99.60 Withdrawal effective Feb 3, 2021
CEN
CEN/TC 285 Non-active surgical implants
European Norm
11.040.40 Implants for surgery, prosthetics and orthotics
ISO 5840-1:2015 is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of the ISO 5840?series provide specific requirements.
ISO 5840-1:2015 is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted.
ISO 5840-1:2015 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 preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
ISO 5840-1:2015 defines operational conditions for heart valve substitutes.
ISO 5840-1:2015 excludes homografts.
NOTE A rationale for the provisions of this part of ISO 5840 is given in Annex A.
Legislation related to this standard
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
WITHDRAWN
EN ISO 5840-1:2015
99.60
Withdrawal effective
Feb 3, 2021
PUBLISHED
EN ISO 5840-1:2021