CSA C22.2 No. 60601-1
E470754
CSA C22.2 No. 60601-1 is the Canadian national standard for the safety and essential performance of medical electrical equipment, harmonized with IEC 60601-1.
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
Canadian standard
ⓘ
medical electrical equipment safety standard ⓘ national standard ⓘ |
| abbreviation | CSA C22.2 60601-1 NERFINISHED ⓘ |
| addresses |
basic safety of medical electrical equipment
ⓘ
essential performance of medical electrical equipment ⓘ |
| applicableEnvironment |
home healthcare environments
ⓘ
professional healthcare facilities ⓘ |
| appliesTo |
medical electrical equipment
ⓘ
medical electrical systems ⓘ |
| basedOn | IEC 60601-1 NERFINISHED ⓘ |
| conformityAssessment | used as reference in product testing and certification in Canada ⓘ |
| conformsTo | IEC 60601-1 structure and clause numbering ⓘ |
| country | Canada ⓘ |
| defines |
general performance requirements for medical electrical equipment
ⓘ
general safety requirements for medical electrical equipment ⓘ |
| field | medical electrical equipment ⓘ |
| harmonizedWith | IEC 60601-1 NERFINISHED ⓘ |
| includes |
requirements for classification of medical electrical equipment
ⓘ
requirements for cleaning, disinfection, and sterilization aspects of equipment design ⓘ requirements for electromagnetic compatibility interfaces ⓘ requirements for environmental conditions of operation ⓘ requirements for protection against electric shock ⓘ |
| language |
English
ⓘ
French ⓘ |
| publishedBy | Canadian Standards Association NERFINISHED ⓘ |
| regulatoryUse | basis for certification of medical electrical equipment in Canada ⓘ |
| relatedTo |
Canadian Electrical Code
NERFINISHED
ⓘ
IEC 60601 series NERFINISHED ⓘ |
| scopeIncludes |
protection against electrical hazards
ⓘ
protection against excessive temperatures ⓘ protection against fire hazards ⓘ protection against ingress of water and solids ⓘ protection against mechanical hazards ⓘ protection against unwanted or excessive radiation ⓘ requirements for construction of medical electrical equipment ⓘ requirements for marking and documentation ⓘ requirements for testing of medical electrical equipment ⓘ |
| sector |
healthcare
ⓘ
medical devices ⓘ |
| status | active standard (subject to periodic revision) ⓘ |
| subject |
essential performance of medical electrical equipment
ⓘ
safety of medical electrical equipment ⓘ |
| typeOfRequirement |
performance requirement
ⓘ
product safety requirement ⓘ |
| usedBy | medical electrical equipment manufacturers in Canada ⓘ |
| usedFor | demonstrating compliance with Canadian safety requirements for medical electrical equipment ⓘ |
Referenced by (1)
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