Reference details
- Reference
- EN 15424:2007
- Official title
- Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
- Organisation
- CEN
- Publisher status in source
- WithdrawnThis is the status recorded in the source, not a statement that this is the latest edition.
- Source access
- 19 October 2026
Research and application
Begin with the official scope and the product configuration. The title identifies a subject; it does not establish every product, use condition or legal requirement covered by the publication.
Product research routes
- Medical devices
Intended medical purpose, device classification and the evidence associated with design, performance and lifecycle controls.
Questions for the evidence file
- Intended purpose
- Classification rationale
- Risk management
- Verification and performance evidence
- Clinical evidence scope
Record the exact edition and associated amendments, the assessed object, the evidence examined and the limits of the conclusion. Explore IESQ research for detailed product and standard studies.
Legal citation
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