YY/T 1629.5-2020 English PDF

US$299.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1629.5-2020: Cutting tools for electric osseous tissue surgical equipment - Part 5: Saw blade
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1629.5-2020	299	Add to Cart	4 days	Cutting tools for electric osseous tissue surgical equipment - Part 5: Saw blade	Valid

Similar standards

YY/T 1860.1   YY/T 1748   YY/T 1653   YY/T 1629.3   YY/T 1629.6   YY/T 1629.4   

Basic data

Standard ID: YY/T 1629.5-2020 (YY/T1629.5-2020)
Description (Translated English): Cutting tools for electric osseous tissue surgical equipment - Part 5: Saw blade
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.30
Word Count Estimation: 16,179
Date of Issue: 2020-09-27
Date of Implementation: 2021-09-01
Regulation (derived from): Announcement No. 108 (2020) of the National Medical Products Administration
Issuing agency(ies): State Drug Administration

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

---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.
Cutting tools for electric osseous tissue surgical equipment - Part 5.Saw blade People's Republic of China Pharmaceutical Industry Standards Released on 2020-09-27 Implementation of 2021-09-01 Issued by the National Medical Products Administration

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. 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 part was proposed by the State Drug Administration. This part is organized by the National Medical Electrical Appliance Standardization Technical Committee Medical Electronic Instrument Standardization Subcommittee (SAC/TC10/SC5) Focus. Drafting organizations of this section. Chongqing Xishan Technology Co., Ltd., Shanghai Medical Device Testing Institute, Chongqing Medical Device Quality Inspection center. The main drafters of this section. Guo Yijun, Xu Chao, Zhou Qing, Zhao Zheng, Lan Yang, Zhong Dingen. Electric bone tissue surgery equipment knife

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 article Pieces. 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 to this document. For ease of use, YY/T 0752 is repeatedly listed below Some terms and definitions in. 3.1 Saw blade body, connecting rod (if equipped), interface, and mechanical protection (if equipped) are composed of structural parts. 3.2 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] 3.3 3.4 3.5 3.6 The saw teeth protrude from both sides of the saw blade body to provide saw cutting clearance. 3.7 3.8 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. 3.9 [YY/T 0752-2016, definition 3.7]

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.δ1 --- 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.δ1 --- 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.δ1 --- 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... ......

Image     

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1629.5-2020_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1629.5-2020_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1629.5-2020_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1629.5-2020_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.