+DE.AE-08 Incidents are declared when adverse events meet the defined incident criteria

DE.AE-08 Incidents are declared when adverse events meet the defined incident criteria

Statement

Incidents are declared when adverse events meet the defined incident criteria

Guidance

Apply incident criteria to known and assumed characteristics of activity in order to determine whether an incident should be declared

Guidance

Take known false positives into account when applying incident criteria

1. Pregled

Naslov Standard

1.1 Sklici

1.2 Ugotovljene zahteve

1.3 Povezani predpisi

2. Ugotovljene zahteve

Zahteve
Vir Zahteva

3. Povezani predpisi

Predpisi
Vir Regulativa

Povezane zadeve