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YY/T 1647-2019 English PDF

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US$119.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1647-2019: Joint replacement implants - Shoulder prostheses - Standard test method for static evaluation of glenoid locking mechanism in shear
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1647-2019	119	Add to Cart	3 days	Joint replacement implants - Shoulder prostheses - Standard test method for static evaluation of glenoid locking mechanism in shear	Valid

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Basic data

Standard ID: YY/T 1647-2019 (YY/T1647-2019)
Description (Translated English): Joint replacement implants - Shoulder prostheses - Standard test method for static evaluation of glenoid locking mechanism in shear
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 6,678
Date of Issue: 2019
Date of Implementation: 2020-10-01
Issuing agency(ies): State Drug Administration
Summary: This standard specifies a test method for the static shear separation force of modular glenoid components in shoulder prostheses. The combined glenoid component should contain a single glenoid liner and glenoid backing. The glenoid lining and glenoid backing can be made from any combination of the following materials: metal alloys, polymeric materials, and composite materials. This standard applies to product design verification and comparison with other prostheses.

YY/T 1647-2019: Joint replacement implants - Shoulder prostheses - Standard test method for static evaluation of glenoid locking mechanism in shear

---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.
Joint replacement implants-Shoulder prostheses-Standard test method for static evaluation of glenoid locking mechanism in shear ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Joint replacement implant shoulder prosthesis Test method for static shear evaluation of glenoid locking mechanism Published on October 23,.2019 2020-10-01 implementation Published by the State Drug Administration

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is supported by the National Orthopaedic Implants Subcommittee (SAC/TC110 / SC1) Centralized. This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Feidu Medical Devices Co., Ltd., Beijing Youcai Beijing Airlines Biological Technology Co., Ltd. The main drafters of this standard. Gao Jintao, Zhang Shu, Wu Jing, Zhao Jianqin, Qin Geji, Du Guoyao. Joint replacement implant shoulder prosthesis Test method for static shear evaluation of glenoid locking mechanism

1 Scope

This standard specifies the test method for the static shear separation force of combined glenoid components in shoulder joint prostheses. Combined glenoid component A separate glenoid lining and glenoid backing should be included. The glenoid lining and glenoid backing can be made from any combination of the following materials. Metal alloys, polymeric materials and composites. This standard applies to product design verification and comparison with other prostheses. Note. See Appendix A for test principles.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 16825.1 Inspection of static uniaxial testing machines Part 1. Inspection and testing of force measurement system of tensile and/or compression testing machines calibration YY/T 0963 Joint replacement implant shoulder joint prosthesis

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Articularinsert The prosthesis part made of polymer material in the combined glenoid component forms an articular surface with the humeral head. 3.2 Glenoid backing The prosthetic part made of metal or composite material in the combined glenoid component is fixed to the scapula. 3.3 Glenoidcomponent Instead of the prosthetic part of the scapula glenoid, it forms an articular surface with the physiological humeral head or prosthesis.

4 Significance and application

4.1 The glenoid component is generally used for shoulder joint replacement and should meet the requirements of YY/T 0963. 4.2 This standard can be used to describe the resistance of the material, processing technology and design factors to the locking mechanism of a glenoid prosthesis with a metal backing. Effect of static shear loading. In view of the fact that the glenoid prosthesis usually with a metal backing is different from the force in this body, The results obtained by this standard cannot be directly used to predict the performance of the product in vivo. However, this standard can be used for different test conditions under similar test conditions. Comparison of Locking Mechanism Designs of Metal-Backed Glenoid Parts. 4.3 This standard does not necessarily apply to all types of implant applications. Users of this standard should consider the test materials and their intended use. Consider the applicability of this standard. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1647-2019_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1647-2019_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1647-2019_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1647-2019_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.