EN 556-2:2024

Reference details

Reference: EN 556-2:2024
Official title: Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
Organisation: CEN
Publisher status in source: PublishedThis 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.

Legislation reference records

The following records come from Commission information lists. A source listing, a publication status and a legal presumption of conformity answer different questions. Check the applicable Official Journal acts, dates and restrictions for the intended claim.