YY/T 0954-2015 Active
YY/T 0954-2015 Nonactive surgical implants—Type Ⅰ collagen implants—Specific requirements
Abstract
This standard specifies the special requirements for injectable collagen implants (hereinafter referred to as implants), which are prepared from purified (non-crosslinked) Type I collagen as raw materials.
This standard stipulates the technical requirements and testing methods for implants. It also provides detailed explanations on the expected performance of the product, design attributes, materials, design evaluation, testing methods, clinical evaluation, post-market supervision, manufacturing, packaging, and information provided by the manufacturer. At the same time, it takes into account the safety factors of implants.
The implants specified in this standard are suitable for clinical use in the dermis and/or subcutaneous injection of the face to eliminate or alleviate facial wrinkles and depressions caused by various reasons.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY/T 0954-2015 |
| CCS | Extracorporeal circulation, artificial organs, and prosthetic devices |
| ICS | Surgical implants, prostheses, and orthoses |
| Implement Date | 2017-01-01 |