AS/NZS 4187:2014
Reprocessing of reusable medical devices in health service organizations
To ensure that health service organisations (HSOs) correctly clean, disinfect and sterilize reuseable medical devices (RMDs) prior to and between patient uses in order to produce RMDs that are able to be used safely without risk of transmission of infectious agents. There are significant differences in the structure, content and terminology of this edition of the Standard and that of the previous 2003 edition.
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AS/NZS 4187:2014 REPROCESSING OF REUSABLE MEDICAL DEVICES IN HEALTH SERVICE ORGANIZATIONS
PREFACE
CONTENTS
FOREWORD
SECTION 1 SCOPE AND GENERAL
1.1 SCOPE
1.2 EXCLUSIONS
1.3 NORMATIVE REFERENCES
1.4 ABBREVIATIONS
1.5 DEFINITIONS
1.5.1 A0
1.5.2 Aeration
1.5.3 Australian Register of Therapeutic Goods (ARTG)
1.5.4 Batch
1.5.5 Bioburden
1.5.6 Biofilm
1.5.7 Biological indicator (BI)
1.5.8 Calibration
1.5.9 Change control
1.5.10 Chemical indicator (CI)
1.5.11 Cleaning
1.5.12 Cleaning agent
1.5.13 Competent person
1.5.14 Condensate
1.5.15 Containment devices
1.5.16 Contamination
1.5.17 Corrective action
1.5.18 Critical medical device
1.5.19 Disinfectant
1.5.20 Disinfection
1.5.21 Drying phase
1.5.22 Exposure time
1.5.23 Fault
1.5.24 Health service organization (HSO)
1.5.25 High level disinfectant
1.5.26 Holding time
1.5.27 Hollowware
1.5.28 Hospital grade disinfectant
1.5.29 Immediate use sterilization
1.5.30 Implantable medical device
1.5.31 Infectious agents
1.5.32 Installation qualification (IQ)
1.5.33 Instrument grade disinfectant
1.5.34 Intermediate level disinfectant
1.5.35 Labile
1.5.36 Liquid chemical sterilizing agent
1.5.37 Loan or trial reusable medical device
1.5.38 Low level disinfectant
1.5.39 Manufacturer™s instructions
1.5.40 Medical device
1.5.41 Microbicidal
1.5.42 Minimum recommended concentration (MRC)
1.5.43 Monitoring
1.5.44 Nonconforming product
1.5.45 Non-critical medical device
1.5.46 Non-invasive medical device
1.5.47 Office based practice (office based health care facility)
1.5.48 Open-but-unused medical device
1.5.49 Operational qualification (OQ)
1.5.50 Overkill approach
1.5.51 Packaging system
1.5.52 Penetration time
1.5.53 Performance qualification (PQ)
1.5.54 Preformed sterile barrier system
1.5.55 Pre-treatment
1.5.56 Preventive action
1.5.57 Process challenge device (PCD)
1.5.58 Process parameter
1.5.59 Process variable
1.5.60 Processing
1.5.61 Processing category
1.5.62 Product family
1.5.63 Product
1.5.64 Protective packaging
1.5.65 Reprocessing
1.5.66 Requalification
1.5.67 Reusable container
1.5.68 Reusable medical device (RMD)
1.5.69 Reverse osmosis (RO)
1.5.70 Safety data sheet (SDS)
1.5.71 Saturated steam
1.5.72 Semi-critical medical device
1.5.73 Shall
1.5.74 Should
1.5.75 Soil
1.5.76 Spaulding Classification System
1.5.77 Specify
1.5.78 Standard precautions
1.5.79 Sterile
1.5.80 Sterile barrier system (SBS)
1.5.81 Sterility
1.5.82 Sterility assurance level (SAL)
1.5.83 Sterilization
1.5.84 Sterilization process
1.5.85 Sterilizing agent
1.5.86 Terminal sterilization
1.5.87 Traceability
1.5.88 Transmission-based precautions
1.5.89 Validation
1.5.90 Verify
1.5.91 Washer-disinfector (WD)
SECTION 2 QUALITY MANAGEMENT
2.1 GENERAL
2.2 DOCUMENTATION
2.2.1 General
2.2.2 Policies and procedures
2.2.3 Records
2.2.4 Control of documents and records
2.3 MANAGEMENT RESPONSIBILITY
2.3.1 General
2.3.2 Resource requirements
2.3.3 Reprocessing facility
2.3.4 Equipment
2.3.5 Contracts
2.4 PRODUCT REALIZATION
2.4.1 General
2.4.2 Purchasing
2.4.3 Identification and traceability of product
2.4.4 Control of monitoring and measuring equipment
2.5 MEASUREMENT, ANALYSIS AND IMPROVEMENT
2.5.1 Audits
2.5.2 Nonconforming RMD
2.5.3 Corrective action
2.5.4 Preventative action
SECTION 3 REPROCESSING AGENT CHARACTERIZATION
3.1 GENERAL
3.1.1 Introduction
3.1.2 Reprocessing agent selection
3.1.3 Reprocessing agent information
3.2 CLEANING AGENTS
3.3 DISINFECTANTS
3.4 STERILIZING AGENTS
3.5 MICROBICIDAL EFFECTIVENESS
3.6 EFFECTS ON RMD MATERIALS
3.7 PERSONNEL AND ENVIRONMENTAL SAFETY
3.7.1 Safety information
3.7.2 Environmental impact
3.7.3 Health and safety procedures
3.7.4 Health and safety training
SECTION 4 PROCESS CHARACTERIZATION AND EQUIPMENT CHARACTERIZATION
4.1 GENERAL
4.2 PROCESS CHARACTERIZATION
4.3 EQUIPMENT CHARACTERIZATION
4.3.1 Equipment specifications
4.3.2 Controlling and monitoring software
4.3.3 Standards for reprocessing equipment
SECTION 5 PRODUCT DEFINITION
5.1 GENERAL
5.1.1 General
5.1.2 Classification for reprocessing
5.1.3 Policies and procedures
5.2 PRODUCT FAMILIES
5.3 LIMITING VALUES
5.4 PRE-DISINFECTION AND PRE-STERILIZATION CLEANLINESS OF RMDs
5.5 PACKAGING SYSTEM
5.5.1 General
5.5.2 Compatibility
5.5.3 Protective packaging
5.6 REPROCESSING ENVIRONMENT
5.6.1 General
5.6.2 Facility design
5.6.3 Facility finishes
5.6.4 Fixtures and finishing
5.6.5 RMD cleaning sinks
5.6.6 Water
5.6.7 Workstations
5.6.8 Lighting
5.6.9 Storage
5.6.10 Facility cleaning
5.6.11 Entry to facility
5.6.12 Hand hygiene
5.6.13 Waste disposal
5.6.14 Ventilation
SECTION 6 PROCESS DEFINITION
6.1 GENERAL
6.1.1 Introduction
6.1.2 Immediate use sterilization
6.2 CLEANING PROCESS DEFINITION
6.2.1 General
6.2.2 Transportation and pre-treatment
6.2.3 Cleaning
6.3 DISINFECTING PROCESS DEFINITION
6.3.1 General
6.3.2 Categorizing RMD for disinfection
6.3.3 Non-critical RMD
6.3.4 Non heat labile semi-critical RMD
6.3.5 Heat labile semi-critical RMD
6.4 PACKAGING PROCESS DEFINITION
6.4.1 General
6.4.2 Packaging procedures
6.5 STERILIZING PROCESS DEFINITION
6.5.1 General
6.5.2 Sterilization procedures
6.5.3 Moist heat sterilization
6.5.4 Ethylene oxide sterilization
6.5.5 Dry heat
6.5.6 Low temperature sterilization systems
SECTION 7 VALIDATION
7.1 GENERAL
7.1.1 General
7.1.2 Stages of validation
7.2 INSTALLATION QUALIFICATION (IQ)
7.2.1 General
7.2.2 Equipment installation qualification
7.2.3 Services qualification
7.3 OPERATIONAL QUALIFICATION (OQ)
7.4 PERFORMANCE QUALIFICATION (PQ)
7.4.1 General
7.4.2 Cleaning processes
7.4.3 Washer-disinfectors
7.4.4 Packaging processes
7.4.5 Sterilizing processes
7.5 REVIEW AND APPROVAL OF VALIDATION
7.5.1 General
7.5.2 Validation report
7.5.3 Approval of validation report
SECTION 8 ROUTINE MONITORING AND CONTROL
8.1 GENERAL
8.2 ROUTINE MONITORING AND CONTROL OF CLEANING PROCESSES
8.2.1 General
8.2.2 Manual cleaning
8.2.3 Washer disinfectors employing thermal disinfection
8.2.4 Ultrasonics
8.2.5 Cleaning efficacy inspection
8.2.6 Drying cabinets
8.3 ROUTINE MONITORING AND CONTROL OF MANUAL CHEMICAL DISINFECTION WITH HIGH LEVEL INSTRUMENT GRADE DISINFECTANT
8.4 ROUTINE MONITORING AND CONTROL OF WASHER DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPE
8.5 MICROBIOLOGICAL SURVEILLANCE OF FLEXIBLE ENDOSCOPES WITH CHANNELS
8.6 ROUTINE MONITORING AND CONTROL OF PACKAGING PROCESSES
8.7 ROUTINE MONITORING AND CONTROL OF STERILIZING PROCESSES
8.7.1 General
8.7.2 Low temperature sterilizing systems
8.7.3 Dry heat
8.7.4 Moist heat
8.7.5 Biological indicators
8.7.6 Chemical indicators
8.7.7 Process challenge devices (PCD)
SECTION 9 RELEASE OF RMDS FOLLOWING REPROCESSING
9.1 GENERAL
9.2 RMD RELEASE CRITERIA
9.3 RMD RELEASE
9.4 RECORDS OF RMD RELEASE
9.5 HANDLING, TRANSPORT AND STORAGE OF RELEASED REPROCESSED RMDS
SECTION 10 MAINTAINING PROCESS EFFECTIVENESS
10.1 GENERAL
10.2 CALIBRATION
10.3 MAINTENANCE OF EQUIPMENT
10.3.1 General
10.3.2 Return to use
10.3.3 Maintenance records
10.3.4 Identifying faults
10.3.5 Cleaning of equipment
10.4 REQUALIFICATION
10.4.1 General
10.4.2 Procedures for requalification
10.4.3 Review and acceptance of requalification
10.5 ASSESSMENT OF CHANGE
APPENDIX A - GUIDANCE
A1 SCOPE OF APPENDIX
A2 GUIDANCE TO SECTION 2: QUALITY MANAGEMENT
A2.1 General
A2.2 Documentation
A2.3 Management responsibility
A2.4 Product realization
A2.5 Measurement, analysis and improvement
A3 GUIDANCE FOR SECTION 3: REPROCESSING AGENT CHARACTERIZATION
A3.1 General
A3.2 Cleaning agent
A3.3 Disinfectants
A3.4 Sterilizing agents
A3.5 Microbicidal effectiveness
A3.6 Effects on RMD materials
A3.7 Personnel and environmental safety
A4 GUIDANCE TO SECTION 4: PROCESS CHARACTERIZATION AND EQUIPMENT CHARACTERIZATION
A4.1 General
A4.2 Process characterization
A4.3 Equipment characterization
A5 GUIDANCE TO SECTION 5: PRODUCT DEFINITION
A5.1 General
A5.2 Product families
A5.3 Limiting values
A5.4 Pre-disinfection and pre-sterilization cleanliness of RMDs
A5.5 Packaging
A5.6 Reprocessing environment
A6 GUIDANCE TO SECTION 6: PROCESS DEFINITION
A6.1 General
A6.2 Cleaning process definition
A6.3 Disinfecting process definition
A6.4 Packaging process definition
A6.5 Sterilizing process definition
A7 GUIDANCE TO SECTION 7: VALIDATION
A7.1 General
A7.2 Installation qualification (IQ)
A7.3 Operational qualification (OQ)
A7.4 Performance qualification (PQ)
A7.5 Review and approval of validation
A8 GUIDANCE TO SECTION 8: ROUTINE MONITORING AND CONTROL
A8.1 General
A8.2 Routine monitoring and control of cleaning processes
A8.3 Routine monitoring and control of manual chemical disinfection with high level instrument grade disinfectant
A8.4 Routine monitoring and control of washer disinfectors employing chemical disinfection for thermolabile endoscope
A8.5 Microbiological surveillance of flexible endoscopes with channels
A8.6 Routine monitoring and control of packaging processes
A8.7 Routine monitoring of control of sterilizing processes
A9 GUIDANCE TO SECTION 9: PRODUCT RELEASE OF RMDS FROM REPROCESSING
A9.1 General
A9.2 RMD release criteria
A9.3 RMD release
A9.4 Records of RMD release
A9.5 Handling, transport and storage of released reprocessed RMDs
A10 GUIDANCE TO SECTION 10: (MAINTAINING PROCESS EFFECTIVENESS)
A10.1 General
A10.2 Calibration
A10.3 Maintenance of equipment
A10.4 Requalification
A10.5 Assessment of change
APPENDIX B - BIBLIOGRAPHY
B1 INFORMATIVE REFERENCED DOCUMENTS
B2 FURTHER READING
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AS/NZS 4187:2014 REPROCESSING OF REUSABLE MEDICAL DEVICES IN HEALTH SERVICE ORGANIZATIONS
PREFACE
CONTENTS
FOREWORD
SECTION 1 SCOPE AND GENERAL
1.1 SCOPE
1.2 EXCLUSIONS
1.3 NORMATIVE REFERENCES
1.4 ABBREVIATIONS
1.5 DEFINITIONS
1.5.1 A0
1.5.2 Aeration
1.5.3 Australian Register of Therapeutic Goods (ARTG)
1.5.4 Batch
1.5.5 Bioburden
1.5.6 Biofilm
1.5.7 Biological indicator (BI)
1.5.8 Calibration
1.5.9 Change control
1.5.10 Chemical indicator (CI)
1.5.11 Cleaning
1.5.12 Cleaning agent
1.5.13 Competent person
1.5.14 Condensate
1.5.15 Containment devices
1.5.16 Contamination
1.5.17 Corrective action
1.5.18 Critical medical device
1.5.19 Disinfectant
1.5.20 Disinfection
1.5.21 Drying phase
1.5.22 Exposure time
1.5.23 Fault
1.5.24 Health service organization (HSO)
1.5.25 High level disinfectant
1.5.26 Holding time
1.5.27 Hollowware
1.5.28 Hospital grade disinfectant
1.5.29 Immediate use sterilization
1.5.30 Implantable medical device
1.5.31 Infectious agents
1.5.32 Installation qualification (IQ)
1.5.33 Instrument grade disinfectant
1.5.34 Intermediate level disinfectant
1.5.35 Labile
1.5.36 Liquid chemical sterilizing agent
1.5.37 Loan or trial reusable medical device
1.5.38 Low level disinfectant
1.5.39 Manufacturer™s instructions
1.5.40 Medical device
1.5.41 Microbicidal
1.5.42 Minimum recommended concentration (MRC)
1.5.43 Monitoring
1.5.44 Nonconforming product
1.5.45 Non-critical medical device
1.5.46 Non-invasive medical device
1.5.47 Office based practice (office based health care facility)
1.5.48 Open-but-unused medical device
1.5.49 Operational qualification (OQ)
1.5.50 Overkill approach
1.5.51 Packaging system
1.5.52 Penetration time
1.5.53 Performance qualification (PQ)
1.5.54 Preformed sterile barrier system
1.5.55 Pre-treatment
1.5.56 Preventive action
1.5.57 Process challenge device (PCD)
1.5.58 Process parameter
1.5.59 Process variable
1.5.60 Processing
1.5.61 Processing category
1.5.62 Product family
1.5.63 Product
1.5.64 Protective packaging
1.5.65 Reprocessing
1.5.66 Requalification
1.5.67 Reusable container
1.5.68 Reusable medical device (RMD)
1.5.69 Reverse osmosis (RO)
1.5.70 Safety data sheet (SDS)
1.5.71 Saturated steam
1.5.72 Semi-critical medical device
1.5.73 Shall
1.5.74 Should
1.5.75 Soil
1.5.76 Spaulding Classification System
1.5.77 Specify
1.5.78 Standard precautions
1.5.79 Sterile
1.5.80 Sterile barrier system (SBS)
1.5.81 Sterility
1.5.82 Sterility assurance level (SAL)
1.5.83 Sterilization
1.5.84 Sterilization process
1.5.85 Sterilizing agent
1.5.86 Terminal sterilization
1.5.87 Traceability
1.5.88 Transmission-based precautions
1.5.89 Validation
1.5.90 Verify
1.5.91 Washer-disinfector (WD)
SECTION 2 QUALITY MANAGEMENT
2.1 GENERAL
2.2 DOCUMENTATION
2.2.1 General
2.2.2 Policies and procedures
2.2.3 Records
2.2.4 Control of documents and records
2.3 MANAGEMENT RESPONSIBILITY
2.3.1 General
2.3.2 Resource requirements
2.3.3 Reprocessing facility
2.3.4 Equipment
2.3.5 Contracts
2.4 PRODUCT REALIZATION
2.4.1 General
2.4.2 Purchasing
2.4.3 Identification and traceability of product
2.4.4 Control of monitoring and measuring equipment
2.5 MEASUREMENT, ANALYSIS AND IMPROVEMENT
2.5.1 Audits
2.5.2 Nonconforming RMD
2.5.3 Corrective action
2.5.4 Preventative action
SECTION 3 REPROCESSING AGENT CHARACTERIZATION
3.1 GENERAL
3.1.1 Introduction
3.1.2 Reprocessing agent selection
3.1.3 Reprocessing agent information
3.2 CLEANING AGENTS
3.3 DISINFECTANTS
3.4 STERILIZING AGENTS
3.5 MICROBICIDAL EFFECTIVENESS
3.6 EFFECTS ON RMD MATERIALS
3.7 PERSONNEL AND ENVIRONMENTAL SAFETY
3.7.1 Safety information
3.7.2 Environmental impact
3.7.3 Health and safety procedures
3.7.4 Health and safety training
SECTION 4 PROCESS CHARACTERIZATION AND EQUIPMENT CHARACTERIZATION
4.1 GENERAL
4.2 PROCESS CHARACTERIZATION
4.3 EQUIPMENT CHARACTERIZATION
4.3.1 Equipment specifications
4.3.2 Controlling and monitoring software
4.3.3 Standards for reprocessing equipment
SECTION 5 PRODUCT DEFINITION
5.1 GENERAL
5.1.1 General
5.1.2 Classification for reprocessing
5.1.3 Policies and procedures
5.2 PRODUCT FAMILIES
5.3 LIMITING VALUES
5.4 PRE-DISINFECTION AND PRE-STERILIZATION CLEANLINESS OF RMDs
5.5 PACKAGING SYSTEM
5.5.1 General
5.5.2 Compatibility
5.5.3 Protective packaging
5.6 REPROCESSING ENVIRONMENT
5.6.1 General
5.6.2 Facility design
5.6.3 Facility finishes
5.6.4 Fixtures and finishing
5.6.5 RMD cleaning sinks
5.6.6 Water
5.6.7 Workstations
5.6.8 Lighting
5.6.9 Storage
5.6.10 Facility cleaning
5.6.11 Entry to facility
5.6.12 Hand hygiene
5.6.13 Waste disposal
5.6.14 Ventilation
SECTION 6 PROCESS DEFINITION
6.1 GENERAL
6.1.1 Introduction
6.1.2 Immediate use sterilization
6.2 CLEANING PROCESS DEFINITION
6.2.1 General
6.2.2 Transportation and pre-treatment
6.2.3 Cleaning
6.3 DISINFECTING PROCESS DEFINITION
6.3.1 General
6.3.2 Categorizing RMD for disinfection
6.3.3 Non-critical RMD
6.3.4 Non heat labile semi-critical RMD
6.3.5 Heat labile semi-critical RMD
6.4 PACKAGING PROCESS DEFINITION
6.4.1 General
6.4.2 Packaging procedures
6.5 STERILIZING PROCESS DEFINITION
6.5.1 General
6.5.2 Sterilization procedures
6.5.3 Moist heat sterilization
6.5.4 Ethylene oxide sterilization
6.5.5 Dry heat
6.5.6 Low temperature sterilization systems
SECTION 7 VALIDATION
7.1 GENERAL
7.1.1 General
7.1.2 Stages of validation
7.2 INSTALLATION QUALIFICATION (IQ)
7.2.1 General
7.2.2 Equipment installation qualification
7.2.3 Services qualification
7.3 OPERATIONAL QUALIFICATION (OQ)
7.4 PERFORMANCE QUALIFICATION (PQ)
7.4.1 General
7.4.2 Cleaning processes
7.4.3 Washer-disinfectors
7.4.4 Packaging processes
7.4.5 Sterilizing processes
7.5 REVIEW AND APPROVAL OF VALIDATION
7.5.1 General
7.5.2 Validation report
7.5.3 Approval of validation report
SECTION 8 ROUTINE MONITORING AND CONTROL
8.1 GENERAL
8.2 ROUTINE MONITORING AND CONTROL OF CLEANING PROCESSES
8.2.1 General
8.2.2 Manual cleaning
8.2.3 Washer disinfectors employing thermal disinfection
8.2.4 Ultrasonics
8.2.5 Cleaning efficacy inspection
8.2.6 Drying cabinets
8.3 ROUTINE MONITORING AND CONTROL OF MANUAL CHEMICAL DISINFECTION WITH HIGH LEVEL INSTRUMENT GRADE DISINFECTANT
8.4 ROUTINE MONITORING AND CONTROL OF WASHER DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPE
8.5 MICROBIOLOGICAL SURVEILLANCE OF FLEXIBLE ENDOSCOPES WITH CHANNELS
8.6 ROUTINE MONITORING AND CONTROL OF PACKAGING PROCESSES
8.7 ROUTINE MONITORING AND CONTROL OF STERILIZING PROCESSES
8.7.1 General
8.7.2 Low temperature sterilizing systems
8.7.3 Dry heat
8.7.4 Moist heat
8.7.5 Biological indicators
8.7.6 Chemical indicators
8.7.7 Process challenge devices (PCD)
SECTION 9 RELEASE OF RMDS FOLLOWING REPROCESSING
9.1 GENERAL
9.2 RMD RELEASE CRITERIA
9.3 RMD RELEASE
9.4 RECORDS OF RMD RELEASE
9.5 HANDLING, TRANSPORT AND STORAGE OF RELEASED REPROCESSED RMDS
SECTION 10 MAINTAINING PROCESS EFFECTIVENESS
10.1 GENERAL
10.2 CALIBRATION
10.3 MAINTENANCE OF EQUIPMENT
10.3.1 General
10.3.2 Return to use
10.3.3 Maintenance records
10.3.4 Identifying faults
10.3.5 Cleaning of equipment
10.4 REQUALIFICATION
10.4.1 General
10.4.2 Procedures for requalification
10.4.3 Review and acceptance of requalification
10.5 ASSESSMENT OF CHANGE
APPENDIX A - GUIDANCE
A1 SCOPE OF APPENDIX
A2 GUIDANCE TO SECTION 2: QUALITY MANAGEMENT
A2.1 General
A2.2 Documentation
A2.3 Management responsibility
A2.4 Product realization
A2.5 Measurement, analysis and improvement
A3 GUIDANCE FOR SECTION 3: REPROCESSING AGENT CHARACTERIZATION
A3.1 General
A3.2 Cleaning agent
A3.3 Disinfectants
A3.4 Sterilizing agents
A3.5 Microbicidal effectiveness
A3.6 Effects on RMD materials
A3.7 Personnel and environmental safety
A4 GUIDANCE TO SECTION 4: PROCESS CHARACTERIZATION AND EQUIPMENT CHARACTERIZATION
A4.1 General
A4.2 Process characterization
A4.3 Equipment characterization
A5 GUIDANCE TO SECTION 5: PRODUCT DEFINITION
A5.1 General
A5.2 Product families
A5.3 Limiting values
A5.4 Pre-disinfection and pre-sterilization cleanliness of RMDs
A5.5 Packaging
A5.6 Reprocessing environment
A6 GUIDANCE TO SECTION 6: PROCESS DEFINITION
A6.1 General
A6.2 Cleaning process definition
A6.3 Disinfecting process definition
A6.4 Packaging process definition
A6.5 Sterilizing process definition
A7 GUIDANCE TO SECTION 7: VALIDATION
A7.1 General
A7.2 Installation qualification (IQ)
A7.3 Operational qualification (OQ)
A7.4 Performance qualification (PQ)
A7.5 Review and approval of validation
A8 GUIDANCE TO SECTION 8: ROUTINE MONITORING AND CONTROL
A8.1 General
A8.2 Routine monitoring and control of cleaning processes
A8.3 Routine monitoring and control of manual chemical disinfection with high level instrument grade disinfectant
A8.4 Routine monitoring and control of washer disinfectors employing chemical disinfection for thermolabile endoscope
A8.5 Microbiological surveillance of flexible endoscopes with channels
A8.6 Routine monitoring and control of packaging processes
A8.7 Routine monitoring of control of sterilizing processes
A9 GUIDANCE TO SECTION 9: PRODUCT RELEASE OF RMDS FROM REPROCESSING
A9.1 General
A9.2 RMD release criteria
A9.3 RMD release
A9.4 Records of RMD release
A9.5 Handling, transport and storage of released reprocessed RMDs
A10 GUIDANCE TO SECTION 10: (MAINTAINING PROCESS EFFECTIVENESS)
A10.1 General
A10.2 Calibration
A10.3 Maintenance of equipment
A10.4 Requalification
A10.5 Assessment of change
APPENDIX B - BIBLIOGRAPHY
B1 INFORMATIVE REFERENCED DOCUMENTS
B2 FURTHER READING
Previous versions
AS/NZS 4187:2014
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