The information contained in the summary
list is a compilation of the references of standards which have been
published in the Official Journal of the European Union.
Although the lists are updated regularly, they
may not be complete and they do not have any legal validity; only
publication in the Official Journal produces legal affect.
|
ESO
(1) |
Reference and title of the harmonised
standard
(and reference document) |
Reference of superseded standard |
Date of cessation of
presumption of conformity of superseded standard
Note 1 |
|
CEN |
EN 375:2001
Information supplied by the manufacturer with in
vitro diagnostic reagents for professional use |
— |
|
|
CEN |
EN 376:2002
Information supplied by the manufacturer with in
vitro diagnostic reagents for self-testing |
— |
|
|
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 |
EN 556:1994 + A1:1998 |
Date expired
(30.04.2002) |
|
|
EN 556-1:2001/AC: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 |
— |
|
|
CEN |
EN 591:2001
Instructions for use for in vitro diagnostic
instruments for professional use |
— |
|
|
CEN |
EN 592:2002
Instructions for use for in vitro diagnostic
instruments for self-testing |
— |
|
|
CEN |
EN 980:2008
Symbols for use in the labelling of medical devices |
EN 980:2003 |
31.05.2010 |
|
CEN |
EN 12286:1998
In vitro diagnostic medical devices - Measurement of
quantities in samples of biological origin - Presentation of reference
measurement procedures |
— |
|
|
|
EN 12286:1998/A1:2000 |
Note 3 |
Date expired
(24.11.2000) |
|
CEN |
EN 12287:1999
In vitro diagnostic medical devices - Measurement of
quantities in samples of biological origin - Description of reference
materials |
— |
|
|
CEN |
EN 12322:1999
In vitro diagnostic medical devices - Culture media
for microbiology - Performance criteria for culture media |
— |
|
|
|
EN 12322:1999/A1:2001 |
Note 3 |
Date expired
(30.04.2002) |
|
CEN |
EN ISO 13485:2003
Medical devices - Quality management systems -
Requirements for regulatory purposes (ISO 13485:2003) |
EN 46003:1999
EN ISO 13485:2000
EN ISO 13488:2000 |
31.07.2009 |
|
|
EN ISO 13485:2003/AC:2007 |
|
|
|
CEN |
EN 13532:2002
General requirements for in vitro diagnostic medical
devices for self-testing |
— |
|
|
CEN |
EN 13612:2002
Performance evaluation of in vitro diagnostic medical
devices |
— |
|
|
CEN |
EN 13640:2002
Stability testing of in vitro diagnostic reagents |
— |
|
|
CEN |
EN 13641:2002
Elimination or reduction of risk of infection related
to in vitro diagnostic reagents |
— |
|
|
CEN |
EN 13975:2003
Sampling procedures used for acceptance testing of in
vitro diagnostic medical devices - Statistical aspects |
— |
|
|
CEN |
EN 14136:2004
Use of external quality assessment schemes in the
assessment of the performance of in vitro diagnostic examination
procedures |
— |
|
|
CEN |
EN 14254:2004
In vitro diagnostic medical devices - Single-use
receptacles for the collection of specimens, other than blood, from
humans |
— |
|
|
CEN |
EN 14820:2004
Single-use containers for human venous blood specimen
collection |
— |
|
|
CEN |
EN ISO 14937:2000
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 14937:2000) |
— |
|
|
CEN |
EN ISO 14971:2007
Medical devices - Application of risk management to
medical devices (ISO 14971:2007) |
EN ISO 14971:2000 |
31.03.2010 |
|
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) |
— |
|
|
CEN |
EN ISO 15225:2000
Nomenclature - Specification for a nomenclature
system for medical devices for the purpose of regulatory data exchange
(ISO 15225:2000) |
— |
|
|
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) |
— |
|
|
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) |
— |
|
|
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) |
— |
|
|
CENELEC |
EEN
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
Reference
document: IEC 61010-2-101:2002 (Modified) |
— |
|
|
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) |
— |
|
|
CENELEC |
EN 62304:2006
Medical device software - Software life-cycle
processes
(IEC 62304:2006) |
— |
|
|
CENELEC |
EN 62366:2008
Medical devices - Application of usability
engineering to medical devices
(IEC 62366:2007) |
— |
|
Note 3: In case of amendments, the referenced standard is EN
CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The
superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its
previous amendments, if any, but without the new quoted amendment. On the date
stated, the superseded standard ceases to give presumption of conformity with
the essential requirements of the directive.
