SN EN 60601-1-1 : 2001

Committees responsible
National foreword
Section 1. General
1. Scope and object
1.201 Scope
2. Terminology and definitions
2.201 Coupling
2.202 Indirect contact
2.203 Medical electrical system
2.204 Patient environment
2.205 Separation device
3. General requirements
3.201 General requirements for the system
4. General requirements for tests
4.201 General requirements for tests for the system
6. Identification, marking and documents
6.1.201 Marking
6.8.201 Accompanying documents
Section 2. Environmental conditions
Section 3. Protection against electric shock hazards
16. Enclosures and protective covers
16.201 Enclosures
17. Separation
17.201 Electrical separation
19. 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 parts
Section 4. Protection against mechanical hazards
22. Moving parts
22.7.201 Protective means
Section 5. Protection against hazards from unwanted or
excessive radiation
Section 6. Protection against hazards of ignition of
flammable anaesthetic mixtures
Section 7. 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 supply
Section 8. Accuracy of operating data and protection
against hazardous output
Section 9. Abnormal operation and fault conditions;
environmental tests
Section 10. Constructional requirements
56.3.201 Connections
56.201 Protective earth conductor
59.201 Protection of wiring
Annexes
AAA. General guidance and rationale
BBB. Examples of combinations of medical electrical
          equipment and non-medical electrical equipment
CCC. Normative references
DDD. Bibliography
Figures
201. Patient environment
202. Symbol 14, table D1, appendix D of IEC 601-1
BBB.201 Combinations of medical electrical equipment
          and non-medical electrical equipment

Describes the safety requirements for medical electrical systems to give protection for the patient, the operator and surroundings. Coverage includes environmental conditions, protection against electric shock hazards, protection against mechanical hazards, protection against hazards from unwanted or excessive radiation, protection against hazards of ignition of flammable anaesthetic mixtures, protection against excessive temperatures and other safety hazards, accuracy of operating data and protection against hazardous output, abnormal operation and fault conditions, and constructional requirements. Also includes annexes and diagrams.