Overview
EN ISO 22413:2021 - Transfer sets for pharmaceutical preparations - Requirements and test methods - defines requirements and test methods for sterilized single-use transfer sets used to transfer, mix or reconstitute pharmaceutical preparations. Adopted by CEN (as EN ISO 22413:2021) and superseding the 2013 edition, this standard focuses on safety, functional performance and labelling of devices such as piercing devices, small-bore connectors and transfer sets with or without housings.
Key topics and technical requirements
The standard covers design features, material and verification requirements and specifies test methods (many consolidated in Annex A). Major technical topics include:
- Design and designation
- Configurations: two piercing devices, piercing device + small-bore connector, metal cannula variants, housings for guided application.
- Materials
- Suitable materials for sterile, single‑use pharmaceutical applications.
- Physical requirements and tests
- Particulate contamination, tensile strength, leakage, free flow, piercing device performance, penetration force, fragmentation, air inlet/outlet, protective caps, small‑bore connector integrity, fluid/particle filters.
- Chemical and biological requirements
- Safety considerations for leachables, extractables and biocompatibility consistent with pharmaceutical use.
- Packaging and labelling
- Sterile barrier and packaging system requirements; unit and multi‑unit labelling including essential information and symbols.
- Disposal
- Guidance reflecting the single‑use character of transfer sets.
- Test annex (Annex A)
- Consolidated physical test methods; includes a new stress‑cracking test for small‑bore connectors and alignment with ISO 8536‑4 testing where applicable.
Practical applications and users
EN ISO 22413:2021 is used by:
- Medical device and pharmaceutical component manufacturers developing single‑use transfer sets and piercing devices.
- R&D and design teams specifying mechanical and fluidic performance (penetration force, leakage, fragmentation).
- Quality assurance / regulatory teams preparing conformity documentation and pre-market submissions.
- Test laboratories performing physical tests described in Annex A.
- Procurement specialists and hospital pharmacies evaluating supplier specifications for transfer sets used in aseptic reconstitution, mixing and transfer operations.
Related standards
This standard references and aligns with several ISO documents, for example:
- ISO 8536 series (infusion equipment) - alignment of test structure and methods
- ISO 11607-1 (packaging for terminally sterilized medical devices)
- ISO 80369 series (small-bore connectors)
- ISO 7864 (sterile hypodermic needles)
- ISO 8871-5 (elastomeric parts) and ISO 15747 (plastic IV injection containers)
For full test procedures, acceptance criteria and normative requirements consult the complete EN ISO 22413:2021 text.
