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

Sets out procedures and process development, which can be validated for the cleaning, disinfection and sterilization of reusable medical and surgical instruments and equipment, and maintenance of associated environments in office-based health care facilities not involved in complex patient procedures and processes. Suitable for medical, dental, surgical, allied health and skin penetration practices. May also be suitable for application to the instruments and equipment used exclusively on animals in a veterinary practice.

This Standard sets out procedures and process development which can be validated for the cleaning, disinfection and sterilization of reusable medical and surgical instruments and equipment, and maintenance of associated environments in office-based health care facilities not involved in complex patient procedures and processes.The Standard is suitable for medical, dental, surgical and allied health facilities and skin penetration establishments. The Standard may also be suitable for application to the instruments and equipment used exclusively on animals in veterinary practice.The Standard does not apply to items intended by the manufacturer for single use only, or complex cleaning, disinfecting and sterilizing processes, such as those involving anaesthetic equipment processing, endoscopy equipment processing and processes involving low temperature sterilizing systems. For these processes, reference to AS 4187 is required.

First published as AS/NZS 4815:2001.