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YY 0341.2-2020 English PDF

YY 0341.2-2020 English PDF

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YY 0341.2-2020: Non-active surgical implants - Osteosynthesis and spinal implants - Part 2: Particular requirements for spinal implants

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Scope

This Part of YY 0341 specifies the special requirements for non-active surgical
spinal implants (hereinafter referred to as "spinal implants"). In addition to the
requirements that are specified in YY/T 0640, it also specifies the definition,
requirements, test methods, manufacturing, sterilization, packaging and
information provided by the manufacturer of spinal implants.
This Part of YY 0341 applies to non-active surgical spinal implants other than
artificial intervertebral disc implants.

Basic Data

Standard ID YY 0341.2-2020 (YY0341.2-2020)
Description (Translated English) Non-active surgical implants - Osteosynthesis and spinal implants - Part 2: Particular requirements for spinal implants
Sector / Industry Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 12,185
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Older Standard (superseded by this standard) YY 0341-2009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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