BS ISO 5841-2:2000 - Implants for surgery. Cardiac pacemakers. Reporting of clinical performance of populations of pulse generators or leads – BSI British Standards

BS ISO 5841-2:2000

Implants for surgery. Cardiac pacemakers. Reporting of clinical performance of populations of pulse generators or leads

Status : Revised, Superseded, Withdrawn   Published : February 2001 Replaced By : BS ISO 5841-2:2014

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Part two of ISO 5841 specifies requirements for reports on the clinical performance in humans of population samples of pulse generators or leads, intended for long-term implantation as cardiac pacemakers, hereinafter referred to as devices.

It includes general requirements for all reports and supplementary requirements for reports
on cumulative experience with devices and estimates of future clinical performance for devices, when appropriate.




Standard NumberBS ISO 5841-2:2000
TitleImplants for surgery. Cardiac pacemakers. Reporting of clinical performance of populations of pulse generators or leads
StatusRevised, Superseded, Withdrawn
Publication Date15 February 2001
Withdrawn Date31 August 2014
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Replaced ByBS ISO 5841-2:2014
ReplacesBS 6902-2:1987, ISO 5841-2:1986
International RelationshipsISO 5841-2
Draft Superseded By99/563146 DC
DescriptorsImplants (surgical), Pacemakers, Artificial organs, Prosthetic devices, Prosthesis, Electrical medical equipment, Cardiology, Heart, Clinical testing, Pulse generators, Performance, Reliability, Life (durability), Reports, Classification systems, Statistical methods of analysis, Statistical data
ICS11.040.40
Title in FrenchImplants chirurgicaux. Stimulateurs cardiaques. Etablissement d'un rapport sur le fonctionnement clinique de populations de generateurs d'impulsions ou de fils-electrodes
Title in GermanChirurgische Implantate. Herzschrittmacher. Berichtswesen ueber das klinische Verhalten von Impulsgeneratoren oder Elektroden
CommitteeCH/150/2
ISBN0 580 36652 9
PublisherBSI
FormatA4
DeliveryNo
Pages28
File Size1.112 MB
Price£182.00


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