ESO (1) Reference and title of the harmonised standard (and reference document) First publication OJ Reference of superseded standard Date of cessation of presumption of conformity of superseded standard Note 1

CEN EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated ‘STERILE’ - Part 1: Requirements for terminally sterilized medical devices 31.7.2002 EN 556:1994 + A1:1998 Note 2.1 Date expired (30.4.2002)

EN 556-1:2001/AC:2006 15.11.2006

CEN EN 556-2:2003 Sterilization of medical devices - Requirements for medical devices to be designated ‘STERILE’ - Part 2: Requirements for aseptically processed medical devices 9.8.2007

CEN EN 980:2008 Symbols for use in the labelling of medical devices 23.7.2008 EN 980:2003 Note 2.1 Date expired (31.5.2010)

CEN EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) This is the first publication

CEN EN 12322:1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media 9.10.1999

EN 12322:1999/A1:2001 31.7.2002 Note 3 Date expired (30.4.2002)

CEN EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) 2.4.2004 EN ISO 13488:2000 EN ISO 13485:2000 Note 2.1 Date expired (31.7.2009)

EN ISO 13485:2003/AC:2009 This is the first publication

CEN EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing 17.12.2002

CEN EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices 17.12.2002

EN 13612:2002/AC:2002 2.12.2009

CEN EN 13640:2002 Stability testing of in vitro diagnostic reagents 17.12.2002

CEN EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents 17.12.2002

CEN EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects 21.11.2003

CEN EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures 15.11.2006

CEN EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans 28.4.2005

CEN EN 14820:2004 Single-use containers for human venous blood specimen collection 28.4.2005

CEN EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) This is the first publication EN ISO 14937:2000 Note 2.1 Date expired (30.4.2010)

CEN EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) This is the first publication EN ISO 14971:2007 Note 2.1 Date expired (21.3.2010)

CEN EN ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009) This is the first publication

CEN EN ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009) This is the first publication

CEN EN ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003) 28.4.2005

EN ISO 15197:2003/AC:2005 2.12.2009

CEN EN ISO 15225:2000 Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) 31.7.2002

EN ISO 15225:2000/A1:2004 2.12.2009 Note 3 Date expired (31.8.2004)

EN ISO 15225:2000/A2:2005 2.12.2009 Note 3 Date expired (31.1.2006)

CEN EN ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) 28.4.2005

CEN EN ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) This is the first publication

CEN EN ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) This is the first publication EN 375:2001 Note 2.1 31.12.2012

CEN EN ISO 18113-3:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) This is the first publication EN 591:2001 Note 2.1 31.12.2012

CEN EN ISO 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) This is the first publication EN 376:2002 Note 2.1 31.12.2012

CEN EN ISO 18113-5:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) This is the first publication EN 592:2002 Note 2.1 31.12.2012

CEN EN ISO 18153:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003) 21.11.2003

CEN EN ISO 20776-1:2006 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006) 9.8.2007

Cenelec EN 61010-2-101:2002 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment IEC 61010-2-101:2002 (Modified) 17.12.2002

Cenelec EN 61326-2-6:2006 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment IEC 61326-2-6:2005 27.11.2008

Cenelec EN 62304:2006 Medical device software - Software life-cycle processes IEC 62304:2006 27.11.2008