YY 0647-2008 Replaced Industry standards-Medicine

YY 0647-2008 Non-active surgical implants—Mammary implants—Particular requirements

Publish Date: 2008-04-25 Implement Date: 2009-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0647-2008

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2008-04-25

Implement Date: 2009-12-01

Pages: 24 pages

Scope

This standard specifies the special requirements for breast implants (also known as breast prostheses, breast implants, and artificial breasts, hereinafter referred to as implants) intended for clinical use. This standard provides specific descriptions of the expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer. At the same time, it takes into account the safety factors of the implants.

Development Information

Word Count: 39 Thousand words Pages: 24 pages

Superseded by the following standards

YY/T 0647-2021 Non-active surgical implants—Particular requirements of mammary implants

Referenced Standards

GB/T 528-1998 Rubber,vulcanized or thermoplastic—Determination of tensile stress-strain properties CB/T 529-1999 YY/T 0640-2008 Non-active surgical implants—General requirements ISO 10993-1:2003 ISO 14155-1 ISO 14155-2 NF S 99-401-1994