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BS EN ISO 25424:2019 Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices >
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BS EN ISO 25424:2019 Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices, 2019
- undefined [Go to Page]
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Quality management system elements
- 4.1 General
- 4.2 Documentation
- 4.3 Management responsibility
- 4.4 Product realization
- 4.5 Control of non-conforming product
- 5 Sterilizing agent characterization
- 5.1 General
- 5.2 Sterilizing agent
- 5.3 Microbicidal effectiveness
- 5.4 Material effects
- 5.5 Environmental considerations
- 6 Process and equipment characterization
- 6.1 General
- 6.2 Process
- 6.3 Equipment
- 7 Product definition
- 8 Process definition
- 9 Validation
- 9.1 General
- 9.2 Installation qualification
- 9.2.1 General
- 9.2.2 Installation
- 9.2.3 Equipment
- 9.3 Operational qualification
- 9.4 Performance qualification
- 9.4.1 General
- 9.4.2 Performance qualification — Physical
- 9.4.3 Performance qualification — Microbiological
- 9.4.4 Performance qualification — Desorption and drying
- 9.5 Review and approval of validation
- 10 Routine monitoring and control
- 10.1 General
- 10.2 Biological indicators
- 10.3 Chemical indicators
- 10.4 Records
- 11 Product release from sterilization
- 12 Maintaining process effectiveness
- 12.1 General
- 12.2 Maintenance of equipment
- 12.3 Requalification
- 12.4 Assessment of change
- Annex A (normative) Process definition based on inactivation of reference microorganisms and knowledge of bioburden on product items to be sterilized
- Annex B (normative) Process definition based on inactivation of reference microorganisms
- Annex C (informative) Guidance on application of this document
- Annex D (informative) Environmental aspects regarding development, validation and routine control of low temperature steam and formaldehyde processes
- Bibliography [Go to Page]
