AS/NZS 4173:2004
Guide to the safe use of lasers in health care
Provides guidance in the safe use of lasers and laser systems for diagnostic, cosmetic and therapeutic uses in health care facilities (including hospitals, private medical facilities and dental practices). To this end, it includes explanations of basic laser physics and radiation/tissue interactions, and also identifies engineering and administrative control measures designed to avoid the most significant hazards. Protocols to be observed during specialist medical and dental procedures are also included.
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AS/NZS 4173:2004 GUIDE TO THE SAFE USE OF LASERS IN HEALTH CARE
PREFACE
CONTENTS
FOREWORD
SECTION 1 SCOPE AND GENERAL
1.1 SCOPE
1.2 APPLICATION
1.3 REFERENCED DOCUMENTS
1.4 DEFINITIONS
1.4.1 Absorption
1.4.2 Accessible emission limit (AEL)
1.4.3 Accessible radiation
1.4.4 Administrative control
1.4.5 Aiming beam
1.4.6 Aperture
1.4.7 Articulated arm delivery system
1.4.8 Attenuate
1.4.9 Average power
1.4.10 Aversion response
1.4.11 Beam attenuator
1.4.12 Beam diameter
1.4.13 Beam divergence
1.4.14 Class of laser
1.4.15 Coherent
1.4.16 Collimated beam
1.4.17 Continuous wave (CW)
1.4.18 Convergence
1.4.19 Corneal hazard
1.4.20 Delivery system
1.4.21 Diffraction
1.4.22 Diffuse reflection
1.4.23 Distal
1.4.24 Divergence
1.4.25 Electromagnetic radiation
1.4.26 Enclosed laser
1.4.27 Energy
1.4.28 Exposure time
1.4.29 Eye protection
1.4.30 Failure to safety
1.4.31 Failure to safety interlock
1.4.32 Fibre optic delivery system
1.4.33 Focal length
1.4.34 Focal point
1.4.35 Hertz (Hz)
1.4.36 Human access
1.4.37 Infra-red radiation
1.4.38 Ionizing radiation
1.4.39 Irradiance
1.4.40 Lambertian surface
1.4.41 Laser
1.4.42 Laser accident
1.4.43 Laser classification
1.4.44 Laser checklist
1.4.45 Laser controlled area
1.4.46 Laser delivery system
1.4.47 Laser emission indicator
1.4.48 Laser incident
1.4.49 Laser operator
1.4.50 Laser user
1.4.51 Laser safety committee (LSC)
1.4.52 Laser safety officer (LSO)
1.4.53 Laser training
1.4.54 Local exhaust ventilator (LEV)
1.4.55 Maintenance
1.4.56 Maximum permissible exposure (MPE)
1.4.57 May
1.4.58 Monochromatic
1.4.59 Need(s) to
1.4.60 Nominal ocular hazard area (NOHA)
1.4.61 Nominal ocular hazard distance (NOHD)
1.4.62 Non-ionizing radiation
1.4.63 Operation
1.4.64 Optical density
1.4.65 Peak power
¿1.4.66 Power ¿
1.4.67 Power density
1.4.68 Proximal
1.4.69 Pulse mode
1.4.70 Q-switch
1.4.71 Radian
1.4.72 Radiant flux
1.4.73 Radiant intensity (of a source in a given direction)
1.4.74 Radiant power
1.4.75 Refraction
1.4.76 Retinal hazard
1.4.77 Scatter
1.4.78 Service
1.4.79 Should
1.4.80 Shutter
1.4.81 Smoke evacuator (local exhaust ventilator)
1.4.82 Solid angle (X)
1.4.83 Specular reflection
1.4.84 Steradian (sr)
1.4.85 Transmission
1.4.86 Ultraviolet radiation
1.4.87 Visible radiation
1.4.88 Watt (W) (joules per second)
1.4.89 Wavelength
SECTION 2 THE LASER AND ITS PROPERTIES
2.1 INTRODUCTION
2.2 WHAT IS A LASER?
2.2.1 General
2.2.2 Laser medium
2.2.3 Energy source
2.2.4 Laser mirrors
2.3 MODES OF OPERATION
2.3.1 General
2.3.2 Continuous wave
2.3.3 Pulsed mode
2.4 PROPERTIES OF LASERS
2.4.1 General
2.4.2 Monochromaticity
2.4.3 Low divergence
2.5 PARAMETERS USED TO CHARACTERIZE LASER OUTPUT
SECTION 3 LASER DELIVERY SYSTEMS
3.1 GENERAL
3.2 DIRECT DELIVERY
3.3 ARTICULATED ARM
3.3.1 General
3.3.2 Limitations of an articulated arm
3.4 HOLLOW FLEXIBLE WAVEGUIDE
3.5 FIBRE OPTIC
3.5.1 General
3.5.2 Limitations of fibre delivery systems
3.5.3 Risk to endoscope
3.6 HANDPIECES AND APPLICATORS
3.6.1 Applicators with focusing lenses
3.6.2 Limitations of lens systems
3.6.3 Sapphire or similar contact tips
3.6.4 Shaped fibres
3.6.5 Metallic or ceramic tips
3.6.6 Diffusers and photodynamic therapy probes
3.6.7 Micromanipulators
SECTION 4 BIOLOGICAL EFFECTS
4.1 LASER INTERACTIONS WITH TISSUE
4.1.1 General
4.1.2 Optical interactions
4.2 THERMAL
4.3 PHOTOABLATIVE
4.4 PHOTOACOUSTIC (ELECTROMECHANICAL)
4.5 PHOTOCHEMICAL
4.6 LOW LEVEL LASER THERAPY
SECTION 5 HAZARDS
5.1 INTRODUCTION
5.2 ORGANS AT RISK
5.2.1 General
5.2.2 The eyes
5.2.3 The skin
5.3 PULSED LASERS
5.4 OPTICAL FIBRE BREAKAGES
5.5 AIRBORNE CONTAMINANTS
5.6 FUMES AND VAPOURS
5.7 UNSHIELDED LASER FLASH LAMPS/OPTICAL CAVITY
5.8 HEATED SURFACES OR INSTRUMENTS
5.9 REFLECTIONS
SECTION 6 EQUIPMENT
6.1 CLASSIFICATION OF LASER PRODUCTS
6.1.1 General
6.1.2 Description of laser classes
6.1.3 Labelling requirements
6.2 LASER EQUIPMENT SAFETY FEATURES
6.3 OPTICAL GUIDES
SECTION 7 ADMINISTRATION
7.1 RESPONSIBILITY
7.2 ADMINISTRATION
7.3 LASER SAFETY COMMITTEE
7.4 LASER SAFETY OFFICER
7.5 TRAINING
7.6 MEDICAL CREDENTIALING
7.7 LASER OPERATOR CERTIFICATION
7.8 STANDARD OPERATING PROCEDURES AND CHECKLISTS
7.9 LASER INCIDENTS
7.10 INCIDENT REPORTING
7.10.1 Incident report
7.10.2 Equipment malfunction and personnel injury
7.11 EYE EXAMINATIONS FOR OPHTHALMIC SURVEILLANCE
7.12 SKIN EXAMINATIONS
SECTION 8 ACCEPTANCE, QUALITY ASSURANCE TESTING AND PREVENTIVE MAINTENANCE
8.1 GENERAL
8.2 ACCEPTANCE INSPECTION AND TESTING
8.3 QUALITY ASSURANCE (QA) TESTS
8.3.1 General
8.3.2 Cables
8.3.3 Emergency laser stop switches
8.3.4 Interlocks
8.3.5 Indicators
8.3.6 Beam power calibration
8.3.7 Articulated arm
8.3.8 Beam coincidence
8.3.9 Optical fibres
8.3.10 Aiming beam
8.3.11 Specialized accessories
8.3.12 Protective eyewear
8.4 PREVENTIVE MAINTENANCE
8.4.1 General
8.4.2 Cleaning and disinfection
8.4.3 Preventive maintenance check list
SECTION 9 SAFE PRACTICES
9.1 GENERAL
9.2 ESSENTIAL SAFETY REQUIREMENTS
9.3 OPERATIONAL PRACTICES
9.4 REMOVAL OF AIRBORNE CONTAMINANTS
9.4.1 General
9.4.2 Operator and patient protection
9.5 REDUCTION OF EXPLOSIVE HAZARD
9.6 NOXIOUS MATERIALS
9.6.1 General
9.6.2 Dye lasers
9.7 USER PRACTICES DURING SPECIALIST CLINICAL APPLICATIONS
9.8 EYE PROTECTION
9.8.1 General
9.8.2 Eye protection with endoscopes
9.8.3 Factors in determining appropriate eyewear
9.9 ADDITIONAL PERSONAL PROTECTION
9.10 AIMING BEAMS AND TARGET INDICATORS
9.11 FIRE PROTECTION
9.12 OPTICAL FIBRE SYSTEMS
9.13 LASER ENVIRONMENT
9.14 INSTALLATION REQUIREMENTS FOR CLASS 3B AND CLASS 4 MEDICAL LASERS
APPENDIX A - SAFETY ISSUES IN LASER APPLICATIONS
A1 SCOPE
A2 USE OF OPTICAL FIBRES
A2.1 Hazard summary
A2.2 Precautions
A3 USE OF LASERS WITH FLEXIBLE ENDOSCOPES
A3.1 Hazard summary
A3.2 Precautions
A4 USE OF LASERS WITH RIGID ENDOSCOPES, MICROSCOPES AND COLPOSCOPES
A4.1 Hazard summary
A4.2 Precautions
A5 USE OF LASERS WITH FREE HAND MANIPULATION CAPABILITY
A5.1 Hazard summary
A5.2 Precautions
A6 USE OF LASERS IN OPHTHALMOLOGY
A6.1 Hazard summary
A6.2 Precautions
A7 USE OF LASERS IN CONJUNCTION WITH ANAESTHESIA
A7.1 Hazard Summary
A7.2 Precautions
A8 USE OF CLASS 3B AND CLASS 4 LASERS ON THE SKIN
A8.1 Hazard summary
A8.2 Precautions
A9 USE OF CLASS 3B AND CLASS 4 LASERS IN DENTISTRY
A9.1 Hazard summary
A9.2 PRECAUTIONS
A10 LOW POWER THERAPEUTIC LASERS
A10.1 Hazard summary
A10.2 Precautions
APPENDIX B - GENERATION OF LASER RADIATION
B1 GENERATION OF LASER RADIATION
B2 SPONTANEOUS EMISSION
B3 STIMULATED EMISSION
B4 SPECIFICATION OF THE BEAM INTENSITY
APPENDIX C - DOCUMENTATION SAMPLES
C1 INTRODUCTION
C2 SAMPLE CHECK LISTS
C3 LASER OPERATOR/USER SKILLS CHECKLIST-GUIDANCE
C3.1 General
C3.2 Equipment set up
C3.3 Procedure competencies
C3.4 Safety
C3.5 Laser knowledge
C4 LASER PROCEDURE LOG
C5 POLICIES AND PROCEDURES
APPENDIX D - ADVISORY AUTHORITIES
APPENDIX E - LASER TRAINING PROGRAMS
E1 SCOPE
E2 CLINICIANS (MEDICAL AND DENTAL)
E3 CLINICAL SUPPORT STAFF
E4 HEALTH CARE FACILITY LASER SAFETY OFFICER (LSO)
E5 LASER EQUIPMENT SERVICE STAFF
E6 SUGGESTED SUBJECT MATTER FOR LASER SAFETY TRAINING PROGRAMS
E6.1 Operational characteristics of lasers
E6.2 Laser hazards
E6.3 Principles and procedures for safe laser use
APPENDIX F - WINDOW SHIELDING
F1 GENERAL
F2 LASER WAVELENGTH
F2.1 Greater than 4000 nm
F2.2 Less than 4000 nm
F3 IRRADIANCE OR RADIANT EXPOSURE
F4 FIRE/HEAT RESISTANCE
F5 ATTACHMENT/DETACHMENT
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References
Approval and test specification - Medical electrical equipment - Particular requirements for safety - High frequency surgical equipment
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AS/NZS 4173:2004 GUIDE TO THE SAFE USE OF LASERS IN HEALTH CARE
PREFACE
CONTENTS
FOREWORD
SECTION 1 SCOPE AND GENERAL
1.1 SCOPE
1.2 APPLICATION
1.3 REFERENCED DOCUMENTS
1.4 DEFINITIONS
1.4.1 Absorption
1.4.2 Accessible emission limit (AEL)
1.4.3 Accessible radiation
1.4.4 Administrative control
1.4.5 Aiming beam
1.4.6 Aperture
1.4.7 Articulated arm delivery system
1.4.8 Attenuate
1.4.9 Average power
1.4.10 Aversion response
1.4.11 Beam attenuator
1.4.12 Beam diameter
1.4.13 Beam divergence
1.4.14 Class of laser
1.4.15 Coherent
1.4.16 Collimated beam
1.4.17 Continuous wave (CW)
1.4.18 Convergence
1.4.19 Corneal hazard
1.4.20 Delivery system
1.4.21 Diffraction
1.4.22 Diffuse reflection
1.4.23 Distal
1.4.24 Divergence
1.4.25 Electromagnetic radiation
1.4.26 Enclosed laser
1.4.27 Energy
1.4.28 Exposure time
1.4.29 Eye protection
1.4.30 Failure to safety
1.4.31 Failure to safety interlock
1.4.32 Fibre optic delivery system
1.4.33 Focal length
1.4.34 Focal point
1.4.35 Hertz (Hz)
1.4.36 Human access
1.4.37 Infra-red radiation
1.4.38 Ionizing radiation
1.4.39 Irradiance
1.4.40 Lambertian surface
1.4.41 Laser
1.4.42 Laser accident
1.4.43 Laser classification
1.4.44 Laser checklist
1.4.45 Laser controlled area
1.4.46 Laser delivery system
1.4.47 Laser emission indicator
1.4.48 Laser incident
1.4.49 Laser operator
1.4.50 Laser user
1.4.51 Laser safety committee (LSC)
1.4.52 Laser safety officer (LSO)
1.4.53 Laser training
1.4.54 Local exhaust ventilator (LEV)
1.4.55 Maintenance
1.4.56 Maximum permissible exposure (MPE)
1.4.57 May
1.4.58 Monochromatic
1.4.59 Need(s) to
1.4.60 Nominal ocular hazard area (NOHA)
1.4.61 Nominal ocular hazard distance (NOHD)
1.4.62 Non-ionizing radiation
1.4.63 Operation
1.4.64 Optical density
1.4.65 Peak power
¿1.4.66 Power ¿
1.4.67 Power density
1.4.68 Proximal
1.4.69 Pulse mode
1.4.70 Q-switch
1.4.71 Radian
1.4.72 Radiant flux
1.4.73 Radiant intensity (of a source in a given direction)
1.4.74 Radiant power
1.4.75 Refraction
1.4.76 Retinal hazard
1.4.77 Scatter
1.4.78 Service
1.4.79 Should
1.4.80 Shutter
1.4.81 Smoke evacuator (local exhaust ventilator)
1.4.82 Solid angle (X)
1.4.83 Specular reflection
1.4.84 Steradian (sr)
1.4.85 Transmission
1.4.86 Ultraviolet radiation
1.4.87 Visible radiation
1.4.88 Watt (W) (joules per second)
1.4.89 Wavelength
SECTION 2 THE LASER AND ITS PROPERTIES
2.1 INTRODUCTION
2.2 WHAT IS A LASER?
2.2.1 General
2.2.2 Laser medium
2.2.3 Energy source
2.2.4 Laser mirrors
2.3 MODES OF OPERATION
2.3.1 General
2.3.2 Continuous wave
2.3.3 Pulsed mode
2.4 PROPERTIES OF LASERS
2.4.1 General
2.4.2 Monochromaticity
2.4.3 Low divergence
2.5 PARAMETERS USED TO CHARACTERIZE LASER OUTPUT
SECTION 3 LASER DELIVERY SYSTEMS
3.1 GENERAL
3.2 DIRECT DELIVERY
3.3 ARTICULATED ARM
3.3.1 General
3.3.2 Limitations of an articulated arm
3.4 HOLLOW FLEXIBLE WAVEGUIDE
3.5 FIBRE OPTIC
3.5.1 General
3.5.2 Limitations of fibre delivery systems
3.5.3 Risk to endoscope
3.6 HANDPIECES AND APPLICATORS
3.6.1 Applicators with focusing lenses
3.6.2 Limitations of lens systems
3.6.3 Sapphire or similar contact tips
3.6.4 Shaped fibres
3.6.5 Metallic or ceramic tips
3.6.6 Diffusers and photodynamic therapy probes
3.6.7 Micromanipulators
SECTION 4 BIOLOGICAL EFFECTS
4.1 LASER INTERACTIONS WITH TISSUE
4.1.1 General
4.1.2 Optical interactions
4.2 THERMAL
4.3 PHOTOABLATIVE
4.4 PHOTOACOUSTIC (ELECTROMECHANICAL)
4.5 PHOTOCHEMICAL
4.6 LOW LEVEL LASER THERAPY
SECTION 5 HAZARDS
5.1 INTRODUCTION
5.2 ORGANS AT RISK
5.2.1 General
5.2.2 The eyes
5.2.3 The skin
5.3 PULSED LASERS
5.4 OPTICAL FIBRE BREAKAGES
5.5 AIRBORNE CONTAMINANTS
5.6 FUMES AND VAPOURS
5.7 UNSHIELDED LASER FLASH LAMPS/OPTICAL CAVITY
5.8 HEATED SURFACES OR INSTRUMENTS
5.9 REFLECTIONS
SECTION 6 EQUIPMENT
6.1 CLASSIFICATION OF LASER PRODUCTS
6.1.1 General
6.1.2 Description of laser classes
6.1.3 Labelling requirements
6.2 LASER EQUIPMENT SAFETY FEATURES
6.3 OPTICAL GUIDES
SECTION 7 ADMINISTRATION
7.1 RESPONSIBILITY
7.2 ADMINISTRATION
7.3 LASER SAFETY COMMITTEE
7.4 LASER SAFETY OFFICER
7.5 TRAINING
7.6 MEDICAL CREDENTIALING
7.7 LASER OPERATOR CERTIFICATION
7.8 STANDARD OPERATING PROCEDURES AND CHECKLISTS
7.9 LASER INCIDENTS
7.10 INCIDENT REPORTING
7.10.1 Incident report
7.10.2 Equipment malfunction and personnel injury
7.11 EYE EXAMINATIONS FOR OPHTHALMIC SURVEILLANCE
7.12 SKIN EXAMINATIONS
SECTION 8 ACCEPTANCE, QUALITY ASSURANCE TESTING AND PREVENTIVE MAINTENANCE
8.1 GENERAL
8.2 ACCEPTANCE INSPECTION AND TESTING
8.3 QUALITY ASSURANCE (QA) TESTS
8.3.1 General
8.3.2 Cables
8.3.3 Emergency laser stop switches
8.3.4 Interlocks
8.3.5 Indicators
8.3.6 Beam power calibration
8.3.7 Articulated arm
8.3.8 Beam coincidence
8.3.9 Optical fibres
8.3.10 Aiming beam
8.3.11 Specialized accessories
8.3.12 Protective eyewear
8.4 PREVENTIVE MAINTENANCE
8.4.1 General
8.4.2 Cleaning and disinfection
8.4.3 Preventive maintenance check list
SECTION 9 SAFE PRACTICES
9.1 GENERAL
9.2 ESSENTIAL SAFETY REQUIREMENTS
9.3 OPERATIONAL PRACTICES
9.4 REMOVAL OF AIRBORNE CONTAMINANTS
9.4.1 General
9.4.2 Operator and patient protection
9.5 REDUCTION OF EXPLOSIVE HAZARD
9.6 NOXIOUS MATERIALS
9.6.1 General
9.6.2 Dye lasers
9.7 USER PRACTICES DURING SPECIALIST CLINICAL APPLICATIONS
9.8 EYE PROTECTION
9.8.1 General
9.8.2 Eye protection with endoscopes
9.8.3 Factors in determining appropriate eyewear
9.9 ADDITIONAL PERSONAL PROTECTION
9.10 AIMING BEAMS AND TARGET INDICATORS
9.11 FIRE PROTECTION
9.12 OPTICAL FIBRE SYSTEMS
9.13 LASER ENVIRONMENT
9.14 INSTALLATION REQUIREMENTS FOR CLASS 3B AND CLASS 4 MEDICAL LASERS
APPENDIX A - SAFETY ISSUES IN LASER APPLICATIONS
A1 SCOPE
A2 USE OF OPTICAL FIBRES
A2.1 Hazard summary
A2.2 Precautions
A3 USE OF LASERS WITH FLEXIBLE ENDOSCOPES
A3.1 Hazard summary
A3.2 Precautions
A4 USE OF LASERS WITH RIGID ENDOSCOPES, MICROSCOPES AND COLPOSCOPES
A4.1 Hazard summary
A4.2 Precautions
A5 USE OF LASERS WITH FREE HAND MANIPULATION CAPABILITY
A5.1 Hazard summary
A5.2 Precautions
A6 USE OF LASERS IN OPHTHALMOLOGY
A6.1 Hazard summary
A6.2 Precautions
A7 USE OF LASERS IN CONJUNCTION WITH ANAESTHESIA
A7.1 Hazard Summary
A7.2 Precautions
A8 USE OF CLASS 3B AND CLASS 4 LASERS ON THE SKIN
A8.1 Hazard summary
A8.2 Precautions
A9 USE OF CLASS 3B AND CLASS 4 LASERS IN DENTISTRY
A9.1 Hazard summary
A9.2 PRECAUTIONS
A10 LOW POWER THERAPEUTIC LASERS
A10.1 Hazard summary
A10.2 Precautions
APPENDIX B - GENERATION OF LASER RADIATION
B1 GENERATION OF LASER RADIATION
B2 SPONTANEOUS EMISSION
B3 STIMULATED EMISSION
B4 SPECIFICATION OF THE BEAM INTENSITY
APPENDIX C - DOCUMENTATION SAMPLES
C1 INTRODUCTION
C2 SAMPLE CHECK LISTS
C3 LASER OPERATOR/USER SKILLS CHECKLIST-GUIDANCE
C3.1 General
C3.2 Equipment set up
C3.3 Procedure competencies
C3.4 Safety
C3.5 Laser knowledge
C4 LASER PROCEDURE LOG
C5 POLICIES AND PROCEDURES
APPENDIX D - ADVISORY AUTHORITIES
APPENDIX E - LASER TRAINING PROGRAMS
E1 SCOPE
E2 CLINICIANS (MEDICAL AND DENTAL)
E3 CLINICAL SUPPORT STAFF
E4 HEALTH CARE FACILITY LASER SAFETY OFFICER (LSO)
E5 LASER EQUIPMENT SERVICE STAFF
E6 SUGGESTED SUBJECT MATTER FOR LASER SAFETY TRAINING PROGRAMS
E6.1 Operational characteristics of lasers
E6.2 Laser hazards
E6.3 Principles and procedures for safe laser use
APPENDIX F - WINDOW SHIELDING
F1 GENERAL
F2 LASER WAVELENGTH
F2.1 Greater than 4000 nm
F2.2 Less than 4000 nm
F3 IRRADIANCE OR RADIANT EXPOSURE
F4 FIRE/HEAT RESISTANCE
F5 ATTACHMENT/DETACHMENT
Previous versions
AS/NZS 4173:2004
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.