AS/NZS 3200.2.35:1999
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Blankets, pads and mattresses intended for heating in medical use
Specifies safety requirements for the design and manufacture of blankets, pads and mattresses, intended for heating in medical use. It is identical with and has been reproduced from IEC 60601-2-35:1996. This Standard refers to its Parent Standard, AS/NZS 3200.1.0:1998. An available copy of AS/NZS 3200.1.0 is essential to the meaningful interpretation of this part.
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AS/NZS 3200.2.35:1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-BLANKETS, PADS AND MATTRESSES INTENDED..
PREFACE
CONTENTS
INTRODUCTION
SECTION ONE – GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
5 Classification
6 Identification, marking and documents
SECTION TWO – ENVIRONMENTAL CONDITIONS
9 Removable protective means (not used)
12 (not used)
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
Appendix L - References – Publications mentioned in this standard
Annex AA - Rationale to particular subclauses
Annex BB - Determination of the lagging material
Annex CC - Procedure for determining whether a HEATING DEVICE provides HIGH or LOW HEAT TRANSFER from the heat source to the con
Annex DD - Procedure for determining whether a HEATING DEVICE provides HIGH or LOW HEAT TRANSFER from the contact surface to the
Annex EE -CONDITIONS OF ADEQUATE HEAT DISCHARGE
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References
Approval and test specification - Safety of electrically heated blankets, pads and similar flexible heating appliances for household use
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AS/NZS 3200.2.35:1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-BLANKETS, PADS AND MATTRESSES INTENDED..
PREFACE
CONTENTS
INTRODUCTION
SECTION ONE – GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
5 Classification
6 Identification, marking and documents
SECTION TWO – ENVIRONMENTAL CONDITIONS
9 Removable protective means (not used)
12 (not used)
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
Appendix L - References – Publications mentioned in this standard
Annex AA - Rationale to particular subclauses
Annex BB - Determination of the lagging material
Annex CC - Procedure for determining whether a HEATING DEVICE provides HIGH or LOW HEAT TRANSFER from the heat source to the con
Annex DD - Procedure for determining whether a HEATING DEVICE provides HIGH or LOW HEAT TRANSFER from the contact surface to the
Annex EE -CONDITIONS OF ADEQUATE HEAT DISCHARGE
AS/NZS 3200.2.35:1999
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