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This is a list of projects currently being worked on by Standards Australia's Standards Development Team.
Project Code
Project Title
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Safe Use of Lasers and Intense Light Sources in Health Care
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Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
International Adoption - Identical
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Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
International Adoption - Identical
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Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
International Adoption - Identical
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Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
International Adoption - Identical
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Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
International Adoption - Identical
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Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance
International Adoption - Identical
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Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
International Adoption - Identical
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The constitution of a Technical Committee consists of the Nominating Organisations that represent various interest groups across the industries. These Nominating Organisations are currently participating in Standards Australia’s Standards Development activity. The Nominating Organisation appoints a representative to represent the views of that organisation’s interest group during the development of a Standard.
Australasian College of Physical Scientists and Engineers In Medicine
Australasian Society for Ultrasound in Medicine (ASUM)
Australian and New Zealand College of Anaesthetists
Australian Chamber of Commerce and Industry
Australian Dental Association
Australian Institute of Radiography
Australian Radiation Protection and Nuclear Safety Agency
Australian Society of Anaesthetists
Canterbury District Health Board
Certification Body Australia (Certification Interests Australia)
College of Biomedical Engineering Engineers Australia
Department of Defence (Australian Government)
Engineers Australia
For Information
Health Industry Suppliers Association of New Zealand
Medical Technology Association of Australia Ltd
MidCentral District Board
New Zealand Institute of Healthcare Engineering
Standards New Zealand
The Royal Australian and New Zealand College of Radiologists
Therapeutic Goods Administration
Wairarapa District Health Board
Waitemata District Health Board
Worksafe New Zealand
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Standards Australia participates in Standards development with the International standards bodies as listed below.
For further information on ISO relationships please visit ISO’s website www.iso.org
For further information on IEC relationships please visit IEC’s website www.iec.ch
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Common aspects of electrical equipment used in medical practice
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Diagnostic imaging equipment
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Electrical equipment in medical practice
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Below is the list of current Standards developed and published by Standards Australia. This list does not display the obsolete, superseded, available superseded and withdrawn Standards. The published Standards are documents that set out specifications and procedures designed to ensure products, services and systems are safe, reliable and consistently perform the way they are intended to.
Purchasing Standards
To purchase a Standard, please contact our publishing partner SAI Global
InfoStore.
Designation
Publication Title
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Radionuclide imaging devices - Characteristics and test conditions - Gamma camera based wholebody imaging systems
Specifies terminology and test methods for declaring the characteristics of gamma camera based wholebody imaging systems. This Standard is identical with and has been reproduced from IEC 61675-3:1998.
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Radionuclide imaging devices - Characteristics and test conditions - Positron emission tomographs
Specifies terminology and test methods for declaring the characteristics of positron emission tomographs. This Standard is identical with and has been reproduced from IEC 61675-1:1998.
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Radionuclide imaging devices - Characteristics and test conditions - Single photon emission computed tomographs
Specifies terminology and test methods for declaring the characteristics of Anger type rotational gamma camera single photon emission computed tomographs. This Standard is identical with and has been reproduced from IEC 61675-2:1998.
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Radiotherapy equipment - Coordinates, movements and scales
Defines a consistent set of coordinate systems for use throughout the process of teleradiotherapy, to enable equipment to be re-aligned with a previously treated site. The Standard is identical with and has been reproduced from IEC 1217:1996.
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Radiotherapy simulators - Functional performance characteristics
Provides guidance to manufacturers on the needs of the radiotherapist in respect to the performance of radiotherapy simulators and guidance to users wishing to check the manufacturer's declared performance characteristics, to carry out acceptance tests and to check periodically the performance throughout the life of the equipment. It is identical with, and reproduced from, IEC 1168:1993.
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Radiotherapy simulators - Guidelines for functional performance characteristics
Applies to radiotherapy simulators which use diagnostic X-ray equipment to simulate a radiotherapy radiation beam so that the treatment volume to be irradiated during radiotherapy can be located and the position and size of the therapeutic radiation field can be confirmed. It is identical with, and reproduced from, IEC 1170:1993.
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Evaluation and routine testing in medical imaging departments - Acceptance tests - Imaging performance of mammographic X-ray equipment
Specifies in-service testing procedures to ensure that the image quality of radiograms produced by mammographic X-ray equipment is maintained within required tolerances. This Standard includes an additional local Appendix ZZ, and is based on but not equivalent to and reproduced from IEC 1223-3-2:1996.
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Evaluation and routine testing in medical imaging departments - Constancy tests - Film processors
Applies to those components of medical X-ray equipment which process radiographic images both on film and by electronic means. It is identical with and reproduced from IEC 1223-2-1:1993.
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AS/NZS 4184.2.6-1995 AMDT 1
Evaluation and routine testing in medical imaging departments - Constancy tests - X-ray equipment for computed tomography
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Evaluation and routine testing in medical imaging departments - Constancy tests - X-ray equipment for computed tomography
Applies to those radiological installations with diagnostic X-ray equipment for computed tomography. It is one of a series of publications intended to assist in the establishment and operation of a quality assurance program in the diagnostic X-ray department. It is identical with and has been reproduced from IEC 1223-2-6:1994.
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Evaluation and routine testing in medical imaging departments - General aspects
Defines test methods to be carried out on equipment and subassemblies of X-ray imaging installations to assess the constancy of functional performance by means of test instrumentation and test devices that are simple to use. It is identical with and reproduced from IEC 1223-1:1993.
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Ultrasonics - Continuous-wave Doppler systems - Test procedures
Describes test methods for measuring the performance of continuous-wave ultrasonic Doppler flowmeters, velocimeters, or foetal heart detectors. It also describes special Doppler test objects for determining performance properties of Doppler ultrasonic systems. It is identical with and reproduced from IEC 1206:1993.
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Ultrasonics - Fields - Guidance for the measurement and characterization of ultrasonic fields generated by medical ultrasonic equipment using hydrophones in the frequency range 0.5 MHz to 15 MHz
Provides guidance on the practical measurement of the acoustic output of various types of medical ultrasonic equipment in the frequency range of 0.5 MHz to 15 MHz based on the use of hydrophones. It is identical with and reproduced from IEC 1220:1993.
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Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting
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Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting
Specifies a series of tests, and the terminology for reporting these tests, to be carried out by manufacturers, enabling them to declare the characteristics of Doppler foetal heartbeat detectors on a common basis, thus allowing the purchaser to compare the performance of various models and chose that one which is best suited to their requirements. This Standard is identical with and has been reproduced from IEC 1266:1994.
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Ultrasonics - Physiotherapy systems - Performance requirements and methods of measurement in the frequency range 0.5 MHz to 5 MHz
Specifies performance requirements for ultrasonic equipment designed for physiotherapy, consisteing of an ultrasonic transducer generating continuous or quasi-continuous wave ultrasonic energy in the frequency range 0.5 MHz and 5 MHz. It mofifies, and has been reproduced from, IEC 61689:1996 with variations for Australia and New Zealand included in a ZZ Appendix.
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Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
Specifies measureable parameters for the declaration of the acoustics output of extracorporeal lithotripsy equipment and methods of measurement and characterization of the pressure field generated by lithotripsy equipment. This Standard is identical with and has been reproduced from IEC 61846:1998.
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Ultrasonics - Pulsed Doppler diagnostic systems - Test procedures to determine performance
Describes test methods for measuring the performance of pulsed Doppler ultrasound systems, and applies to tests made on overall pulsed Doppler ultrasound system which is not disassembled or disconnected, and to tests made on pulsed Doppler ultrasound systems whether they are stand-alone or as part of another ultrasound instrument. Electrical safety, acoustic output and electromagnetic compatibility (EMC) are not covered in this technical specification. It is identical with and reproduced from IEC TS 61895:1999.
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Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
Specifies the essential non-thermal output characteristics of ultrasonic surgical units, methods of measurement of these output characteristics, those characteristics which should be declared by the manufacturers of such equipment. This Standard is identical with and has been reproduced from IEC 61847:1998.
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Ultrasound power measurement in liquids in the frquency range 0.5 MHz to 25 MHz
Specifies a method of determining the total radiated acoustic power of ultrasonic transducers being used to test the calibration of ultrasound physiotherapy equipment. This Standard is identical with and has been reproduced from IEC 61161:1992 and its first Amendment (1998).
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Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
International adoption identical
Adopts IEC 60601-2-22: 2012, which sets out requirements for the basic safety and essential performance of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for use on humans or animals, classified as a Class 3B or Class 4 laser product.
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Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
International adoption identical
Adopts IEC 60601-2-57:2011, which sets out requirements for the basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3000 nm, with the exception of laser radiation, intended to create non-visual photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications.
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AS/NZS IEC 60601.1.3:2015
Medical electrical equipment, Part 1.3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
International adoption identical
Adopts IEC 60601-1-3 Ed.2.1 to specify general requirements for protection against X-radiation in X-ray equipment, in order that the irradiation of the human patient, the operator, staff, and members of the public can be kept low as reasonably achievable, without jeopardizing the benefit of the radiological procedure. It considers radiation protection aspects related to X-radiation only. To be read in conjunction with AS/NZS IEC 60601.1:2015.
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AS/NZS IEC 60601.2.1:2015
Medical electrical equipment - Part 2.1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
International adoption identical
Adopts IEC60601-2-1Ed.3.1 to specify particular basic safety and essential performance requirements for electron accelerators in the range 1MeV to 50MeV and to specify tests to check compliance to those requirements. To be read in conjunction with AS/NZS IEC 60601.1:2015.
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AS/NZS IEC 60601.2.16:2015
Medical electrical equipment - Part 2.16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
International adoption identical
Adopts IEC 60601-2-16, Ed.4.0 to specify basic safety and essential performance requirements for haemodialysis, haemodiafiltration and haemofiltration equipment. It does not take into consideration the dialysis fluid control system of haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. To be read in conjunction with AS/NZSIEC60601.1:2015.
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Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
Establishes requirements for the declaration of the acoustic output of medical diagnostic equipment for the information of intending purchasers. This Standard is identical with and reproduced from IEC 1157:1993.
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Management programs for medical equipment
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Management programs for medical equipment
Specifies procedures required to develop equipment management programs for medical equipment. Includes procedures for procurement, acceptance, fault management, routine testing and disposal of medical equipment. Intended to cover all medical equipment, whether hospital property, privately owned, on loan or on trial, except for the commissioning requirements for permanently installed medical electrical equipment in cardiac and body-protected patient pre-treatment areas.
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Protective devices against diagnostic medical X-radiation - Determination of attenuation properties of materials
Specifies the methods of determining and indicating the attenuation properties of protective devices against X-radiation. This Standard is identical with and has been reproduced from IEC 61331-1:1994.
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Protective devices against diagnostic medical X-radiation - Protective clothing and protective devices for gonads
Provides requirements for the design and manufacture of clothing and devices for protection against X-radiation. This Standard is identical with and has been reproduced from IEC 61331-3:1998.
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Protective devices against diagnostic medical X-radiation - Protective glass plates
Specifies requirememnts for protective glass plates used for the manufacturing of protective devices against X-radiation. This Standard is identical with and has been reproduced from IEC 61331-2:1994.
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Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
Specifies methods for identifying the most important characteristics of diagnostic X-ray equipment and the relevant associated test methods, so that the characteristics can be stated in a standardized way to facilitate comparison between devices. This Standard is identical with and reproduced from IEC 1267:1994.
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Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Determination of the contrast ratio and veiling glare index
Applies to electro-optical X-ray image intensifiers for medical use, as components of diagnostic X-ray systems. It describes a method of determining the contrast ratio and veiling glare index of the intensifier. This Standard is identical with and has been reproduced from IEC 1262-6:1994.
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Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Determination of the conversion factor
Applies to electro-optical X-ray image intensifiers for medical use, as components of diagnostic X-ray systems. It describes a method of determining the conversion factor of the intensifier. This Standard is identical with and has been reproduced from IEC 1262-2:1994.
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Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Determination of the detective quantum efficiency
Applies to electro-optical X-ray image intensifiers for medical use, as components of diagnostic X-ray systems. It describes a method of determining the detective quantum efficiency of the intensifier. This Standard is identical with and has been reproduced from IEC 1262-5:1994.
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Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Determination of the entrance field size
Applies to electro-optical X-ray image intensifiers for medical use, as components of diagnostic X-ray systems. It describes a method of determining the entrance field size of the intensifier. This Standard is identical with and has been reproduced from IEC 1262-1:1994.
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Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Determination of the image distortion
Applies to electro-optical X-ray image intensifiers for medical use, as components of diagnostic X-ray systems. It describes a method of determining the image distortion of the intensifier. This Standard is identical with and has been reproduced from IEC 1262-4:1994.
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Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Determination of the luminance distribution and luminance non-uniformity
Applies to electro-optical X-ray image intensifiers for medical use, as components of diagnostic X-ray systems. It describes a method of determining the luminance distribution and luminance non-uniformity of the intensifier. This Standard is identical with and has been reproduced from IEC 1262-3:1994.
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Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Determination of the modulation transfer function
Describes a method of determining the modulation transfer functions of X-ray image intensifiers. It is identical with and has been reproduced from IEC 1262-7:1995.
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Medical electrical equipment - Digital imaging and communications in medicine (DICOM) - Radiotherapy objects
Defines a number of information objects applicable to the domain of radiation oncology to support the transfer of radiotherapy related data between devices within or outside of a radiotherapy department. It is identical with and has been reproduced from IEC 61852:1998.
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Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
Sets out performance requirements of radiotherapy dosimeters which measure air kerma, absorbed dose, or the corresponding rates, in photon and electron radiation. The Standard is technically equivalent to and is reproduced from IEC 60731:1997 and includes a ZZ Appendix with one variation for Australia and New Zealand.
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Medical electrical equipment - Fundamental aspects of safety Standards
Identifies fundamental considerations to be taken into account in developing Standards to ensure the safety of medical electrical equipment. It also provides a guide to the strategies and methodologies used in developing the IEC 601 and AS/NZS 3200 series of Standards. It is identical with and reproduced from IEC 513:1994.
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Medical electrical equipment - General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
Adopts IEC 60601-1-2:2004 to specify requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems.
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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
Adopts IEC 60601-1-8:2003 to specify requirements for alarm systems and alarm signals in medical electrical equipment and medical electrical systems. Also provides guidance for the application of alarm systems.
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Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
Specifies test procedures for the determination and disclosure of functional performance characteristics for electron accelerators to enable intending purchasers to compare performance of different models. It is identical with and has been reproduced from IEC 976:1989.
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Medical electrical equipment - Medical electron accelerators - Periodic function performance testing
Takes the performance figures obtained in the first part of this Standard and applies them to a continuing in-service testing regime. It is identical with and has been reproduced from IEC 977:1989.
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Guide to the safe use of electricity in patient care
Provides a guide to the safe use and application of electricity operated equipment used in health care. In addition to providing protection against electric shock to patients and staff, provision to safeguard against hazards such as thermal, radiant and mechanical, are also included. Measures required to provide and maintain patient and operator safety, including specification of the class of equipment and electrical installation to be employed for particular medical procedures, are also included.
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Guide to the safe use of infusion pumps and controllers
Provides advice on the safe use of infusion pumps, infusion controllers, syringe pumps and pumps for ambulatory use in hospitals and health care facilities.
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Guide to the safe use of lasers in health care
Provides guidance for the safe use of lasers and laser systems in diagnostic, cosmetic, therapeutic, medical and dental procedures in the treatment of humans.
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Conditioning equipment for the treatment of nocturnal enuresis (bedwetting)
Specifies requirements for the performance and safety of equipment for use in the conditioning treatment of nocturnal enuresis (bedwetting). It applies to both battery-powered and mains-powered equipment. This edition references AS 3200.1.0-1990. It has been re-written to clarify the issue of resetting equipment.
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AS/NZS 3551:2012 Amd 2:2016
Management programs for medical equipment
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Medical electrical equipment - Particular requirements for the safety of operating tables
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.
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Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance
Specifies methods for identifying the most important characteristics of radionuclide calibrators and the relevant associated test methods, so that the characteristics can be stated in a standardized way to facilitate comparison between devices. This Standard is identical with and reproduced from IEC 1303:1994.
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Approval and test specification - Medical electrical equipment - Particular requirements for safety - Direct blood-pressure monitoring equipment
Specifies medical electrical equipment, including transducers, used for monitoring and recording the internal blood-pressure of patients. This Standard is to be read in conjunction with AS 3200.1.0-1990. It is identical with and reproduced from IEC 601-2-34:1994.
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Approval and test specification - Medical electrical equipment - Particular requirements for safety - Extracorporeally induced lithotripsy
Specifies safety requirements for the design and manufacture of devices (lithotripters) intended to generate acoustic pulses from outside the human body for the purpose of fragmenting calculi ('stones') within the body. This Standard is to be read in conjunction with AS 3200.1.0-1990. It is identical with and reproduced from IEC 60601-2-36:1997.
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Approval and test specification - Medical electrical equipment - Particular requirements for safety - Infant apnoea monitors for domestic use
Specifies general requirements for the safety of infant apnoea monitoring equip ment, for domestic use. This Standard is to be read in conjunction with AS 3200.1.0-1990.
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Characteristics and test conditions of radionuclide imaging devices - Anger type gamma cameras
Specifies a series of tests, and the terminology for reporting these tests, to be carried out by manufacturers and which enables them to declare the characteristics of gamma cameras on a common basis, thus allowing purchasers to compare the performance of various models and choose that one which is best suited to their requirements. This Standard is identical with and has been reproduced from IEC 789:1992.
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Ophthalmic instruments - Fundamental requirements and test methods
Specifies requirements for non-invasive, active and non-active ophthalmic instruments.
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AS/NZS IEC 60601.2.28:2015
Medical electrical equipment - Part 2.28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
International adoption identical
Adopts IEC60601-2-28,Ed.2.0(2010) to specify particular basic safety and essential performance requirements for X-ray tube assemblies for medical diagnosis. To be read in conjunction with AS/NZSIEC60601.1:2015.
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AS/NZS IEC 60601.2.8:2015
Medical electrical equipment - Part 2.8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
International adoption identical
Adopts IEC60601-2-8,Ed.2.0(2010) to specify requirements for the safety of therapeutic X-ray equipment, including the accuracy and reproducibility of performance to the extent that these are related to radiation quality and the quantity of ionizing radiation produced. To be read in conjunction with AS/NZSIEC60601.1:2015.
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AS/NZS IEC 60601.2.29:2015
Medical electrical equipment - Part 2.29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
International adoption identical
Adopts IEC60601-2-29,Ed.3.0(2008) to specify particular basic safety and essential performance requirements for radiotherapy simulators. To be read in conjunction with AS/NZSIEC60601.1:2015.
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AS/NZS 4356.1:1996 Rec:2016
Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 1: Determination of the entrance field size
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AS/NZS 4356.2:1996 Rec:2016
Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 2: Determination of the conversion factor
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AS/NZS 4356.3:1996 Rec:2016
Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 3: Determination of the luminance distribution and luminance non-uniformity
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AS/NZS 4356.4:1996 Rec:2016
Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 4: Determination of the image distortion
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AS/NS 4356.5:1996 Rec:2016
Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 5: Determination of the detective quantum efficiency
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AS/NZS 4356.6:1996 Rec:2016
Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 6: Determination of the contrast ratio and veiling glare index
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AS/NZS 4356.7:1996 Rec:2016
Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 7: Determination of the modulation transfer function
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AS/NZS 4580:1999 Rec:2016
Medical electrical equipment - Digital imaging and communications in medicine (DICOM) - Radiotherapy objects
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Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts
Specifies a method of testing the laser resistance of the shaft of a tracheal tube.
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Medical electrical equipment - Particular requirements for safety - High voltage generators of diagnostic X-ray generators
Specifies particular requirements for the safety of high voltage X-ray generators. It is based on but not equivalent to and reproduced from IEC 60601-2-7:1998 with additional requirements for Australia and New Zealand provided in an appendix. 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.
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Medical electrical equipment - Particular requirements for safety - Infusion pumps and controllers
Provides particular requirements for the safety of infusion pumps, infusion controllers syringe pumps and pumps for ambulatory use. A thorough working knowlege of its parent Standard, AS/NZS 3200.1.0:1998, or a readily available copy, is necessary to deal with some of the technical issues raised. This Standard is technically equivalent to and has been reproduced from IEC 60601-2-24:1998. It includes an Appendix ZZ, of additional requirements specific to Australia and New Zealand.
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Medical electrical equipment - Particular requirements for safety - Microwave therapy equipment (IEC 60601-2-6:1984, MOD)
Adopts IEC 60601-2-6:1984 with national modifications to provide requirements for the safety of microwave therapy equipment used in medical practice. Does not apply to equipment specified for hyperthermia.
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Medical electrical equipment - Particular requirements for safety - Oxygen concentrators for individual patient use
Adopts ISO 8359:1996 to specify safety requirements for continuous-flow oxygen concentrators. Does not apply to oxygen concentrators intended to supply gas to several patients via a piped medical gas installation or to those intended for use in the presence of flammable anaesthetic and/or cleaning agents.
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Medical electrical equipment - Particular requirements for safety - Peritoneal dialysis equipment
Specifies requirements for the design and manufactrure of electrically safe peritoneal dialysis equipment. This Standard is identical with and reproduced from IEC 60601-2-39:1999.
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Medical electrical equipment - Particular requirements for safety - Surgical luminaires and luminaires for diagnosis
Specifies the requirements to be applied to surgical luminaires and luminaires for diagnosis. Does not apply to headlights, endoscopes, laparoscopes and their light sources, luminaires used in dentistry, luminaires for general purposes and luminaires of an emergency lighting. This Standard is to be read in conjunction with AS/NZS 3200.1.1:1998. It modifies, and has been reproduced from, IEC 60601-2-41:2000 with variations for Australia and New Zealand included in an Appendix.
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Medical electrical equipment - Particular requirements for safety - Transcutaneous partial pressure monitoring equipment
Specifies the particular requirements for the safety, including essential performances, of transcutaneaous partial pressure monitoring equipment, and applies to equipment used with adults, children and neonates, including their use in foetal monitoring during birth. It does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin. This Standartd is to be read in conjunction with AS/NZS 3200.1.0:1998. It is identical with, and reproduced from, IEC 60601-2-23:1999.
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Medical electrical equipment - Particular requirements for safety - Ultrasonic physiotherapy equipment
Specifies requirements for the safety of ultrasonic physiotherapy equipment used in medical practice. It modifies, and has been reproduced from, IEC 60601-2-5:2000 with variations for Australia and New Zealand included in a ZZ Appendix.
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AS/NZS IEC 60601.2.17:2015
Medical electrical equipment - Part 2.17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
International adoption identical
Adopts IEC60601-2-17,Ed.3.0(2013) to specify particular basic safety and essential performance requirements for automatically-controlled brachytherapy afterloading ME equipment. To be read in conjunction with AS/NZS60601.1:2015.
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AS/NZS IEC 60601.2.18:2015
Medical electrical equipment - Part 2.18: Particular requirements for the basic safety and essential performance of endoscopic equipment
International adoption identical
Adopts IEC60601-2-18,Ed.3.0 (2009) to specify particular basic safety and essential performance requirements for endoscopic equipment. To be read in conjunction with AS/NZSIEC60601.1:2015.
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AS/NZS IEC 60601.2.21:2015
Medical electrical equipment - Part 2.21: Particular requirements for the basic safety and essential performance of infant radiant warmers
International adoption identical
Adopts IEC60601-2-21,Ed.2.0(2009) to specify particular basic safety and essential performance requirements for endoscopic equipment. To be read in conjunction with AS/NZSIEC60601.1:2015.
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AS/NZS IEC 60601.2.31:2016
Medical electrical equipment - Part 2.31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
International adoption identical
Adopts IEC60601-2-31,Ed.2.1(2011) to specify particular basic safety and essential performance requirements for external pacemakers. To be read in conjunction with AS/NZSIEC60601.1:2015.
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
International adoption identical
Adopts IEC 60601-1, Ed.3.1 to specify general requirements for basic safety and essential performance of medical electrical equipment and medical electrical systems.
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AS/NZS IEC 60601.2.2:2016
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
International adoption identical
Adopts IEC 60601-2-2, Ed.5.0 (2009) to establish particular basic safety and essential performance requirements for medical electrical equipment, including associated accessories intended for the performance of surgical operations, such as, the cutting or coagulation of biological tissues by means of high frequency currents. To be read in conjunction with AS/NZS IEC 60601.1:2015.
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AS/NZS IEC 60601.2.27:2016
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
International adoption identical
Adopts IEC 60601-2-27, Ed.3.0 (2011) to establish particular requirements for basic safety and essential performance of electrocardiographic (ECG) monitoring equipment. To be read in conjunction with AS/NZSIEC60601.1:2015.
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AS/NZS IEC 60601.2.45:2015
Medical electrical equipment - Part 2.45: Particular requirements for basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
International adoption identical
Adopts IEC 60601-2-45, Ed.3.1 (2015) to specify basic safety and essential performance requirements for mammographic X-ray equipment, including equipment for mammographic tomosynthesis, and mammographic stereotactic devices. To be used in conjunction with AS/NZS IEC 60601.1:2015.
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Approval and test specification - Beauty therapy equipment
Prescribes the safety requirements for certain types of beauty therapy equipment powered by mains supply or batteries.
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Approval and test specification - Medical electrical equipment - Particular requirements for safety - Electrocardiographs
Specifies the particular safety requirements for electrocardiographs intended for the production of detachable electrocardiographs for diagnostic purposes. It also applies to vector-cardiographs and equipment for stress testing. This Standard is to be read in conjunction with AS 3200.1.0-1990, and is technically equivalent to IEC 601-2-25:1993.
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Approval and test specification - Medical electrical equipment - General requirements for safety - Collateral Standard: Programmable electrical medical systems
Specifies requirements for the process by which a programmable electrical medical system is designed. This Standard is supplementary to AS 3200.1.0-1990, and is identical with and reproduced from IEC 60601-1-4:1996.
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AS/NZS 3200.1.1-1995 AMDT 1
Approval and test specification - Medical electrical equipment - General requirements for safety - Collateral Standard: Safety requirements for medical electrical systems
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Approval and test specification - Medical electrical equipment - General requirements for safety - Collateral Standard: Safety requirements for medical electrical systems
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.
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Approval and test specification - Medical electrical equipment - Particular requirements for safety - Associated equipment of X-ray equipment
Applies to equipment and devices associated with X-ray equipment for supporting and positioning the functional components used for the application of the X-radiation. This Standard is to be read in conjunction with AS 3200.1.0-1990. It is identical with and reproduced from IEC 601-2-32:1994.
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Approval and test specification - Medical electrical equipment - Particular requirements for safety - Capacitor discharge X-ray generators
Applies to capacitor discharge X-ray generators operating in intermittent mode for medical radiography, in which the electrical energy for loading of the X-ray tube is completely or mainly capacitively stored at, and switched in, the high voltage circuit. This Standard is to be read in conjunction with AS 3200.1.0-1990. It is identical with and reproduced from IEC 601-2-15:1988.
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Electrical, thermal and loading characteristics of rotating anode X-ray tubes for medical diagnosis
Defines the most common operating characteristics of rotating anode X-ray tubes, during and after energization, to facilitate comparison between these devices. Identical with and has been reproduced from IEC 613:1989.
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Graphic symbols for use on medical electrical equipment
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Graphic symbols for use on medical electrical equipment
Provides the only readily available and comprehensive listing of symbols for use on medical electrical equipment for both safety and identification purposes. This Standard is identical with and has been reproduced from BS 7139:1989.
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X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
Describes measuring methods and requirements for test arrangements to be applied to the focal spots in diagnostic X-ray tube assemblies for medical use. This Standard is identical with and has been reproduced from IEC 336:1993.
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Guidelines for radiotherapy treatment rooms design
Applies to those aspects of a radiotherapy installation which ensure the safety of the patient, the equipment operator and other persons present during the period in which the equipment is in use. General construction requirements are not addressed. This Standard is identical with and has been reproduced from IEC 61859:1997.
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Medical electrical equipment - Particular requirements for safety - Anaesthetic systems
Adopts IEC 60601-2-13:2003 to provide safety and essential requirements for an anaesthetic system as well as individual devices designed for use in an anaesthetic system. Does not apply to anaesthetic systems intended for use with flammable anaesthetic agents, portable anaesthetic systems for use in remote sites, open fields for rescue operations or in disaster areas, or to dental analgesia apparatus.
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Medical electrical equipment - Particular requirements for safety - Automatic cycling non-invasive blood pressure monitoring equipment
Specifies the particular requirements for the safety, including essential performances, of automatic cycling non-invasive blood pressure monitoring equipment, which may be attended or unattended. It does not apply to blood pressure measuring equipment which uses finger transducers or to semi-automatic blood pressure measuring equipment, typically in which each determination needs to be initiated manually. This Standard is to be read in conjunction with AS/NZS 3200.1.0:1998. It modifies and has been reproduced from IEC 60601-2-30:1999 with variations for Australia and New Zealand included in Appendix ZZ.
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Medical electrical equipment - Particular requirements for safety - Blankets, pads and mattresses intended for heating in medical use
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.
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Medical electrical equipment - Particular requirements for safety - Cardiac defibrillators
Adopts IEC 60601-2-4:2005 to specify requirements for the safety of cardiac defibrillators. Does not apply to implantable defibrillators, remote control defibrillators, external transcutaneous pacemakers, or separate stand alone cardiac monitors. Cardiac monitors which use separate ECG monitoring electrodes are not within the scope of the Standard unless they are used as the sole basis for AED rhythm recognition detection or beat detection for synchronized cardioversion.
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Medical electrical equipment - Particular requirements for safety - Dento-maxillofacial X-ray equipment
Specifies requirements for the design and manufacture of dento-maxillofacial X-ray equipment. It is a locally developed Standard, that follows the style and technical prerequisites of IEC 60601-1. It refers to AS/NZS 3200.1.0, the local version of IEC 60601-1, and should be read in conjunction with AS 3200.1.0.
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Medical electrical equipment - Particular requirements for safety - Electrically and manually operated medical beds for adult use (IEC 60601-2-38, Ed.1.0(1996) MOD)
Adopts IEC 60601-2-38 with national modifications to specify requirements for the design, manufacture and safety of electrically operated and manually operated medical beds for adult use in a full range of environments.
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Medical electrical equipment - Particular requirements for safety - Electroencephalographs
Adopts IEC 60601-2-26:2002 to specify requirements for electroencephalographs. The Standard does not cover the special requirements for other equipment also used in electroencephalography.
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Medical electrical equipment - Particular requirements for safety - Electromyographs and evoked response equipment
Specifies safety requirements for the design and manufacture of electromyographs and evoked response equipment. It is identical with and has been reproduced from IEC 60601-2-40:1998. This Standard refers extensively to its Parent Standard, AS/NZS 3200.1.0. An available copy of AS/NZS 3200.1.0 is essential to the meaningful interpretation of this Part.
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Medical electrical equipment - Particular requirements for safety - Gamma beam therapy equipment
Specifies requirements for the safety of gamma beam therapy equipment used in medical practices on human patients. This Standard is identical with and has been reproduced from IEC 60601-2-11:1997. This Standard refers extensively to its Parent Standard, AS/NZS 3200.1.0. An available copy of AS/NZS 3200.1.0 is essential to the meaningful interpretation of this Part.
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AS/NZS IEC 60601.2.25:2016
Medical electrical equipment - Part 2.25: Particular requirements for the basic safety and essential performance of electrocardiographs
International adoption identical
Adopts IEC 60601-2-25, Ed. 2.0 (2011), which applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes.
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Medical electrical equipment, Part 1.8: General requirements for basic safety and essential performance--Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equ
International adoption identical
Adopts IEC 60601-1-8 to specify basic safety and essential performance requirements and tests for alarm systems in medical equipment (ME) and ME systems and to provide guidance for their application.
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Medical electrical equipment, Part 1.6: General requirements for basic safety and essential performance--Collateral standard: Usability
International adoption identical
Adopts IEC 60601-1-6 to specify a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical equipment (ME).
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Medical electrical equipment, Part 1.2: General requirements for basic safety and essential performance--Collateral standard: Electromagnetic compatibility--Requirements and tests
International adoption identical
The objective of this Standard is to specify general requirements and tests for the basic safety and essential performance of medical equipment (ME) and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by ME equipment and systems.
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Medical electrical equipment, Part 1.9: General requirements for basic safety and essential performance--Collateral Standard: Requirements for environmentally conscious design
International adoption identical
The objective of this Standard is to improve the environmental impact for the entire range of medical equipment (ME), taking into account all stages of the product life cycle: product specification, design, manufacturing, sales, logistics, installation, use and end of life management.
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Medical electrical equipment, Part 1.10: General requirements for basic safety and essential performance--Collateral Standard: Requirements for the development of physiologic closed-loop controllers
International adoption identical
The objective of this Standard is to improve the environmental impact for the entire range of medical equipment (ME), taking into account all stages of the product life cycle: product specification, design, manufacturing, sales, logistics, installation, use and end of life management.
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Medical electrical equipment, Part 1.11: General requirements for basic safety and essential performance--Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used
International adoption identical
The objective of this Standard is to specify requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller (PCLC) as part of a physiologic closed-loop control system (PCLCS) in medical electrical (ME) equipment and ME systems to control a physiologic variable.
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Medical electrical equipment, Part 1.12: General requirements for basic safety and essential performance--Collateral Standard: Requirements for medical electrical equipment and medical electrical systems inten
International adoption identical
The objective of this Standard is to specify requirements for the basic safety and essential performance of medical electrical (ME) equipment and ME systems for use in the home healthcare environment. It applies regardless of whether the ME equipment or ME system is intended for use by a lay operator or by trained healthcare personnel.
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The Sub Committees within the Technical Committee are listed here.
HE-003-01 General Safety Requirements
HE-003-02 High Frequency Equipment
HE-003-03 Medical Ultrasound
HE-003-04 Drug Infusion Pumps
HE-003-05 Incubators and other Infant Care Units
HE-003-06 Infant Apnoea Monitors
HE-003-07 Patient Monitoring Equipment, Electrocon
HE-003-08 Dialysis Equipment
HE-003-09 Safe Use of Electricity in Patient Care
HE-003-10 Enuresis Alarms
HE-003-11 Beauty Therapy Equipment
HE-003-12 Lasers in Medical Procedures
HE-003-15 Radiotherapy Equipment