GB 12279-2008 Active
GB 12279-2008 Cardiovasular implants—Cardiac valve prostheses
Abstract
1.1 This standard specifies the requirements for the necessary tests and the instruments used to detect the physical, biological, and mechanical properties of all types of artificial heart valves, their materials, and components.
1.2 This standard sets forth the requirements for preclinical evaluation of artificial heart valves in vivo, clinical evaluation requirements, and the reporting requirements for the results of all tests and evaluations in the standard. These requirements do not constitute a complete test procedure.
1.3 This standard also stipulates the requirements for the packaging and labeling of artificial heart valves.
1.4 This standard does not apply to artificial heart valves made from all human tissues and some human tissues.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB 12279-2008 |
| CCS | Orthopaedic surgery, orthopaedic instruments |
| ICS | Surgical implants, prostheses, and orthoses |
| Implement Date | 2009-12-01 |