BS EN ISO 22413:2021

What is ISO 22413 about?

ISO 22413 is one of a series of documents for transfer sets for pharmaceutical preparations and specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.

The transfer sets consist either of two piercing devices or of a piercing device in combination with a small-bore connector, which can relate to each other in different ways. Transfer sets can have housing.

Who is ISO 22413 for?

ISO 22413 is applicable to-

• Manufacturers of Transfer sets for pharmaceutical preparations
• Medical laboratories
• Healthcare facilities
• Research centres

Why should you use ISO 22413?

Transfer sets for pharmaceutical preparations transmit fluids from one container to another. The transfer sets mix fluids or dissolve dry substances and are used in combination with infusion and injection containers

ISO 22413 helps manufacturers with design and minimum requirements for Transfer sets for pharmaceutical preparations to aim to avoid fragments being emitted and ensure no transmission of infectious substance has taken place. It provides recognized solutions for the protection of patients’ health and safety.

What’s changed since the last update?

BS EN ISO 22413:2021 supersedes ISO 22413:2010, which has been withdrawn. BS EN ISO 22413:2021 has some significant technical changes with respect to ISO 22413:2010, these include:

• Table 1 on penetration force was amended by a new entry
• 7 (formerly 5.7) on fragmentation was clarified
• Former Clause 12 on storage was deleted
• Clause 10 (formerly Clause 13) on labelling was updated
• Clause 11 on the disposal has been added due to the single-use character of the product
• Former Annexes A and B on testing of fragmentation of transfer sets were moved to a new Annex A on physical tests