YY/T 0640-2016 Active
YY/T 0640-2016 Non-active surgical implants—General requirements
Abstract
This standard specifies the general requirements for passive surgical implants (hereinafter referred to as implants). This standard does not apply to dental implants, dental restorative materials, endodontic implants, intraocular lenses, and implants of viable animal tissues.
Regarding safety, this standard specifies the requirements for expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and manufacturer-provided information, as well as the tests to verify compliance with these requirements.
Other tests are provided in secondary and tertiary standards.
Note: This standard does not require a quality management system for implant manufacturers, but if manufacturers have a quality management system in accordance with ISO 13485, it will greatly assist in ensuring the achievement of the expected performance of implants.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY/T 0640-2016 |
| CCS | Extracorporeal circulation, artificial organs, and prosthetic devices |
| ICS | Surgical implants, prostheses, and orthoses |
| Implement Date | 2017-06-01 |