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YY/T 0815-2010 English PDF

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YY/T 0815-2010: Standard test method for measurement of enthalpy of fusion, percent crystallinity, and melting point of ultra-high-molecular weight polyethylene by means of differential scanning calorimetry
Status: Valid
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YY/T 0815-2010English209 Add to Cart 3 days [Need to translate] Standard test method for measurement of enthalpy of fusion, percent crystallinity, and melting point of ultra-high-molecular weight polyethylene by means of differential scanning calorimetry Valid YY/T 0815-2010

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Basic data

Standard ID YY/T 0815-2010 (YY/T0815-2010)
Description (Translated English) Standard test method for measurement of enthalpy of fusion, percent crystallinity, and melting point of ultra-high-molecular weight polyethylene by means of differential scanning calorimetry
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 9,993
Date of Issue 2010-12-27
Date of Implementation 2012-06-01
Quoted Standard ASTM D3418; ASTM E793; ASTM E967; ASTM E968; ASTM E1953
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 ultra-high molecular to polyethylene (UHMWPE) melting enthalpy and melting point determination method, and degree of crystallinity is calculated. This method can be used for powder, after curing of the material, product, or used UHMWPE. This method can be used by radiation or chemical crosslinking of UHMWPE melting enthalpy determination of the melting point and crystallinity. This method does not specify the degree of crystallinity for specific applications or melting range. The values ??stated in SI units as the standard value. The values ??in parentheses are for reference only. This standard does not attempt to have all of the security issues involved in elaborate, even those associated with its use of security issues between. Establish appropriate safety and operating standards, as well as in the application of the applicability of regulatory limitations prior to clear, is the standard user 's own responsibility.

YY/T 0815-2010: Standard test method for measurement of enthalpy of fusion, percent crystallinity, and melting point of ultra-high-molecular weight polyethylene by means of differential scanning calorimetry



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Standard test method for measurement of enthalpy of fusion, percent crystallinity, and melting point of ultra-high-molecular weight polyethylene by means of differential scanning calorimetry ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Determination of Ultrahigh Molecular Weight Polyethylene by Differential Scanning Calorimetry Melting enthalpy, crystallinity and melting point Standardtestmethodformeasurementofenthalpyoffusion, percent crystalinity, andmeltingpointofultra-high-molecular weightpolyethyleneby 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 F2625-2007 "differential scanning calorimetry for the determination of ultra-high molecular weight polyethylene Enthalpy, crystallinity and melting point ". The technical differences between this and ASTM F2625-2007 are as follows. --- Remove Chapter 15 "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. Ma Chunbao, Jiang Xi, Qi Baofen. Determination of Ultrahigh Molecular Weight Polyethylene by Differential Scanning Calorimetry Melting enthalpy, crystallinity and melting point

1 Scope

This standard describes the melting enthalpy and melting point of ultra high molecular weight polyethylene (UHMWPE) methods, as well as the calculation of crystallinity. The method can be used for powder, cured molding of the material, finished or used UHMWPE. The method can also be used for radiation Or chemical cross-linked UHMWPE melting enthalpy, melting point and the determination of crystallinity. The method does not specify a crystallinity range or melting point for a particular application. The value expressed in international units is the standard value. The values in parentheses are for reference only. 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 operational specifications 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. ASTM D3418 differential scanning calorimetry for the determination of polymer transition temperature (Testmethodfortransitiontemperatures ofpolymersbydifferentialscanningcalorimetry) Determination of enthalpy and crystallinity by differential scanning calorimetry (ASTME793) (Testmethodforenthalpiesoffusionand crystalizationbydifferentialscanningcalorimetry ASTME967 differential scanning calorimeter and differential thermal analyzer temperature calibration method (Testmethodfortemperaturecali- brationofdifferentialscanningcalorimetersanddifferentialthermalanalyzers) ASTME968 differential scanning calorimeter heat flow calibration procedures (Practiceforheatflowcalibrationofdiffer- entialscanningcalorimeters ASTME1953 thermal analyzer and rheometer operating procedures (Practicefordescriptionofthermalanalysisand rheology app

3 symbols and definitions

The following symbols and definitions apply to this document. 3.1 ΔHf The theoretical melting enthalpy (J/g) for the 100% material. 3.2 ΔHs Quality of the test sample Normalized enthalpy of fusion (J/g). 3.3 Tp Melting the endothermic melting point (° C).

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