DS/EN ISO 5840-2:2015 (Valid to: 31-08-2021)

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes


Status:
Valid to: 31-08-2021
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
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Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


Legislation

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 

Links

Scope

This part of ISO 5840 is applicable to heart valve substitutes intended for implantation in human hearts,
generally requiring cardiopulmonary bypass and generally with direct visualization.
This part of ISO 5840 is applicable to both newly developed and modified surgical heart valve substitutes
and to the accessories, packaging, and labelling required for their implantation and for determining the
appropriate size of the surgical heart valve substitute to be implanted.
This part of ISO 5840 outlines an approach for qualifying the design and manufacture of a surgical 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 surgical 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 surgical heart valve substitute.
This part of ISO 5840 defines performance requirements for surgical heart valve substitutes where
adequate scientific and/or clinical evidence exists for their justification.
For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this International
Standard and ISO 5840-3 might be relevant and shall be considered as applicable to the specific device
design and shall be based on the results of the risk analysis.
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 homografts.


Number of pages: 68

Published: 2015-12-03

Date of approval: 2015-11-17

International relationships : EN ISO 5840-2:2015 IDT ISO 5840-2:2015 IDT

ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics

Item number: M285787

*Expected revoked date: 31-08-2021


Committees

Committee

  • CEN/TC 285
  • ISO/TC 150/SC 2
  • ISO/TC 150/SC 2/WG 1

Danish committee

DS/S-160