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    AS/NZS 3200.1.1:1995

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Approval and test specification - Medical electrical equipment General requirements for safety - Collateral Standard: Safety requirements for medical electrical systems

    Available format(s):  Hardcopy, PDF 1 User, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  30-03-2022

    Language(s): 

    Published date:  05-07-1995

    Publisher:  Standards Australia

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    Table of Contents - (Show below) - (Hide below)

    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 - (Show below) - (Hide below)

    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 - (Show below) - (Hide below)

    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 - (Show below) - (Hide below)

    Committee HE-003
    Document Type Standard
    Publisher Standards Australia
    Status Withdrawn
    Supersedes

    History - (Show below) - (Hide below)

    Amendment 1 to AS/NZS 3200.1.1:1995 see DR 96370 First published as AS/NZS 3200.1.1:1995.

    Standards Referenced By This Book - (Show below) - (Hide below)

    AS/NZS 3260:1993 Approval and test specification - Safety of information technology equipment including electrical business equipment
    AS/NZS 3250:1995 Approval and test specification - Mains operated electronic and related equipment for household and similar general use
    AS 1852.826-1983 International electrotechnical vocabulary - Electrical installations of buildings
    AS/NZS 3200.2.200:2005 Medical electrical equipment Particular requirements for safety - Oxygen concentrators for individual patient use

    Standards Referencing This Book - (Show below) - (Hide below)

    AS 3979-2006 Hydrotherapy pools (Reconfirmed 2018)
    AS/NZS 2500:1995 Guide to the safe use of electricity in patient care
    AS/NZS 3200.2.13:1999 Medical electrical equipment - Particular requirements for safety - Anaesthetic workstations
    AS/NZS 3200.2.2:1999 Medical electrical equipment - Particular requirements for safety - High frequency surgical equipment
    AS/NZS 3551:1996 Technical management programs for medical devices
    AS/NZS 60335.2.90:2006 Household and Similar Electrical Appliances - Safety Particular requirements for commercial microwave ovens
    AS/NZS 4173:2018 Safe use of lasers and intense light sources in health care
    AS/NZS 3200.2.5:2002 Medical electrical equipment Particular requirements for safety - Ultrasonic physiotherapy equipment (IEC 60601-2-5:2000, MOD)
    AS/NZS 60745.1:2009 Hand-held motor-operated electric tools-Safety General requirements (IEC 60745-1 Ed 4, MOD) (Reconfirmed 2020)
    AS/NZS 3200.2.18:1997 Approval and test specification - Medical electrical equipment Particular requirements for safety - Endoscopic equipment
    AS/NZS 3551:2004 Technical management programs for medical devices
    AS/NZS 3200.2.9:1997 Approval and test specification - Medical electrical equipment Particular requirements for safety - Patient contact dosemeters used in radiotherapy with electrically connected detectors
    AS/NZS 3200.1.0-1998 Medical electrical equipment General requirements for safety - Parent Standard
    AS/NZS 3003:2003 Electrical installations - Patient treatment areas of hospitals and medical, dental practices and dialyzing locations
    AS/NZS 3200.2.22:1997 Approval and test specification - Medical electrical equipment Particular requirements for safety - Diagnostic and therapeutic laser equipment
    AS/NZS 3200.1.2:2005 Medical electrical equipment General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
    AS/NZS 3200.1.8:2005 Medical electrical equipment General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
    AS/NZS 3200.2.40:1999 Medical electrical equipment Particular requirements for safety - Electromyographs and evoked response equipment
    AS/NZS 3200.2.33:2005 Medical electrical equipment Particular requirements for safety - Magnetic resonance equipment for medical diagnosis
    AS/NZS 60598.2.25:2001 Luminaires Particular requirements - Luminaires for use in clinical areas of hospitals and health care buildings (IEC 60598.2.25:1994, MOD) (Reconfirmed 2013)
    AS/NZS 3200.1.2:1995 Approval and test specification - Medical electrical equipment General requirements for safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests
    AS 4774.2-2002 Work in compressed air and hyperbaric facilities - Hyperbaric oxygen facilities
    AS 60118.14-2007 Hearing aids Specification of a digital interface device (Reconfirmed 2019)
    AS/NZS 3200.1.4:1997 Approval and test specification - Medical electrical equipment General requirements for safety - Collateral Standard: Programmable electrical medical systems
    AS/NZS 2500:2004 Guide to the safe use of electricity in patient care
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