CSA ISO 5841-2 : 0
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
IMPLANTS FOR SURGERY - CARDIAC PACEMAKERS - PART 2: REPORTING OF CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS OR LEADS
Hardcopy , PDF
07-30-2009
English
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. It includes general requirements for all reports; it also includes supplementary requirements for reports on cumulative experience with devices and estimates of future clinical performance for devices, when appropriate.
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