YY 0500-2004 Replaced Industry standards-Medicine

YY 0500-2004 Cardiovasular implants—Tubular vascular prostheses

Publish Date: 2004-11-08 Implement Date: 2005-11-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0500-2004

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2004-11-08

Implement Date: 2005-11-01

Pages: 31 pages

Scope

1.1 This standard specifies the test methods, packaging, marking, and terminology requirements for sterile artificial blood vessels. Sterile artificial blood vessels refer to artificial blood vessels that can replace, bypass, or shunt any part of the human blood vessel system. The artificial blood vessels referred to in this standard can be completely or partially made of biological materials, synthetic woven materials, or synthetic non-woven materials. In addition, the standard also explains the characteristics and differences between combined artificial blood vessels and mixed artificial blood vessels. The standard also specifies the names and structures of the raw materials of artificial blood vessels, as well as the names of the length and diameter of artificial blood vessels. The biological requirements for the raw materials and finished products of artificial blood vessels in this standard refer to the provisions of GB/T 16886. This standard specifies the names of various mechanical properties of artificial blood vessels. Moreover, this standard also lists some manufacturers' testing and measurement methods for the geometric shapes and mechanical properties of artificial blood vessels. The standard also mentions the sterilization methods of artificial blood vessels and makes provisions for the packaging and marking of products. The standard also lists the definitions of some commonly used terms related to artificial blood vessels. 1.2 This standard does not list all the performance indicators or geometric shapes of artificial blood vessels. However, the detection methods listed in this standard can verify whether the performance indicators provided by manufacturers are within an acceptable range. However, this does not mean that the methods recommended in this standard can constitute a complete set of test methods for artificial blood vessels. 1.3 The test methods, results, and other information listed in this standard are only applicable to the requirements o