Table of Contents

1 -  AS/NZS 3200.1.1:1995 APPROVAL AND TEST SPECIFICATION-MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY-COLLATERAL..
4 -  PREFACE
6 -  CONTENTS
9 -  SECTION 1: GENERAL
9 -  1 Scope and object
9 -  *1201 Scope
9 -  2 Terminology and definitions
9 -  2.201 COUPLING:
9 -  2.202 INDIRECT CONTACT:
9 -  *2.203 MEDICAL ELECTRICAL SYSTEM
9 -  *2.204 PATIENT ENVI RONMENT:
9 -  2.205 SEPARATION DEVICE:
10 -  *2.206 MULTIPLE PORTABLE SOCKET-OUTLET
10 -  3 General requirements
10 -  3.201 General requirements for the SYSTEM
10 -  4 General requirements for tests
10 -  *4.201 General requirements for tests for the SYSTEM
11 -  6 Identification, marking and documents
11 -  6.1.201 Marking
11 -  *6.8.201 Accompanying documents
11 -  SECTION 2: ENVIRONMENTAL CONDITIONS
11 -  SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
11 -  16 ENCLOSURES and PROTECTIVE COVERS
11 -  16.201 ENCLOSURES
12 -  17 Separation
12 -  *17.201 Electrical separation
13 -  19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
13 -  *19.201 LEAKAGE CURRENTS
13 -  19.201.1 ENCLOSURE LEAKAGE CURRENT
13 -  19.201.2 PATIENT LEAKAGE CURRENT
13 -  19.201.3 Connection of SIGNAL INPUT PARTS or SIGNAL OUTPUT PARTS
13 -  SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
13 -  22 Moving parts
13 -  22.7. 201 Protecti ve means
14 -  SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
14 -  SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
14 -  SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
14 -  *43.201 Fire prevent
14 -  44.7. 201 Cleaning, sterilizat ion and disinfection
14 -  *49.201 Interruption of the power supply
14 -  SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
14 -  SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
14 -  SECTION 10: CONSTRUCTIONAL REQUIREMENTS
14 -  56.3.201 Connections
15 -  57.2 MAINS CONNECTORS, APPLIANCE INLETS and the like
15 -  *57.2.201 MULTIPLE PORTABLE SOCKET-OUTLET
15 -  57.10 CREEPAGE DISTANCES AND AIR CLEARANCES
15 -  57.10.201 SEPARATION DEVICE
15 -  *58.201 PROTECTIVE EARTH CONDUCTOR
15 -  59.201 Protection of wiring
17 -  Annex AAA - General guidance and rationale
22 -  Annex BBB - Examples of combinations of MEDICAL ELECTRICAL EQUIPMENT and non-medical electrical equipment
22 -  BBB.1 Introduction
22 -  BBB.2 Localities in a medical environment
22 -  BBB.3 Basic principles
23 -  BBB.4 Assumptions on EQUIPMENT
23 -  BBB.5 Equipment codes
23 -  BBB.6 Codes assi gned to feasible solutions
25 -  BBB.7 Summary of situations
27 -  Annex CCC - Normative references
28 -  Annex DDD - Bibliography
29 -  Annex EEE - Requirements for MULTIPLE PORTABLE SOCKET-OUTLETS
29 -  EEE.1 MULTIPLE PORTABLE SOCKET-OUTLETS with separating transformers
29 -  EEE.2 MULTIPLE PORTABLE SOCKET-OUTLETS without separating transformers
31 -  Annex FFF - Examples of application of MULTIPLE PORTABLE SOCKET-OUTLETS
33 -  APPENDIX ZZ - VARIATIONS TO THIS STANDARD APPLICABLE IN AUSTRALIA AND NEW ZEALAND

Abstract

Applies to the safety of medical electrical systems. It describes the safety requirements for these systems necessary to provide protection to the patient and operator. This Standard is supplementary to AS 3200.1.0-1990, and is identical with and has been reproduced from IEC 60601-1-1:1992.

Scope

This standard applies to the safety of MEDICAL ELECTRICAL SYSTEMS, as defined in 2.203. It describes the safety requirements necessary to provide protection for the PATIENT, the OPERATOR and surroundings.
NOTE - It is presumed that the party assembling or modifying the MEDICA L ELECTRIC AL SYSTEMS will take the necessary steps to assure compliance with this standard.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
Pages
ISBN
Committee	HE-003
Supersedes	DR 94303