Standard
Track updates
AS 5369:2023
[Current]Reprocessing of reusable medical devices and other devices in health and non-health related facilities
AS 5369:2023 specifies the requirements and practices necessary for the effective and safe reprocessing, storage, handling and transportation of reusable medical devices and other devices used in human health care and other treatments.
Published: 15/12/2023
Pages: 132
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Introduction
1 Scope and general
1.1 Scope
1.2 Exclusions
1.3 Normative references
1.4 Abbreviations
1.5 Terms and definitions
2 Quality assurance
2.1 General
2.1.1 Overview
2.1.2 Critical elements in product realization
2.1.3 Calibration and preventive maintenance
2.2 Risk-based approach
2.3 Documentation
2.3.1 General
2.3.2 Policies and procedures
2.3.3 Records
2.3.4 Control of documents and records
2.4 Management responsibility
2.4.1 General
2.4.2 Resource requirements
2.4.3 Reprocessing facility
2.4.4 Equipment
2.4.5 Contracts
2.5 Product realization
2.5.1 General
2.5.2 Purchasing
2.5.3 Identification and traceability of product
2.5.3.1 General
2.5.3.2 Traceability records
2.5.4 Control of monitoring and measuring equipment
2.5.4.1 General
2.5.4.2 Documentation
2.5.4.3 Nonconformance
2.6 Measurement, analysis and improvement
2.6.1 Audits
2.6.2 Nonconforming RMD/other device
2.6.3 Corrective action
2.6.3.1 General
2.6.3.2 Recall procedure
2.6.3.3 Recall report
2.6.4 Preventive action
3 Reprocessing agent characterization
3.1 General
3.1.1 Introduction
3.1.2 Reprocessing agent register
3.1.3 Reprocessing agent information
3.2 Cleaning agents
3.3 Disinfection agents and systems
3.3.1 Disinfection agents
3.3.2 Disinfection systems
3.4 Sterilizing agents
3.5 Microbicidal effectiveness
3.6 Effects on RMD/other device
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
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
5 Product definition
5.1 General
5.1.1 General requirements
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/other devices
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/other device 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 Personal protective equipment (PPE)
5.6.14 Waste disposal
5.6.15 Ventilation
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
6.2.2.1 Transportation
6.2.2.2 Pre-treatment
6.2.3 Cleaning
6.3 Disinfection process definition
6.3.1 General
6.3.2 Categorizing RMD/other device for disinfection
6.3.3 Non-critical RMD/other device
6.3.4 Non-heat-labile semi-critical RMD/other device
6.3.5 Heat-labile semi-critical RMD/other device
6.4 Packaging process definition
6.4.1 General
6.4.2 Packaging procedures
6.5 Sterilization 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
7 Validation
7.1 Stages of validation
7.2 Installation Qualification (IQ)
7.2.1 General
7.2.2 Equipment installation qualification
7.2.3 Services qualification
7.2.3.1 Water quality
7.2.3.2 Steam supply
7.2.3.2.1 Steam quality tests
7.2.3.2.2 Steam generation for sterilizers
7.3 Operational Qualification (OQ)
7.4 Performance Qualification (PQ)
7.4.1 General
7.4.2 Cleaning processes
7.4.3 Washer-disinfectors (WDs)
7.4.4 Controlled-environment storage cabinets for thermolabile endoscopes
7.4.5 Packaging processes
7.4.5.1 General
7.4.5.2 Heat sealing process performance qualification (PQ)
7.4.5.3 Wrapping process performance qualification (PQ)
7.4.5.4 Reusable container performance qualification (PQ)
7.4.6 Sterilization processes
7.5 Review and approval of validation
7.5.1 General
7.5.2 Validation report
7.5.3 Approval of validation report
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 Ultrasonic cleaners
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 sterilization processes
8.7.1 General
8.7.2 Low temperature sterilization 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)
9 Release of RMDs/other devices following reprocessing
9.1 General
9.2 RMD/other device release criteria
9.3 RMD/other device release
9.4 Records of RMD/other device release
9.5 Handling, transport and storage of released reprocessed RMDs/other devices
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
A.1 Scope
A.2 Guidance to Section 2: Quality assurance
A.2.1 General
A.2.1.1 Critical elements in product realization
A.2.1.2 Calibration and preventive maintenance
A.2.2 Risk-based approach
A.2.3 Documentation
A.2.3.1 General
A.2.3.2 Policies and procedures
A.2.3.3 Records
A.2.3.4 Control of documents and records
A.2.4 Management responsibility
A.2.4.1 General
A.2.4.2 Resource requirements
A.2.4.3 Reprocessing facility
A.2.4.4 Equipment
A.2.4.5 Contracts
A.2.5 Product realization
A.2.5.1 General
A.2.5.2 Purchasing
A.2.5.3 Identification and traceability of product
A.2.5.3.1 General
A.2.5.3.2 Traceability records
A.2.5.4 Control of monitoring and measuring equipment
A.2.5.4.1 General
A.2.5.4.2 Documentation
A.2.5.4.3 Nonconformance
A.2.6 Measurement, analysis and improvement
A.2.6.1 Audits
A.2.6.2 Nonconforming RMD/other device
A.2.6.3 Corrective action
A.2.6.3.1 General
A.2.6.3.2 Recall procedure
A.2.6.3.3 Recall report
A.2.6.4 Preventive action
A.3 Guidance to Section 3: Reprocessing agent characterization
A.3.1 General
A.3.1.1 Introduction
A.3.1.2 Reprocessing agent register
A.3.1.3 Reprocessing agent information
A.3.2 Cleaning agent
A.3.3 Disinfectants
A.3.4 Sterilizing agents
A.3.5 Microbicidal effectiveness
A.3.6 Effects on RMD/other device materials
A.3.7 Personnel and environmental safety
A.3.7.1 Safety information
A.3.7.2 Environmental impact
A.3.7.3 Health and safety procedures
A.3.7.4 Health and safety training
A.4 Guidance to Section 4: Process characterization and equipment characterization
A.4.1 General
A.4.2 Process characterization
A.4.3 Equipment characterization
A.4.3.1 Equipment specifications
A.4.3.2 Controlling and monitoring software
A.4.3.3 Standards for reprocessing equipment
A.5 Guidance to Section 5: Product definition
A.5.1 General
A.5.1.1 General requirements
A.5.1.2 Classification for reprocessing
A.5.1.3 Policies and procedures
A.5.2 Product families
A.5.3 Limiting values
A.5.4 Pre-disinfection and pre-sterilization cleanliness of RMDs/other devices
A.5.5 Packaging system
A.5.5.1 General
A.5.5.2 Compatibility
A.5.5.3 Protective packaging
A.5.6 Reprocessing environment
A.5.6.1 General
A.5.6.2 Facility design
A.5.6.3 Facility finishes
A.5.6.4 Fixtures and finishing
A.5.6.5 RMD/other device cleaning sinks
A.5.6.6 Water
A.5.6.7 Workstations
A.5.6.8 Lighting
A.5.6.9 Storage
A.5.6.10 Facility cleaning
A.5.6.11 Entry to facility
A.5.6.12 Hand hygiene
A.5.6.13 Personal protective equipment (PPE)
A.5.6.14 Waste disposal
A.5.6.15 Ventilation
A.6 Guidance to Section 6: Process definition
A.6.1 General
A.6.1.1 Introduction
A.6.1.2 Immediate-use sterilization
A.6.2 Cleaning process definition
A.6.2.1 General
A.6.2.2 Transportation and pre-treatment
A.6.2.2.1 Transportation
A.6.2.2.2 Pre-treatment
A.6.2.3 Cleaning
A.6.3 Disinfection process definition
A.6.4 Packaging process definition
A.6.4.1 General
A.6.4.2 Packaging procedures
A.6.5 Sterilization process definition
A.6.5.1 General
A.6.5.2 Sterilization procedures
A.6.5.3 Moist heat sterilization
A.6.5.4 Ethylene oxide sterilization
A.6.5.5 Dry heat
A.6.5.6 Low temperature sterilization systems
A.7 Guidance to Section 7: Validation
A.7.1 Stages of validation
A.7.2 Installation qualification (IQ)
A.7.2.1 General
A.7.2.2 Equipment installation qualification
A.7.2.3 Services qualification
A.7.2.3.1 Water quality
A.7.2.3.2 Steam supply
A.7.3 Operational qualification (OQ)
A.7.4 Performance qualification (PQ)
A.7.4.1 General
A.7.4.2 Cleaning processes
A.7.4.3 Washer-disinfectors
A.7.4.4 Controlled-environment storage cabinets for thermolabile endoscopes
A.7.4.5 Packaging processes
A.7.4.5.1 General
A.7.4.5.2 Heat sealing process
A.7.4.5.3 Wrapping process
A.7.4.5.4 Reusable containers
A.7.4.6 Sterilization processes
A.7.5 Review and approval of validation
A.7.5.1 General
A.7.5.2 Validation report
A.7.5.3 Approval of validation report
A.8 Guidance to Section 8: Routine monitoring and control
A.8.1 General
A.8.2 Routine monitoring and control of cleaning processes
A.8.3 Routine monitoring and control of manual chemical disinfection with high-level instrument grade disinfectant
A.8.4 Routine monitoring and control of washer disinfectors employing chemical disinfection for thermolabile endoscope
A.8.5 Microbiological surveillance of flexible endoscopes with channels
A.8.6 Routine monitoring and control of packaging processes
A.8.7 Routine monitoring and control of sterilization processes
A.9 Guidance to Section 9: Product release of RMDs/other devices from reprocessing
A.9.1 General
A.9.2 RMD/other device release criteria
A.9.3 RMD/other device release
A.9.4 Records of RMD/other device release
A.9.5 Handling, transport and storage of released reprocessed RMDs/other devices
A.10 Guidance to Section 10: Maintaining process effectiveness
A.10.1 General
A.10.2 Calibration
A.10.3 Maintenance of equipment
A.10.3.1 General
A.10.3.2 Return to use
A.10.3.3 Maintenance records
A.10.3.4 Identifying faults
A.10.3.5 Cleaning of equipment
A.10.4 Requalification
A.10.4.1 General
A.10.4.2 Procedures for requalification
A.10.4.3 Review and acceptance of requalification
A.10.5 Assessment of change
Appendix B
B.1 General
B.2 Risk-based program
B.2.1 Assemble a team
B.2.2 Develop a process flow
B.2.3 Risk analysis
B.3 Risk evaluation
B.4 Risk control
B.5 Risk evaluation
B.6 Review
Bibliography
Cited references in this standard
EN 16442
Controlled environment storage cabinet for processed thermolabile endoscopes
EN 14180
Sterilizers for medical purposes — Low temperature steam formaldehyde sterilizers — Requirements and testing
EN 13060
Small steam sterilizers
EN 1422
Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods
EN 285
Sterilization — Steam sterilizers — Large sterilizers
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