AS/NZS 2500:2020
Safe use of medical electrical equipment in health care
Standard sets out guidelines for the safe use of electrical medical equipment in patient care. The major changes in this edition are as follows: The removal of all appendices. Inclusion of Clauses 3.8 to 3.11. Alignment of this Standard with the requirement in AS/NZS 3003 that all patient areas be at least body-protected. Alignment of this Standard with the requirement of AS/NZS 3003 for socket-outlets to be colour coded in order to distinguish between essential, non-essential, UPS, and cleaners’ socket-outlets. Recommendations for medical electrical systems and upgrading of mobile communications. Upgrading of defibrillator recommendations.
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AS/NZS 2500:2020 Safe use of medical electrical equipment in health care
Preface
Introduction
Section 1 Scope and general
1.1 Scope
1.2 Application
1.2.1 Setting
1.2.2 Personnel
1.3 Normative references
1.4 Terms and definitions
Section 2 Nature of electricity
2.1 Need for care
2.2 Supply systems
2.3 Function of fuses and circuit-breakers
2.4 Socket-outlets
2.4.1 General
2.4.2 Colour coding of socket-outlets
2.5 Basic equipment safety
2.5.1 Forms of construction
2.5.2 Classification of applied parts
2.6 Leakage current
Section 3 Nature of hazards
3.1 General
3.2 Electric shock
3.2.1 Causes of electric shock
3.2.2 Contributing factors
3.2.3 Levels of susceptibility to electric shock
3.3 Thermal hazards
3.3.1 General
3.3.2 Electric burns
3.3.3 Thermal burns
3.3.4 Temperature of infused fluids
3.3.5 Fire and explosion
3.4 Radiant energy hazards
3.4.1 General
3.4.2 Ultrasonic energy
3.4.3 Laser and intense light sources
3.5 Electromagnetic interference
3.6 Electrostatic hazards
3.7 Loss of electrical power
3.8 Software hazards
3.8.1 General
3.8.2 Cybersecurity threats
3.8.3 Software updates
3.9 Equipment configuration
3.10 Alarm management
3.11 Data integration
3.12 Impact of repairs
Section 4 Compatibility of medical procedure, equipment and patient areas
4.1 Safety triangle
4.2 Medical procedures
4.2.1 General
4.2.2 Inadvertent contact with live conductors
4.2.3 Body-type procedure — Applied parts not involving the heart
4.2.4 Cardiac-type procedure — Applied parts involving the heart
4.3 Safe electrical environment
4.3.1 Protection levels
4.3.2 Components of protective wiring system
4.3.3 Use of socket-outlets in cardiac-protected patient areas
4.4 Applied parts of medical electrical equipment
4.4.1 Classification
4.4.2 Protection under fault conditions
4.5 Safe use of medical electrical equipment
4.6 Temporary arrangements for cardiac-type procedures
4.7 Home care medical procedures
4.8 Home care medical equipment – NZ only
Section 5 Administration
5.1 Policies and procedures
5.2 Recognition and location of electrically susceptible patients
5.2.1 General
5.2.2 Design of patient areas
5.3 Training
5.4 Documentation
5.5 Medical electrical equipment
5.5.1 Procurement of equipment
5.5.2 Equipment used but not owned by the responsible organization
5.5.3 Operator instructions
5.5.4 Life-supporting equipment
5.5.5 Mains power supply failure
5.5.6 Back-up equipment
5.6 Maintenance of medical electrical equipment and patient areas
5.6.1 Equipment maintenance
5.6.2 Maintenance of electrical systems of patient areas
5.6.3 Clinical impact of maintenance of distribution equipment and switchboards
5.7 Modification of medical electrical equipment
5.7.1 Australia
5.7.2 New Zealand
5.8 Non-medical electrical equipment
5.8.1 General
5.8.2 Cleaning equipment
5.8.3 Entertainment equipment
5.8.4 Patient-comfort equipment
5.8.5 Patient-supplied equipment
5.8.6 Mobile communications
5.9 Medical equipment malfunction or failure
5.9.1 General
5.9.2 Fault tags
5.9.3 Adverse event reporting
5.9.4 Repair of equipment
Section 6 General use practices
6.1 General
6.2 User observation and checks before use
6.3 Precautions to be observed during use
6.4 User precautions/practices to be observed after use
6.5 Additional precautions to be observed in the use of high-energy apparatus
6.6 Flexible cords and plugs
6.6.1 Inspections
6.6.2 Faulty cords and plugs
6.7 Double adaptors and extension cords
6.8 Medical equipment systems
6.9 Protective devices in patient areas
6.9.1 Introduction
6.9.2 RCD-protected supply
6.9.3 Isolated supply
6.10 Re-use of accessories labelled for “single use only”
Bibliography
Previous versions
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AS/NZS 2500:2020 Safe use of medical electrical equipment in health care
Preface
Introduction
Section 1 Scope and general
1.1 Scope
1.2 Application
1.2.1 Setting
1.2.2 Personnel
1.3 Normative references
1.4 Terms and definitions
Section 2 Nature of electricity
2.1 Need for care
2.2 Supply systems
2.3 Function of fuses and circuit-breakers
2.4 Socket-outlets
2.4.1 General
2.4.2 Colour coding of socket-outlets
2.5 Basic equipment safety
2.5.1 Forms of construction
2.5.2 Classification of applied parts
2.6 Leakage current
Section 3 Nature of hazards
3.1 General
3.2 Electric shock
3.2.1 Causes of electric shock
3.2.2 Contributing factors
3.2.3 Levels of susceptibility to electric shock
3.3 Thermal hazards
3.3.1 General
3.3.2 Electric burns
3.3.3 Thermal burns
3.3.4 Temperature of infused fluids
3.3.5 Fire and explosion
3.4 Radiant energy hazards
3.4.1 General
3.4.2 Ultrasonic energy
3.4.3 Laser and intense light sources
3.5 Electromagnetic interference
3.6 Electrostatic hazards
3.7 Loss of electrical power
3.8 Software hazards
3.8.1 General
3.8.2 Cybersecurity threats
3.8.3 Software updates
3.9 Equipment configuration
3.10 Alarm management
3.11 Data integration
3.12 Impact of repairs
Section 4 Compatibility of medical procedure, equipment and patient areas
4.1 Safety triangle
4.2 Medical procedures
4.2.1 General
4.2.2 Inadvertent contact with live conductors
4.2.3 Body-type procedure — Applied parts not involving the heart
4.2.4 Cardiac-type procedure — Applied parts involving the heart
4.3 Safe electrical environment
4.3.1 Protection levels
4.3.2 Components of protective wiring system
4.3.3 Use of socket-outlets in cardiac-protected patient areas
4.4 Applied parts of medical electrical equipment
4.4.1 Classification
4.4.2 Protection under fault conditions
4.5 Safe use of medical electrical equipment
4.6 Temporary arrangements for cardiac-type procedures
4.7 Home care medical procedures
4.8 Home care medical equipment – NZ only
Section 5 Administration
5.1 Policies and procedures
5.2 Recognition and location of electrically susceptible patients
5.2.1 General
5.2.2 Design of patient areas
5.3 Training
5.4 Documentation
5.5 Medical electrical equipment
5.5.1 Procurement of equipment
5.5.2 Equipment used but not owned by the responsible organization
5.5.3 Operator instructions
5.5.4 Life-supporting equipment
5.5.5 Mains power supply failure
5.5.6 Back-up equipment
5.6 Maintenance of medical electrical equipment and patient areas
5.6.1 Equipment maintenance
5.6.2 Maintenance of electrical systems of patient areas
5.6.3 Clinical impact of maintenance of distribution equipment and switchboards
5.7 Modification of medical electrical equipment
5.7.1 Australia
5.7.2 New Zealand
5.8 Non-medical electrical equipment
5.8.1 General
5.8.2 Cleaning equipment
5.8.3 Entertainment equipment
5.8.4 Patient-comfort equipment
5.8.5 Patient-supplied equipment
5.8.6 Mobile communications
5.9 Medical equipment malfunction or failure
5.9.1 General
5.9.2 Fault tags
5.9.3 Adverse event reporting
5.9.4 Repair of equipment
Section 6 General use practices
6.1 General
6.2 User observation and checks before use
6.3 Precautions to be observed during use
6.4 User precautions/practices to be observed after use
6.5 Additional precautions to be observed in the use of high-energy apparatus
6.6 Flexible cords and plugs
6.6.1 Inspections
6.6.2 Faulty cords and plugs
6.7 Double adaptors and extension cords
6.8 Medical equipment systems
6.9 Protective devices in patient areas
6.9.1 Introduction
6.9.2 RCD-protected supply
6.9.3 Isolated supply
6.10 Re-use of accessories labelled for “single use only”
Bibliography
Previous versions
AS/NZS 2500:2020
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.