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    AS/NZS 3200.1.2:1995

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    Approval and test specification - Medical electrical equipment General requirements for safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests

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

    Superseded date:  30-06-2017

    Language(s):  English

    Published date:  05-10-1995

    Publisher:  Standards Australia

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

    1 - AS/NZS 3200.1.2:1995 APPROVAL AND TEST SPECIFICATION-MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY-COLLATERAL..
    4 - PREFACE
    6 - CONTENTS
    7 - SECTION 1: GENERAL
    7 - 1 Scope and object
    7 - 1.201 Scope
    7 - 1.202 Object
    7 - 2 Terminology and definitions
    7 - 2.201 LIFE SUPPORTING EQUIPMENT and/or SYSTEM
    7 - 2.202 PATIENT COUPLED EQUIPMENT and/or SYSTEM
    7 - 2.203 EMC Definitions from IEC 50(161)
    7 - 2.203.1 ELECTROMAGNETIC ENVIRONMENT
    7 - 2.203.2 ELECTROMAGNETIC NOISE
    8 - *2.203.3 ELECTROMAGNETIC DISTURBANCE
    8 - 2.203.4 ELECTROMAGNETIC COMPATIBILITY: EMC
    8 - 2.203.5 (ELECTROMAGNETIC) EMISSION
    8 - 2.203.6 DEGRADATION (of performance)
    8 - 2.203.7 IMMUNITY (to a disturbance)
    8 - 2.203.8 (ELECTROMAGNETIC) SUSCEPTIBILITY
    8 - 2.203.9 ELECTROSTATIC DISCHARGE: ESD (abbreviation)
    8 - 2.203.10 TRANSIENT (adjective and noun)
    8 - 2.203.11 PULSE
    9 - 2.203.12 BURST (of PULSES or oscillations)
    9 - 2.203.13 CLICK
    9 - *2.203.14 CLICK RATE
    9 - 2.203.15 INFORMATION TECHNOLOGY EQUIPMENT: ITE (abbreviation)
    9 - 2.203.16 VOLTAGE CHANGE
    9 - *2.203.17 VOLTAGE FLUCTUATION
    9 - 2.203.18 VOLTAGE DIP
    9 - 2.203.19 VOLTAGE SURGE
    10 - 2.204 Definition from IEC 601-1-1: Safety requirements for medical electrical systems
    10 - 2.204.1 MEDICAL ELECTRICAL SYSTEM (hereinafter referred to as: SYSTEM)
    10 - 6 Identification, marking and documents
    10 - 6.1.201 Marking on the outside of EQUIPMENT or EQUIPMENT parts
    10 - 6.8.201 ACCOMPANYING DOCUMENTS
    10 - SECTIONS 2 to 4: Not used
    10 - SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
    10 - 36 Electromagnetic compatibility
    10 - 36.201 EMISSIONS
    10 - 36.201.1 Radio frequency (RF) EMISSIONS
    11 - 36.201.2 Low frequency EMISSIONS
    12 - 36.202 IMMUNITY
    12 - *36.202.1 ELECTROSTATIC DISCHARGE
    12 - 36.202.2 Radiated radio-frequency electromagnetic fields
    13 - 36.202.3 TRANSIENTS
    13 - *36.202.4 VOLTAGE DIPS, short interruptions and voltage variations on power supply input lines
    13 - *36.202.5 Conducted disturbances, induced by radio-frequency fields above 9 kHz
    13 - *36.202.6 Magnetic fields
    13 - SECTIONS 6 to 10: Not used
    14 - ANNEX AAA - General guidance and rationale
    17 - Annex BBB - Normative references
    18 - INDEX OF DEFINED TERMS

    Abstract - (Show below) - (Hide below)

    Applies only to medical electrical equipment, medical electrical systems and information technology equipment used in medical electrical applications which is, or may be, susceptible to electromagnetic interference. This Standard is supplementary to AS 3200.1.0-1990, and is identical with and has been reproduced from IEC 60601-1-2:1993.

    Scope - (Show below) - (Hide below)

    This standard applies only to MEDICAL ELECTRICAL EQUIPMENT, MEDICAL ELECTRICAL SYSTEMS, INFORMATION TECHNOLOGY EQUIPMENT used in medical electrical application, and all other equipment forming part of MEDICAL ELECTRICAL SYSTEMS, hereinafterreferred to as EQUIPMENT and/or SYSTEM(S).

    General Product Information - (Show below) - (Hide below)

    Committee HE-003
    Document Type Standard
    Publisher Standards Australia
    Status Superseded
    Superseded By
    Supersedes
    Under Revision

    History - (Show below) - (Hide below)

    First published as AS/NZS 3200.1.2:1995.

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

    AS/NZS 1044:1995 Limits and methods of measurement of radio disturbance characteristics of electrical motor-operated and thermal appliances for household and similar purposes, electric tools and similar electric apparatus
    AS/NZS 2064.1:1992 Limits and methods of measurement of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio-frequency equipment General requirements
    AS/NZS 3200.1.1:1995 Approval and test specification - Medical electrical equipment General requirements for safety - Collateral Standard: Safety requirements for medical electrical systems

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

    AS/NZS 3200.2.13:1999 Medical electrical equipment - Particular requirements for safety - Anaesthetic workstations
    AS/NZS 3200.2.31:1996 Medical electrical equipment - Particular requirements for safety - External cardiac pacemakers with internal power source
    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 3200.2.200:2005 Medical electrical equipment Particular requirements for safety - Oxygen concentrators for individual patient use
    AS 3811-1998 Hard-wired patient alarm systems
    AS/NZS 3200.2.16:1999 Medical electrical equipment Particular requirements for safety - Haemodialysis, haemodiafiltration and haemofiltration 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 3200.2.40:1999 Medical electrical equipment Particular requirements for safety - Electromyographs and evoked response equipment
    AS/NZS 3200.2.33:1996 Approval and test specification - Medical electrical equipment Particular requirements for safety - Magnetic resonance equipment for medical diagnosis
    AS/NZS 3824:1998 Guidelines for radiotherapy treatment rooms design
    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 4774.2-2002 Work in compressed air and hyperbaric facilities - Hyperbaric oxygen facilities
    AS/NZS 3200.2.36:1998 Approval and test specification - Medical electrical equipment Particular requirements for safety - Extracorporeally induced lithotripsy
    AS/NZS 3200.2.38:1997 Approval and test specification - Medical electrical equipment Particular requirements for safety - Electrically operated hospital beds
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