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BS ISO 22441:2022 Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices >
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BS ISO 22441:2022 Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices, 2022
- National foreword
- Foreword
- Introduction
- 1 Scope [Go to Page]
- 2 Normative references
- 3 Terms and definitions
- 4 Quality management system elements
- 5 Sterilizing agent characterization [Go to Page]
- 6 Process and equipment characterization [Go to Page]
- 7 Product definition
- 8 Process definition
- 9 Validation [Go to Page]
- 10 Routine monitoring and control
- 11 Product release from sterilization
- 12 Maintaining process effectiveness [Go to Page]
- Annex A (normative) Factors to be considered in selection of microorganisms for demonstrating microbicidal effectiveness
- Annex B (normative) Approach 1 — Process definition based on inactivation of the microbial population in its natural state (bioburden method)
- Annex C (normative) Approach 2 — Process definition based on inactivation of reference microorganisms and knowledge of bioburden (BI/bioburden method)
- Annex D (normative) Approach 3 — Conservative process definition based on inactivation of reference microorganisms (overkill method)
- Annex E (informative) Guidance on application of this document
- Annex F (informative) Schematic example of a VH2O2 sterilization cycle
- Annex G (informative) Environmental aspects
- Annex H (informative) Justification for the number of temperature sensors and biological indicators (BIs)
- Annex I (informative) Aspects of VH2O2
- Annex J (informative) Recommended validation tests
- Annex K (informative) Recommended validation test procedures
- Bibliography [Go to Page]