STANDARDS FOR IN-VITRO DIAGNOSTIC MEDICAL DEVICES (98/79/EC)

Annex L

European Standards (EN) as listed in the Official Journal of the European Union (the “OJ”) as forming the list drawn up by common agreement

between the bodies notified by the Member States, under Article 5 of the Directive.

When the standards in the following table are adopted in the UK, they are prefixed with the letters BS EN.

Standard Number/issue date of Std	Official Journal Ref No	Title	BS Adoptions
CEN	OJ2002/C182/06	Information supplied by the manufacturer with	BS EN 375:2001
EN 375:2001	OJ2005/C103/03	in vitro diagnostic reagents for professional use
CEN	OJ2002/C182/06	Information supplied by the manufacturer with	BS EN 376:2002
EN 376:2002	OJ2005/C103/03	in vitro diagnostic reagents for self-testing
CEN	OJ2002/C182/06	Sterilisation of medical devices—Requirements	BS EN 556-1:2001
EN556-1:2001	OJ2005/C103/03	for medical devices to be designated
“STERILE”—Part 1: Requirements for
terminally sterilised medical devices
CEN	OJ2002/C182/06	Instructions for use of in vitro diagnostic	BS EN 591:2001
EN591:2001	OJ2005/C103/03	instruments for professional use
CEN	OJ2002/C182/06	Instructions for use for in vitro diagnostic	BS EN 592:2002
EN 592:2002	OJ2005/C103/03	instruments for self-testing
CEN	OJ2002/C182/06	Lung ventilators—Part 1: Particular	BS EN 794-1:1997
EN 794-1:1997 +	OJ2005/C103/03	requirements for critical care ventilators	(Amendment
Amendment A1 2000	incorporated)
CEN	OJ99/C227/08	In vitro diagnostic systems. Guidance on the	BS EN 928:1996
EN 928:1995	OJ2005/C103/03	application of EN 29001 and EN 46001 and EN
29002 and EN 46002 for in vitro diagnostic
medical devices
CEN	OJ2004/C83/03	Graphical symbols for use in the labelling of	BS EN 980:2003
EN 980:2003	OJ2005/C103/03	medical devices
CEN	OJ2002/C182/06	Agent specific filling systems for anaesthetic	BS EN 1280-1:1997
EN 1280-1:1997	OJ2005/C103/03	vaporisers—Part 1: Rectangular keyed filling	(Amendment
Amendment A1:2000	systems	incorporated)
CEN	OJ2002/C182/06	Anaesthetic and respiratory equipment—	BS EN ISO 4135:2001
EN ISO 4135:2001	OJ2005/C103/03	Vocabulary (ISO 4135:2001)
CEN	OJ2002/C182/06	Biological evaluation of medical devices—Part 8:	BS EN ISO 10993-
EN ISO 10993-8:2000	OJ2005/C103/03	Selection and qualification of reference materials	8:2001
for biological tests (ISO 10993-8:2000)
CEN	OJ99/C227/08	In vitro diagnostic medical devices.	BS EN 12286:1999
EN 12286:1998	OJ2005/C103/03	Measurement of quantities in samples of
biological origin. Presentation of reference
measurement procedures
CEN	OJ2001/C319/04	In vitro diagnostic medical devices.	BS EN 12286:1999
EN 12286:1998	OJ2005/C103/03	Measurement of quantities in samples of	(Amendment
Amendment A1:2000	biological origin. Presentation of reference	incorporated)
measurement procedures
CEN	OJ2000/C293/10	In vitro diagnostic medical devices—	BS EN 12287:1999
EN 12287:1999	OJ2005/C103/03	Measurement of quantities in samples of
biological origin—Description of reference
materials
CEN	OJ99/C288/10	In vitro diagnostic medical devices. Culture	BS EN 12322:1999
EN 12322:1999	OJ2005/C103/03	media for microbiology. Performance criteria for
culture media
CEN	OJ2002/C182/06	In vitro diagnostic medical devices—Culture	BS EN 12322:1999
EN 12322:1999	OJ2005/C103/03	media for microbiology—Performance criteria	(Amendment
Amendment A1:2001	for culture media incorporated)
CEN	OJ2002/C182/05	Quality systems—Medical devices—Particular	BS EN ISO 13485:2001
EN ISO 13485:2000	OJ2003/C32/04	requirements for the application of EN ISO
9001:1994 (revision of EN 13485:1996) (identical
to ISO 13485:1996)
CEN	OJ2004/C83/03	Medical devices—Quality management	BS EN ISO 13485:2003
EN ISO 13485:2003	OJ2005/C103/03	systems—Requirements for regulatory purposes
(ISO 13485:2003)
CEN	OJ2002/C182/05	Quality systems—Medical devices—Particular	BS EN ISO 13488:2001
EN ISO 13488:2000	OJ2003/C32/04	requirements for the application of EN ISO
9002:1994 (revision of EN 46002:1996)
Warning:

—EN ISO 13485:2003 replaces two earlier standards; EN ISO 13485:2000 and EN ISO 13488:2000.

—The earlier standards EN ISO 13485:2000 and EN ISO 13488:2000 will cease to provide presumption of conformity with relevant Essential

Requirements on 31 July 2006 at the end of the agreed transition period.

CEN	OJ2002/C314/06	General requirements for in vitro diagnostic	BS EN 13532:2002
EN 13532:2002	OJ2005/C103/03	medical devices for self-testing
CEN	OJ2002/C314/06	Performance evaluation of in-vitro diagnostic	BS EN 13612:2002
EN 13612:2002	OJ2005/C103/03	medical devices
CEN	OJ2002/C314/06	Stability testing of in-vitro diagnostic reagents	BS EN 13640:2002
EN 13640:2002	OJ2005/C103/03
CEN	OJ2002/C314/06	Elimination or reduction of risk of infection	BS EN 13641:2002
EN 13641:2002	OJ2005/C103/03	related to in-vitro diagnostic reagents
CEN	OJ2003/C280/07	Sampling procedures used for acceptance testing	BS EN 13975:2003
EN 13975:2003	OJ2005/C103/03	of in vitro diagnostic medical devices—Statistical
aspects
CEN	OJ2005/C103/03	In vitro diagnostic medical devices—Single-use	BS EN 14254:2004
EN 14254:2004	receptacles for the collection of specimens, other
than blood, from humans
CEN	OJ2005/C103/03	Single-use containers for human venous blood	BS EN 14820:2004
EN 14820:2004	specimen collection
CEN	OJ2002/C182/06	Sterilisation of health care products—General	BS EN ISO 14937:2001
EN ISO 14937:2000	OJ2005/C103/03	requirements for characterisation of a sterilising
agent and the development, validation and
routine control of a sterilisation process for
medical devices (ISO) 14937:2000)
CEN	OJ2002/C182/05	Medical devices—Application of risk	BS EN 14971:2001
EN 14971:2000	OJ2005/C103/03	management to medical devices (ISO
14971:2000)
CEN	OJ2005/C103/03	Amendment 1 BS EN 14971:2001
EN 14971:2000/A1:2003	(Amendment
incorporated)
CEN	OJ2005/C103/03	In vitro diagnostic test systems—Requirements	BS EN ISO 15197:2003
EN ISO 15197:2003	for blood-glucose monitoring systems for self-
testing in managing diabetes mellitus (ISO
15197:2003)
CEN	OJ2002/C182/06	Nomenclature—Specification for a nomenclature	BS EN ISO 15225:2000
EN ISO 15225:2000	OJ2005/C103/03	system for medical devices for the purpose of
regulatory data exchange (ISO 15225:2000)
CEN	OJ2005/C103/03	In vitro diagnostic medical devices—	BS EN ISO 17511:2003
EN ISO 17511:2003	Measurement of quantities in biological
samples—Metrological traceability of values
assigned to calibrators and control materials
(ISO 17511:2003)
CEN	OJ2003/C280/07	In vitro diagnostic medical devices—	BS EN ISO 18153:2003
EN ISO 18153:2003	OJ2005/C103/03	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	OJ2002/C314/07	Safety requirements for electrical equipment for	BS EN 61010-2-
EN 61010-2-101:2002	measurement, control, and laboratory use—Part	101:2002
2-101: Particular requirements for in-vitro
diagnostic (IVD) medical equipment