Statements (28)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:International_Standard
|
| gptkbp:appliesTo |
essential performance of medical electrical equipment
safety of medical electrical equipment |
| gptkbp:basisFor |
national standards (e.g., EN 60601)
|
| gptkbp:category |
electrical safety standards
medical device standards |
| gptkbp:firstPublished |
1977
|
| gptkbp:focusesOn |
medical electrical equipment
|
| gptkbp:hasPart |
gptkb:IEC_60601-1
gptkb:IEC_60601-1-2 gptkb:IEC_60601-1-6 gptkb:IEC_60601-2-2 gptkb:IEC_60601-2-24 gptkb:IEC_60601-2-27 gptkb:IEC_60601-2-54 |
| gptkbp:language |
gptkb:French
English |
| gptkbp:publishedBy |
gptkb:International_Electrotechnical_Commission
|
| gptkbp:thirdEditionPublished |
2005
|
| gptkbp:thirdPlace |
harmonized with ISO 14971
|
| gptkbp:updated |
multiple times
|
| gptkbp:usedBy |
regulatory agencies
medical device manufacturers |
| gptkbp:usedFor |
gptkb:certification
compliance assessment |
| gptkbp:bfsParent |
gptkb:IEC_62304
|
| gptkbp:bfsLayer |
6
|
| https://www.w3.org/2000/01/rdf-schema#label |
IEC 60601 series
|