Standard Number: YY/T 0811-2021(YY/T0811-2021)
Chinese:外科植入物用大剂量辐射交联超高分子量聚乙烯制品
English:Extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications
Effective Date:2022-09-01
ICS:11.040.40
Standard Applicability:This standard specifies the relevant requirements and test methods for high-dose radiation cross-linked (high cross-linking) ultra-high molecular weight polyethylene (UHMWPE) products for surgical implants. This standard applies to large-dose radiation crosslinked UHMWPE products produced by pure resin powder as required by GB/T 19701.1 or molding plastic as required by GB/T 19701.2. This standard applies only to UHMWPE products that have been subjected to large doses of radiation by γ-ray 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 at a dose of less than 40kGy, i.e., materials that have only been routinely sterilized.
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