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YY/T 0813-2010: Standard test method for in situ determination of network parameters of crosslinked ultra high molecular weight polyethylene (UHMWPE)
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YY/T 0813-2010: Standard test method for in situ determination of network parameters of crosslinked ultra high molecular weight polyethylene (UHMWPE)

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Standard test method for in situ determination of network parameters of crosslinked ultra high molecular weight polyethylene (UHMWPE) ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Crosslinked ultrahigh molecular weight polyethylene (UHMWPE) In situ determination of parameters of the network structure to standard methods crosslinkedultrahighmolecularweightpolyethylene (UHMWPE) Issued on. 2010-12-27 2012-06-01 implementation State Food and Drug Administration issued

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. The standard reference method using redrafted ASTMF2214-2002 "crosslinked ultrahigh molecular weight polyethylene (UHMWPE) molecules Mesh In situ determination of structural parameters of the standard method "establishment. Technical differences between this standard and ASTMF2214-2002 follows. --- Deleted the Chapter 15, "keyword"; --- In Appendix X1 to Appendix A, and Appendix X2 to Appendix B, remains unchanged. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard by the national surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Technical Committee (SAC/TC110/SC1) centralized. This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Jiang Xi, Ma Chun Bao, Qi Baofen. Crosslinked ultrahigh molecular weight polyethylene (UHMWPE) In situ determination of parameters of the network structure to standard methods

1 Scope

This test method describes how immersion measured in o-xylene ultra high molecular weight polyethylene (hereinafter referred to as UHMWPE) Swelling of the sample, to ionizing radiation or by chemical crosslinking of UHMWPE crosslink density, molecular weight between cross-linking points and repeating The number of cells was measured. Test techniques and methods of the standard will be used in the above measurement examples will be explained. This test method is used to measure height changes when UHMWPE samples immersed in o-xylene solvent. The degree of swelling measured volume Suppose a given sample is cross-linked and isotropic dimensional change in all directions are the same. This test method is avoided due to solvent evaporation or temperature change Technology may lead to uncertainty. This standard does not attempt to all security issues related to the elaborate, even those safety issues associated with their use. Really Li appropriate safety and health practices and regulatory limitations prior to use clear applicability of this standard is the user's own responsibility.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. ASTMD2765 Standard Test Method for Determination of cross-linked polyethylene plastic swelling degree and gel content (Testmethodsfordeter- minationofgelcontentandswelratioofcrosslinkedethyleneplastics) ASTME691 inter-laboratory test methods to guide precision measurement standards (Practiceforconductinganinter- laboratorystudytodeterminetheprecisionofatestmethod)

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Crosslink density crosslinkdensity νd The average number of crosslinking points per unit volume of the sample contained theoretically [mol/dm3]. 3.2 Molecular weight between crosslinking points molecularweightbetweencrosslinks Mc Crosslinking between the theoretical sample point average molecular weight [g/mol]. 3.3 The degree of swelling swelratio qs Volume ratio of the volume of the sample material does not swell in a swollen equilibrium state. ...