DIN ISO 8536-12:2010-07 [PLEASE NOTE: DOCUMENT WITHDRAWN]
Title (german): Infusionsgeräte zur medizinischen Verwendung - Teil 12: Rückschlagventile (ISO 8536-12:2007)
Title (english): Infusion equipment for medical use - Part 12: Check valves (ISO 8536-12:2007)
Document type: Standard
Publication date: 2010-07
The standard contains the German translation of the International Standard ISO 8536-12:2007, which has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use" with the participation of German experts. At DIN, the German Institute for Standardization e. V., the responsible Committee is Working Committee NA 063-02-02 "Transfusions-/Infusionsbehältnisse und -geräte aus Kunststoffen" ("Transfusion/infusion containers and equipment made from plastics") of the Medical Standards Committee (NAMed). This part of ISO 8536 applies to sterilized check valves intended for single use and used with infusion equipment for gravity-feed infusion and/or with pressure infusion apparatus. The functional requirements also apply to built-in check valves. The standard specifies minimum requirements for the materials to be used, the packaging and labelling. Furthermore, the physical, chemical and biological requirements are specified; in the case of chemical and biological requirements reference is given to other standards. Verification of compliance with the physical requirements is carried out by performing corresponding tests described in Annex A.