DIN EN ISO 8836:2015-02

This standard specifies basic requirements, dimensions and size designations for suction catheters made of plastics for use in suctioning of the respiratory tract. The specifications regarding dimensions and size designations are intended to assist clinicians in the selection of a suction catheter for a particular patient. The size of the outside diameter is crucial for the catheter selection because of its relationship to the ease with which the catheter can be passed through a tracheal or tracheostomy tube. In comparison to DIN EN ISO 8836:2009-08, the scope has been extended to include closed suction catheters and associated requirements including test procedures for such catheters have been incorporated. Further essential technical changes include: a) supplement of general requirements relating to risk evaluation and safety; b) Inclusion of the term and definition "suction catheter connector" including the specification of requirements for this connector; c) specification of the force required to detach components not securely attached, including the test method; d) addition of the requirement that suction catheters shall not contain natural rubber latex; e) supplement of a requirement for radiopacity including the test method; f) revision of the requirements for the marking of suction catheters and for the labelling of individual packs and shelf/multi-unit packs for suction catheters. The standard has been prepared by CEN/TC 215 "Respiratory and anaesthetic equipment" (secretariat: BSI, United Kingdom), in collaboration with ISO/TC 121/SC 2 "Airways and related equipment" (secretariat: ANSI, USA), with the participation of German experts. The responsible body at DIN is Working Committee NA 053-03-02 AA "Medizinprodukte für das Atemwegssystem" ("Airways and related equipment") at NARK.