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Older Standard (superseded by this standard) | YY 0341-2009 |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