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YY/T 1133-2020Instrumentation for use in association with non-active surgical implants-Metallic bone drill bits (English PDF)

无源外科植入物联用器械金属骨钻

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 30, 2020

Implementation date

June 1, 2021

Scope

YY/T 1133-2020 is the English-translated version of 无源外科植入物联用器械金属骨钻.

YY/T 1133-2020 is the Chinese pharmaceutical industry standard for metal bone drills used with non-active surgical implants, the drills that prepare the hole for a screw or a pin.

It sets the requirements, the test methods and the marking, covering the material and its hardness, the geometry and dimensions of the flutes and the point, the shank and its fit to the driver, the corrosion resistance and the cutting performance and durability of the drill.

It does not cover drills with a surface coating. Issued on 30 June 2020, it has applied since 1 June 2021.

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Document preview — YY/T 1133-2020

National Standard of the People's Republic of China

Classification: C 35
Replacing: YY 91133-1999

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Requirements
4 Test method
5 Mark

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.

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 document. 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.

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 […]

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

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 0726-2020|YY/T 0647-2021|YY/T 0919-2014|YY 0341.1-2020|YY 0341.2-2020|YY/T 1706.1-2020

Editions of YY/T 1133

Edition	Title	Revision	Status
YY/T 1133-2020	Instrumentation for use in association with non-active surgical implants-Metallic bone drill bits	current edition	Current
YY 91133-1999	Instrumentation for use in association with non-active surgical implants-Metallic bone drill bits	previous edition	Superseded

This page sells the current edition, YY/T 1133-2020. Earlier editions are listed for reference only.

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