Reference details
- Reference
- EN ISO 11607-1:2020/A1:2023
- Official title
- Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)
- 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.
- Packaging, logistics and handling equipment
Protection, transport conditions, package systems and equipment interfaces throughout distribution.
Questions for the evidence file
- Intended purpose
- Classification rationale
- Risk management
- Verification and performance evidence
- Clinical evidence scope
- Package-and-content configuration
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
No Commission citation record has been linked to this reference in the IESQ index. That is an index result, not a conclusion that the standard is uncited. Consult the relevant Commission list and Official Journal acts.
Browse legislation reference lists →