SN EN 60601-2-16 : 1998

Foreword
Introduction
Section 1. General
1 Scope and object
2 Terminology and definitions
3 General requirements
6 Identification, marking and documents
Section 2. Environmental conditions
Section 3. Protection against electric shock hazards
19 Continuous LEAKAGE CURRENT and PATIENT AUXILIARY
    CURRENTS
Section 4. Protection against mechanical hazards
Section 5. Protection against hazards from unwanted
           or excessive radiation
36 Electromagnetic compatibility
Section 6. Protection against hazards of ignition of
           flammable anaesthetic mixtures
Section 7. Protection against excessive temperatures
           and other safety hazards
44 Overflow, spillage, leakage, humidity, ingress of
   liquids, cleaning, sterilization and disinfection
49 Interruption of the power supply
Section 8. Accuracy of operating data and protection
           against hazardous output
51 Protection against hazardous output
Section 9. Abnormal operation and fault conditions;
           environmental tests
Section 10. Constructional requirements
54 General
56 Components and general assembly
57 MAINS PARTS, components and layout
Annex L - References - Publications mentioned in this
          standard
Annex AA (informative) General guidance and rationale
Annex ZA (normative) Normative references to international
         publications with their corresponding European
         publications
Annex ZB (informative) Other international publications
         mentioned in this standard with the references
         of the relevant European publications
Table 1 - PROTECTIVE SYSTEM inspection times

Defines the minimum safety requirements for single patient haemodialysis, haemodiafiltration and haemofiltration equipment meant to be used either by medical staff or under their supervision, including operation of the equipment by the patient.