ISO 5841-2:2014 specifies requirements for reports on the clinical performance in humans of population samples of cardiac pulse generators or leads, intended for long-term implantation, 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.
Document published on: 2014-08-01 Edition: 3 (Monolingual) ICS: 11.040.40 Status: Published Stage: 60.60 (2014-07-29) TC/SC: ISO/TC 150/SC 6 Number of Pages: 26
Revises: ISO 5841-2:2000
No corrigenda or amendments available