YY/T 1629.1-2018Cutting tools for electric osseous tissue surgical equipment - Part 1: Burs (English PDF)

Foreword

YY/T 1629 "Electric Bone Tissue Surgery Equipment Tool" is divided into 6 parts.

--- Part 1. Grinding head;

--- Part 2. Skull drills;

--- Part 3. Drills;

--- Part 4. Milling cutters;

---Part 5. saw blade;

--- Part 6. Scythe. This part is the first part of YY/T 1629.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This part of YY/T 1629 specifies the terms and definitions, materials, requirements, and tests for the use of cutter heads in electric bone tissue surgical equipment. Test methods, instructions and labels.

This section is applicable to the grinding machine that performs the mechanical rotary motion provided by the electric bone tissue surgery equipment and performs the grinding and resection of the bone tissue. Head (hereinafter referred to as the product).

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 1220 stainless steel rod

GB/T 2411-2008 Plastics and hard rubbers using a durometer to determine indentation hardness (Shore hardness) (ISO 868:2003, IDT)

GB/T 4340.1-2009 - Vickers hardness test for metallic materials - Part 1. Test methods (ISO 6507-1:2005, MOD)

GB/T 6406-2016 Superhard abrasive grain size inspection

GB/T 6408-2003 super hard abrasive cubic boron nitride

GB/T 6682 Analytical laboratory water specifications and test methods

GB/T 11336-2004 Straightness error detection

GB/T 14233.1-2008 Medical infusions, blood transfusions, injecting machines - Test methods - Part 1

GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (ISO 10993-1:2009, IDT)

GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (ISO 10993-5.:1999, IDT)

GB/T 16886.10-2017 Biological evaluation of medical devices - Part 10. Stimulation and skin sensitization test (ISO 10993-10. 2002, IDT)

GB/T 23536-2009 Superhard abrasive synthetic diamond

YY/T 0149-2006 Test Method for Corrosion Resistance of Stainless Steel Medical Devices (ISO 13402:1995, MOD)

YY/T 0752-2016 Electric bone tissue surgery equipment

JB/T 7989-2012 Technical requirements for superabrasive synthetic diamond

JB/T 11428-2013 Electroplated grinding head for super-hard abrasive products Chinese Pharmacopoeia (2015 Edition)

3 Terms and definitions

The terms and definitions defined in YY/T 0752-2016 and the following terms apply to this document. For ease of use, the following is repeated Certain terms and definitions in YY/T 0752.