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YY/T 0809.2-2020 English PDF (YY/T0809.2-2020)

YY/T 0809.2-2020 English PDF (YY/T0809.2-2020)

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YY/T 0809.2-2020: Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials

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Scope

This part of YY/T 0809 specifies requirements for the articulating surfaces of those
types of total and partial hip joint prostheses that provide a joint replacement of ball
and socket configuration, as follows:
a) sphericity and surface finish requirements for metallic and ceramic femoral
prostheses for partial hip joint replacement that are in accordance with
classification a) of YY/T 0809.1-2010;
b) sphericity and surface finish requirements for bipolar heads with plastics inner
surfaces which articulate on femoral components that are in accordance with
classification a) of YY/T 0809.1-2010 and with metallic or ceramic outer surfaces
which articulate on the biological acetabulum;
c) sphericity and surface finish requirements and dimensional tolerances for plastics
acetabular components that are in accordance with classification b) of YY/T
0809.1-2010;
d) sphericity and surface finish requirements and dimensional tolerances for metallic
or ceramic femoral components of total hip joint prostheses that are in accordance
with classification c) of YY/T 0809.1-2010.
This Part is applicable to articulating surfaces of all types of total and partial hip joint
prostheses that provide a joint replacement of ball and socket configuration.

Basic Data

Standard ID YY/T 0809.2-2020 (YY/T0809.2-2020)
Description (Translated English) Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
Sector / Industry Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 9,920
Date of Issue 2020-09-27
Date of Implementation 2021-09-01
Older Standard (superseded by this standard) YY/T 0809.2-2010
Regulation (derived from) Announcement No. 108 (2020) of the National Medical Products Administration
Issuing agency(ies) State Drug Administration


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