AS/NZS 3200.2.46:2003

Table of Contents

1 -  AS/NZS 3200.2.46:2003 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF OPERATING TABLES
4 -  PREFACE
5 -  CONTENTS
7 -  INTRODUCTION
9 -  Section one – General
9 -  1 Scope and object
10 -  2 Terminology and definitions
11 -  4 General requirements for tests
11 -  5 Classification
11 -  6 Identification, marking and documents
12 -  Section two – Environmental conditions
12 -  Section three – Protection against electric shock hazards
12 -  17 Separation
12 -  18 Protective earthing, functional earthing and potential equalization
13 -  19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
13 -  20 Dielectric strength
13 -  Section four – Protection against mechanical hazards
13 -  21 Mechanical strength
14 -  22 Moving parts
14 -  24 Stability in NORMAL USE
15 -  Section five – Protection against hazards from unwanted or excessive radiation
15 -  29 X-Radiation
15 -  36 Electromagnetic compatibility
16 -  Section six – Protection against hazards of ignition or flammable anaesthetic mixtures
16 -  39 Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT
16 -  Section seven – Protection against excessive temperatures and other safety hazards
16 -  44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
16 -  49 Interruption of the power supply
17 -  Section eight – Accuracy of operating data and protection against hazardous output
17 -  50 Accuracy of operating data
17 -  Section nine – Abnormal operation and fault conditions; environmental tests
17 -  Section ten – Constructional requirements
17 -  56 Components and general assembly
20 -  Annexes
21 -  Annex AA - General guidance and rationale to clause 5: Classification of OPERATING TABLES with regard to their...

Abstract

Specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the table top to or from the base or pedestal of an operating table with detachable table top.

Scope

This clause of the General Standard applies, except as follows:
1.1 Scope
Addition:
This Particular Standard specifies safety requirements for OPERATING TABLES, as defined in
2.12.101, whether or not having electrical parts, including TRANSPORTERS, as defined in 2.12.104, used for the transportation of the table top to or from the base or pedestal of an OPERATING TABLE with detachable table top.
This Particular Standard does not apply to
– dental patient chairs;
– examination chairs and couches;
– patient-supporting systems of diagnostic and therapeutic devices;
– operating table heating blankets;
– patient transfer equipment;
– delivery tables and beds;
– hospital beds;
– field tables.
1.3 Particular Standards
Addition:
This Particular Standard refers to IEC 60601-1 (1988 ): Medical electrical equipment – Part 1:
General requirements for safety as amended by its amendments 1 (1991) and 2 (1995).
For brevity, part 1 is referred to in this Particular Standard either as the "General Standard" or as the "General Requirements(s)".
The numbering of sections, clauses and subclauses of this Particular Standard corresponds to that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words.
"Replacement" means that the clause or subclause of the General Standard is replaced completely by the text of this Particular Standard.
"Addition" means that the text of this Particular Standard is additional to the requirements of
the General Standard.
"Amendment" means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
The term "this Standard" is used to make reference to the General Standard and this Particular Standard taken together.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard, although possibly not relevant, applies
without modification; where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard.
The requirements of this Particular Standard take priority over those of the General Standard.
An asterisk (*) beside a clause or subclause number indicates that some explanatory notes are
given in the "General guidance and rationale" section at the end of this Particular Standard.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
ProductNote	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
ISBN
Committee	HE-003
Supersedes	DR 03169 CP