Standard Svensk standard · SS-EN ISO 5840-3:2013

Hjärt- och kärlimplantat - Proteser för hjärtklaffar - Del 3: Hjärtklaffssubstitut implanterade med kateterburen teknik (ISO 5840-3:2013)

Status: Gällande

Omfattning
ISO 5840-3:2013 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be 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 can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. ISO 5840-3:2013 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. ISO 5840-3:2013 is applicable to all devices intended for implantation in human hearts as a transcatheter heart valve substitute. ISO 5840-3:2013 is applicable to both newly developed and modified transcatheter 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.

Ämnesområden

Kirurgiska implantat, proteser och ortoser (11.040.40)


Produktinformation

Språk: Engelska

Framtagen av: Implantat, SIS/TK 340/AG 03

Internationell titel: Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)

Artikelnummer: STD-89507

Utgåva: 1

Fastställd: 2013-03-22

Antal sidor: 124

Ersätter: SS-EN ISO 5840:2009