标准号：ISO 5840-2005
实施状态：作废
中文名称：心血管植入物.心脏瓣膜假体
英文名称：Cardiovascular implants - Cardiac valve prostheses
发布日期：2005-03
被替代标准：ISO 5840-1-2015;ISO 5840-2-2015
代替标准：ISO 5840-1996;ISO/FDIS 5840-2004
采用标准：DIN EN ISO 5840-2006,IDT;DIN EN ISO 5840-2009,IDT;DIN EN ISO 5840-2003,IDT;DIN EN ISO 5840/A1-2009,IDT;ANSI/AAMI/ISO 5840-2005,IDT;BS EN ISO 5840-2006,IDT;BS EN ISO 5840-2009,IDT;EN ISO 5840-2005,IDT;EN ISO 5840-2009,IDT;prEN ISO 5840-2008,IDT;NF S94-200-2009,IDT;NF S94-200-2009,IDT;S94-200PR,IDT;SN EN ISO 5840-2006,IDT;SN EN ISO 5840-2009,IDT;OENORM EN ISO 5840-2006,IDT;OENORM EN ISO 5840-2009,IDT;PN-EN ISO 5840-2006,IDT;PN-EN ISO 5840-2009,IDT;UNE-EN ISO 5840-2007,IDT;UNE-EN ISO 5840-2009,IDT
起草单位：ISO/TC 150
标准简介：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 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.
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, biological
and mechanical properties of heart valve substitutes and of their materials and components. The tests may
also 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 for
heart 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.
文件格式：PDF
文件大小：942.03KB
文件页数：92
（以上信息更新时间为：2019-11-22）
ISO 5840-2005 心血管植入物.心脏瓣膜假体.pdf
(942.03 KB)
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