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YY/T 1765-2020 English PDF

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US$319.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1765-2020: Test methods for determination of total knee replacement constraint
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1765-2020	319	Add to Cart	4 days	Test methods for determination of total knee replacement constraint	Valid

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Basic data

Standard ID: YY/T 1765-2020 (YY/T1765-2020)
Description (Translated English): Test methods for determination of total knee replacement constraint
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 17,193
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 1765-2020: Test methods for determination of total knee replacement constraint

---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.
(Test method of restraint degree of total knee joint prosthesis) ICS 11:040:40 C35 People's Republic of China Pharmaceutical Industry Standard Test method of restraint degree of total knee joint prosthesis 2020-09-27 release 2021-09-01 implementation Issued by the State Drug Administration

Foreword Ⅰ 1 Scope 1 2 Terms and definitions 1 3 Device 5 4 Test sample 6 5 Sample measurement 6 6 Test conditions 8 7 Test Step 8 8 Report 9 Appendix A (informative appendix) Basic principles 11 Appendix B (informative appendix) Significance and application 12 Appendix C (informative appendix) Neutral coordinate system 13 Reference 14

Foreword

This standard was drafted in accordance with the rules given in GB/T 1:1-2009: Please note that certain contents of this document may involve patents: The issuing agency of this document is not responsible for identifying these patents: This standard was proposed by the State Drug Administration: This standard is organized by the Orthopedic Implants Sub-Technical Committee of the National Standardization Technical Committee for Surgical Implants and Orthopedic Devices (SAC/TC110/ SC1) Centralized: Drafting organizations of this standard: Suzhou MicroPort Joint Medical Technology Co:, Ltd:, Tianjin Medical Device Quality Supervision and Inspection Center, National Drugs Supervision Administration Medical Device Technology Review Center, Trauson Medical Devices (China) Co:, Ltd:, Johnson & Johnson (Shanghai) Medical Devices Co:, Ltd: The main drafters of this standard: Zhang Chen, Dong Shuangpeng, Yu Tianbai, Shi Wei, Zhang Jiazhen, Zhen Zhen, Chen Changsheng, Wang Jian, Kong Weiping, Chen Yanfeng: Test method of restraint degree of total knee joint prosthesis

1 Scope

This standard specifies the use of specific loading conditions to conduct in vitro tests on the design contour of the inherent articular surface to quantify the total knee joint prosthesis: Dynamic constraint method: This standard is applicable to the knee joint back and forth movement, medial and lateral shearing, rotation loosening, varus and valgus rotation motion restraint testing, and can also be used for joints Out of restraint test: Note 1: This standard aims to establish a standard test method for evaluating the restraint of total knee joint prosthesis, which can be used to establish the activity characteristic data of total knee joint prosthesis Library: See Appendix A for the basic principles of this standard, and Appendix B for its meaning and application: Note 2: This standard is not a wear test method: Note 3: This standard also includes the identification of the geometric parameters of the joint contact surface that may affect the above motions and the method of reporting the test results:

2 Terms and definitions

The following terms and definitions apply to this document: 2:1 Geometrical and kinematic terms and definitions of total knee prosthesis 2:1:1 Anteriorposterior The geometric length in the front and rear direction: 2:1:2 Anteriorposteriordisplacement The relative displacement between components in the front and rear directions: 2:1:3 Anteriorposteriordrawload The load applied in the forward and backward direction of the movable part causes or is expected to cause forward and backward displacement: 2:1:4 Bearing surface The area on the component that is in contact with the matched component and conducts load transfer: 2:1:5 Condyles Simulates the articular surface part of the knee joint anatomy, mainly using geometric characteristics to transmit the reaction force of the joint, which is dominant to a certain extent Kinematics performance of total knee prosthesis: 2:1:6 Get out of distraction The femoral component and the tibial component are separated in the z-axis direction: 2:1:7 Femoral side constraint femoralside constraint Constraints provided by the upper articular surface: Note: When measuring the movable platform knee prosthesis, the lower joint of the tibial pad needs to be fixed: ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1765-2020_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1765-2020_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 1765-2020_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1765-2020_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.