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CEI EN IEC 81001-5-1

CEI Classification: 62-275

Sicurezza, efficacia e protezione del software sanitario e dei sistemi IT sanitari
Parte 5-1: Protezione - Attività nel ciclo di vita del prodotto
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Publication Date: 2022-10
ValidFrom: 2022-11
Language: EN
Pages: 66
Issue Num.:  18852 E
Commitee: CEI-SC62A, CEI-CT62
La presente Norma definisce i requisiti del CICLO DI VITA per lo sviluppo e la manutenzione del SOFTWARE SANITARIO necessario per supportare la conformità alla Norma IEC 62443-4-1, tenendo conto delle esigenze specifiche del SOFTWARE SANITARIO. L'insieme di PROCESSI, ATTIVITÀ e INCARICHI, descritti in questo documento, stabilisce un quadro comune per i PROCESSI DEL CICLO DI VITA DEI SOFTWARE SANITARI sicuri.
Lo scopo è aumentare la CYBER-SICUREZZA del SOFTWARE SANITARIO stabilendo determinate ATTIVITÀ e COMPITI nel PROCESSO DEL CICLO DI VITA DEL SOFTWARE SANITARIO e anche aumentando la SICUREZZA degli stessi PROCESSI DEL CICLO DI VITA DEL SOFTWARE.
È importante mantenere un equilibrio appropriato delle proprietà chiave SICUREZZA del paziente o operatore, efficacia e SICUREZZA informatica, come discusso nella ISO 81001-1.
Questa Norma non specifica prescrizioni relative alla DOCUMENTAZIONE DI ACCOMPAGNAMENTO.
La Norma in oggetto viene pubblicata dal CEI nella sola lingua inglese, in quanto particolarmente mirata a settori specialistici.
La presente Norma recepisce il testo originale inglese della Pubblicazione IEC.

See also

EN IEC 81001-5-1:2022
IEC 81001-5-1:2021

International Coding Standard (ICS)

11.040.01
Medical equipment in general
35.240.80
IT applications in health care technology
* Including computer tomography

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ICS

International Classification for Standards (ICS) is an international classification system for technical standards.

The ICS is a hierarchical classification organized on three levels.

Level 1 covers the main fields of activity in standardization, e.g. road vehicle engineering, agriculture, metallurgy.

Each field has a two-digit notation, e.g.

  43    Road Vehicle Engineering

The main fields are subdivided into groups (level 2). The notation of a group consists of the field notation and a three-digit group number, separated by a point, e.g.

  43.040    Road vehicle systems

Some groups are further divided into sub-groups (level 3). The notation of a sub-group consists of the group notation and a two-digit number, separated by a point, e.g.

  43.040.20 Lighting, signaling and warning devices

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