ISO 5840-2005 心血管植入物.心脏瓣膜假体

标准号：ISO 5840-2005
中文标准名称：心血管植入物.心脏瓣膜假体
英文标准名称：Cardiovascular implants - Cardiac valve prostheses
标准类型：C45
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C45
国际标准分类号：11.040.40
适用范围：This International Standard is applicable to all devices intended for implantation in human hearts, as a heart valve substitute.This International Standard is applicable to both newly developed and modified heart valve substitutesand to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.This International Standard outlines an approach for qualifying the design and manufacture of a heartvalve substitute through risk management. The selection of appropriate qualification tests and methods arederived from the risk assessment. The tests may include those to assess the physical, chemical, biologicaland mechanical properties of heart valve substitutes and of their materials and components. The tests mayalso include those for pre-clinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.This International Standard imposes design specifications and minimum performance specifications forheart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.This International Standard excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.