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YY 0341.1-2020 English PDF

YY 0341.1-2020 English PDF

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YY 0341.1-2020: Non-active surgical implants - Osteosynthesis and spinal implants - Part 1: Particular requirements for osteosynthesis implants

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Scope

This part of YY 0341 specifies the special requirements for non-active surgical
implants for osteosynthesis (hereinafter referred to as "osteosynthesis
implants"), including the terms and definitions, requirements, test methods,
manufacturing, sterilization, packaging and information provided by the
manufacturer, etc. of osteosynthesis implants.
This part of YY0341 applies to osteosynthesis implants, not to the coating part
of osteosynthesis implants with surface coating.

Basic Data

Standard ID YY 0341.1-2020 (YY0341.1-2020)
Description (Translated English) Non-active surgical implants - Osteosynthesis and spinal implants - Part 1: Particular requirements for osteosynthesis implants
Sector / Industry Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 14,166
Date of Issue 2020-09-27
Date of Implementation 2022-06-01
Older Standard (superseded by this standard) YY 0341-2009
Regulation (derived from) Announcement No. 108 (2020) of the National Medical Products Administration
Issuing agency(ies) State Drug Administration


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