ΕΛΟΤ EN IEC 80001-1 Ε2
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
ΕΛΟΤ EN IEC 80001-1 Ε2
Abstract
This document specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders.
Info
Publication Date
2021-10-29
Greek Title
Ασφάλεια, αποτελεσματικότητα και ασφάλεια στην υλοποίηση και χρήση συνδεδεμένων ιατρικών συσκευών ή συνδεδεμένου λογισμικού υγείας - Μέρος 1: Εφαρμογή διαχείρισης διακινδύνευσης
English Title
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
Standard Stage
Techincal Body
YReplaces
ΕΛΟΤ EN 80001.01:2011Related Documents
