YY/T 0810.1-2010: Implants for surgery. Total knee joint prostheses. Part 1: Determination of endurance properties of knee tibial trays

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Scope

This Part of YY/T 0810 specifies a test method for determining the endurance properties,
under specified laboratory conditions, of tibial trays used in knee-joint prostheses to
support and secure the plastics articulating surface. This test method applies to tibial
trays which cover both the medial and lateral plateaux of the tibia.
The test method does not apply to tibial components manufactured solely from plastics
materials.
This Part does not cover methods of examining and reporting the final condition of the
test specimen; these may be the subject of agreement between the test laboratory and
the parties submitting the specimen for test.

Basic Data

Standard ID	YY/T 0810.1-2010 (YY/T0810.1-2010)
Description (Translated English)	Implants for surgery. 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	9,944
Date of Issue	2010-12-27
Date of Implementation	2012-06-01
Quoted Standard	ISO 4965-1979; ISO 7207-1-1994
Adopted Standard	ISO 14879-1-2000, IDT
Regulation (derived from)	State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the real face in a particular room conditions, measured knee prosthesis in support and protection of plastic articular surface of the tibial tray fatigue test methods. This test method is suitable for covering the inner lateral tibial tibial tray. This test method is not only of a plastic material for the tibial component. This section does not involve the final state of the test specimens and reporting methods. These are provided by the testing laboratory and the sample in consultation OK.