ISO 22413:2021

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

• ISO 8536 (Infusion equipment), especially ISO 8536‑4
• ISO 7864 (Sterile hypodermic needles)
• ISO 80369 series (Small-bore connectors) and ISO 80369‑20
• ISO 11607‑1 (Packaging for terminally sterilized medical devices)
• ISO 8871‑5, ISO 15747, ISO 15759

Keywords: ISO 22413:2021, transfer sets, pharmaceutical preparations, single-use, sterilized, test methods, piercing device, particulate contamination, penetration force.