Overview

This standard applies to sterilized single use transfer sets that are used for pharmaceutical preparations. Transfer sets for pharmaceutical preparations transmit fluids from one container to another. The transfer sets mix fluids or dissolve dry substances. They are used in combination with infusion and injection containers. They consist either of two piercing devices or of a piercing device in combination with a Luer connector, which may be connected with each other in different ways. They may have a housing. Examples of different designs of these sets are: - two piercing devices connected to each other (similar to piercing devices of infusion containers) - a metal cannula, bevelled on both sides or a combination of both examples named above - metal cannulae mostly having a hub or a grip plate in the middle to be fixed to the plastic part - plastic piercing devices directly connected to a grip plate, or held by a tube at a distance to allow a higher hydrostatic pressure - piercing devices with an additional ventilation channel that may end in the other tip or outside - piercing devices also with an air filter - piercing devices with housings serving, among other things, as a guide and a fixation on the connected containers for a secure, injury-free and contactless application - piercing device in combination with a Luer connector - piercing device in combination with a Luer connector and a particle filter. The new version of DIN EN ISO 22413 takes into account in Annex ZA the current EU Commission guidelines regarding content and structure of Table ZA.1. The standard contains the German translation of the European Standard EN ISO 22413:2013, which has been prepared by CEN/TC 205 "Non-active medical devices". The responsible national standardization committee is Working Committee NA 063-02-02 AA "Transfusions-/Infusionsbehältnisse und -geräte aus Kunststoffen" ("Transfusion/infusion containers and equipment made from plastics") of NAMed.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-04-03 AA - Transfusion/infusion containers and equipment made from plastics and disposable sample containers for the in-vitro diagnostics  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 76/WG 1 - Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment