Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (Text with EEA relevance)
Date: 2008-07-23
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device, medical diagnosis

23.7.2008

EN

Official Journal of the European Union

C 186/25

Commission communication in the framework of the implementation of the Directive 98/79/EC of
the European Parliament and of the Council on in vitro diagnostic medical devices

(Text with EEA relevance)

(Publication of titles and references of harmonised standards under the directive)

(2008/C 186/08)

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

EN 375:2001
Information supplied by the manufacturer with in vitro diagnostic
reagents for professional use

EN 376:2002
Information supplied by the manufacturer with in vitro diagnostic
reagents for self-testing

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—

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
(30.4.2002)

EN 556-1:2001/AC:2006

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

EN 591:2001
Instructions for use for in vitro diagnostic instruments for professional
use

EN 592:2002
Instructions for use for in vitro diagnostic instruments for self-testing

—

—

—

EN 980:2008
Symbols for use in the labelling of medical devices

EN 980:2003

31.5.2010

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

EN 12287:1999
In vitro diagnostic medical devices — Measurement of quantities in
samples of biological origin — Description of reference materials

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

EN 12322:1999/A1:2001

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Note 3

—

—

Note 3

Date expired
(24.11.2000)

Date expired
(30.4.2002)

ESO (1)

CEN

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C 186/26

EN

Official Journal of the European Union

23.7.2008

ESO (1)

CEN

CEN

CEN

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Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

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

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

31.7.2009

EN ISO 13485:2003/AC:2007

EN 13532:2002
General
self-testing

requirements

for

in vitro diagnostic medical devices

for

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

EN 13640:2002
Stability testing of in vitro diagnostic reagents

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

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

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

EN 14254:2004
In vitro diagnostic medical devices — Single-use receptacles for the collec-
tion of specimens, other than blood, from humans

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

EN ISO 14937:2000
Sterilization of health care products — General
for
characterization of a sterilizing agent and the development, validation
for medical devices
and routine control of a sterilization process
(ISO 14937:2000)

requirements

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EN ISO 14971:2007
Medical devices — Application of risk management to medical devices
(ISO 14971:2007)

EN ISO 14971:2000

31.3.2010

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

for

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

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23.7.2008

EN

Official Journal of the European Union

C 186/27

ESO (1)

CEN

CEN

CEN

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

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

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)

EN ISO 20776-1:2006
Clinical laboratory testing and in vitro diagnostic test systems — Suscept-
ibility testing of infectious agents and evaluation of performance of anti-
microbial 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)

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—

—

(1) ESO: European Standardisation Organisation:

— CEN: rue de Stassart 36, B-1050 Brussels, Tel. (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cen.eu)
— Cenelec: rue de Stassart 35, B-1050 Brussels, Tel. (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org)
— ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. (33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org).

Note 1 Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’),
set by the European Standardisation Organisation, but attention of users of these standards is drawn
to the fact that in certain exceptional cases this can be otherwise.

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.

Note:

— Any information concerning the availability of the standards can be obtained either from the European
Standardisation Organisations or from the national standardisation bodies of which the list is annexed to
the Directive 98/34/EC of the European Parliament and of the Council (1) amended by the Directive
98/48/EC (2).

— Publication of the references in the Official Journal of the European Union does not imply that the stan-

dards are available in all the Community languages.

— This list replaces all the previous lists published in the Official Journal of the European Union. The Commis-

sion ensures the updating of this list.

More information about harmonised standards on the Internet at:

http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/

(1) OJ L 204, 21.7.1998, p. 37.
(2) OJ L 217, 5.8.1998, p. 18.