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NEN-EN 50061/A1

Safety of implantable cardiac pacemakers

inactive
Organization: NEN
Publication Date: 1 August 1995
Status: inactive
Page Count: 24
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

NEN-EN 50061/A1/C1
November 1, 1995
Safety of implantable cardiac pacemakers
A description is not available for this item.
NEN-EN 50061/A1
August 1, 1995
Safety of implantable cardiac pacemakers
A description is not available for this item.
NEN-EN 50061
August 1, 1991
Safety of implantable cardiac pacemakers
This standard specifies safety and other requirements exclusively for all types of wholly implantable cardiac pacemakers. This standard also establishes basic terminology and definitions and includes...

References

This document references:
89/336/EEG - Richtlijn van de Raad van 3 mei 1989 betreffende de onderlinge aanpassing van de wetgevingen van de Lid-Staten inzake elektro-magnetische compatibiliteit
Published by NEN on May 23, 1989
A description is not available for this item.
This document references:
90/385/EEG - COUNCIL DIRECTIVE of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC)
Published by NEN on July 20, 1990
The devices must be designed and manufactured in such a way that, when implanted under the conditions and for the purposes laid down, their use does not compromise the clinical condition or the...
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