ISO 25424:2009
Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 25424:2009 specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.
ISO 25424:2009 is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices.
ISO 25424:2009 covers sterilization processes that use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.
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Scope
Inclusions
Exclusions
Normative references
Terms and definitions
Quality management system elements
Documentation
Management responsibility
Product realization
Control of non-conforming product
Sterilizing agent characterization
General
Sterilizing agent
Microbicidal effectiveness
Material effects
Environmental considerations
Process and equipment characterization
General
Process
Equipment
Product definition
Process definition
Validation
General
Installation qualification
General
Installation
Equipment
Operational qualification
Performance qualification
General
Performance qualification – physical
Performance qualification – microbiological
Performance qualification – desorption and drying
Desorption
Drying
Review and approval of validation
Routine monitoring and control
General
Biological indicators
Chemical indicators
Records
Product release from sterilization
Maintaining process effectiveness
General
Maintenance of equipment
Requalification
Assessment of change
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AS/NZS 4187:2014
Reprocessing of reusable medical devices in health service organizations
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AS/NZS 4187:2014 A1
Reprocessing of reusable medical devices in health service organizations: Amendment 1:2015 -
AS/NZS 4187:2014 A2
Reprocessing of reusable medical devices in health service organizations, Amendment 2 -
AS/NZS 4815:2006
Office-based health care facilities - Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment
Scope
Inclusions
Exclusions
Normative references
Terms and definitions
Quality management system elements
Documentation
Management responsibility
Product realization
Control of non-conforming product
Sterilizing agent characterization
General
Sterilizing agent
Microbicidal effectiveness
Material effects
Environmental considerations
Process and equipment characterization
General
Process
Equipment
Product definition
Process definition
Validation
General
Installation qualification
General
Installation
Equipment
Operational qualification
Performance qualification
General
Performance qualification – physical
Performance qualification – microbiological
Performance qualification – desorption and drying
Desorption
Drying
Review and approval of validation
Routine monitoring and control
General
Biological indicators
Chemical indicators
Records
Product release from sterilization
Maintaining process effectiveness
General
Maintenance of equipment
Requalification
Assessment of change