EN ISO 5840:2009

Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

Publication date:   Feb 28, 2010

General information

99.60 Withdrawal effective   Sep 30, 2015


CEN/TC 285 Non-active surgical implants

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics



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ISO 5840:2005 is applicable to all devices intended for implantation in human hearts, as a heart valve substitute.
It 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.
ISO 5840:2005 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.
ISO 5840:2005 imposes design specifications and minimum performance specifications for heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
It excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.

Related legislation

Legislation related to this standard


Medical devices


Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle


EN ISO 5840:2005


EN ISO 5840:2009
99.60 Withdrawal effective
Sep 30, 2015


EN ISO 5840-2:2015


Adopted from ISO 5840:2005 IDENTICAL