The In-Vitro Diagnostic Medical Devices Regulations

Standard Number/	Official Journal	Title	BS Adoptions
Issue date of Std	Reference No.
CEN	OJ2002/C182/06	Information supplied by the manufacturer with	BSEN375:2001
EN375:2001	in vitro diagnostic reagents for professional use
CEN	OJ2002/C182/06	Information supplied by the manufacturer with	BSEN376:2002
EN376:2002	in vitro diagnostic reagents for self-testing
CEN	OJ2001/C319/06	Medical gloves for single use. Requirements and	BSEN455-1:2000
EN455-1:2000	testing for freedom from holes
CEN	OJ2002/C182/06	Medical gloves for single use - Part 2:	BSEN455-2:2000
EN455-2:2000	Requirements and testing for physical
properties (including Corrigendum 1996)
CEN	OJ2002/C182/06	Sterilisation of medical devices - Validation and	BSEN552:1994
EN552:1994	routine control of sterilisation by irradiation	(Amendment incorporated)
Amendment A2 2000
CEN	OJ2002/C182/06	Sterilisation of medical devices - Requirements	BSEN556-1:2001
EN556-1:2001	for medical devices to be designated ‘Sterile’ -
Part 1: Requirements for terminally sterilised
medical devices
CEN	OJ2002/C182/06	Instructions for use for in vitro diagnostic	BSEN591:2001
EN591:2001	instruments for professional use
CEN	OJ2002/C182/06	Instructions for use for in vitro diagnostic	BSEN592:2002
EN592:2002	instruments for self-testing
CEN	OJ2002/C182/06	Lung ventilators - Part 1: Particular	BSEN794-1:1997
EN794-1:1997	requirements for critical care ventilators	(Amendment incorporated)
Amendment A1 2000
CEN	OJ99/C227/08	In vitro diagnostic systems. Guidance on the	BSEN928:1996
EN928:1995	application of EN29001 and EN29002 and
EN46002 for in vitro diagnostic medical devices
CEN	OJ2001/C319/04	Graphical symbols for use in the	BSEN980:1997
EN980:1996	labelling of medical devices	(Amendment Incorporated)
Amendment A1 1999
CEN	OJ2002/C182/06	Graphical symbols for use in the	BSEN980:1997
EN980:1996	labelling of medical devices	(Amendment incorporated)
Amendment A2 2001
CEN	OJ2002/C182/06	Agent specific filling systems for	BSEN1280-1:1997
EN1280-1:1997	anaesthetic vaporisers - Part 1:Rectangular	(Amendment incorporated)
Amendment A1 2000	keyed filling systems
CEN	OJ99/C227/08	Requirements for making of in vitro	BSEN1658:1997
EN1658:1996	diagnostic instruments
CEN	OJ2002/C182/06	Natural latex rubber condoms	BSENISO4074:2002
ENISO4074:2002	Requirements and test methods (ISO4074:2002)
CEN	OJ2002/C182/06	Anaesthetic and respiratory	BSENISO4135:2001
ENISO4135:2001	equipment - Vocabulary (ISO4135:2001)
CEN	OJ2001/C319/06	Anaesthetic and respiratory equipment.	BSENISO9360-1:2000
ENISO9360-1:2000	Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans. HMEs
for use with minimum tidal volumes of 250 ml
(ISO9360-1:2000)
CEN	OJ2002/C182/06	Biological evaluation of medical devices -	BSENISO10993-8:2001
ENISO10993-8:2001	Part 8: Selection and qualification of reference
materials for biological tests (ISO10993-8:2000)
CEN	OJ2002/C182/06	Biological evaluation of medical devices -	BSENISO10993-14:2001
ENISO10993-14:2001	Part 14: Identification and quantification of
degradation products from ceramics
(ISO10993-14:2001)
CEN	OJ2001/C319/06	Biological evaluation of medical devices.	BSENISO10993-15:2001
ENISO10993-15:2000	Identification and quantification of degradation
products from metals and alloys (ISO10993-15:2000)
CEN	OJ99/C227/08	In vitro diagnostic medical devices.	BSEN12286:1999
EN12286:1998	Measurement of quantities in samples of
biological origin. Presentation of reference
measurement procedures
CEN	OJ2001/C319/04	In vitro diagnostic medical devices.	BSEN12286:1999
EN12286:1998	Measurement of quantities in samples of	(Amendment incorporated)
Amendment A1 2000	biological origin. Presentation of reference
measurement procedures
CEN	OJ2000/C293/10	In vitro diagnostic medical devices -	BSEN12287:1999
EN12287:1999	Measurement of quantities in samples of
biological origin - Description of reference materials
CEN	OJ99/C288/10	In vitro diagnostic medical devices. Culture	BSEN12322:1999
EN12322:1999	media for microbiology. Performance criteria	(Amendment incorporated)
for culture media
CEN	OJ2002/C182/06	In-vitro diagnostic medical devices - Culture	BSEN12322:1999
EN12322:1999	media for microbiology - Performance criteria
Amendment A1 2001	for culture media
CEN	OJ2002/C182/06	Medical compression hosiery	BSEN12718:2001
EN12718:2001
CEN	OJ2002/C182/06	Medical thrombosis prophylaxis hosiery	BSEN12719:2001
EN12719:2001
CEN	OJ2002/C182/06	Breathing system filters for anaesthetic and	BSEN13328-1:2001
EN13328-1:2001	respiratory use - Part 1: Test method to assess
filtration performance
CEN	OJ2002/C182/05	Quality systems - Medical devices - Particular	BSENISO13485:2001
ENISO13485:2000	requirements for the application of ENISO9001
(revison of EN 13485:1996)
(identical to ISO13485:1996)
CEN	OJ2002/C182/05	Quality systems - Medical devices - Particular	BSENISO13488:2001
ENISO13488:2000	requirements for the application of EN 46002:
1996), 9002 (identical to ISO13488:1996)
CEN	OJ2002/C314/06	General requirements for in vitro	BSEN13532:2002
EN13532:2002	diagnostic medical devices for self-testing
CEN	OJ2002/C182/06	Respiratory therapy equipment - Part 1:	BSEN13544-1:2001
EN13544-1:2001	Nebulising systems and their components
CEN	OJ2002/C182/06	Respiratory therapy equipment - Part 3:	BSEN13544-3:2001
EN13544-3:2001	Air entrainment devices
CEN	OJ2002/C314/06	Performance evaluation of in-vitro diagnostic	BSEN13612:2002
EN13612:2002	medical devices
CEN	OJ2002/C314/06	Stability testing of in-vitro diagnostic medical	BSEN13640:2002
EN13640:2002	devices
CEN	OJ2002/C314/06	Elimination or reduction of risk of infection	BSEN13641:2002
EN13641:2002	related to in-vitro diagnostic reagents
CEN	OJ2002/C182/06	Sterilisation of health care products - General	BSENISO14937:2001
ENISO14937:2000	requirements for characterisation of a
sterilising agent and the development,
validation and routine control of a sterilisation
process for medical devices (ISO14937:2000)
CEN	OJ2002/C182/05	Medical devices - Application of risk	BSENISO14971:2001
ENISO14971:2000	management to medical devices (ISO14971:2000)
CEN	OJ2002/C182/06	Nomenclature - Specification for a	BSENISO15225:2000
ENISO15225:2000	nomenclature system for medical devices for
the purpose of regulatory data exchange
(ISO15225:2000)
CEN	OJ2002/C314/06	Safety requirements for electrical equipment for	_
EN61010-2-101:2002	measurement, control, and laboratory use -
Part 2-101: Particular requirements for in-vitro
diagnostic (IVD) medical equipment