Standard
UPDATE AVAILABLE
AS/NZS 4187:2014
[Superseded]Reprocessing of reusable medical devices in health service organisations
Specifies the requirements and practices necessary for the effective and safe reprocessing, storage, handling and transportation of reusable medical devices (RMDs) in human health care.
Published: 15/12/2014
Pages: 102
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 Definitions
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
2.4.3.1 General
2.4.3.2 Traceability records
2.4.4 Control of monitoring and measuring equipment
2.4.4.1 General
2.4.4.2 Documentation
2.4.4.3 Nonconformance
2.5 Measurement, analysis and improvement
2.5.1 Audits
2.5.2 Nonconforming RMD
2.5.3 Corrective action
2.5.3.1 General
2.5.3.2 Recall procedure
2.5.3.3 Recall report
2.5.4 Preventative action
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
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
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
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 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
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
7.2.3.1 Water quality
7.2.3.2 Steam supply
7.2.3.2.1 Steam quality
7.2.3.2.2 Steam purity
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
7.4.4.1 General
7.4.4.2 Heat sealing process performance qualification (PQ)
7.4.4.3 Wrapping process performance qualification (PQ)
7.4.4.4 Reusable container performance qualification (PQ)
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
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)
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
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 of Appendix
A.2 Guidance to Section 2: Quality management
A.2.1 General
A.2.2 Documentation
A.2.2.1 General
A.2.2.2 Policies and procedures
A.2.2.3 Records
A.2.2.4 Control of documents and records
A.2.3 Management responsibility
A.2.3.1 General
A.2.3.2 Resource requirements
A.2.3.3 Reprocessing manager
A.2.3.4 Equipment
A.2.3.5 Contracts
A.2.4 Product realization
A.2.4.1 General
A.2.4.2 Purchasing
A.2.4.3 Identification and traceability of product
A.2.4.3.1 General
A.2.4.3.2 Traceability records
A.2.4.4 Control of monitoring and measuring equipment
A.2.4.4.1 General
A.2.4.4.2 Documentation
A.2.4.4.3 Nonconformance
A.2.5 Measurement, analysis and improvement
A.2.5.1 Audits
A.2.5.2 Nonconforming RMD
A.2.5.3 Corrective action
A.2.5.3.1 General
A.2.5.3.2 Recall procedure
A.2.5.3.3 Recall report
A.2.5.4 Preventative action
A.3 Guidance for 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 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
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
A.5.5 Packaging
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 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 Waste disposal
A.5.6.14 Ventilation
A.6 Guidance to Section 6: Process definition
A.6.1 General
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 Disinfecting process definition
A.6.4 Packaging process definition
A.6.4.1 General
A.6.4.2 Packaging procedures
A.6.5 Sterilizing process definition
A.7 Guidance to Section 7: Validation
A.7.1 General
A.7.1.1 General
A.7.1.2 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 Packaging processes
A.7.4.4.1 General
A.7.4.4.2 Heat sealing process performance qualification (PQ)
A.7.4.4.3 Container performance qualification (PQ)
A.7.4.5 Sterilizing processes
A.7.5 Review and approval of validation
General
A.7.5.2 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 of control of sterilizing processes
A.9 Guidance to Section 9: Product release of RMDs from reprocessing
A.9.1 General
A.9.2 RMD release criteria
A.9.3 RMD release
A.9.4 Records of RMD release
A.9.5 Handling, transport and storage of released reprocessed RMDs
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 Informative referenced documents
B.2 Further reading
Amendment control sheets
AS 4187:2014
Amendment No. 1 (2015)
Revised text amendment
Amendment No. 2 (2019)
Revised text amendment
Cited references in this standard
[Current]
The use of ventilation and airconditioning in buildings, Part 2: Mechanical ventilation in buildings
[Current]
Textiles for health care facilities and institutions, Part 8: Recyclable barrier fabrics
[Current]
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
Content history
[Current]
[Superseded]
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