YY/T 0811-2021: Extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications

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Scope

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 γ 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. The following mechanical tests are commonly
used to assess the repeatability of manufacturing procedures and are suitable for comparative studies
of different materials.
NOTE 2: The following warning text applies only to the test method part of Chapter 5. This
Standard does not attempt to describe all the safety issues involved, even those related to its use. It
is the responsibility of the user of this Standard to establish appropriate safety and operating
practices, and to clarify the applicability of regulatory limitations prior to application.

Basic Data

Standard ID	YY/T 0811-2021 (YY/T0811-2021)
Description (Translated English)	Extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C35
Word Count Estimation	10,181
Issuing agency(ies)	State Drug Administration