JIS T 0601-1-1:2005

Introduction1 Scope and object 1.201 Scope2 Terminology and definitions 2.201 Coupling 2.202 Indirect contact 2.203 Medical electrical system 2.204 Patient environment 2.205 Separation device 2.206 Multiple portable socket-outlet3 General requirements 3.201 General requirements for the system4 General requirements for tests 4.201 General requirements for tests for the system6 Identification, marking and documents 6.1.201 Marking 6.8.201 Accompanying documentsSection Two - Environmental conditionsSection Three - Protection against electric shock hazards16 Enclosures and protective covers 16.201 Enclosures17 Separation 17.201 Electrical separation19 Continuous leakage currents and patient auxiliary currents 19.201 Leakage currents 19.201.1 Enclosure leakage current 19.201.2 Patient leakage current 19.201.3 Connection of signal input parts or signal output partsSection Four - Protection against mechanical hazards22 Moving parts 22.7.201 Protective meansSection Five - Protection against hazards from unwanted or excessive radiationSection Six - Protection against hazards of ignition of flammable anaesthetic mixturesSection Seven - Protection against excessive temperatures and other safety hazards 43.201 Fire prevention 44.7.201 Cleaning, sterilization and disinfection 49.201 Interruption of the power supplySection Eight - Accuracy of operating data and protection against hazardous outputSection Nine - Abnormal operation and fault conditions; environmental testsSection Ten - Constructional requirements 56.3.201 Connections 57.2 Mains connectors, appliance inlets and the like 57.2.201 Multiple portable socket-outlet 57.10 Creepage distances and air clearances 58.201 Protective earth conductor 59.201 Protection of wiringFigures201 Example of patient environment202 Symbol 14, Table D1 of JIS T 0601-1AnnexesAAA (informative) General guidance and rationaleBBB (informative) Examples of combinations of medical electrical equipment and non-medical electrical equipmentCCC (normative) Normative referencesDDD (informative) BibliographyEEE (normative) Requirements for multiple portable socket-outletsFFF (informative) Examples of application of multiple portable socket-outlets

Defines safety of medical electrical systems. It describes the safety requirements for medical electrical systems to provide protection for the patient, the operator and surroundings.

2005(R2009) [01/10/2009]2005 [25/03/2005]99 [27/12/1999]