YY 0647-2008: Non-active surgical implants. Mammary implants. Particular requirements

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Scope

This Standard specifies particular requirements for mammary implants (or
called breast prosthesis, breast implants and artificial breasts, hereinafter
referred to as the implants) for clinical practice.
With regard to safety, this Standard specifies requirements for intended
performance, design attributes, materials, design evaluation, manufacturing,
sterilization, packaging and information supplied by the manufacturer.

Basic Data

Standard ID	YY 0647-2008 (YY0647-2008)
Description (Translated English)	Non-active surgical implants. Mammary implants. Particular requirements
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C35
Classification of International Standard	11.040.40
Word Count Estimation	26,233
Date of Issue	2008-04-25
Date of Implementation	2009-12-01
Quoted Standard	GB/T 528-1998; GB/T 529-1999; YY/T 0640-2008; ISO 10993-1-2003; ISO 14155-1; ISO 14155-2; NF S99-401-1994
Adopted Standard	ISO 14607-2007, IDT
Regulation (derived from)	SFDA [2008] No. 192
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard provides for the clinical use of breast implants (otherwise known as breast implants, breast implants and artificial breasts, etc., hereinafter referred to as the implant) special requirements. This standard expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information provided by the manufacturer, and so do the specific instructions. Taking into account the safety of the implant factors.