HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189760 (18 Oct 2025)

YY/T 1430-2016 English PDF

US$179.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1430-2016: Standard test method for small punch testing of ultra-high molecular weight polyethylene used in surgical implants
Status: Valid
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 1430-2016English179 Add to Cart 3 days [Need to translate] Standard test method for small punch testing of ultra-high molecular weight polyethylene used in surgical implants Valid YY/T 1430-2016

PDF similar to YY/T 1430-2016


Standard similar to YY/T 1430-2016

YY/T 1705   YY/T 1653   YY/T 1137   YY/T 1426.3   YY/T 1426.1   

Basic data

Standard ID YY/T 1430-2016 (YY/T1430-2016)
Description (Translated English) Standard test method for small punch testing of ultra-high molecular weight polyethylene used in surgical implants
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 9,910
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Quoted Standard GB/T 16825.1; GB/T 19701.2; YY/T 0651.1; YY/T 1426.1
Adopted Standard ASTM F2183, NEQ
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Food and Drug Administration
Summary This standard is suitable for characterizing the performance of UHMWPE surgical materials after plunger extrusion or compression molding. It is also suitable for the evaluation of radiation-crosslinked and sterilized plants of the same process, as well as for the recovery of In vivo removal) of the corresponding implants were tested. The parameters of the small punch test, that is, the peak load, the ultimate displacement, the ultimate load and the failure force, can provide a measure of yield strength, ultimate strength, ductility and toughness of UHMWPE under multi-axial loading conditions. Because the mechanical properties of UHMWPE under uniaxial and multi-axis loading conditions are not the same,

YY/T 1430-2016: Standard test method for small punch testing of ultra-high molecular weight polyethylene used in surgical implants


---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.
Standard test method for small punch testing of ultra-high molecular weight polyethylene used in surgical implants ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Surgical implants are made of ultra high molecular weight polyethylene Small punch test method 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface I 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 meaning and application 2 5 equipment 3 6 Test sample 4 Number of samples 4 8 test speed 4 9 Condition 4 10 Procedure 4 11 Calculate 5 12 Report 5 Reference 6

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the re-drafting method for reference ASTMF2183-2008 "Ultra-high molecular weight polyethylene small punching test for surgical implants Law "system. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard is nationalized by the National Standardization Technical Committee on Surgical Implants and Orthopedic Instruments (SAC/TC110). The standard drafting unit. Tianjin Medical Device Quality Supervision and Inspection Center, Chuangsheng Medical Devices China (limited) company, Shanghai minimally invasive bone Branch Medical Technology Co., Ltd. The main drafters of this standard. Zhang, Zhao Binghui, Zhang Lu, Chen Changsheng, Wang Jian, Wang Shengqiang, Lin Zhong. Surgical implants are made of ultra high molecular weight polyethylene Small punch test method

1 Scope

This standard is a small disc test (thickness 0.5mm, diameter 6.4mm) small punching test method to determine the ultra-high molecular The mechanical properties of polyethylene (UHMWPE). This standard applies to characterization of plunger extrusion or compression molding after UHMWPE surgery The properties of the material are also suitable for the evaluation of radiation cross-linked and sterilized after the same process to manufacture the implant, but also for the recovery of the human body (Taken from the body) of the corresponding implants were tested. The small punch test parameters, that is, peak load, ultimate displacement, ultimate load and loss of work, can provide UHMWPE in the multi-axis Measurement of yield strength, ultimate strength, ductility and toughness under loading conditions. Due to UHMWPE under uniaxial and multi-axis loading conditions Mechanical properties are not the same, small punching test GB/T 19701.2 Chinese medicine grade UHMWPE uniaxial tensile test conducted a mechanical test Test technology. In addition to the study tools for implantation analysis, the small punch test can also be used in laboratory screening tests to evaluate the new UH- MWPE material, such as gamma irradiation or electron beam irradiation. The test method is also applicable to accelerated aging of UHMWPE materials (Eg, ASTMF2003), and can specify the mechanical properties of different UHMWPE samples after oxidative aging Down grade. Small punch test can be used for other polymers, including polymethyl methacrylate (PMMA) bone cement, polyacetal and high density polyethylene (HDPE). However, other polymer non-UHMWPE materials, small punching test is not within the scope of this standard test method. International units (SI) are used in this standard. This standard does not attempt to address all the security issues involved, even those related to its use. establish Appropriate safety and health practices, as well as the applicability of regulatory restrictions before application, are the responsibility of the user of this standard.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 16825.1 Tests for static uniaxial testing machines - Part 1. Testing and testing of force systems for tension and/or pressure testing machines (GB/T 16825.1-2008, ISO 7500-1..2004, IDT) GB/T 19701.2 Surgical implants - Ultrahigh molecular weight polyethylene - Part 2. Molded plastics (GB/T 19701.2-2005, ISO 5834-2..1998, IDT) YY/T 0651.1 Surgical implants for wear of total hip prostheses Part 1. Load and displacement parameters for wear testing machines and Related test environmental conditions (YY/T 0651.1-2016, ISO 14242-1..2012, IDT) YY/T 1426.1 Surgical implants of total knee prosthesis wear - Part 1. Load - controlled wear test machine load and Displacement parameters and associated test environmental conditions (YY/T 1426.1-2016, ISO 14243-1..2009, IDT)

3 terms and definitions

The following terms and definitions apply to this document.

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1430-2016_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1430-2016_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 1430-2016_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1430-2016_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 [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.