Overview

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 2012 edition, Figure 5 on arrangement and dimensions of agent-specific male adapters for use with isoflurane and sevoflurane has been amended. In addition, the informative Annex ZA on the relationship between clauses of the standard and essential requirements of Directive 93/42/EEC concerning medical devices has been revised. 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") at DIN Standards Committee Rescue Services and Hospital (NARK).

Document: references other documents

Responsible national committee

NA 176-05-03 AA - Anaesthesia and artificial respiration  

Responsible european committee

CEN/TC 215 - Respiratory and anaesthetic equipment  

Responsible international committee

ISO/TC 121/SC 1 - Breathing attachments and anaesthetic machines