SN EN 60601-2-39 : 2008 AMD 11 2011

Section 1 - General
1 Scope and object
2 Terminology and definitions
3 General requirements
4 General requirements for tests
6 Identification, marking and documentation
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
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, disinfection and
      compatibility
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 - Construction Requirements
59 Construction and layout
Annexes

Defines minimum safety criteria for Peritoneal Dialysis Equipment. Covers equipment used by medical staff, or under medical expert supervision, as well as equipment which is patient operated, without regards to whether it is used in a domestic environment or hospital. Requirements for Dialysing Solution, the Dialysing Solution circuit, or continuous ambulatory use Peritoneal Dialysis Equipment is not covered.