Hivatkozási szám

MSZ EN ISO 5840-3:2013

Dokumentumazonosító

156346

Cím

Szív- és érrendszeri implantátumok. Szívbillentyű-protézisek. 3. rész: Transzkatéteres technikával beültetett szívbillentyűpótlások (ISO 5840-3:2013)

Angol cím

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

Alkalmazási terület

This part of ISO 5840 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. This part of ISO 5840 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. This part of ISO 5840 is applicable to all devices intended for implantation in human hearts as a transcatheter heart valve substitute. This part of ISO 5840 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. This part of ISO 5840 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices. This part of ISO 5840 excludes valve-in-valve configurations and homografts. This part of ISO 5840 does not specifically address non-traditional surgically implanted heart valve substitutes (e.g. sutureless). For these devices, the requirements of both this part of ISO 5840 and ISO 5840:2005 might be relevant and can be considered. NOTE A rationale for the provisions of this part of ISO 5840 is given in Annex A.

ICS

11.040.40 Sebészeti implantátumok, protézisek és ortézisek

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2013-08-01

A visszavonás napja

2021-06-01

Forrás

idt EN ISO 5840-3:2013; idt ISO 5840-3:2013

Előd

Utód

MSZ EN ISO 5840-3:2021

Módosítás

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

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