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YY/T 0814-2010 PDF English

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YY/T 0814-2010: Standard test method for evaluating trans-vinylene yield in irradiated ultra-high-molecular-weight polyethylene fabricated forms intended for surgical implants by infrared spectroscopy
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YY/T 0814-2010English229 Add to Cart 3 days [Need to translate] Standard test method for evaluating trans-vinylene yield in irradiated ultra-high-molecular-weight polyethylene fabricated forms intended for surgical implants by infrared spectroscopy

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Basic data

Standard ID YY/T 0814-2010 (YY/T0814-2010)
Description (Translated English) Standard test method for evaluating trans-vinylene yield in irradiated ultra-high-molecular-weight polyethylene fabricated forms intended for surgical implants by infrared spectroscopy
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 10,179
Date of Issue 2010-12-27
Date of Implementation 2012-06-01
Quoted Standard YY/T 1772.4; ASTM E691; ASTM E1421
Regulation (derived from) State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the medical implant figure pots ultra-high molecular polyethylene (UHMWPE) in the number of trans-vinylene group determination method that uses infrared spectroscopy to analyze the material. This test method is based on YY/T 0772. 4 making. Infrared spectroscopy applicability in other reports in the literature already described. The method utilizes in 1 370cm-1 absorption peak centered CH (area) normalized thickness of the sample, through tests conducted in accordance with ASTM E691 room between the study (ILS) method validation. This standard does not attempt to have all of the security issues involved in elaborate, even those safety issues associated with their use. Establish appropriate safety and health practices, as well as in the application of the applicability of regulatory limitations prior to clear, is the standard user's own responsibility.

YY/T 0814-2010: Standard test method for evaluating trans-vinylene yield in irradiated ultra-high-molecular-weight polyethylene fabricated forms intended for surgical implants by infrared spectroscopy







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Standard test method for research trans-vinylene yield in irradiated ultra-high-molecular-weight polyethylene fabricated individuals intended for surgical implants by infrared spectroscopy ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Infrared Spectroscopy Evaluation of Surgical Implants with Radiation Trans - vinylidene in ultra - high molecular weight polyethylene products Content of the standard test method 2010-12-27 release 2012-06-01 implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the re-drafting method to refer to ASTM F2381-2004 "Infrared Spectroscopy for Evaluating Surgical Implants with Radiation Ultra- Amount of polyethylene products in the trans-vinylidene content of the standard test method "preparation. The technical differences between this standard and ASTMF2381-2004 are as follows. --- on the normative reference documents, this standard has made a technical differences in the adjustment to meet China's technical conditions, adjust the situation The situation is reflected in Chapter 2, "Normative references", as follows. • Replace the ASTMF2102 with YY/T 0772.4. --- removed Chapter 12 "Keyword"; --- change Appendix X1 to Appendix A, the same. 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 by the National Surgical Implantation and Orthopedic Equipment Standardization Technical Committee Materials and Orthopedic Implants Subcommittee (SAC / TC110/SC1). The drafting unit. the State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Jiang Xi, Ma Chunbao, Qi Baofen. Infrared Spectroscopy Evaluation of Surgical Implants with Radiation Trans - vinylidene in ultra - high molecular weight polyethylene products Content of the standard test method

1 Scope

This test method describes the determination of the number of trans-vinylidene groups in medical implants of ultra-high molecular weight polyethylene (UHMWPE) Method, should use infrared spectroscopy to analyze the material. The test method is based on YY/T 0772.4. The applicability of IR spectroscopy has been described in other literature reports. This method utilizes CH absorption centered at 1370 cm-1 The thickness of the normalized area of the peak (area) is verified by the inter-laboratory study (ILS) according to ASTME691. This standard does not attempt to address all the security issues involved, even those related to its use. Indeed It is the responsibility of the user of this standard to establish appropriate safety and health practices and to apply the limits of management clearly before application.

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. YY/T 0772.4 Surgical implants - Ultrahigh molecular weight polyethylene - Part 4. Test method for oxidation index ASTME691 Guidelines for laboratory test methods for the determination of precision (Practice forconductinganinter- laboratorystudytodetermineprecisionofatestmethod Performance Description and Measurement of ASTME1421 Fourier Transform Infrared (FT-IR) Spectrometer. Level 0 and Level 1 fordescribingandmeasuringperfomanceoffouriertransforminfrared (FTIR) spectrometers. Level zeroandlevelonetests)

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Trans - vinyleneindex trans - vinyleneindex TVI The ratio of the absorption peak area between 950 cm-1 and 980 cm-1 and the absorption peak area between 1330 cm-1 and 1396 cm-1. 3.2 Positioning depth depthlocator DL Measure the average distance from the joint surface or the study surface to the acquisition spectrum and calculate the collection point corresponding to the TVI. 3.3 Trans-vinyleneindexprofile trans-vinyleneindexprofile A pattern in which the transethylene index varies with the distance from the articular surface or the surface of the study surface. The graphic is TVI-DL song ...

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