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 (1)
| Label | Occurrences |
|---|---|
| IEC 60601-1-8 canonical | 1 |
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 NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ |
| provides |
guidance for alarm systems in medical electrical equipment
ⓘ
guidance for alarm systems in medical electrical systems ⓘ |
| publishedBy | International Electrotechnical Commission NERFINISHED ⓘ |
| relatedTo |
IEC 60601-1
NERFINISHED
ⓘ
IEC 60601-1-2 NERFINISHED ⓘ |
| 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 ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.