Table of Contents
FOREWORD
SECTION 1 - SCOPE AND GENERAL
1.1 SCOPE
1.2 REFERENCED DOCUMENTS
1.3 DEFINITIONS
1.4 PROCESSING 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 CLEANING AREA
2.6 SORTING OF ITEMS IN THE STERILIZING
PROCESSING FACILITY PRIOR TO CLEANING
2.7 CLEANING PRECAUTIONS
2.8 CLEANING AGENTS
2.9 CLEANING METHODS
2.10 DRYING OF ITEMS
2.11 MONITORING OF CLEANING PROCESSES
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
3.5 METHODS OF WRAPPING
3.6 SEALING OF PACKS AND BAGS
SECTION 4 - STERILIZING EQUIPMENT
4.1 GENERAL
4.2 STEAM STERILIZERS
4.3 DRY HEAT STERILIZERS
4.4 LOW TEMPERATURE STERILIZERS AND LIQUID
STERILANTS
SECTION 5 - LOADING OF STERILIZERS
5.1 FOR STEAM STERILIZATION
5.2 FOR DRY HEAT STERILIZATION
5.3 FOR ETHYLENE OXIDE GAS STERILIZATION
5.4 FOR HYDROGEN PEROXIDE PLASMA STERILIZATION
5.5 FOR PERACETIC ACID LIQUID CHEMICAL STERILIZATION
5.6 EFFECT OF LOAD CONTENT AND MANNER OF LOADING
SECTION 6 - UNLOADING OF STERILIZERS
6.1 STEAM STERILIZERS
6.2 DRY HEAT STERILIZERS
6.3 ETHYLENE OXIDE STERILIZERS
6.4 HYDROGEN PEROXIDE PLASMA STERILIZERS
6.5 PERACETIC ACID LIQUID CHEMICAL STERILIZATION
SYSTEM
6.6 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
7.4 RECOMMISSIONING AND PERFORMANCE REQUALIFICATION
OF THE STERILIZER
7.5 CALIBRATION OF STERILIZER
7.6 MONITORING OF STERILIZERS
7.7 MAINTENANCE OF STERILIZERS
7.8 ASSOCIATED EQUIPMENT
SECTION 8 - QUALITY MANAGEMENT
8.1 STERILIZING PROCESSING FACILITY MANAGEMENT
8.2 DOCUMENTATION
8.3 PERFORMANCE MANAGEMENT
8.4 EDUCATION AND TRAINING
8.5 MATERIALS MANAGEMENT
8.6 MONITORING STERILIZING CYCLES
8.7 VALIDATION PROCESSES
8.8 CRITERIA FOR RELEASE OF PROCESSED ITEMS
8.9 MONITORING OF PACKAGING FOLLOWING STERILIZATION
8.10 OCCUPATIONAL HEALTH AND SAFETY
8.11 ENVIRONMENTAL CONTROL
8.12 EVALUATION, FEEDBACK AND OUTCOMES
8.13 OFF-SITE REPROCESSING
SECTION 9 - STORAGE AND HANDLING OF PROCESSED ITEMS
9.1 GENERAL
9.2 STORAGE AREAS FOR STERILE ITEMS
9.3 PLASTIC DUST COVERS
9.4 TRANSPORTATION/DISTRIBUTION OF STERILE ITEMS
9.5 COMMERCIALLY PREPARED ITEMS
9.6 SHELF-LIFE/ROTATION OF STOCK
SECTION 10 - DISINFECTION
10.1 GENERAL
10.2 MEANS OF DISINFECTION
SECTION 11 - CLEANING OF THE STERILIZING PROCESSING
FACILITY 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
12.3 SPECIAL CONSIDERATIONS
12.4 SPECIALIZED INSTRUMENTS
12.5 USE OF INSTRUMENT SHEATHS/SLEEVES
SECTION 13 - USE OF OPERATING ROOM TEXTILES
13.1 GENERAL
13.2 SPECIFIC CONSIDERATIONS
13.3 INSPECTION
13.4 MENDING
13.5 EQUIPMENT
APPENDICES
A - RATIONALE
B - CARE AND HANDLING OF POWERED TOOLS
C - CARE AND HANDLING OF FLEXIBLE AND RIGID ENDOSCOPES,
ACCESSORY ITEMS AND ASSOCIATED EQUIPMENT
D - GUIDE TO THE SELECTION OF CLEANING AGENTS
E - SELECTION AND USE OF RIGID REUSABLE STERILIZATION
CONTAINERS
F - HEAT SEALING EQUIPMENT
G - GUIDELINES FOR THE SELECTION OF PORTABLE ('BENCHTOP')
STERILIZERS IN HEALTH CARE FACILITIES
H - VALIDATION PROTOCOL FOR MOIST HEAT STERILIZATION
PROCESS
I - METHOD FOR MEASUREMENT OF TEMPERATURE AND PRESSURE
IN STEAM STERILIZERS, OR TEMPERATURE ONLY IN DRY
HEAT STERILIZERS
J - HANDWASHING
K - BIBLIOGRAPHY
Abstract
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 health care facilities. May be suitable for application to the instruments and equipment used exclusively on animals in veterinary practice.
Scope
This Standard sets out procedures and process development which may be validated for the cleaning,disinfection and sterilization of reusable medical and surgical instruments and equipment,and maintenance of associated environments in health care facilities.
The Standard may 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,nor to items that may be contaminated with unconventional infective agents,e.g.Creutzfeldt-Jakob,nor to goods such as dressings and bandages which should be obtained sterile from commercial sources,ready for use.
NOTE: Reference should be made to current national guidelines relating to Creutzfeldt-Jakob disease and other transmissible spongiform encephalopathies.
History
First published as AS 4187-1994.
Second edition 1998.
Jointly revised and designated AS/NZS 4187:2003.