AS/NZS 4815:2006


Office-based health care facilities — Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment

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, surgical and allied health facilities and skin penetration establishments. May also be suitable for application to the instruments and equipment used exclusively on animals in veterinary practice. Does not apply to day surgical or day procedures centres or items that may be contaminated with prions capable of causing TSEs, e.g. Creutzfeldt-Jakob.
Published: 06/04/2006
Pages: 81
Table of contents
Cited references
Content history
Table of contents
About this publication
1 Scope and general
1.1 Scope
1.2 Referenced documents
1.3 Definitions
1.4 Reprocessing environment
1.5 Reprocessing of instruments and equipment
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 General Cleaning agents and equipment for manual cleaning Method of cleaning Manual cleaning of respiratory equipment
2.9.3 Mechanical cleaning General Instrument washers Ultrasonic cleaners
2.10 Rinsing of instruments
2.11 Drying of instruments
2.11.1 General
2.11.2 Drying methods
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 Paper Woven and non-woven Flexible packaging Rigid reusable sterilization containers Nylon packaging material
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
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
5 Loading of sterilizers
5.1 For steam sterilization
5.1.1 General
5.1.2 Loading of small steam (benchtop) sterilizers Cycles with a drying stage Cycles without a drying stage
5.2 For dry heat sterilization
5.2.1 General
5.2.2 Loading
5.3 Effect of load content and manner of loading
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
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 Validation process Frequency of validation Accessibility of technical support
7.3.2 Commissioning of sterilizers General Installation qualification Operational qualification
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 Leak rate/vacuum test Air removal and steam penetration test Air detector test
7.7.4 Physical monitors for heat sterilization Monitoring physical parameters during sterilizing cycles Methods of temperature and pressure measurement
7.7.5 Chemical indicators Classes of chemical indicators Information from the supplier Using chemical indicators
7.7.6 Biological/enzymatic indicators General Selection of biological/enzymatic indicators Frequency of use of biological/enzymatic indicators Incubation of 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
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 Batch control numbers Sterilizing cycle records Sterilizer maintenance records
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
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
10 Disinfection
10.1 General
10.2 Means of disinfection
10.2.1 Thermal disinfection
10.2.2 Chemical disinfection General Instrument grade disinfectants Hospital grade disinfectants
11 Cleaning of the sterilizing area and associated equipment
11.1 General
11.2 Equipment
11.3 Waste disposal
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
13 Use of textiles
Appendix A
Appendix B
B1 Scope
B2 Cleaning of powered instruments and hoses
B3 Lubrication and maintenance
B4 Inspection and testing
B5 Sterilization
Appendix C
Appendix D
D1 Uses
D2 Types of equipment
D3 Width of seal
Appendix E
Appendix F
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
G1 Scope
G2 Principle
G3 Apparatus
G4 Installation of apparatus
G5 Assuring measurement accuracy
G6 Procedure
G7 Report
Cited references in this standard
EN 13060
Small steam sterilizers
prEN ISO 15883-1
Washer-disinfectors, Part 1: General requirements, terms and definitions and tests.
Sterilizers — Steam — Downward-displacement
Sterilization of health care products — Chemical indicators — Part 1: General requirements
NZS 4304
New Zealand Standard management of health care wastes
Content history
DR 03655
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