AS/NZS 4815:2006
Office-based health care facilities - Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment
Provides procedures for cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and the maintenance of associated environments as applicable to each profession.
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AS/NZS 4815:2006 OFFICE-BASED HEALTH CARE FACILITIES-REPROCESSING OF REUSABLE MEDICAL AND SURGICAL INSTRUMENTS AND...
PREFACE
CONTENTS
FOREWORD
SECTION 1 SCOPE AND GENERAL
1.1 SCOPE
1.2 REFERENCED DOCUMENTS
1.3 DEFINITIONS
1.3.1 Autoclave
1.3.2 Batch principle
1.3.3 Benchtop steam sterilizer (see also small steam sterilizer)
1.3.4 Bioburden
1.3.5 Biofilm
1.3.6 Biological indicator
1.3.7 Calibration
1.3.8 Chemical indicator
1.3.9 Cleaning
1.3.10 Commissioning
1.3.11 Condensate
1.3.12 Contamination
1.3.13 Critical medical device
1.3.14 Cytotoxic
1.3.15 Disinfection
1.3.16 Drying cycle
1.3.17 Drying stage (drying cycle)
1.3.18 Endotoxins
1.3.19 Enzymatic cleaner
1.3.20 Enzymatic indicator
1.3.21 Health care facility
1.3.22 Holding time
1.3.23 Hollow load type A
1.3.24 Hollow load type B
1.3.25 Implantable item
1.3.26 Installation qualification (IQ)
1.3.27 Instruments on loan (loan instruments)
1.3.28 Item
1.3.29 Low temperature sterilization
1.3.30 May
1.3.31 Monitoring
1.3.32 Non-critical medical device
1.3.33 Office-based health care facility (office-based practice)
1.3.34 Operational qualification (OQ)
1.3.35 Parametric release
1.3.36 Pathogenic organism
1.3.37 Penetration time (equilibration time)
1.3.38 Performance qualification (PQ)
1.3.39 Performance requalification
1.3.40 Pre-vacuum air removal
1.3.41 Process challenge device (PCD)
1.3.42 Process recorder
1.3.43 Processing time
1.3.44 Recommissioning
1.3.45 Reprocessing
1.3.46 Reusable device
1.3.47 Revalidation
1.3.48 Semi-critical medical device
1.3.49 Shall
1.3.50 Should
1.3.51 Small steam sterilizer (see also benchtop steam sterilizer)
1.3.52 Soil
1.3.53 Standard Precautions
1.3.54 Sterile
1.3.55 Sterility assurance level (SAL)
1.3.56 Sterilization
1.3.57 Sterilization cycle
1.3.58 Sterilizing agent
1.3.59 Store pack
1.3.60 Superheated steam
1.3.61 Tape
1.3.62 Type B cycle
1.3.63 Type N cycle
1.3.64 Type S cycle
1.3.65 Unit pack
1.3.66 Validation
1.3.67 Washer/disinfector
1.3.68 Wet steam
1.4 REPROCESSING ENVIRONMENT
1.5 REPROCESSING OF INSTRUMENTS AND EQUIPMENT
SECTION 2 CLEANING AND HANDLING OF USED ITEMS
2.1 WATER QUALITY FOR CLEANING
2.2 INITIAL TREATMENT OF USED ITEMS
2.3 COLLECTION PROCEDURES
2.4 COLLECTION EQUIPMENT
2.5 REPROCESSING AREA
2.6 SORTING OF ITEMS IN THE REPROCESSING AREA PRIOR TO CLEANING
2.7 CLEANING PRECAUTIONS
2.8 CLEANING AGENTS
2.9 CLEANING METHODS
2.9.1 General
2.9.2 Manual cleaning
2.9.3 Mechanical cleaning
2.10 RINSING OF INSTRUMENTS
2.11 DRYING OF INSTRUMENTS
2.11.1 General
2.11.2 Drying methods
SECTION 3 PACKAGING AND WRAPPING OF ITEMS PRIOR TO STERILIZATION
3.1 GENERAL
3.2 PACK SIZE
3.3 LABELLING OF PACKS AND BAGS PRIOR TO STERILIZATION
3.4 SPECIFIC PACKAGING AND WRAPPING REQUIREMENTS
3.4.1 Instruments
3.4.2 Hollowware
3.4.3 Types of packaging and wrapping materials
3.4.4 Selection of packaging materials
3.5 METHODS OF WRAPPING
3.6 SEALING OF PACKS AND BAGS
3.6.1 General
3.6.2 Heat sealing
3.6.3 Sterilizing indicator tape
SECTION 4 STERILIZING EQUIPMENT
4.1 GENERAL
4.2 STEAM STERILIZERS
4.2.1 General
4.2.2 Small steam sterilizers
4.3 DRY HEAT STERILIZERS
SECTION 5 LOADING OF STERILIZERS
5.1 FOR STEAM STERILIZATION
5.1.1 General
5.1.2 Loading of small steam (benchtop) sterilizers
5.2 FOR DRY HEAT STERILIZATION
5.2.1 General
5.2.2 Loading
5.3 EFFECT OF LOAD CONTENT AND MANNER OF LOADING
SECTION 6 UNLOADING OF STERILIZERS
6.1 STEAM STERILIZERS
6.1.1 Cycles with drying stage
6.1.2 Cycles without drying stage
6.2 DRY HEAT STERILIZERS
6.3 MONITORING OF THE UNLOADING PROCEDURE
SECTION 7 PURCHASING, VALIDATION, MONITORING AND MAINTENANCE OF STERILIZERS AND ASSOCIATED EQUIPMENT
7.1 GENERAL
7.2 PURCHASING STERILIZERS AND ASSOCIATED EQUIPMENT
7.3 VALIDATION
7.3.1 General
7.3.2 Commissioning of sterilizers
7.3.3 Performance qualification
7.4 RECOMMISSIONING AND PERFORMANCE REQUALIFICATION OF THE STERILIZER
7.4.1 General
7.4.2 Recommissioning
7.4.3 Performance requalification
7.5 CERTIFICATION OF VALIDATION
7.6 CALIBRATION
7.7 PERFORMANCE TESTING AND MONITORING OF STERILIZERS
7.7.1 Performance testing
7.7.2 Monitoring
7.7.3 Special performance tests for steam sterilizers using mechanical means of air removal
7.7.4 Physical monitors for heat sterilization
7.7.5 Chemical indicators
7.7.6 Biological/enzymatic indicators
7.7.7 Process challenge devices
7.7.8 Supplementary methods of process monitoring
7.8 MAINTENANCE OF STERILIZERS
7.9 ASSOCIATED EQUIPMENT
7.9.1 General
7.9.2 Validation of processes involving associated equipment
7.9.3 Commissioning
7.9.4 Performance qualification
7.9.5 Recommissioning and performance requalification
7.9.6 Calibration, monitoring and maintenance of associated equipment
SECTION 8 QUALITY MANAGEMENT
8.1 STERILIZING MANAGEMENT
8.2 DOCUMENTATION
8.3 PERFORMANCE MANAGEMENT
8.4 EDUCATION AND TRAINING
8.5 MATERIALS MANAGEMENT
8.5.1 General
8.5.2 Product identification and traceability
8.5.3 Deviation, fault analysis and complaint analysis
8.5.4 Recall protocol
8.6 VALIDATION AND ROUTINE MONITORING OF STERILIZATION PROCESSES
8.7 CRITERIA FOR RELEASE OF PROCESSED ITEMS
8.7.1 General
8.7.2 Selection of method
8.7.3 Parametric release
8.7.4 Non-parametric release
8.7.5 Release documentation
8.8 MONITORING OF PACKAGING FOLLOWING STERILIZATION
8.9 OCCUPATIONAL HEALTH AND SAFETY
8.9.1 Staff health
8.9.2 Staff attire
8.9.3 Handwashing/hand hygiene
8.10 ENVIRONMENTAL CONTROL
8.11 EVALUATION, FEEDBACK AND OUTCOMES
8.12 OFF-SITE REPROCESSING
SECTION 9 STORAGE AND HANDLING OF PROCESSED ITEMS
9.1 GENERAL
9.1.1 Sterile items
9.1.2 Storage of unwrapped critical medical items
9.1.3 Storage of unwrapped semi-critical and non-critical medical items
9.2 STORAGE AREAS FOR STERILE ITEMS
9.2.1 General
9.2.2 Access to stored items
9.3 PLASTIC DUST COVERS
9.4 TRANSPORTATION OF STERILE ITEMS
9.5 COMMERCIALLY PREPARED ITEMS
9.6 SHELF-LIFE/ROTATION OF STOCK
9.6.1 General
9.6.2 Stock which is nonconforming
9.6.3 Factors which compromise sterile stock
SECTION 10 DISINFECTION
10.1 GENERAL
10.2 MEANS OF DISINFECTION
10.2.1 Thermal disinfection
10.2.2 Chemical disinfection
SECTION 11 CLEANING OF THE STERILIZING AREA AND ASSOCIATED EQUIPMENT
11.1 GENERAL
11.2 EQUIPMENT
11.3 WASTE DISPOSAL
SECTION 12 SELECTION AND CARE OF INSTRUMENTS
12.1 GENERAL
12.2 GENERAL CONSIDERATIONS
12.2.1 Education and training
12.2.2 Interchange and reprocessing of instruments used for necropsy, human and animal use
12.2.3 Instruments on loan
12.2.4 Identification
12.2.5 Removal of soil
12.2.6 Sorting instruments and inspection
12.2.7 Sterilization of unwrapped instruments*
12.2.8 Small steam sterilizers without a drying cycle
12.2.9 Lubrication
12.3 SPECIAL CONSIDERATIONS
12.4 SPECIALIZED INSTRUMENTS
12.4.1 Microsurgical instruments
12.4.2 Insulated instruments
12.4.3 Handpieces
12.4.4 Air water syringes for dental procedures
12.4.5 Ultrasonic scalers for dental procedures
12.4.6 Diagnostic ultrasound transducers.
12.5 USE OF INSTRUMENT SHEATHS/SLEEVES/PROTECTIVE BARRIERS
SECTION 13 USE OF TEXTILES
APPENDIX A - LIST OF REFERENCED DOCUMENTS
APPENDIX B - CARE AND HANDLING OF POWERED INSTRUMENTS
B1 SCOPE
B2 CLEANING OF POWERED INSTRUMENTS AND HOSES
B3 LUBRICATION AND MAINTENANCE
B4 INSPECTION AND TESTING
B5 STERILIZATION
APPENDIX C - GUIDE TO THE SELECTION OF CLEANING AGENTS
APPENDIX D - HEAT SEALING EQUIPMENT
D1 USES
D2 TYPES OF EQUIPMENT
D3 WIDTH OF SEAL
APPENDIX E - GUIDE TO SMALL STEAM STERILIZER CYCLE TYPES AND ASSOCIATED MECHANISMS FOR AIR REMOVAL
APPENDIX F - VALIDATION PROTOCOL FOR MOIST HEAT STERILIZATION PROCESS
F1 GENERAL
F2 INSTALLATION QUALIFICATION (IQ)
F3 OPERATIONAL QUALIFICATION (OQ)
F4 PERFORMANCE QUALIFICATION (PQ)
F5 PERFORMANCE QUALIFICATION REPORT
F6 CERTIFICATION OF VALIDATION
F7 RECOMMISSIONING
F8 PERFORMANCE REQUALIFICATION
F9 STERILIZATION AND VALIDATION
APPENDIX G - METHOD FOR MEASUREMENT OF TEMPERATURE AND PRESSURE IN STEAM STERILIZERS, OR TEMPERATURE ONLY IN DRY HEAT...
G1 SCOPE
G2 PRINCIPLE
G3 APPARATUS
G4 INSTALLATION OF APPARATUS
G5 ASSURING MEASUREMENT ACCURACY
G6 PROCEDURE
G7 REPORT
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AS/NZS 4815:2006 OFFICE-BASED HEALTH CARE FACILITIES-REPROCESSING OF REUSABLE MEDICAL AND SURGICAL INSTRUMENTS AND...
PREFACE
CONTENTS
FOREWORD
SECTION 1 SCOPE AND GENERAL
1.1 SCOPE
1.2 REFERENCED DOCUMENTS
1.3 DEFINITIONS
1.3.1 Autoclave
1.3.2 Batch principle
1.3.3 Benchtop steam sterilizer (see also small steam sterilizer)
1.3.4 Bioburden
1.3.5 Biofilm
1.3.6 Biological indicator
1.3.7 Calibration
1.3.8 Chemical indicator
1.3.9 Cleaning
1.3.10 Commissioning
1.3.11 Condensate
1.3.12 Contamination
1.3.13 Critical medical device
1.3.14 Cytotoxic
1.3.15 Disinfection
1.3.16 Drying cycle
1.3.17 Drying stage (drying cycle)
1.3.18 Endotoxins
1.3.19 Enzymatic cleaner
1.3.20 Enzymatic indicator
1.3.21 Health care facility
1.3.22 Holding time
1.3.23 Hollow load type A
1.3.24 Hollow load type B
1.3.25 Implantable item
1.3.26 Installation qualification (IQ)
1.3.27 Instruments on loan (loan instruments)
1.3.28 Item
1.3.29 Low temperature sterilization
1.3.30 May
1.3.31 Monitoring
1.3.32 Non-critical medical device
1.3.33 Office-based health care facility (office-based practice)
1.3.34 Operational qualification (OQ)
1.3.35 Parametric release
1.3.36 Pathogenic organism
1.3.37 Penetration time (equilibration time)
1.3.38 Performance qualification (PQ)
1.3.39 Performance requalification
1.3.40 Pre-vacuum air removal
1.3.41 Process challenge device (PCD)
1.3.42 Process recorder
1.3.43 Processing time
1.3.44 Recommissioning
1.3.45 Reprocessing
1.3.46 Reusable device
1.3.47 Revalidation
1.3.48 Semi-critical medical device
1.3.49 Shall
1.3.50 Should
1.3.51 Small steam sterilizer (see also benchtop steam sterilizer)
1.3.52 Soil
1.3.53 Standard Precautions
1.3.54 Sterile
1.3.55 Sterility assurance level (SAL)
1.3.56 Sterilization
1.3.57 Sterilization cycle
1.3.58 Sterilizing agent
1.3.59 Store pack
1.3.60 Superheated steam
1.3.61 Tape
1.3.62 Type B cycle
1.3.63 Type N cycle
1.3.64 Type S cycle
1.3.65 Unit pack
1.3.66 Validation
1.3.67 Washer/disinfector
1.3.68 Wet steam
1.4 REPROCESSING ENVIRONMENT
1.5 REPROCESSING OF INSTRUMENTS AND EQUIPMENT
SECTION 2 CLEANING AND HANDLING OF USED ITEMS
2.1 WATER QUALITY FOR CLEANING
2.2 INITIAL TREATMENT OF USED ITEMS
2.3 COLLECTION PROCEDURES
2.4 COLLECTION EQUIPMENT
2.5 REPROCESSING AREA
2.6 SORTING OF ITEMS IN THE REPROCESSING AREA PRIOR TO CLEANING
2.7 CLEANING PRECAUTIONS
2.8 CLEANING AGENTS
2.9 CLEANING METHODS
2.9.1 General
2.9.2 Manual cleaning
2.9.3 Mechanical cleaning
2.10 RINSING OF INSTRUMENTS
2.11 DRYING OF INSTRUMENTS
2.11.1 General
2.11.2 Drying methods
SECTION 3 PACKAGING AND WRAPPING OF ITEMS PRIOR TO STERILIZATION
3.1 GENERAL
3.2 PACK SIZE
3.3 LABELLING OF PACKS AND BAGS PRIOR TO STERILIZATION
3.4 SPECIFIC PACKAGING AND WRAPPING REQUIREMENTS
3.4.1 Instruments
3.4.2 Hollowware
3.4.3 Types of packaging and wrapping materials
3.4.4 Selection of packaging materials
3.5 METHODS OF WRAPPING
3.6 SEALING OF PACKS AND BAGS
3.6.1 General
3.6.2 Heat sealing
3.6.3 Sterilizing indicator tape
SECTION 4 STERILIZING EQUIPMENT
4.1 GENERAL
4.2 STEAM STERILIZERS
4.2.1 General
4.2.2 Small steam sterilizers
4.3 DRY HEAT STERILIZERS
SECTION 5 LOADING OF STERILIZERS
5.1 FOR STEAM STERILIZATION
5.1.1 General
5.1.2 Loading of small steam (benchtop) sterilizers
5.2 FOR DRY HEAT STERILIZATION
5.2.1 General
5.2.2 Loading
5.3 EFFECT OF LOAD CONTENT AND MANNER OF LOADING
SECTION 6 UNLOADING OF STERILIZERS
6.1 STEAM STERILIZERS
6.1.1 Cycles with drying stage
6.1.2 Cycles without drying stage
6.2 DRY HEAT STERILIZERS
6.3 MONITORING OF THE UNLOADING PROCEDURE
SECTION 7 PURCHASING, VALIDATION, MONITORING AND MAINTENANCE OF STERILIZERS AND ASSOCIATED EQUIPMENT
7.1 GENERAL
7.2 PURCHASING STERILIZERS AND ASSOCIATED EQUIPMENT
7.3 VALIDATION
7.3.1 General
7.3.2 Commissioning of sterilizers
7.3.3 Performance qualification
7.4 RECOMMISSIONING AND PERFORMANCE REQUALIFICATION OF THE STERILIZER
7.4.1 General
7.4.2 Recommissioning
7.4.3 Performance requalification
7.5 CERTIFICATION OF VALIDATION
7.6 CALIBRATION
7.7 PERFORMANCE TESTING AND MONITORING OF STERILIZERS
7.7.1 Performance testing
7.7.2 Monitoring
7.7.3 Special performance tests for steam sterilizers using mechanical means of air removal
7.7.4 Physical monitors for heat sterilization
7.7.5 Chemical indicators
7.7.6 Biological/enzymatic indicators
7.7.7 Process challenge devices
7.7.8 Supplementary methods of process monitoring
7.8 MAINTENANCE OF STERILIZERS
7.9 ASSOCIATED EQUIPMENT
7.9.1 General
7.9.2 Validation of processes involving associated equipment
7.9.3 Commissioning
7.9.4 Performance qualification
7.9.5 Recommissioning and performance requalification
7.9.6 Calibration, monitoring and maintenance of associated equipment
SECTION 8 QUALITY MANAGEMENT
8.1 STERILIZING MANAGEMENT
8.2 DOCUMENTATION
8.3 PERFORMANCE MANAGEMENT
8.4 EDUCATION AND TRAINING
8.5 MATERIALS MANAGEMENT
8.5.1 General
8.5.2 Product identification and traceability
8.5.3 Deviation, fault analysis and complaint analysis
8.5.4 Recall protocol
8.6 VALIDATION AND ROUTINE MONITORING OF STERILIZATION PROCESSES
8.7 CRITERIA FOR RELEASE OF PROCESSED ITEMS
8.7.1 General
8.7.2 Selection of method
8.7.3 Parametric release
8.7.4 Non-parametric release
8.7.5 Release documentation
8.8 MONITORING OF PACKAGING FOLLOWING STERILIZATION
8.9 OCCUPATIONAL HEALTH AND SAFETY
8.9.1 Staff health
8.9.2 Staff attire
8.9.3 Handwashing/hand hygiene
8.10 ENVIRONMENTAL CONTROL
8.11 EVALUATION, FEEDBACK AND OUTCOMES
8.12 OFF-SITE REPROCESSING
SECTION 9 STORAGE AND HANDLING OF PROCESSED ITEMS
9.1 GENERAL
9.1.1 Sterile items
9.1.2 Storage of unwrapped critical medical items
9.1.3 Storage of unwrapped semi-critical and non-critical medical items
9.2 STORAGE AREAS FOR STERILE ITEMS
9.2.1 General
9.2.2 Access to stored items
9.3 PLASTIC DUST COVERS
9.4 TRANSPORTATION OF STERILE ITEMS
9.5 COMMERCIALLY PREPARED ITEMS
9.6 SHELF-LIFE/ROTATION OF STOCK
9.6.1 General
9.6.2 Stock which is nonconforming
9.6.3 Factors which compromise sterile stock
SECTION 10 DISINFECTION
10.1 GENERAL
10.2 MEANS OF DISINFECTION
10.2.1 Thermal disinfection
10.2.2 Chemical disinfection
SECTION 11 CLEANING OF THE STERILIZING AREA AND ASSOCIATED EQUIPMENT
11.1 GENERAL
11.2 EQUIPMENT
11.3 WASTE DISPOSAL
SECTION 12 SELECTION AND CARE OF INSTRUMENTS
12.1 GENERAL
12.2 GENERAL CONSIDERATIONS
12.2.1 Education and training
12.2.2 Interchange and reprocessing of instruments used for necropsy, human and animal use
12.2.3 Instruments on loan
12.2.4 Identification
12.2.5 Removal of soil
12.2.6 Sorting instruments and inspection
12.2.7 Sterilization of unwrapped instruments*
12.2.8 Small steam sterilizers without a drying cycle
12.2.9 Lubrication
12.3 SPECIAL CONSIDERATIONS
12.4 SPECIALIZED INSTRUMENTS
12.4.1 Microsurgical instruments
12.4.2 Insulated instruments
12.4.3 Handpieces
12.4.4 Air water syringes for dental procedures
12.4.5 Ultrasonic scalers for dental procedures
12.4.6 Diagnostic ultrasound transducers.
12.5 USE OF INSTRUMENT SHEATHS/SLEEVES/PROTECTIVE BARRIERS
SECTION 13 USE OF TEXTILES
APPENDIX A - LIST OF REFERENCED DOCUMENTS
APPENDIX B - CARE AND HANDLING OF POWERED INSTRUMENTS
B1 SCOPE
B2 CLEANING OF POWERED INSTRUMENTS AND HOSES
B3 LUBRICATION AND MAINTENANCE
B4 INSPECTION AND TESTING
B5 STERILIZATION
APPENDIX C - GUIDE TO THE SELECTION OF CLEANING AGENTS
APPENDIX D - HEAT SEALING EQUIPMENT
D1 USES
D2 TYPES OF EQUIPMENT
D3 WIDTH OF SEAL
APPENDIX E - GUIDE TO SMALL STEAM STERILIZER CYCLE TYPES AND ASSOCIATED MECHANISMS FOR AIR REMOVAL
APPENDIX F - VALIDATION PROTOCOL FOR MOIST HEAT STERILIZATION PROCESS
F1 GENERAL
F2 INSTALLATION QUALIFICATION (IQ)
F3 OPERATIONAL QUALIFICATION (OQ)
F4 PERFORMANCE QUALIFICATION (PQ)
F5 PERFORMANCE QUALIFICATION REPORT
F6 CERTIFICATION OF VALIDATION
F7 RECOMMISSIONING
F8 PERFORMANCE REQUALIFICATION
F9 STERILIZATION AND VALIDATION
APPENDIX G - METHOD FOR MEASUREMENT OF TEMPERATURE AND PRESSURE IN STEAM STERILIZERS, OR TEMPERATURE ONLY IN DRY HEAT...
G1 SCOPE
G2 PRINCIPLE
G3 APPARATUS
G4 INSTALLATION OF APPARATUS
G5 ASSURING MEASUREMENT ACCURACY
G6 PROCEDURE
G7 REPORT
Previous versions
AS/NZS 4815:2006
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.