|
US$219.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1927-2024: Implants for sports medicine - Suture button
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1927-2024 | English | 219 |
Add to Cart
|
3 days [Need to translate]
|
Implants for sports medicine - Suture button
| Valid |
YY/T 1927-2024
|
PDF similar to YY/T 1927-2024
Basic data | Standard ID | YY/T 1927-2024 (YY/T1927-2024) | | Description (Translated English) | Implants for sports medicine - Suture button | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 10,112 | | Date of Issue | 2024-02-07 | | Date of Implementation | 2025-03-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the performance requirements for sports medicine implantable device loop fixation plates (hereinafter referred to as loop fixation plates), describes the corresponding test methods, and specifies the manufacturing, sterilization, biological safety evaluation, packaging and manufacturer information provided, etc. This document is applicable to the testing and evaluation of loop fixation plates used for fixation of soft tissue and bone or bone and bone. | YY/T 1927-2024: Implants for sports medicine - Suture button---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.
ICS 11.040.40
CCSC35
Pharmaceutical Industry Standards of the People's Republic of China
Sports Medicine Implant Device with Loop Fixation Plate
Released on 2024-02-07
2025-03-01 Implementation
The State Drug Administration issued
Table of Contents
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirement 2
5 Test methods 4
6 Manufacturing 6
7 Sterilization 6
8 Biosafety Assessment 6
9 Packaging 6
10 Information provided by the manufacturer 6
References 7
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110).
This document was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, National Medical Products Administration Medical Device Technical Review Center
Center, National Medical Products Administration Medical Device Technical Review and Inspection Greater Bay Area Center, Yunyi (Beijing) Medical Device Co., Ltd., Beijing De
Yidamei Medical Technology Co., Ltd., Beijing Tianxing Bomaidi Medical Equipment Co., Ltd., Beijing Medical Equipment Inspection Institute (Beijing Medical Equipment Inspection Institute
Biological Protection Equipment Inspection and Research Center), Dabao Medical Technology Co., Ltd., Beijing Fule Technology Development Co., Ltd., Beijing Natong
Technology Group Co., Ltd., Shanghai Ligetai Biotechnology Co., Ltd., Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., Smith & Nephew Medical Products
Pin International Trading (Shanghai) Co., Ltd. and Beijing Aikang Yicheng Medical Equipment Co., Ltd.
The main drafters of this document are. Li Wenjiao, Jing Ming, Wang Ying, Guo Xiaolei, Zhai Bao, Zhang Yidan, Peng Pu, Liu Jimei, Zhao Xuedong, Kong Qingjun, Wei Ning,
Hou Suhua, Dong Wenxing, Han Qizhi, Wang Lixia, Zeng Da, Ye Yanjie, Bai Yanli, Zhao Wenwen, Chen Dandan, Chen Ruikai, He Xueqin, Wang Caimei.
Sports Medicine Implants with Loop Fixation Plates
1 Scope
This document specifies the performance requirements for sports medicine implants with loop fixation plates (hereinafter referred to as "loop fixation plates") and describes the corresponding
The standard specifies test methods, manufacturing, sterilization, biological safety evaluation, packaging and information provided by the manufacturer.
This document applies to the testing and evaluation of fixation plates with loops for fixation of soft tissue to bone or bone to bone.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 4340.1 Vickers hardness test for metallic materials Part 1.Test method
GB/T 10610 Geometrical Product Specification (GPS) Rules and methods for evaluating surface structure using the surface structure profile method
GB/T 14233.1-2022 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods
GB/T 14233.2 Test methods for medical infusion, blood transfusion and injection equipment Part 2.Biological test methods
GB/T 16886 (all parts) Biological evaluation of medical devices
YY 0167-2020 Non-absorbable surgical sutures
YY/T 0343 Liquid Penetrant Testing of Surgical Metal Implants
YY/T 0640 General requirements for passive surgical implants
YY/T 1074 Pitting Potential of Stainless Steel Products for Surgical Implants
YY/T 1832 Tensile test method for sutures of sports medicine implants
Pharmacopoeia of the People's Republic of China
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Suturebutton with loop fixing plate
Medical devices used to connect and fix ligaments or tendons to bones, or bones to bones in orthopedic reconstruction surgery. See Figure 1 for a schematic diagram.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1927-2024_English be delivered?Answer: Upon your order, we will start to translate YY/T 1927-2024_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 1927-2024_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1927-2024_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+ countriesQuestion 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 [email protected]. 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.
|