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Home / Frameworks / IEC TR 60601-4-5

IEC TR 60601-4-5 v2024

Official SCF Download

Medical Device Security

Framework data extracted from the Secure Controls Framework (SCF) v2025.4 Set Theory Relationship Mapping (STRM) files, licensed under CC BY-ND 4.0 . Attribution required per license terms.

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1 — Scope (1 requirements)

1.0Scope

2 — Normative References (1 requirements)

2.0Normative References

3 — Terms and Definitions (1 requirements)

3.0Terms and Definitions

6 — Security Requirements (1 requirements)

6.0Security Requirements Overview

6(a) — Automatic Logoff (1 requirements)

6(a)Automatic Logoff

6(b) — Audit Controls (1 requirements)

6(b)Audit Controls

6(c) — Authorization (1 requirements)

6(c)Authorization

6(d) — Configuration of Security Features (1 requirements)

6(d)Configuration of Security Features

6(e) — Cyber Security Product Upgrades (1 requirements)

6(e)Cyber Security Product Upgrades

6(f) — Data De-Identification (1 requirements)

6(f)Data De-Identification

6(g) — Data Integrity and Authenticity (1 requirements)

6(g)Data Integrity and Authenticity

6(h) — Data Backup and Recovery (1 requirements)

6(h)Data Backup and Recovery

6(i) — Emergency Access (1 requirements)

6(i)Emergency Access

6(j) — Health Data Storage Confidentiality (1 requirements)

6(j)Health Data Storage Confidentiality

6(k) — Malware Detection/Protection (1 requirements)

6(k)Malware Detection and Protection

6(l) — Node Authentication (1 requirements)

6(l)Node Authentication

6(m) — Person Authentication (1 requirements)

6(m)Person Authentication

6(n) — Physical Locks (1 requirements)

6(n)Physical Locks

6(o) — System and Application Hardening (1 requirements)

6(o)System and Application Hardening

6(p) — Security Guides (1 requirements)

6(p)Security Guides

6(q) — Health Data Integrity and Confidentiality (1 requirements)

6(q)Health Data Integrity and Confidentiality

6(r) — Transmission Integrity (1 requirements)

6(r)Transmission Integrity

6(s) — Transmission Confidentiality (1 requirements)

6(s)Transmission Confidentiality

6(t) — Software Bill of Materials (1 requirements)

6(t)Software Bill of Materials

6(u) — Third-Party Components in Product Lifecycle (1 requirements)

6(u)Third-Party Components in Product Lifecycle

6(v) — Security Risk Management (1 requirements)

6(v)Security Risk Management