协调标准.doc

ESO(1) Reference and title of the harmonised standard(and reference document) 协调标准 First publication OJ公告时间 Reference of superseded standard被替代标准 Date of cessation of presumption of conformity of superseded standardNote 1失效时间 CEN EN 285:2006+A1:2008Sterilization - Steam sterilizers - Large sterilizers 19/02/2009 EN 285:2006Note 2.1 Date expired(30/11/2008) CEN EN 455-1:2000Medical gloves for single use - Part 1: Requirements and testing for freedom from holes 30/09/2005 EN 455-1:1993Note 2.1 Date expired(30/04/2001) CEN EN 455-2:2000Medical gloves for single use - Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996) 31/07/2002 EN 455-2:1995Note 2.1 Date expired(30/04/2001) CEN EN 455-3:2006Medical gloves for single use - Part 3: Requirements and testing for biological evaluation 09/08/2007 EN 455-3:1999Note 2.1 Date expired(30/06/2007) CEN EN 556-1:2001Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices 31/07/2002 EN 556:1994 + A1:1998Note 2.1 Date expired(30/04/2002) ? EN 556-1:2001/AC:2006 15/11/2006 ? ? CEN EN 556-2:2003Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices 09/08/2007 ? ? CEN EN 794-1:1997Lung ventilators - Part 1: Particular requirements for critical care ventilators 08/11/1997 ? ? ? EN 794-1:1997/A1:2000 31/07/2002 Note 3 Date expired(31/05/2001) CEN EN 794-3:1998Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators 28/06/1999 ? ? ? EN 794-3:1998/A1:2005 02/06/2006 Note 3 Date expired(31/12/2005) CEN EN 980:2008Symbols for use in the labelling of medical devices 23/07/2008 EN 980:2003Note 2.1 31/05/2010 CEN EN 1041:2008Information supplied by the manufacturer of medical devices 19/02/2009 EN 1041:1998Note 2.1 31