ISO 22413:2021 PDF

Scope: This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.

ISO 22413:2021 Referenced Document

ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
ISO 15747 Plastic containers for intravenous injections
ISO 15759 Medical infusion equipment - Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process
ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
ISO 80369-1 Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
ISO 8871-5 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing

2021 ISO 22413:2021 Transfer sets for pharmaceutical preparations - Requirements and test methods
2010 ISO 22413:2010 Transfer sets for pharmaceutical preparations - Requirements and test methods
2007 ISO 22413:2007 Transfer sets for pharmaceutical preparations - Requirements and test methods