. 4.4 Corrosion resistance Carry out the test according to the method specified in YY/T 0149-2006. 4.5 Surface roughness Use the sample comparison method or the electrical measurement method specified in GB/T 10610.The electrical measurement method is the arbitration inspection method, and the number of samples should not be less than 3 pieces. 4.6 Appearance Observe visually. 4.7 Dimensions The size of the metal bone drill is measured with a general measuring tool or a special measuring tool. 4.8 Radial circular runout The radial runout of the metal bone drill should be tested with a special gauge or instrument, and the number of samples should not be less than 3 pieces. 4.9 Cutting performance The manufacturer shall specify the corresponding cutting performance test method according to the role and function of the metal bone drill. Such as number of revolutions, applied force, cutting Medium, etc.

5 mark

Product marking should meet the requirements of YY/T 1052. references

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