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YY/T 0811-2021 English PDF (YYT0811-2021)

YY/T 0811-2021 English PDF (YYT0811-2021)

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YY/T 0811-2021: Extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications
This Standard specifies relevant requirements and test methods for irradiation-crosslinked (extensively crosslinked) ultra-high molecular weight polyethylene fabricated (UHMWPE) forms for surgical implant applications. This Standard is applicable to pure resin powder required by GB/T 19701.1 or extensively irradiation-crosslinked UHMWPE products produced by molding compounds required by GB/T 19701.2. This Standard is only applicable to UHMWPE products that have been extensively irradiated by ?? rays and electron beam ionizing radiation sources. This Standard does not apply to UHMWPE that has only been treated with gas plasma, ethylene oxide or ionizing radiation with a dose of less than 40kGy, that is, materials that have undergone routine sterilization only. NOTE 1: The exact relationship between the mechanical properties of the above articles and the in vivo performance has not been established. Although scientists are devoted to the study of the relationship between polymer structure, polymer properties and polymer design, the above relationship has not been satisfactorily explained.

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