T/CAMDI 079-2022 High-dose radiation cross-linked ultra-high molecular weight polyethylene products for surgical implants
T/CAMDI 079-2022 High-dose radiation cross-linked ultra-high molecular weight polyethylene products for surgical implants
Basic Information
Scope
Scope: This document specifies the requirements and test methods for high-dose irradiated cross-linked ultra-high molecular weight polyethylene (hereinafter referred to as cross-linked ultra-high molecular weight polyethylene) products used in surgical implants. This document applies to ultra-high molecular weight polyethylene resin powders, molded plastics (rods, boards) processed from them, and cross-linked products that meet all the requirements of GB/T 19701.1 and GB/T 19701.2. This document is only applicable to ultra-high molecular weight polyethylene products that have undergone irradiation with gamma rays or electron beams at doses of 40 kGy or higher. Main technical content: This document specifies the requirements and test methods for high-dose irradiated cross-linked ultra-high molecular weight polyethylene (hereinafter referred to as cross-linked ultra-high molecular weight polyethylene) products used in surgical implants. This document applies to ultra-high molecular weight polyethylene resin powders, molded plastics (rods, boards) processed from them, and cross-linked products that meet all the requirements of GB/T 19701.1 and GB/T 19701.2. This document is only applicable to ultra-high molecular weight polyethylene products that have undergone irradiation with gamma rays or electron beams at doses of 40 kGy or higher.