I.S. EN ISO 25424:2019
Current
The latest, up-to-date edition.
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
Hardcopy , PDF
English
08-12-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
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
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