AS/NZS 3200.2.35:1999

1 - AS/NZS 3200.2.35:1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-BLANKETS, PADS AND MATTRESSES INTENDED..
4 - PREFACE
7 - CONTENTS
9 - INTRODUCTION
11 - SECTION ONE – GENERAL
11 - 1 Scope and object
12 - 2 Terminology and definitions
14 - 3 General requirements
14 - 5 Classification
14 - 6 Identification, marking and documents
16 - SECTION TWO – ENVIRONMENTAL CONDITIONS
16 - 9 Removable protective means (not used)
16 - 12 (not used)
17 - SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
17 - 17 Separation
17 - 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
18 - SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
18 - 21 Mechanical strength
19 - SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
19 - 36 Electromagnetic compatibility
19 - SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
19 - SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
19 - 42 Excessive temperatures
20 - 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
21 - 46 Human errors
21 - 49 Interruption of the power supply
21 - SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
21 - 50 Accuracy of operating data
24 - 51 Protection against hazardous output
25 - SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
25 - 52 Abnormal operation and fault conditions
29 - SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
29 - 54 General
31 - 56 Components and general assembly
32 - 57 MAINS PARTS, components and layout
33 - 59 Construction and layout
43 - Appendix L - References – Publications mentioned in this standard
44 - Annex AA - Rationale to particular subclauses
49 - Annex BB - Determination of the lagging material
50 - Annex CC - Procedure for determining whether a HEATING DEVICE provides HIGH or LOW HEAT TRANSFER from the heat source to the con
52 - Annex DD - Procedure for determining whether a HEATING DEVICE provides HIGH or LOW HEAT TRANSFER from the contact surface to the
53 - Annex EE -CONDITIONS OF ADEQUATE HEAT DISCHARGE

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.

Addition:This Particular Standard specifies requirements for BLANKETS, PADS, and MATTRESSES including air-flotation MATTRESSES and forced-air systems as defined in 2.2.102, 2.2.106 and 2.2.107.NOTE û In this Particular Standard they are referred to separately as BLANKETS, PADS, or MATTRESSES, but when referred to collectively the term HEATING DEVICE is used.HEATING DEVICES are intended for medical and paramedical use.

First published as AS/NZS 3200.2.35:1999.