Table of Contents
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AS/NZS 3200.2.35:1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-BLANKETS, PADS AND MATTRESSES INTENDED..
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PREFACE
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CONTENTS
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INTRODUCTION
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SECTION ONE GENERAL
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1 Scope and object
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2 Terminology and definitions
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3 General requirements
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5 Classification
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6 Identification, marking and documents
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SECTION TWO ENVIRONMENTAL CONDITIONS
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9 Removable protective means (not used)
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12 (not used)
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SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
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17 Separation
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19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
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SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS
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21 Mechanical strength
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SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
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36 Electromagnetic compatibility
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SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
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SECTION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
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42 Excessive temperatures
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44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
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46 Human errors
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49 Interruption of the power supply
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SECTION EIGHT ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
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50 Accuracy of operating data
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51 Protection against hazardous output
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SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
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52 Abnormal operation and fault conditions
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SECTION TEN CONSTRUCTIONAL REQUIREMENTS
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54 General
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56 Components and general assembly
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57 MAINS PARTS, components and layout
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59 Construction and layout
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Appendix L - References Publications mentioned in this standard
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Annex AA - Rationale to particular subclauses
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Annex BB - Determination of the lagging material
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Annex CC - Procedure for determining whether a HEATING DEVICE provides HIGH or LOW HEAT TRANSFER from the heat source to the con
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Annex DD - Procedure for determining whether a HEATING DEVICE provides HIGH or LOW HEAT TRANSFER from the contact surface to the
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Annex EE -CONDITIONS OF ADEQUATE HEAT DISCHARGE
Abstract
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.
Scope
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 รป 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.
General Product Information
Published
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Document Type
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Standard |
Status
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Current |
Publisher
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Standards Australia
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ProductNote
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Pending Revision indicates that as a result of the Aged Standards review process, the document needs updating. If no project proposal, meeting the quality criteria, is received within the 12 month timeframe, the document shall be withdrawn. |
Pages
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ISBN
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Committee
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HE-003 |
Supersedes
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