This European Standard specifies requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems. It includes requirements for the design of the neck, size designation, distension and, where relevant, for electrical resistance. This document is not applicable to special-purpose bags, for example bellows and self-expanding bags. Bags for use with anaesthetic gas scavenging systems are not considered to be anaesthetic reservoir bags and are thus outside the scope of this document.
EN 1820:2005+A1:2009 Referenced Document
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2024-04-20 Update
EN 60601-1:1990 Medical Electrical Equipment Part 1: General Requirements for Safety Includes Amendments A1:1993, A11:1993, A12:1993, A2:1995 and A13:1996; Incorporates Corrigendum July 1994; Incorporates Corrigendum August 2005; IEC 60601-1:1988 + A1:1991 + A2:1995 + c
EN ISO 4287:1998 Geometrical product specification (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parameters Incorporates Amendment A1: 2009
EN ISO 5356-1:2004 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets ; ISO 5356-1:2004 [Superseded: SN NS-EN 1281-1:1997/A1:1998]
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 7000:2004 Graphical symbols for use on equipment - Index and synopsis