DIN EN ISO 5360:2012-04

This standard applies for agent-specific filling systems for use with agent-specific anaesthetic vaporizers. The anaesthetic agents isoflurane, enflurane, halothane, methoxyflurane, sevoflurane and desflurane were taken into account, whereas because of the unique properties of desflurane, dimensions for this agent have not been specified in the standard. The standard contains in addition to the specifications for design, dimensions and colour coding requirements for the performance of agent-specific filling systems, for example, with regard to leakage and filling rate. The information to be provided by the manufacturer is also specified. With respect to the August 2009 edition, requirements and indications have been incorporated which result from the Amending Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market. This includes requirements or indications for usability, clinical evaluation and information provided by the manufacturer. Furthermore, editorial modifications have been made. The standard has been prepared by ISO/TC 121 "Anaesthetic and respiratory equipment" (secretariat: ANSI, USA), in cooperation with CEN/TC 215 "Respiratory and anaesthetic equipment") (secretariat: BSI, United Kingdom). The responsible German committee is Working Committee NA 053-03-01 AA "Anästhesie und Beatmung" ("Anaesthesia and respiration") of NARK.