EN 60601-2-35:1996

INTRODUCTION
1 Scope and object
2 Terminology and definitions
3 General requirements
5 Classification
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK
HAZARDS
17 Separation
19 Continuous leakage currents and patient auxiliary
    currents
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of
    liquids, cleaning, sterilization, disinfection and
    compatibility
46 Human errors
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS:
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
54 General
56 Components and general assembly
57 Mains parts, components and layout
59 Construction and layout
Figures
101aPositioning of temperature sensors on the contact
    surface of the heated area of a heating device
101bExample of the positioning of temperature sensors
    on the contact surface of the heated areas of a
    heating device having more than one separately heated
    area
102 Ramp for the impact test on pads
103 Partial covering conditions
104 Method of folding blankets
105 Examples of folds
106 Positions of a blanket for the ruck-resistance test
107aApparatus for the spark ignition test
107bDetails of an apparatus for the spark ignition test
108 Illustration of the main requirements of this
    Standard
Appendix/Annexes
L References - publications mentioned in this standard
AA (informative) Rationale to particular subclause
BB (normative) Determination of the lagging material
CC (normative) Procedure for determining whether a
    heating device provides high or low heat transfer
    from the heat source to the contact surface (i.e.
    towards the patient
DD (normative) Procedure for determining whether a heating
    device provides high or low heat transfer from the
    contact surface to the heat source (i.e. away from
    the patient)
EE (normative) Normative references to international
    publications with their corresponding European
    publications
ZB (informative) Normative references to international
    publications with their corresponding European
    publications

Establishes requirements, which minimize hazards to patient and operator, for heating devices such as blankets, pads, mattresses and fluid-filled mattresses. Specifies tests by which compliance can be verified.