YY/T 0810.1-2024: Joint replacements - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays

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Scope

This document describes the test method for determining the endurance properties of knee tibial
trays that support and protect plastic articular surfaces in knee prostheses under specific
laboratory conditions.
This document applies to knee tibial trays that cover the mediolateral tibia.
This document does not apply to tibial components made of plastic materials only.
This document does not cover the test and reporting methods of the final state of specimens,
which are determined by the test laboratory and the specimen provider through negotiation.

Basic Data

Standard ID	YY/T 0810.1-2024 (YY/T0810.1-2024)
Description (Translated English)	Joint replacements - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C35
Classification of International Standard	11.040.40
Word Count Estimation	14,128
Date of Issue	2024-07-08
Date of Implementation	2025-07-20
Older Standard (superseded by this standard)	YY/T 0810.1-2010
Issuing agency(ies)	State Drug Administration