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BS ISO 22441:2022

BS ISO 22441:2022

$215.11

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

Published By Publication Date Number of Pages
BSI 2022 90
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PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
8 Introduction
11 1 Scope
1.1 Inclusions
1.2 Exclusions
12 2 Normative references
3 Terms and definitions
20 4 Quality management system elements
21 5 Sterilizing agent characterization
5.1 General
5.2 Sterilant and sterilizing agent
5.3 Microbicidal effectiveness
22 5.4 Effects on materials
5.5 Safety and the environment
23 6 Process and equipment characterization
6.1 General
6.2 Process characterization
24 6.3 Equipment characterization
25 7 Product definition
26 8 Process definition
27 9 Validation
9.1 General
28 9.2 Installation qualification (IQ)
9.2.1 General
9.2.2 Equipment
29 9.3 Operational qualification (OQ)
9.4 Performance qualification (PQ)
31 9.5 Review and approval of validation
10 Routine monitoring and control
32 11 Product release from sterilization
12 Maintaining process effectiveness
12.1 General
12.2 Recalibration
12.3 Maintenance of equipment
33 12.4 Requalification
12.5 Assessment of change
34 Annex A (normative) Factors to be considered in selection of microorganisms for demonstrating microbicidal effectiveness
36 Annex B (normative) Approach 1 — Process definition based on inactivation of the microbial population in its natural state (bioburden method)
38 Annex C (normative) Approach 2 — Process definition based on inactivation of reference microorganisms and knowledge of bioburden (BI/bioburden method)
40 Annex D (normative) Approach 3 — Conservative process definition based on inactivation of reference microorganisms (overkill method)
43 Annex E (informative) Guidance on application of this document
66 Annex F (informative) Schematic example of a VH2O2 sterilization cycle
67 Annex G (informative) Environmental aspects
72 Annex H (informative) Justification for the number of temperature sensors and biological indicators (BIs)
74 Annex I (informative) Aspects of VH2O2
77 Annex J (informative) Recommended validation tests
82 Annex K (informative) Recommended validation test procedures
88 Bibliography

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BS ISO 22441:2022
$215.11