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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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Medical electrical equipment, Part 2.19: Particular requirements for the basic safety and essential performance of infant incubators
International Adoption - Modified
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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 - Modified
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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 - Modified
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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 - Modified
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Medical electrical equipment, Part 2.5: Particular requirements for the basic safety and essential performance
International Adoption - Modified
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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 - Modified
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Guide to the safe use of electricity in patient care
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Medical electrical equipment, Part 2.4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
International Adoption - Modified
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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.
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Australasian College of Physical Scientists and Engineers In Medicine
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Australasian Society for Ultrasound in Medicine (ASUM)
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Australian and New Zealand College of Anaesthetists
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Australian Chamber of Commerce and Industry
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Australian Dental Association
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Australian Institute of Radiography
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Australian Radiation Protection and Nuclear Safety Agency
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Australian Society of Anaesthetists
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Canterbury District Health Board
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Certification Body Australia (Certification Interests Australia)
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College of Biomedical Engineering Engineers Australia
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Department of Defence (Australian Government)
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Department of Health (Australian Government)
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Engineers Australia
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For Information
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Independent Chairperson (Australia)
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Medical Technology Association of Australia Ltd
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Medical Technology Association of New Zealand
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MidCentral District Board
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Standards New Zealand
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The Royal Australian and New Zealand College of Radiologists
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Therapeutic Goods Administration
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Wairarapa District Health Board
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Waitemata District Health Board
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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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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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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 1.6: 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 1.8: 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 1.9: 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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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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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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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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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: 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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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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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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AS/NZS 3551:2012 Amd 2:2016
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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Management programs for medical equipment
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Safe Use of Lasers and Intense Light Sources in Health Care
Specifies requirements for the safe use of lasers and laser systems as well as intense light sources in the treatment of humans for diagnostic, cosmetic, therapeutic, medical and dental uses in health care facilities, including hospitals, private medical facilities and dental practices, and the cosmetic industry.
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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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Graphic symbols for use on medical electrical equipment
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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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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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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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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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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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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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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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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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AS/NZS 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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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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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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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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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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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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Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting
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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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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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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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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 60601.2.1:2015
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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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 60601.2.2:2016
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 60601.2.21:2015
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 60601.2.25:2016
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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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 60601.2.28:2015
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 60601.2.29:2015
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 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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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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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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The Sub Committees within the Technical Committee are listed here.
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HE-003-01 General Safety Requirements
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HE-003-02 High Frequency Equipment
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HE-003-03 Medical Ultrasound
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HE-003-04 Drug Infusion Pumps
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HE-003-05 Incubators and other Infant Care Units
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HE-003-06 Infant Apnoea Monitors
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HE-003-07 Patient Monitoring Equipment, Electrocon
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HE-003-08 Dialysis Equipment
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HE-003-09 Safe Use of Electricity in Patient Care
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HE-003-10 Enuresis Alarms
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HE-003-11 Beauty Therapy Equipment
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HE-003-12 Lasers in Medical Procedures
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HE-003-15 Radiotherapy Equipment