IEC 60601
E489377
IEC 60601 is an international standard that specifies safety and essential performance requirements for medical electrical equipment.
Observed surface forms (8)
| Surface form | Occurrences |
|---|---|
| IEC 60601-1 | 0 |
| IEC 60601-1-10 | 0 |
| IEC 60601-1-11 | 0 |
| IEC 60601-1-2 | 0 |
| IEC 60601-1-3 | 0 |
| IEC 60601-1-6 | 0 |
| IEC 60601-1-8 | 0 |
| IEC 60601-1-9 | 0 |
Statements (67)
| Predicate | Object |
|---|---|
| instanceOf |
collateral standard
ⓘ
collateral standard ⓘ collateral standard ⓘ collateral standard ⓘ collateral standard ⓘ collateral standard ⓘ collateral standard ⓘ general standard ⓘ international standard ⓘ medical device safety standard ⓘ |
| appliesTo |
medical electrical equipment
ⓘ
medical electrical systems ⓘ |
| coreStandard | IEC 60601-1 NERFINISHED ⓘ |
| defines |
essential performance requirements
ⓘ
safety requirements ⓘ |
| field | medical electrical equipment ⓘ |
| focusesOn |
electromagnetic safety
ⓘ
mechanical safety ⓘ operator safety ⓘ patient safety ⓘ radiation safety ⓘ thermal safety ⓘ |
| goal |
ensure acceptable essential performance of medical equipment
ⓘ
reduce risk of harm to operators ⓘ reduce risk of harm to patients ⓘ |
| hasAbbreviation | IEC 60601 NERFINISHED ⓘ |
| hasConcept |
applied part
ⓘ
classification by degree of protection against ingress of water ⓘ classification by mode of operation ⓘ classification by protection against electric shock ⓘ means of patient protection ⓘ |
| hasPart |
IEC 60601-1
NERFINISHED
ⓘ
IEC 60601-1-10 NERFINISHED ⓘ IEC 60601-1-11 NERFINISHED ⓘ IEC 60601-1-2 NERFINISHED ⓘ IEC 60601-1-3 NERFINISHED ⓘ IEC 60601-1-6 NERFINISHED ⓘ IEC 60601-1-8 NERFINISHED ⓘ IEC 60601-1-9 NERFINISHED ⓘ IEC 60601-2-xx series NERFINISHED ⓘ |
| includes | particular standards for specific medical devices ⓘ |
| includesRequirementType |
accuracy of controls and indicators
ⓘ
construction requirements ⓘ fire prevention ⓘ instructions for use ⓘ marking and labeling requirements ⓘ protection against electric shock ⓘ protection against excessive temperatures ⓘ protection against mechanical hazards ⓘ protection against unwanted radiation ⓘ |
| partOf | IEC 60601 NERFINISHED ⓘ |
| publishedBy | International Electrotechnical Commission NERFINISHED ⓘ |
| relatedTo |
IEC 62304
NERFINISHED
ⓘ
IEC 62366 NERFINISHED ⓘ ISO 14971 NERFINISHED ⓘ |
| subject |
alarm systems
ⓘ
electromagnetic compatibility ⓘ environmentally conscious design ⓘ home healthcare environment requirements ⓘ physiologic closed-loop controllers ⓘ radiation protection in diagnostic X-ray equipment ⓘ usability ⓘ |
| supports | regulatory approval of medical devices ⓘ |
| title | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance ⓘ |
| usedBy |
medical device manufacturers
ⓘ
regulatory authorities ⓘ testing laboratories ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.