IEC 60601-1-11
E483948
IEC 60601-1-11 is a collateral standard specifying additional requirements for the safety and performance of medical electrical equipment and systems used in the home healthcare environment.
All labels observed (1)
| Label | Occurrences |
|---|---|
| IEC 60601-1-11 canonical | 1 |
Statements (46)
| Predicate | Object |
|---|---|
| instanceOf |
IEC standard
ⓘ
medical device safety standard ⓘ |
| addresses |
cleaning and disinfection in home environments
ⓘ
electrical hazards in home healthcare use ⓘ environmental conditions in home healthcare ⓘ instructions for use for lay operators ⓘ marking and labeling for home use equipment ⓘ mechanical hazards in home healthcare use ⓘ protective earth and protective means in home use ⓘ reliability of power supply in home healthcare ⓘ transport and storage conditions for home healthcare equipment ⓘ transport of medical electrical equipment for home use ⓘ |
| appliesTo |
home healthcare environment
ⓘ
medical electrical equipment ⓘ medical electrical systems ⓘ |
| belongsToCategory | medical device regulation and standards ⓘ |
| defines | home healthcare environment ⓘ |
| focusesOn | use of medical electrical equipment in home healthcare ⓘ |
| hasAbbreviation | IEC 60601-1-11 NERFINISHED ⓘ |
| hasApplicationArea |
home dialysis equipment
ⓘ
home infusion pumps ⓘ home monitoring equipment ⓘ home ventilators ⓘ |
| hasEdition | 2nd edition ⓘ |
| hasScope | medical electrical equipment and systems intended for use in the home healthcare environment ⓘ |
| hasTitle | Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment NERFINISHED ⓘ |
| intendedForUseBy |
manufacturers of medical electrical equipment
ⓘ
regulatory authorities ⓘ test laboratories ⓘ |
| isCollateralStandardTo | IEC 60601-1 NERFINISHED ⓘ |
| language |
English
ⓘ
French ⓘ |
| partOf | IEC 60601 series NERFINISHED ⓘ |
| publishedBy | International Electrotechnical Commission NERFINISHED ⓘ |
| relatedTo |
IEC 60601-1-10
NERFINISHED
ⓘ
IEC 60601-1-12 NERFINISHED ⓘ |
| requires |
adequate usability for home users
ⓘ
consideration of lay operator capabilities ⓘ consideration of reasonably foreseeable misuse in home healthcare ⓘ risk management considering home use conditions ⓘ |
| revises | IEC 60601-1-11:2010 NERFINISHED ⓘ |
| specifies |
additional requirements for basic safety
ⓘ
additional requirements for essential performance ⓘ |
| supplements | IEC 60601-1 basic safety and essential performance requirements ⓘ |
| supports | regulatory compliance for home-use medical electrical equipment ⓘ |
| usedIn | conformity assessment of home-use medical devices ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.