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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 surgicalspinal 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Older Standard (superseded by this standard) | YY 0341-2009 |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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