IEC 60601-1-8

E478489

IEC 60601-1-8 is a collateral standard within the IEC 60601 series that specifies requirements for alarm systems in medical electrical equipment and systems to ensure safe and effective clinical use.

All labels observed (2)

How this entity was disambiguated

Statements (46)

Predicate Object
instanceOf IEC standard ⓘ
medical device standard ⓘ
aimsToReduce alarm fatigue ⓘ
appliesTo equipment with advisory alarms ⓘ
equipment with physiological monitoring alarms ⓘ
equipment with technical alarms ⓘ
medical electrical equipment ⓘ
medical electrical systems ⓘ
classification collateral standard to IEC 60601-1 ⓘ
covers alarm notification ⓘ
alarm priority ⓘ
alarm signal characteristics ⓘ
alarm system design ⓘ
alarm system validation ⓘ
alarm system verification ⓘ
defines requirements for alarm signal audibility ⓘ
requirements for alarm signal recognition ⓘ
requirements for alarm signal visibility ⓘ
focusesOn patient safety ⓘ
risk management of alarm systems ⓘ
fullTitle Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ⓘ
linked to: IEC 60601-1-8
hasType collateral standard ⓘ
includes requirements for alarm documentation ⓘ
requirements for alarm marking and labeling ⓘ
requirements for alarm system usability ⓘ
intendedForUseIn clinical environments ⓘ
language English ⓘ
objective ensure effective clinical use of alarm systems ⓘ
ensure safe clinical use of alarm systems ⓘ
partOf IEC 60601 series ⓘ
linked to: IEC 60601
provides guidance for alarm systems in medical electrical equipment ⓘ
guidance for alarm systems in medical electrical systems ⓘ
publishedBy International Electrotechnical Commission ⓘ
relatedTo IEC 60601-1 ⓘ
IEC 60601-1-2 ⓘ
scope alarm systems that are part of medical electrical equipment ⓘ
alarm systems that are part of medical electrical systems ⓘ
specifies general requirements for alarm systems ⓘ
tests for alarm systems ⓘ
subject alarm systems ⓘ
basic safety ⓘ
essential performance ⓘ
usedAsBasisFor conformity assessment of medical electrical equipment alarm systems ⓘ
usedBy medical device manufacturers ⓘ
regulatory authorities ⓘ
test laboratories ⓘ

How these facts were elicited

Referenced by (4)

Full triples — surface form annotated when it differs from this entity's canonical label.

IEC 60601-1 → isBasisFor → IEC 60601-1-8 ⓘ
IEC 60601-1-10 → relatedTo → IEC 60601-1-8 ⓘ
IEC 60601 → hasPart → IEC 60601-1-8 ⓘ
IEC 60601-1-8 → fullTitle → Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ⓘ
linked to: IEC 60601-1-8