AS/NZS 4815:2001

1 - AS/NZS 4815:2001 OFFICE-BASED HEALTH CARE FACILITIES NOT INVOLVED IN COMPLEX PATIENT PROCEDURES AND PROCESSES-CLEANING....
4 - PREFACE
5 - CONTENTS
8 - FOREWORD
10 - SECTION 1 SCOPE AND GENERAL
10 - 1.1 SCOPE
10 - 1.2 REFERENCED DOCUMENTS
10 - 1.3 DEFINITIONS
10 - 1.3.1 Autoclave
10 - 1.3.2 Batch principle
10 - 1.3.3 Benchtop steam sterilizer
10 - 1.3.4 Bioburden
10 - 1.3.5 Biofilm
11 - 1.3.6 Biological indicator
11 - 1.3.7 Calibration
11 - 1.3.8 Chemical indicator
11 - 1.3.9 Cleaning
11 - 1.3.10 Commissioning
11 - 1.3.11 Condensate
11 - 1.3.12 Contamination
11 - 1.3.13 Critical medical device
11 - 1.3.14 Disinfection
11 - 1.3.15 Drying cycle
11 - 1.3.16 Endotoxins
11 - 1.3.17 Enzymatic indicator
12 - 1.3.18 Health care facility
12 - 1.3.19 Holding time
12 - 1.3.20 Implantable item
12 - 1.3.21 May
12 - 1.3.22 Monitoring
12 - 1.3.23 Low temperature sterilization
12 - 1.3.24 Non-critical medical device
12 - 1.3.25 Office-based health care facility (office- based practice)
12 - 1.3.26 Parametric release
12 - 1.3.27 Pathogenic organism
12 - 1.3.28 Penetration time
12 - 1.3.29 Porous load sterilizer
12 - 1.3.30 Process challenge device
12 - 1.3.31 Reprocessing
13 - 1.3.32 Reusable device
13 - 1.3.33 Revalidation
13 - 1.3.34 Safety factor
13 - 1.3.35 Semi-critical medical device
13 - 1.3.36 Shall
13 - 1.3.37 Should
13 - 1.3.38 Soil
13 - 1.3.39 Standard Precautions
13 - 1.3.40 Sterile
13 - 1.3.41 Sterility assurance level (SAL)
13 - 1.3.42 Sterilization
13 - 1.3.43 Sterilization cycle
13 - 1.3.44 Sterilization time
14 - 1.3.45 Sterilizing agent
14 - 1.3.46 Superheated steam
14 - 1.3.47 Tape
14 - 1.3.48 Unit pack
14 - 1.3.49 Validation
14 - 1.3.50 Washer/disinfector
14 - 1.3.51 Wet steam
14 - 1.4 PROCESSING ENVIRONMENT
14 - 1.5 REPROCESSING OF INSTRUMENTS AND EQUIPMENT
16 - SECTION 2 CLEANING AND HANDLING OF USED ITEMS
16 - 2.1 WATER QUALITY FOR CLEANING
16 - 2.2 INITIAL TREATMENT OF USED ITEMS
16 - 2.3 COLLECTION PROCEDURES
16 - 2.4 COLLECTION EQUIPMENT
17 - 2.5 CLEANING AREA
17 - 2.6 SORTING OF ITEMS IN THE PROCESSING AREA PRIOR TO CLEANING
17 - 2.7 CLEANING PRECAUTIONS
18 - 2.8 CLEANING AGENTS
19 - 2.9 CLEANING METHODS
19 - 2.9.1 General
19 - 2.9.2 Manual cleaning
21 - 2.9.3 Mechanical cleaning
22 - 2.10 DETERGENT AND RINSE ADDITIVE RESIDUES
22 - 2.11 DRYING OF INSTRUMENTS
22 - 2.11.1 General
22 - 2.11.2 Drying
23 - 2.12 MONITORING OF CLEANING
24 - SECTION 3 PACKAGING AND WRAPPING OF ITEMS PRIOR TO STERILIZATION
24 - 3.1 GENERAL
24 - 3.2 PACK SIZE
24 - 3.3 LABELLING OF PACKS AND BAGS PRIOR TO STERILIZATION
24 - 3.4 SPECIFIC PACKAGING AND WRAPPING REQUIREMENTS
24 - 3.4.1 Instruments
25 - 3.4.2 Hollowware
25 - 3.4.3 Types of packaging and wrapping materials
26 - 3.5 METHODS OF WRAPPING
26 - 3.6 SEALING OF PACKS AND BAGS
26 - 3.6.1 General
26 - 3.6.2 Heat sealing
27 - 3.6.3 Sterilizing indicator tape
31 - SECTION 4 STERILIZING EQUIPMENT
31 - 4.1 GENERAL
31 - 4.2 STEAM STERILIZERS
31 - 4.2.1 General
32 - 4.2.2 Portable steam sterilizers (benchtop sterilizers)
33 - 4.3 DRY HEAT STERILIZERS
34 - SECTION 5 LOADING OF STERILIZERS
34 - 5.1 FOR STEAM STERILIZATION
34 - 5.1.1 General
34 - 5.1.2 Loading of portable (benchtop) sterilizers
34 - 5.2 FOR DRY HEAT STERILIZATION
34 - 5.2.1 General
34 - 5.2.2 Loading
34 - 5.3 EFFECT OF LOAD CONTENT AND MANNER OF LOADING
35 - SECTION 6 UNLOADING OF STERILIZERS
35 - 6.1 STEAM STERILIZERS
35 - 6.1.1 With drying cycle
35 - 6.1.2 Without drying cycle
35 - 6.2 DRY HEAT STERILIZERS
35 - 6.3 MONITORING OF THE UNLOADING PROCEDURE
36 - SECTION 7 PURCHASING, COMMISSIONING, MONITORING OF CALIBRATION, PERFORMANCE TESTING, MAINTENANCE OF STERILIZERS AND ANY .....
36 - 7.1 PURCHASING
36 - 7.2 COMMISSIONING AND RECORDS OF EQUIPMENT TESTING AND MAINTENANCE
36 - 7.3 MONITORING, CALIBRATION AND PERFORMANCE TESTING OF STERILIZERS AND ASSOCIATED EQUIPMENT
36 - 7.3.1 General
36 - 7.3.2 Sterilizers
37 - 7.3.3 Associated equipment
37 - 7.4 MAINTENANCE OF STERILIZERS
37 - 7.4.1 General
37 - 7.4.2 Steam sterilizers
38 - 7.4.3 Dry heat sterilizers
38 - 7.5 MAINTENANCE OF ASSOCIATED EQUIPMENT
38 - 7.5.1 Portable ultrasonic cleaners
38 - 7.5.2 Instrument washers
38 - 7.5.3 Heat sealers
39 - 7.6 VALIDATION OF THE STERILIZATION PROCESS
39 - 7.6.1 General
39 - 7.6.2 Validation
39 - 7.6.3 Revalidation
48 - SECTION 8 QUALITY MANAGEMENT
48 - 8.1 STERILIZING MANAGEMENT
48 - 8.2 DOCUMENTATION
48 - 8.3 EDUCATION AND TRAINING
49 - 8.4 PERFORMANCE MANAGEMENT
49 - 8.5 MATERIALS MANAGEMENT
49 - 8.5.1 General
49 - 8.5.2 Product identification and traceability
50 - 8.5.3 Deviation, fault analysis and complaint analysis
50 - 8.5.4 Recall protocol
50 - 8.6 MONITORING STERILIZING CYCLES
50 - 8.6.1 Physical monitors
50 - 8.6.2 Chemical indicators
52 - 8.6.3 Biological/enzymatic indicators
52 - 8.6.4 Special performance tests for pre-vacuum steam sterilizers
53 - 8.6.5 Implantable items
53 - 8.7 MONITORING OF THE PACKAGING PROCESS
53 - 8.8 VALIDATION PROCESSES
54 - 8.9 OCCUPATIONAL HEALTH AND SAFETY
54 - 8.9.1 Staff health
54 - 8.9.2 Staff attire
54 - 8.9.3 Handwashing/hand hygiene
54 - 8.10 ENVIRONMENTAL CONTROL
55 - 8.11 EVALUATION, FEEDBACK AND OUTCOMES
55 - 8.12 OFF-SITE REPROCESSING
56 - SECTION 9 STORAGE AND HANDLING OF PROCESSED ITEMS
56 - 9.1 PREVENTION OF CONTAMINATION
56 - 9.1.1 General
56 - 9.1.2 Storage of unwrapped critical medical devices
56 - 9.1.3 Storage of unwrapped semi- critical and non-critical medical devices
56 - 9.2 STORAGE AREAS FOR STERILE ITEMS
56 - 9.2.1 General
56 - 9.2.2 Access to stored items
57 - 9.3 TRANSPORTATION OF STERILE ITEMS
57 - 9.4 COMMERCIALLY PREPARED ITEMS
57 - 9.5 SHELF-LIFE/ROTATION OF STOCK
57 - 9.5.1 General
57 - 9.5.2 Stock which is nonconforming
58 - 9.5.3 Factors which compromise sterile stock
59 - SECTION 10 DISINFECTION OF REUSABLE INSTRUMENTS
59 - 10.1 GENERAL
59 - 10.2 MEANS OF DISINFECTION
59 - 10.2.1 Thermal disinfection
60 - 10.2.2 Chemical disinfection
61 - SECTION 11 CLEANING OF THE STERILIZING AREA AND ASSOCIATED EQUIPMENT
61 - 11.1 GENERAL
61 - 11.2 EQUIPMENT
61 - 11.3 WASTE DISPOSAL
62 - SECTION 12 SELECTION AND CARE OF INSTRUMENTS
62 - 12.1 GENERAL
62 - 12.2 GENERAL CONSIDERATIONS
62 - 12.2.1 General
62 - 12.2.2 Identification
62 - 12.2.3 Removal of soil
63 - 12.2.4 Sorting instruments and inspection
63 - 12.2.5 Benchtop sterilizers without a drying cycle
63 - 12.2.6 Lubrication
63 - 12.3 SPECIAL CONSIDERATIONS
64 - 12.4 SPECIALIZED INSTRUMENTS
64 - 12.4.1 Microsurgical instruments
64 - 12.4.2 Insulated instruments
64 - 12.4.3 Instruments on loan
64 - 12.4.4 Handpieces
65 - 12.4.5 Aspiration systems
65 - 12.4.6 Triplex syringe
65 - 12.4.7 Ultrasonic scalers
66 - SECTION 13 USE OF TEXTILES
66 - 13.1 GENERAL
66 - 13.2 SPECIFIC CONSIDERATIONS
66 - 13.3 MENDING
67 - APPENDIX A - LIST OF REFERENCED DOCUMENTS
68 - APPENDIX B - CARE AND HANDLING OF POWERED TOOLS
68 - B1 SCOPE
68 - B2 CLEANING OF POWERED INSTRUMENTS AND HOSES
68 - B3 LUBRICATION
68 - B4 INSPECTION AND TESTING
69 - B5 STERILIZATION
70 - APPENDIX C - GUIDE TO THE SELECTION OF CLEANING AGENTS
71 - APPENDIX D - SELECTION AND USE OF RIGID REUSABLE STERILIZATION CONTAINERS
71 - D1 SCOPE
71 - D2 GENERAL
71 - D3 SPECIFIC CONSIDERATIONS
71 - D3.1 Acquisition
71 - D3.2 Inspection and maintenance
71 - D3.3 Validation
71 - D3.4 Packing techniques and protection of instruments
71 - D3.5 Mass
71 - D3.6 Storage
72 - APPENDIX E - HEAT SEALING EQUIPMENT
72 - E1 USES
72 - E2 TYPES OF EQUIPMENT
72 - E3 WIDTH OF SEAL
72 - E4 TYPE OF SEAL
73 - APPENDIX F - GUIDELINES FOR THE SELECTION OF PORTABLE (‘BENCHTOP’) STERILIZERS IN OFFICE-BASED HEALTH CARE FACILITIES
73 - F1 GENERAL
73 - F2 SELECTION OF STERILIZERS
73 - F2.1 Steam-under-pressure sterilizer with drying cycle
73 - F2.2 Steam-under-pressure sterilizer without drying cycle
73 - F2.3 Dry heat sterilizer
74 - APPENDIX G - METHOD FOR MEASUREMENT OF TEMPERATURE IN STEAM OR DRY HEAT STERILIZERS
74 - G1 SCOPE
74 - G2 PRINCIPLE
74 - G3 APPARATUS
74 - G4 PROCEDURE
75 - G5 REPORT
76 - APPENDIX H - VALIDATION PROTOCOL FOR STERILIZATION PROCESS
76 - H1 GENERAL
76 - H2 VALIDATION PROTOCOL
76 - H3 VALIDATION REPORT
78 - APPENDIX I - HANDWASHING
78 - I1 FACILITIES REQUIRED
78 - I2 HANDWASHING
78 - I3 HANDWASHING AGENT
78 - I4 FREQUENCY OF HANDWASHING
78 - I5 ROUTINE HANDWASHING PROCEDURE (see Figure I1)
80 - APPENDIX J - BIBLIOGRAPHY