YY 0647-2008
Non-active surgical implants.Mammary implants—Particular requirements (English Version)
- Standard No.
- YY 0647-2008
- Language
- Chinese, Available in English version
- Release Date
- 2008
- Published By
- Professional Standard - Medicine
- Status
- 2022-12
- Replace By
- YY/T 0647-2021
- Latest
- YY/T 0647-2021
- Scope
- This standard specifies the special requirements for breast implants (also known as breast prostheses, breast implants, artificial breasts, etc., hereinafter referred to as implants) for clinical use. This standard specifies expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information provided by the manufacturer. Also take into account the safety factors of the implant.
YY 0647-2008 Referenced Document
- GB/T 528-1998 Rubber, vulcanized or thermoplastic--Determination of tensile stress-strain properties
- GB/T 529-1999 Rubber, vulcanized or thermoplastic--Determination of tear strength (Trouser, angle and crescent test pieces)
- ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
- ISO 14155-1 Clinical investigation of medical devices for human subjects - Part 1: General requirements
- ISO 14155-2 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
- YY/T 0640-2008 Non-active surgical implants-General requirements
YY 0647-2008 history
- 2021 YY/T 0647-2021 Passive Surgical Implants Specific Requirements for Breast Implants
- 2008 YY 0647-2008 Non-active surgical implants.Mammary implants—Particular requirements
YY 0647-2008 Non-active surgical implants.Mammary implants—Particular requirements was changed to YY/T 0647-2021 Passive Surgical Implants Specific Requirements for Breast Implants.
