Standard No.:	YY/T 0811-2021
English Name:	Extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications
Chinese Name:	外科植入物用大剂量辐射交联超高分子量聚乙烯制品
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Issued by:	National Medical Products Adminstration
Issued on:	2021-09-06
Implemented on:	2022-9-1
Status:	valid
Superseding:	YY/T 0811-2010 Standard guide for extensively irradiation—Crosslinked ultrahigh molecular weight polyethylene fabricated forms for surgical implant applications
Language:	English
File Format:	PDF
Word Count:	5500 words
Price(USD):	165.00
Delivery:	via email in 1~3 business day

本标准规定了外科植入物用大剂量辐射交联（高交联）超高分子量聚乙烯（UHMWPE）制品的相关要求及试验方法。
本标准适用于GB/T 19701.1所要求的纯树脂粉料或GB/T 19701.2所要求的模塑料生产的大剂量辐射交联的UHMWPE制品。
本标准仅适用于经γ射线和电子束电离辐射源大剂量辐射的UHMWPE制品。
本标准不适用于只接受过气体等离子、环氧乙烷或小于40kGy剂量的电离辐射处理的UHMWPE，即只经过常规灭菌处理的材料。