YY 0954-2015: Nonactive surgical implants - Type I collagen implants - Specific requirements

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Scope

This standard specifies the specific requirements for injectable collagen
implants (abbreviated as implants) which are prepared from purified (non-
cross-linked) type I collagen as a starting material.
This standard specifies the implant technical requirements and testing methods.
It also specifies the expected performance, design properties, materials, design
evaluation, test methods, clinical evaluation, post-marketing surveillance,
manufacturing, packaging, and information provided by the manufacturer,
taking into account the safety factors of implant.
The implants as specified in this standard are suitable for use in dermal layers
and/or subcutaneous injections for clinical use, in order to eliminate or reduce
facial wrinkles and depressions caused by various reasons.

Basic Data

Standard ID	YY 0954-2015 (YY0954-2015)
Description (Translated English)	Nonactive surgical implants - Type I collagen implants - Specific requirements
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C45
Classification of International Standard	11.040.40
Word Count Estimation	20,244
Date of Issue	2015-03-02
Date of Implementation	2017-01-01
Quoted Standard	GB/T 16886.1; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5; GB/T 16886.6; GB/T 16886.10; GB/T 16886.11; GB/T 16886.12; GB/T 16886.17; GB/T 16886.18; YY/T 0640-2008; YY/T 0771.1; YY/T 0771.2; YY/T 0771.3; YBB 0006; YBB 0007; YBB 0008; YBB 0009; YBB 0010; YBB 0011; ISO 14155-2011
Regulation (derived from)	The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies)	State Food and Drug Administration
Summary	This Standard specifies the requirements for injectable collagen implant agent, it is purified (non-crosslinked) I collagen as a raw material preparation. This Standard specifies the implant agent requirements and test methods. Also expected product performance, design attributes, materials, design evaluation, testing methods, clinical evaluation, any post-market monitoring, manufacturing, packaging and information supplied by the manufacturer, and so do the specific instructions. Taking into account the safety of implanted Jing factor. This Standards required by applicable implant agent used clinically in the face of the dermis and/or subcutaneous injection, in order to eliminate or mitigate a variety of causes facial wrinkles and depressions.