標準號：BS EN 12006-2-1998+A1-2009
中文標準名稱：非活性外科植入物.心臟和血管植入物的特殊要求.包括心瓣導管在內的血管假體
英文標準名稱：Non-active surgical implants - Particular requirements for cardiac and vascular implants - Vascular prostheses including cardiac valve conduits
標準類型：C45
發布日期：1998/7/15 12:00:00
實施日期：1998/7/15 12:00:00
中國標準分類號：C45
國際標準分類號：11.040.40
引用標準：prEN 12006-1;EN ISO 14630-1997;ISO/DIS 7198
適用范圍：This standard describes specific requirements for vascular prostheses, including cardiac valve conduits, of synthetic or biological origin intended to replace, to reconstruct, to bypass or to form shunts between segments of the cardio-vascular system in humans.This European Standard is not applicable to prostheses derived from host tissue (autografts).NOTE A valve conduit is regarded as a composite prosthesis and falls within the scope of this standard.With regard to safety it gives in addition to EN ISO 14630:1997, requirements for intended performance,design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.This European Standard specifies the designation of materials of the manufacturer and the construction of the device, and the designation of sizes and dimensions of vascular prostheses. It specifies biological requirements for the materials of construction and for the finished product by references to appropriate International and European Standards.In addition this European Standard specifies the designation of mechanical properties. It describes methods for the measurement and verification of the dimensions and mechanical properties stated by themanufacturer, including durability testing.This standard also gives requirements for packaging and labelling. It provides definitions of the terms in common use.This European Standard does not specify all possible performance or dimensional characteristics. In suchcases, the European Standard does however include methods to verify the nominal values stated by themanufacturer.