YY/T 0640-2016: Non-active surgical implants--General requirements

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Scope

This Standard specifies general requirements for non-active surgical implants,
hereafter referred to as implants. This Standard is not applicable to dental
implants, dental restorative materials, trans-endodontic and trans-radicular
implants, intra-ocular lenses and implants utilizing viable animal tissue.
With regard to safety, this Standard specifies requirements for intended
performance, design attributes, materials, design evaluation, manufacture,
sterilization, packaging and information supplied by the manufacturer, and
tests to demonstrate compliance with these requirements.
Additional tests are given or referred to in level 2 and level 3 standards.
NOTE: This Standard does not require that the manufacturer have a quality management
system in place. However, the application of a quality management system, such as that
described in ISO 13485, might be appropriate to help ensure that the implant achieves its
intended performance.

Basic Data

Standard ID	YY/T 0640-2016 (YY/T0640-2016)
Description (Translated English)	Non-active surgical implants--General requirements
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C45
Classification of International Standard	11.040.40
Word Count Estimation	15,191
Date of Issue	2016-07-29
Date of Implementation	2017-06-01
Older Standard (superseded by this standard)	YY/T 0640-2008
Regulation (derived from)	State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies)	State Food and Drug Administration