Overview
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 transmit, mix or dissolve pharmaceutical liquids between containers. The standard applies to transfer sets with and without housings and covers component design, materials, physical/chemical/biological performance, packaging, labelling and disposal considerations.
Key Topics
- Scope and definitions
- Applies to single-use, sterilized transfer sets used with infusion and injection containers.
- Defines a transfer set as a medical device to transmit liquid pharmaceutical preparations.
- Design and designation
- Illustrative designs for transfer sets with/without housings, channels, air inlets/outlets, filters, small-bore connectors and protective caps.
- Maximum outer diameter of piercing device: ≤ 6.5 mm.
- Materials
- Materials must meet chemical and biological requirements when in contact with transferred fluids; compatibility references include ISO 8536‑4.
- Physical requirements and test methods (Annex A)
- Particulate contamination: manufacturing must minimize particles; tested per A.2 against a contamination index limit.
- Tensile strength: must withstand a static tensile force of ≥ 15 N for 15 s (A.3).
- Leakage and sterility: airtight with no air/liquid leaks (A.4).
- Free flow: ensures unobstructed fluid/air transfer (A.5).
- Piercing devices: smooth, burr-free surfaces after puncture (A.6).
- Penetration force limits: specified maximums (A.7), e.g. metal piercing device against injection closures 10 N, plastic piercing devices against infusion closures 80 N, against plastic IV containers 200 N.
- Fragmentation: individual evaluation of pierced closure fragmentation; criteria and tests included.
- Small-bore connectors, filters, protective caps: functional and safety requirements described.
- Packaging, labelling and disposal
- Requirements for sterile barrier packaging (ISO 11607‑1), unit/multi-unit labelling and end-of-life single-use disposal guidance.
Applications
- Practical use: design, testing, manufacture, quality control and regulatory compliance for devices that transfer sterile pharmaceutical liquids (e.g., reconstitution of lyophilized drugs, container-to-container transfers).
- Who uses this standard:
- Medical device and pharmaceutical manufacturers
- Product designers and R&D teams (transfer set components, piercing devices)
- Quality assurance and regulatory affairs professionals
- Test laboratories and conformity assessment bodies
- Procurement and clinical engineering teams specifying compatible transfer sets
Related Standards
Keywords: ISO 22413:2021, transfer sets, pharmaceutical preparations, single-use, sterilized, test methods, piercing device, particulate contamination, penetration force.
