DIN EN ISO 5840-2009 心血管植入物.心脏瓣膜修复术(ISO 5840-2005).德文版本EN ISO 5840-2009

标准号：DIN EN ISO 5840-2009
中文标准名称：心血管植入物.心脏瓣膜修复术(ISO 5840-2005).德文版本EN ISO 5840-2009
英文标准名称：Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005); English version of DIN EN ISO 5840:2009-08
标准类型：C45
发布日期：1999/12/31 12:00:00
实施日期：2009/8/1 12:00:00
中国标准分类号：C45
国际标准分类号：01.040.11;11.040.40
引用标准：ISO 8601-2000;ISO 10993-1-1997;ISO 10993-2-1992;ISO 11134-1994;ISO 11135-1994;ISO 11137-1995;ISO 11607-2003;ISO 13485;ISO 14155-1-2003;ISO 14160;ISO 14630;ISO 14937-2000;ISO 14971-2000;EN 12442-1;EN 12442-2;EN 12442-3
适用范围： 1.1 This International Standard is applicable to all devices intended for implantation in human hearts, as a heart valve substitute. 1.2 This International Standard is applicable to both newly developed and modified heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. 1.3 This International Standard outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived 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.1.4 This International Standard imposes design specifications and minimum performance specifications forheart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.1.5 This International Standard excludes heart valve substitutes designed for implantation in artificial heartsor heart assist devices.NOTE A rationale for the provisions of this International Standard is given in Annex A.