GB 12279-2008 Active National standards force_standard

GB 12279-2008 Cardiovasular implants—Cardiac valve prostheses

Publish Date: 2008-12-31 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: GB 12279-2008

Standard Type: National standards

Standard Status: Active

is_force_gb: yes

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2008-12-31

Implement Date: 2009-12-01

Pages: 34 pages

Scope

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.