The Active Implantable Medical Devices Regulations

Standard Number/	Official Journal	Title	BS Adoptions
Issue date of Std	Reference No.
CEN	OJ95/C307/14	Clinical investigation of medical devices for	BSEN540:1993
EN540:1993	humans
CEN	OJ94/C277/06	Sterilisation of medical devices - Validation	BSEN550:1994
EN550:1994	and routine control of ethylene oxide sterilisation
CEN	OJ94/C277/06	Sterilisation of medical devices - Validation	BSEN552:1994
EN552:1994	and routine control of sterilisation by irradiation
CEN	OJ94/C277/06	Sterilisation of medical devices - Validation	BSEN554:1994
EN554: 1994	and routine control of sterilisation by moist heat
CEN	OJ95/C307/14	Sterilisation of medical devices - requirements	BSEN556:1995
EN556:1994	for medical devices to be labelled sterile
CEN	OJ97/C149/05	Packaging materials and systems for medical	BSEN868-1:1997
EN868-1:1997	devices which are to be sterilised - Part 1:
General requirements and test methods
CEN	OJ2000/C293/07	Graphical symbols for use in the labelling	BSEN980:1997
EN980:1996	of medical devices	(Amendment incorporated)
Amendment 1 1999
CEN	OJ98/C268/03	Information supplied by the manufacturer	BSEN1041:1998
EN1041:1998	with medical devices
CEN	OJ96/C245/05	Sterilisation of medical devices - estimation	BSEN1174-1:1996
EN1174-1:1996	of the population of micro-organisms on product -
Part 1: Requirements
CEN	OJ97/C149/05	Sterilisation of medical devices - estimation	BSEN1174-2:1997
EN1174-2:1996	of the population of micro-organisms on product -
Part 2: Guidance
CEN	OJ97/C149/05	Sterilisation of medical devices - estimation	BSEN1174-3:1997
EN1174-3:1996	of the population of micro-organisms on product -
Part 3: Guide to methods for validation of
microbiological techniques
CEN EN	OJ98/C144/03	Medical devices - risk analysis.	BSEN1441:1998
N1441:1997
CEN	OJ2003/C16/04	Biological evaluation of medical devices -	–
ENISO10993-4:2002	Part 4: Selection of tests for interactions
with blood (ISO10993-4:2002) Tests for irritation
and delayed-type hypersensitivity
(ISO10993-10:2002)
CEN	OJ2000/C293/07	Biological evaluation of medical devices -	BSENISO10993-7:1996
ENISO10993-7:1995	Part 7: Ethylene oxide sterilisation residuals
(ISO10993-7:1995)
CEN	OJ97/C149/05	Biological evaluation of medical devices -	BSENISO10993-10:1995
ENISO10993-10:1995	Part 10: Tests for irradiation and sensitisation
CEN	OJ2003/C16/04	Biological evaluation of medical devices -	–
ENISO1 0993-10:2002	Part 10: Tests for irritation and delayed-type
hypersensitivity (ISO10993-10:2002)
CEN	OJ97/C149/05	Biological evaluation of medical devices -	BSENISO10993-12:1997
ENISO1 0993-12:1996	Part 12: Sample preparation and reference
materials
CEN	OJ98/144/03	Biological evaluations of medical devices.	BSENISO10993-16:1997
ENISO10993-16:1997	Part 16 Toxicokinetic study design for
degradation products and leachables.
CEN	OJ94/C277/06	Biological evaluation of medical devices -	BSEN30993-3:1994
EN30993-3:1993	Part 3: Tests for genotoxicity,
carcinogenicity and reproductive toxicity
CEN	OJ94/C277/06	Biological evaluation of medical devices -	BSEN30993-4:1994
EN30993-4:1993	Part 4 Selection of test for interactions with blood
CEN	OJ94/C277/06	Biological evaluation of medical devices -	BSEN30993-5:1994
EN30993-5:1993	Part 5 - Tests for cytotoxicity - in vitro methods
CEN	OJ95/C307/14	Biological evaluation of medical devices -	BSEN30993-6:1995
EN30993-6:1994	Part 6 - Tests for local effects after implementation
CEN	OJ97/C338/11	Biological evaluation of medical devices -	BSENISO10993-11:1996
EN30993-11:1995	Part 11 tests for systemic toxicity
CEN	OJ98/C268/04	Active implantable medical devices - Part 1:	BSEN45502-1:1998
EN45502-1:1997	General requirements for safety, marking and
information to be provided by the manufacturer.
CEN	OJ94/C277/06	Quality systems, medical devices - particular	BSEN46001:1994
EN46001:1993	requirements for the application of EN29001/1992
CEN	OJ96/C245/05	Quality systems, medical devices - particular	BSEN46001:1997
EN46001: 1995	requirements for the application of EN29001
CEN	OJ94/C277/06	Quality systems, medical devices - particular	BSEN46002: 1992
EN46002:1993	requirements for the application of EN29002
CEN	OJ96/C245/05	Quality systems - Medical devices - Particular	BSEN46002: 1997
EN46002:1995	requirements for the application of EN29002
CEN / CENELEC	OJ2000/C293/07	Quality systems - Medical devices - Particular	BSEN46003:1999
EN46003:1999	requirements for the application of ENISO9003
CEN	OJ96/C245/06	Guidance on the application of EN29001 and	BSEN50103:1996
EN50103:1994	EN46001 and of EN29002 and EN46002 for the active (including active implantable) medical device industry
CENELEC	OJ96/C245/06	Medical electrical equipment - Part 1:	BSEN60601-1:1990
EN60601-1:1990	General requirements for safety	BS5724-1:1989