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YY/T 1629.5-2020Cutting tools for electric osseous tissue surgical equipment - Part 5: Saw blade (English PDF)

电动骨组织手术设备刀具 第5部分:锯片

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 27, 2020

Implementation date

September 1, 2021

Scope

YY/T 1629.5-2020 is the English-translated version of 电动骨组织手术设备刀具 第5部分:锯片.

YY/T 1629.5-2020 is the Chinese pharmaceutical industry standard for the saw blades used as cutting tools on electric bone tissue surgery equipment, the blades driven in oscillating or reciprocating motion to cut bone.

It is the fifth part of the YY/T 1629 series and gives the terms and definitions, the structure types, the materials, the requirements, the test methods, the instructions and the marking, covering the teeth and the set of the blade, the fixing to the handpiece, the hardness and corrosion resistance, the cutting performance and the durability under load. Issued on 27 September 2020, it has applied since 1 September 2021.

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Document preview — YY/T 1629.5-2020

National Standard of the People's Republic of China

ICS
11.040.30
Classification
C 35

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

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions YY/T 0752 and the following
  • 4 Structure type
  • 5 Material
  • 6 Requirements

Foreword

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

---Part 1: Grinding head;

---Part 2: Skull drill bit;

---Part 3: Drill bit;

---Part 4: Milling cutter;

---Part 5: Saw blade;

---Part 6: File. This part is part 5 of YY/T 1629.

This section was 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, structure types, materials, requirements, Test methods, instructions and labels.

This part is applicable to the equipment that is powered by electric bone tissue surgery equipment for mechanical swing or reciprocating motion and sawing of bone tissue. Saw blade (hereinafter referred to as the product).

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 1184 shape and position tolerance without tolerance value

GB/T 1220 stainless steel rod

GB/T 4340.1 Vickers Hardness Test of Metallic Materials Part 1: Test Method

GB/T 6682 Analysis laboratory water specifications and test methods

GB/T 14233.1 Test methods for medical infusion, blood transfusion and injection equipment Part 1: Chemical analysis methods

GB/T 16886.1-2011 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in the Process of Risk Management

GB/T 16886.5-2017 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Test

GB/T 16886.10-2017 Biological Evaluation of Medical Devices Part 10: Irritation and Skin Sensitization Test

YY/T 0752 Electric bone tissue surgery equipment The Pharmacopoeia of the People's Republic of China

3 Terms and definitions

YY/T 0752 and the following terms and definitions apply.

terms and definitions apply to this document. For ease of use, YY/T 0752 is repeatedly listed below Some terms and definitions in.

3.1 Saw blade

Saw blade body, connecting rod (if equipped), interface, and mechanical protection (if equipped) are composed of structural parts.

3.2 Handpiece

The formula is composed of the (power) handle that can provide power to the machine head, the machine head that clamps the tool, and (or) the speed changing mechanism and other components. [YY/T 0752-2016, definition 3.5]

3.5 Saw set

The saw teeth protrude from both sides of the saw blade body to provide saw cutting clearance.

3.7 Mechanical protection

The sheet body and other places form the required protective sheath and other structures.

Note. Except for the mechanical protection structure provided by the mobile phone.

4 Structure type

4.1 Reciprocating saw blade

The structure of the reciprocating saw blade and the names of each part are shown in Figure 1.

Note. The illustration is only an example.

Figure 1 Schematic diagram of reciprocating saw blade structure

4.2 Pendulum saw blade

The structure of the swing saw blade and the names of each part are shown in Figure 2.

Note. The illustration is only an example.

Figure 2 Schematic diagram of the structure of the pendulum saw blade

4.3 Circular saw blade

The structure of the circular saw blade and the names of each part are shown in Figure 3.

4.4 Saw blade with protective sheath

The structure of the saw blade with protective sheath and the names of each part are shown in Figure 4. Description. 1---Sawtooth; 2---Saw blade body; 3---Interface; 4---Protective sheath.

Note. The illustration is only an example.

Figure 4 Schematic diagram of the structure of the saw blade with protective sheath

5 Material

5.1 The product can be made of stainless steel materials specified in GB/T 1220, or other materials deemed suitable by the manufacturer.

5.2 The coating can be made of titanium nitride material, or other materials deemed suitable by the manufacturer.

6 Requirements

6.1 Appearance

6.1.1 The surface of the product should be smooth and free of rust, sharp edges (except the part used for tissue removal), burrs and obvious pits.

6.1.2 The saw teeth should be clear, complete, free from ablation, crimping, chipping, and no missing teeth. The teeth should be uniform, and there should be no obvious deviation. phenomenon.

6.1.3 The color of the serrated coating part should be uniform and consistent, the surface film layer should be complete, and the boundary line with the uncoated part should be clear and distinct.

6.2 Dimensions

6.2.1 Reciprocating saw blade

The schematic diagram of the reciprocating saw blade is shown in Figure 5.

Note 1.Examples of saw blade shapes only show conventional shapes.

Note 2.delta1 --- the thickness of the saw blade body.

Note 3.T1---thickness of sawtooth.

Note 4.L1---effective cutting length.

Note 5.For products that are not within the size range shown in this table, the manufacturer shall specify the corresponding tolerance.

6.2.2 Pendulum saw blade

The schematic diagram of the pendulum saw blade is shown in Figure 6, and the size should meet the requirements of Table 2.

Note 1.Examples of saw blade shapes only show conventional shapes.

Note 2.delta1 --- the thickness of the saw blade body.

Note 3.T1---thickness of sawtooth.

Note 4.T2---the thickness of the osteotomy.

Note 5.H---the cutting depth claimed by the manufacturer.

Note 6.W1---saw blade width.

Note 7.L2 --- the effective extension length claimed by the manufacturer.

Note 8.For products that are not within the size range shown in this table, the manufacturer shall specify the corresponding tolerance.

6.2.3 Circular saw blade

The schematic diagram of the circular saw blade is shown in Figure 7, and the size should meet the requirements of Table 3.

Note 1.Examples of saw blade shapes only show conventional shapes.

Note 2.delta1 --- the thickness of the saw blade body.

Note 3.T1---thickness of sawtooth.

Note 4.D---Maximum diameter of saw blade.

Note 5.For products that are not within the size range shown in this table, the manufacturer shall specify the corresponding tolerance.

6.2.4 Saw blade with protective sheath

The schematic diagram of the saw blade with protective sheath is shown in Figure 8.The size should meet the requirements of Table 4.

Note 1.Examples of saw blade shapes only show conventional shapes.

Note 2.T1---Sawtooth thickness.

Note 3.T3---the thickness of the protective sheath.

Note 4.H---the cutting depth claimed by the manufacturer.

Note 5.W1---saw blade width.

Note 6.W2---the width of the protective sheath.

Note 7.W3---the cutting width claimed by the manufacturer.

Note 8.For products that are not within the size range shown in this table, the manufacturer shall specify...

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.

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