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Medicines
CE MARKING FOR MEDICAL DEVICES
STANDARDS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES (90/385/EEC)
Annex J
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 EN 550:1994 |
OJ94/C277/06 OJ2005/C153/20 |
Sterilisation of medical devices—Validation and routine control of ethylene oxide
sterilisation |
BS EN 550:1994 |
| CEN EN 552:1994 |
OJ94/C277/06 OJ2005/C153/20 |
Sterilisation of medical devices—Validation and routine control of sterilisation by irradiation | BS EN 552:1994 |
| CEN EN 554:1994 |
OJ94/C277/06 OJ2005/C153/20 |
Sterilisation of medical devices—Validation and routine control of sterilisation by moist heat | BS EN 554:1994 |
| CEN EN 556-1:2001 |
OJ2005/C153/20 | Sterilization of medical devices—Requirements for medical devices to be designated “STERILE”—Part 1: Requirements for terminally sterilized medical devices | BS EN 556-1:2001 |
| CEN EN 556-2:2003 |
OJ2005/C153/20 | Sterilization of medical devices—Requirements for medical devices to be designated “STERILE”—Part 2: Requirements for aseptically processed medical devices | BS EN 556-2:2003 |
| CEN EN 868-1:1997 |
OJ97/C149/05 OJ2005/C153/20 |
Packaging materials and systems for medical devices which are to be sterilised—Part 1: General requirements and test methods | BS EN 868-1:1997 |
| CEN EN 980:2003 |
OJ2004/C83/7 OJ2005/C153/20 |
Graphical symbols for use in the labelling of medical devices | BS EN 980:2003 |
| CEN EN 1041:1998 |
OJ98/C268/03 OJ2005/C153/20 |
Information supplied by the manufacturer with medical devices | BS EN 1041:1998 |
| CEN EN 1174-1:1996 |
OJ96/C245/05 OJ2005/C153/20 |
Sterilisation of medical devices—estimation of the population of micro-organisms on product—Part 1: Requirements | BS EN 1174-1:1996 |
| CEN EN 1174-2:1996 |
OJ97/C149/05 OJ2005/C153/20 |
Sterilisation of medical devices—estimation of the population of micro-organisms on product—Part 2: Guidance | BS EN 1174-2: 1997 |
| CEN EN 1174-3:1996 |
OJ97/C149/05 OJ2005/C153/20 |
Sterilisation of medical devices—estimation of the population of micro-organisms on product—Part 3: Guide to methods for validation of microbiological techniques | BS EN 1174-3:1997 |
| CEN EN ISO 10993-1:2003 |
OJ2005/C153/20 | Biological evaluation of medical devices—Part 1: Evaluation and testing (ISO 10993-1:2003) | BS EN ISO 10993-1:2003 |
| CEN EN ISO 10993-4:2002 |
OJ2003/C16/06 OJ2005/C153/20 |
Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002) | BS EN ISO 10993-4:2002 |
| CEN EN ISO 10993-5:1999 |
OJ2005/C153/20 | Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999) | BS EN ISO 10993-5:1999 |
| CEN EN ISO 10993-7:1995 |
OJ2000/C293/07 | Biological evaluation of medical devices—Part 7: ethylene oxide sterilisation residuals (ISO 10993-7:1995) | BS EN ISO 10993-7:1996 |
| CEN EN ISO 10993-9:1999 |
OJ2005/C153/20 | Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) | BS EN ISO 10993-9:1999 |
| CEN EN ISO 10993-10:2002 |
OJ2003/C16/06 OJ2005/C153/20 |
Biological evaluation of medical devices—Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002) | BS EN ISO 10993-10:2002 |
| CEN EN ISO 10993-11:1995 |
OJ2005/C153/20 | Biological evaluation of medical devices—Part 11: Tests for systemic toxicity (ISO 10993-11:1993) | BS EN ISO 10993-11:1996 |
| CEN EN ISO 10993-12:2004 |
OJ2005/C153/20 | Biological evaluation of medical devices—Part 12: Sample preparation and reference materials (ISO 10993-12:2002) | BS EN ISO 10993-12:2004 |
| CEN EN ISO 10993-13:1998 |
OJ2005/C153/20 | Biological evaluation of medical devices—Part 13: Identification and quantification of degredation products from polymeric medical devices (ISO 10993-13:1998) | BS EN ISO 10993-13:1999 |
| CEN EN ISO 10993-16:1997 |
OJ98/144/03 OJ2005/C153/20 |
Biological evaluations of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) | BS EN ISO 10993-16:1997 |
| CEN EN ISO 10993-17:2002 |
OJ2003/C270/2 OJ2005/C153/20 |
Biological evaluation of medical devices—Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) | BS EN ISO 10993-17:2002 |
| CEN EN ISO 13485:2003 |
OJ2004/C83/7 OJ2005/C153/20 |
Medical devices—Quality management systems—Requirements for regulatory purposes (ISO 13485:2003) | BS EN ISO 13485:2003 |
| CEN EN 13488:2000 |
OJ2003/C32/14 |
Quality systems—Medical devices—Particular requirements for the application of EN ISO 9002:1994 (revision of EN 46002:1996) | BS EN 13488:2001 |
—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 EN ISO 13824:2004 |
OJ2005/C153/20 |
Sterilisation of medical devices—Aseptic processing of liquid medical devices—Requirements | BS EN 13824:2004 |
| CEN EN ISO 14155-1:2003 |
OJ2003/C270/2 OJ2005/C153/20 |
Clinical investigation of medical devices for human subjects—Part 1: General requirements (ISO 14155-1:2003) | BS EN ISO 14155:2003 |
| CEN EN ISO 14155-2:2003 |
OJ2003/C270/2 OJ2005/C153/20 |
Clinical investigation of medical devices for human subjects—Part 2: Clinical investigation plans (ISO 14155-2:2003) | BS EN ISO 14155-2:2003 |
| CEN EN ISO 14971:2000 |
OJ2005/C153/20 | Medical devices—Application of risk management to medical devices (ISO 14971:2000) | BS EN ISO 14971:2001 |
| EN ISO 14971:2000/A1:2003 | OJ2005/C153/20 | Amendment No 1 | BS EN ISO 14971:2001 (Amendment incorporated) |
| EN ISO 14971:2000/AC:2002 | OJ2004/C42/14 | Amendment AC | BS EN ISO 14971:2001 (Amendment incorporated) |
| CEN EN 30993-6:1994 |
OJ95/C307/14 OJ2005/C153/20 |
Biological evaluation of medical devices—Part 6—Tests for local effects after implementation | BS EN 30993-6:1995 |
| CEN/CENELEC EN 45502-1:1997 |
OJ2004/C176/03 OJ2005/C153/20 |
Active implantable medical devices—Part 1: General requirements for safety, marking and information to be provided by the manufacturer | BS EN 45502-1:1998 |
| CEN/CENELEC EN 45502-2-1:2004 |
OJ2004/C176/03 OJ2005/C153/20 |
Active implantable medical devices—Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) | |
| CEN/CENELEC EN 46003:1999 |
OJ2004/C176/03 |
Quality systems—Medical devices—Particular requirements for the application of EN ISO 9003 | BS EN 46003:1999 |
| CENELEC EN 60601-1:1990 |
OJ2004/C176/03 |
Medical electrical equipment—Part 1: General requirements for safety | BS EN 60601-1:1990 BS 5724-1:1989 |
| OJ2004/C176/03 |
Amendment A1:1993 to EN 60601-1:1990 | ||
| OJ2004/C176/03 |
Amendment A2:1995 to EN 60601-1:1990 | ||
| OJ2004/C176/03 |
Amendment A13:1996 to EN 60601-1:1990 |
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 EN 375:2001 |
OJ2002/C182/06 OJ2005/C103/03 |
Information supplied by the manufacturer with in vitro diagnostic reagents for professional use | BS EN 375:2001 |
| CEN EN 376:2002 |
OJ2002/C182/06 OJ2005/C103/03 |
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing | BS EN 376:2002 |
| CEN EN556-1:2001 |
OJ2002/C182/06 OJ2005/C103/03 |
Sterilisation of medical devices—Requirements for medical devices to be designated “STERILE”—Part 1: Requirements for terminally sterilised medical devices | BS EN 556-1:2001 |
| CEN EN591:2001 |
OJ2002/C182/06 OJ2005/C103/03 |
Instructions for use of in vitro diagnostic instruments for professional use | BS EN 591:2001 |
| CEN EN 592:2002 |
OJ2002/C182/06 OJ2005/C103/03 |
Instructions for use for in vitro diagnostic instruments for self-testing | BS EN 592:2002 |
| CEN EN 794-1:1997 + Amendment A1 2000 |
OJ2002/C182/06 OJ2005/C103/03 |
Lung ventilators—Part 1: Particular requirements for critical care ventilators | BS EN 794-1:1997 (Amendment incorporated) |
| CEN EN 928:1995 |
OJ99/C227/08 OJ2005/C103/03 |
In vitro diagnostic systems. Guidance on the application of EN 29001 and EN 46001 and EN 29002 and EN 46002 for in vitro diagnostic medical devices | BS EN 928:1996 |
| CEN EN 980:2003 |
OJ2004/C83/03 OJ2005/C103/03 |
Graphical symbols for use in the labelling of medical devices | BS EN 980:2003 |
| CEN EN 1280-1:1997 Amendment A1:2000 |
OJ2002/C182/06 OJ2005/C103/03 |
Agent specific filling systems for anaesthetic vaporisers—Part 1: Rectangular keyed filling systems | BS EN 1280-1:1997 (Amendment incorporated) |
| CEN EN ISO 4135:2001 |
OJ2002/C182/06 OJ2005/C103/03 |
Anaesthetic and respiratory equipment—Vocabulary (ISO 4135:2001) | BS EN ISO 4135:2001 |
| CEN EN ISO 10993-8:2000 |
OJ2002/C182/06 OJ2005/C103/03 |
Biological evaluation of medical devices—Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000) | BS EN ISO 10993-8:2001 |
| CEN EN 12286:1998 |
OJ99/C227/08 OJ2005/C103/03 |
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Presentation of reference measurement procedures | BS EN 12286:1999 |
| CEN EN 12286:1998 Amendment A1:2000 |
OJ2001/C319/04 OJ2005/C103/03 |
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Presentation of reference measurement procedures | BS EN 12286:1999 (Amendment incorporated) |
| CEN EN 12287:1999 |
OJ2000/C293/10 OJ2005/C103/03 |
In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Description of reference materials | BS EN 12287:1999 |
| CEN EN 12322:1999 |
OJ99/C288/10 OJ2005/C103/03 |
In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media | BS EN 12322:1999 |
| CEN EN 12322:1999 Amendment A1:2001 |
OJ2002/C182/06 OJ2005/C103/03 |
In vitro diagnostic medical devices—Culture media for microbiology—Performance criteria for culture media | BS EN 12322:1999 (Amendment incorporated) |
| CEN EN ISO 13485:2000 |
OJ2002/C182/05 OJ2003/C32/04 |
Quality systems—Medical devices—Particular requirements for the application of EN ISO 9001:1994 (revision of EN 13485:1996) (identical to ISO 13485:1996) | BS EN ISO 13485:2001 |
| CEN EN ISO 13485:2003 |
OJ2004/C83/03 OJ2005/C103/03 |
Medical devices—Quality management systems—Requirements for regulatory purposes (ISO 13485:2003) | BS EN ISO 13485:2003 |
| CEN EN ISO 13488:2000 |
OJ2002/C182/05 OJ2003/C32/04 |
Quality systems—Medical devices—Particular requirements for the application of EN ISO 9002:1994 (revision of EN 46002:1996) | BS EN ISO 13488:2001 |
—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 EN 13532:2002 |
OJ2002/C314/06 OJ2005/C103/03 |
General requirements for in vitro diagnostic medical devices for self-testing | BS EN 13532:2002 |
| CEN EN 13612:2002 |
OJ2002/C314/06 OJ2005/C103/03 |
Performance evaluation of in-vitro diagnostic medical devices | BS EN 13612:2002 |
| CEN EN 13640:2002 |
OJ2002/C314/06 OJ2005/C103/03 |
Stability testing of in-vitro diagnostic reagents | BS EN 13640:2002 |
| CEN EN 13641:2002 |
OJ2002/C314/06 OJ2005/C103/03 |
Elimination or reduction of risk of infection related to in-vitro diagnostic reagents | BS EN 13641:2002 |
| CEN EN 13975:2003 |
OJ2003/C280/07 OJ2005/C103/03 |
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices—Statistical aspects | BS EN 13975:2003 |
| CEN EN 14254:2004 |
OJ2005/C103/03 | In vitro diagnostic medical devices—Single-use receptacles for the collection of specimens, other than blood, from humans | BS EN 14254:2004 |
| CEN EN 14820:2004 |
OJ2005/C103/03 | Single-use containers for human venous blood specimen collection | BS EN 14820:2004 |
| CEN EN ISO 14937:2000 |
OJ2002/C182/06 OJ2005/C103/03 |
Sterilisation of health care products—General requirements for characterisation of a sterilising agent and the development, validation and routine control of a sterilisation process for medical devices (ISO) 14937:2000) | BS EN ISO 14937:2001 |
| CEN EN 14971:2000 |
OJ2002/C182/05 OJ2005/C103/03 |
Medical devices—Application of risk management to medical devices (ISO 14971:2000) | BS EN 14971:2001 |
| CEN EN 14971:2000/A1:2003 |
OJ2005/C103/03 | Amendment 1 | BS EN 14971:2001 (Amendment incorporated) |
| CEN EN ISO 15197:2003 |
OJ2005/C103/03 | In vitro diagnostic test systems—Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003) | BS EN ISO 15197:2003 |
| CEN EN ISO 15225:2000 |
OJ2002/C182/06 OJ2005/C103/03 |
Nomenclature—Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) | BS EN ISO 15225:2000 |
| CEN EN ISO 17511:2003 |
OJ2005/C103/03 | In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) | BS EN ISO 17511:2003 |
| CEN EN ISO 18153:2003 |
OJ2003/C280/07 OJ2005/C103/03 |
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) | BS EN ISO 18153:2003 |
| CEN EN 61010-2-101:2002 |
OJ2002/C314/07 | Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 2-101: Particular requirements for in-vitro diagnostic (IVD) medical equipment | BS EN 61010-2-101:2002 |
DEVICES (93/42/EEC)
Annex K
European Standards (EN) as listed in the Official Journal of the European Community
(the “OJ”) as forming the list drawn up by common agreement between the bodies notified
by the Member States, under Article 5 of the Medical Devices 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 EN 285:1996 |
OJ99/C181/03 | Sterilisation—Steam sterilisers—Large sterilisers | BS EN 285:1997 |
| CEN EN 375:2001 |
OJ2002/C182/06 | Information supplied by the manufacturer with in vitro diagnostic reagents for professional use | BS EN 375:2001 |
| CEN EN 376:2002 |
OJ2002/C182/06 | Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing | BS EN 376:2002 |
| CEN EN 455-1:2000 |
OJ2001/C319/06 | Medical gloves for single use. Requirements and testing for freedom from holes | BS EN 455-1:2000 |
| CEN EN 455-2:2000 |
OJ2002/C182/06 | Medical gloves for single use—Part 2: Requirements and testing for physical properties (including Corrigendum 1996 | BS EN 455-2:2000 |
| CEN EN 455-3:1999 |
OJ2000/C293/06 | Medical gloves for single use—Part 3: Requirements and testing for biological evaluation | BS EN 455-3:2000 |
| CEN EN 475:1995 |
OJ99/C181/03 | Medical devices. Electrically generated alarm signals | BS EN 475:1995 |
| CEN EN 540:1993 |
OJ99/C181/03 | Clinical investigation of medical devices for humans | BS EN 540:1993 This standard has been replaced by BS EN ISO 14155-1:2003 |
| CEN EN 550:1994 |
OJ99/C181/03 | Sterilisation of medical devices. Validation and routing control of ethylene oxide sterilisation | BS EN 550:994 |
| CEN EN 552:1994 |
OJ99/C181/03 | Sterilisation of medical devices. Validation and routine control of sterilisation by irradiation | BS EN 552:1994 |
| CEN EN 552:1994 Amendment A1 1999 |
OJ99/C288/43 | Sterilisation of medical devices—Validation and routine control of sterilisation by irradiation | BS EN 552:1994 (Amendment incorporated) |
| CEN EN 552:1994/ Amendment A2:2000 |
OJ2002/C182/06 | Sterilisation of medical devices—Validation and routine control of sterilisation by irradiation | BS EN 552:1994 (Amendment incorporated) |
| CEN EN 554:1994 |
OJ99/C181/03 | Sterilisation of medical devices. Validation and routine control of sterilisation by moist heat | BS EN 554:1994 |
| CEN EN 556:1994 |
OJ99/C181/03 | Sterilisation of medical devices. Requirements for medical devices to be labelled “sterile” | BS EN 556:1995 |
| CEN EN 556-1:2001 |
OJ2002/C182/06 | Sterilisation of medical devices—Requirements for medical devices to be designated “Sterile”—Part 1: Requirements for terminally sterilised medical devices | BS EN 556-1:2001 |
| CEN EN 591:2001 |
OJ2002/C182/06 | Instructions for use in vitro diagnostic instruments for professional use | BS EN 591:2001 |
| CEN EN 592:2002 |
OJ2002/C182/06 | Instructions for use for in vitro diagnostic instruments for self-testing | BS EN 592:2002 |
| CEN EN 600:1996 |
OJ99/C181/03 | Natural rubber latex male condoms | BS EN 600:1996 |
| CEN EN 724:1994 |
OJ99/C181/03 | Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices | BS EN 724:1995 |
| CEN EN 737-1:1998 |
OJ99/C181/03 | Medical gas pipeline systems—Part 1: Terminal units for compressed medical gases and vacuum | BS EN 737-1:1998 |
| CEN EN 737-2:1998 |
OJ99/C181/03 | Medical gas pipeline systems—Part 2: Anaesthetic gas scavenging disposal systems—basic requirements | BS EN 737-2:1998 |
| CEN EN 737-2:1998 Amendment A1 1999 |
OJ2000/C293/06 | Medical gas pipeline systems—Part 2: Anaesthetic gas scavenging disposal systems—Basic requirements | BS EN 737-2:1998 (Amendment incorporated) |
| CEN EN 737-3:1998 |
OJ99/237 | Medical gas pipeline systems—Part 3: Pipelines for compressed medical gases and vacuum | BS EN 737-3:2000 |
| CEN EN 737-3:1998 Amendment A1 1999 |
OJ2000/C293/06 | Medical gas pipeline systems—Part 3: Pipelines for compressed medical gases and vacuum | BS EN 737-3:2000 (Amendment incorporated) |
| CEN EN 737-4:1998 |
OJ99/C181/03 | Medical gas pipeline systems—Part 4: Terminal units for anaesthetic gas scavenging systems | BS EN 737-4:1998 |
| CEN EN 738-1:1997 |
OJ99/C181/03 | Pressure regulators for use with medical gases—Part 1: Pressure regulators and pressure regulators with flow metering devices | BS EN 738-1:1997 |
| CEN EN 738-1:1997/ Amendment A1/2002 |
OJ2002/C310/04 | Pressure regulators for use with medical gases—Part 1: Pressure regulators and pressure regulators with flow metering devices | BS EN 738-1:1997 incorporates the amendment |
| CEN EN 738-2:1998 |
OJ2000/C293/06 | Pressure regulators for use with medical gases—Part 2: Manifold and line pressure regulators | BS EN 738-2:1999 |
| CEN EN 738-3:1998 |
OJ2000/C293/06 | Pressure regulators for use with medical gases—Part 3: Pressure regulators integrated with cylinder valves | BS EN 738-3:1999 |
| CEN EN 738-3:1998/ Amendment A1:2002 |
OJ2002/C310/04 | Pressure regulators for use with medical gases—Part 3: Pressure regulators integrated with cylinder valves | BS EN 738-3:1999 amendment incorporated |
| CEN EN 738-4:1998 |
OJ2000/C293/06 | Pressure regulators for use with medical gases—Part 4: Low-pressure regulators intended for incorporation into medical equipment | BS EN 738-4:1999 |
| CEN EN 738-4:1998/ Amendment A1:2002 |
OJ2002/C310/04 | Pressure regulators for use with medical gases—Part 4: Low-pressure regulators intended for incorporation into medical equipment | BS EN 738-4:1999 incorporates the amendment |
| CEN EN 739:1998 |
OJ99/C181/03 | Low-pressure hose assemblies for use with medical gases | BS EN 739:1998 |
| CEN EN 739:1998/ Amendment A1:2002 |
OJ2002/C310/04 | Low-pressure hose assemblies for use with medical gases | BS EN 739:1998 amendment incorporated |
| CEN EN 740:1998 |
OJ99/C227/09 | Anaesthetic workstations and their modules—particular requirements | BS EN 740:1999, BS 5724-2.204:1999 |
| CEN EN 793:1997 |
OJ99/C181/03 | Particular requirements for the safety of medical supply units | BS EN 793:19998 withdrawn and superseded by BS EN ISO 11197:2004 |
| CEN EN 794-1:1997 |
OJ99/C181/03 | Lung ventilators—Part 1: Particular requirements for critical ventilators | BS EN 794-1:1997 BS 5724-2.202:1997 |
| CEN EN 794-1:1997/ Amendment A1:2000 |
OJ2002/C182/06 | Lung ventilators—Part 1: Particular requirements for critical ventilators | BS EN 794-1:1997 incorporates the amendment |
| CEN EN 794-2:1997 |
OJ99/C181/03 | Lung ventilators—Part 2: Particular requirements for home care use | BS EN 794-2:1997 BS 5724-2.203:1997 withdrawn and superseded by BS EN ISO 10651-2:2004 |
| CEN EN 794-3:1998 |
OJ99/C181/03/04 | Medical electrical equipment—lung ventilators—Part 3: Particular requirements for emergency and transport ventilators | BS EN 794-3:1999 |
| CEN EN 864:1996 |
OJ99/C181/03 | Medical electrical equipment—capnometers for use with humans—particular requirements | BS EN 864:1997 BS 5724-2.30:1997 withdrawn and superseded by BS EN ISO 21647:2004 |
| CEN EN 865:1997 |
OJ99/C181/03 | Pulse oximeters—particular requirements | BS EN 865:1997 BS 5724-2.201:1997 withdrawn and superseded by BS EN ISO 9919:2005 |
| CEN EN 867-2:1997 |
OJ99/C181/03 | Non-biological systems for use in sterilisers—Part 2: Process indicators (class A) | BS EN 867-2:1997 |
| CEN EN 867-3:1997 |
OJ99/C181/03 | Non-biological systems for use in sterilisers—Part 3: Specification for class B indicators for use in the Bowie and Dick test | BS EN 867-3:1997 |
| CEN EN 868-1:1997 |
OJ99/C181/03 | Packaging materials and systems for medical devices which are to be sterilised—Part 1: General requirements and test methods | BS EN 868-1:1997 |
| CEN EN 980:1996 |
OJ2000/C293/07 | Graphical symbols for use in the labelling of medical devices | BS EN 980:1997 (amendment incorporated) |
| CEN EN 980:1996 Amendment A1:1999 |
OJ2001/C319 | Graphical symbols for use in the labelling of medical devices | BS EN 980:1997 Incorporates the amendment |
| CEN EN 980:1996/ Amendment A2:2001 |
OJ2002/C182/06 | Graphical symbols for use in the labelling of medical devices | BS EN 980:1997 Incorporates the amendment |
| CEN EN 980:2003 |
OJ2004/C83/03 | Graphical symbols for use in the labelling of medical devices | BS EN 980:2003 |
| CEN EN 1041:1998 |
OJ99/C181/03 | Information to be supplied by the manufacturer with medical devices | BS EN 1041:1998 |
| CEN EN 1060-1:1995 |
OJ99/C181/03 | Non-invasive sphygmomanometers. Part 1: General requirements | BS EN 1060-1:1996 |
| CEN EN 1060-1:1995/ Amendment A1:2002 |
OJ2002/C310/04 | Non-invasive sphygmomanometers. Part 1: General requirements | BS EN 1060-1:1996 incorporates the amendment |
| CEN EN 1060-2:1995 |
OJ99/C181/03 | Non-invasive sphygmomanometers. Part 2: Supplementary requirements for mechanical sphygmomanometer | BS EN 1060-2:1996 |
| CEN EN 1060-3:1997 |
OJ99/C181/03 | Non-invasive sphygmomanometers. Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems | BS EN 1060-3:1997 |
| CEN EN 1089-3:1997 |
OJ99/C181/03 | Transportable gas cylinders—Cylinder identification—Part 3: Colour coding | BS EN 1089-3:1997 |
| CEN EN 1089-3:1997/ Amendment A1:1999 |
OJ2000/C293/06 | Transportable gas cylinders—Gas cylinder identification—Part 3: Colour coding | EN 1089-3:1997 incorporates the amendment |
| CEN EN 1174-1:1996 |
OJ99/C181/03 | Sterilisation of medical devices. Estimation of the population of micro-organisms on products. Part 1: Requirements | BS EN 1174-1:1996 |
| CEN EN 1174-2:1996 |
OJ99/C181/03 | Sterilisation of medical devices—Estimation of the population of micro-organisms on product—Part 2: guidance | BS EN 1174-2:1997 |
| CEN EN 1174-3:1996 |
OJ99/C181/03 | Sterilisation of medical devices—Estimation of the population of micro-organisms on product—Part 3: guide to the methods for validation of microbiological technique | BS EN 1174-3:1997 |
| CEN EN 1280-1:1997 |
OJ99/C181/03 | Agent specific filling systems for anaesthetic vaporisers—Part 1: Rectangular keyed filling systems | BS EN 1280-1:1997 |
| CEN EN 1280-1:1997/ Amendment A1:2000 |
OJ2002/C182/06 | Agent specific filling systems for anaesthetic vaporisers—Part 1: Rectangular keyed filling systems | BS EN 1280-1:1997 incorporates the amendment |
| CEN EN 1281-1:1997 |
OJ99/C181/03 | Anaesthetic and respiratory equipment. Conical connectors. Part 1: Cones and sockets | BS EN 1281-1:1997 withdrawn and superseded by BS EN ISO 5356-1:2004 |
| CEN EN 1281-1:1997/ Amendment A1:1998 |
OJ99/C181/03/03 | Anaesthetic and respiratory equipment. Conical connectors. Part 1: Cones and sockets | BS EN 1281-1:1997 incorporates the amendment |
| CEN EN 1281-2:1995 |
OJ99/C181/03/03 | Anaesthetic and respiratory equipment. Conical connectors. Part 2: Screw threaded weight bearing connectors | BS EN 1281-2:1996 |
| CEN EN 1282-1:1996 |
OJ99/C181/03 | Anaesthetic and respiratory equipment. Tracheotomy tubes. Part 1: Tubes for use in adults | BS EN 1282-1:1997 withdrawn and superseded by BS EN ISO 5366-1:2004 |
| CEN EN 1282-2:1996 |
OJ99/C181/03 | Tracheostomy tubes—Part 2: Paediatric tubes | BS EN 1282-2:1997 |
| CEN EN 1422:1997 |
OJ99/C181/03 | Sterilisers for medical purposes—ethylene oxide sterilisers—requirements and test methods | BS EN 1422:1998 |
| CEN EN 1441:1997 superseded |
OJ99/C181/03 | Medical devices—risk analysis | BS EN 1441:1998 withdrawn and superseded by BS EN ISO 14971:2001 |
| CEN EN 1618:1997 |
OJ99/C181/03 | Catheters other than intravascular catheters—test methods for common properties | BS EN 1618:1997 |
| CEN EN 1639:1996 |
OJ99/C181/03 | Dentistry. Medical devices for dentistry. Instruments | BS EN 1639:1997 withdrawn and superseded by BS EN 1639:2004 |
| CEN EN 1640:1996 |
OJ99/C181/03 | Dentistry. Medical devices for dentistry. Equipment | BS EN 1640:1997 withdrawn and superseded by BS EN 1640:2004 |
| CEN EN 1641:1996 |
OJ99/C181/03 | Dentistry. Medical devices for dentistry. Materials | BS EN 1641:1997 withdrawn and superseded by BS EN 1641:2004 |
| CEN EN 1642:1996 |
OJ99/C181/03 | Dentistry. Medical devices for dentistry. Dental implants | BS EN 1642:1997 withdrawn and superseded by BS EN 1642:2004 |
| CEN EN 1707:1996 |
OJ99/C181/03 | Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. Lock fittings | BS EN 1707:1997 |
| CEN EN 1782:1998 |
OJ99/C181/03 | Tracheal tubes and connectors | BS EN 1782:1998 |
| CEN EN 1789:1999/ A1:2003 |
OJ2003/C268/12 | Medical vehicles and their equipment—Road ambulances | BS EN 1789:2000 incorporates amendment A1 |
| CEN EN 1819:1997 |
OJ99/C181/03 | Laryngoscopes for tracheal intubation—particular requirements | BS EN 1819:1998 withdrawn and superseded by BS EN ISO 7376:2003 |
| CEN EN 1820:1997 |
OJ99/C181/03 | Anaesthetic reservoir bags | BS EN 1820:1997 |
| CEN EN 1865:1999 |
OJ2000/C293/06 | Specifications for stretchers and other patient handling equipment used in road ambulances | BS EN 1865:2000 |
| CEN EN 1970:2000 |
OJ2001/C319/05 | Adjustable beds for disabled persons. Requirements and test methods | BS EN 1970:2000 |
| CEN EN 1985:1998 |
OJ99/C227/09 | Walking aids—General requirements and test methods | BS EN 1985:1999 |
| CEN EN ISO 4074:2002 |
OJ2002/C182/06 | Natural latex rubber condoms—Requirements and test methods (ISO 4074:2002) | BS EN ISO 4074:2002 |
| CEN EN ISO 4135:1996 |
OJ99/C181/03 | Anaesthesiology. Vocabulary (ISO 4135:1995) | BS EN ISO 4135:1996 withdrawn and superseded by BS EN ISO 4135:2001 |
| CEN EN ISO 4135:2001 |
OJ2002/C182/06 | Anaesthetic and respiratory equipment—Vocabulary (ISO 4135:2001) | BS EN ISO 4135:2001 |
| CEN EN ISO 8185:1997 |
OJ99/C181/03 | Humidifiers for medical use—General requirements for humidification systems | BS EN ISO 8185:1998 BS 5724-2.24:1998 |
| CEN EN ISO 8359:1996 |
OJ99/C181/03 | Oxygen concentrators for medical use—Safety requirements | BS EN ISO 8359:1997 BS 5724-2.23:1997 |
| CEN EN ISO 9360-1:2000 |
OJ2001/C319/06 | Anaesthetic and respiratory equipment. Heat and moisture exchangers (HMEs) for humidifying respired gases in humans. HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) | BS EN ISO 9360-1:2000 |
| CEN EN ISO 9360-2:2002 |
OJ2003/C75/09 | Anaesthetic and respiratory equipment—Heat and moisture exchangers (HMEs) for humidifying respired gases in humans—Part 2: HMES for use with tracheostomised patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001) | BS EN ISO 9360-2:2002 |
| CEN EN ISO 9703-3:1998 |
OJ99/C227/09 | Anaesthesia and respiratory care alarm signals—Part 3: Guidance on application of alarms (ISO 9703-3:1998) | BS EN ISO 9703-3:1999 |
| CEN EN ISO 10079-1:1996 |
OJ99/C181/03 | Medical suction equipment—Part1: Electrically powered suction equipment—Safety requirements (ISO 10079-1:1991, including technical corrigendum 1:1992 and technical corrigendum 2:1993) | BS EN ISO 10079-1:1997 BS 5724-2.28 withdrawn and superseded by BS EN ISO 10079-1:2000 |
| CEN EN ISO 10079-1:1999 |
OJ2000/C293/06 | Medical suction equipment—Part 1: Electrically powered suction equipment—Safety requirements (ISO 10079-1:1999) | BS EN ISO 10079-1:2000 BS 5724-2.28 |
| CEN EN ISO 10079-2:1996 |
OJ99/C181/03 | Medical suction equipment—Part 2: Manually powered suction equipment | BS EN ISO 10079-2:1997 withdrawn and superseded by BS EN ISO 10079-2:2000 |
| CEN EN ISO 10079-2:1999 |
OJ2000/C293/06 | Medical suction equipment—Part 2: Manually powered suction equipment (ISO 10079-2:1999) | BS EN ISO 10079-2:2000 |
| CEN EN ISO 10079-3:1996 |
OJ97/C149/03 | Medical suction equipment—Part 3: Suction equipment powered from vacuum or pressure source | BS EN ISO 10079-3:1997 withdrawn and replaced by BS EN ISO 10079-3:2000 |
| CEN EN ISO 10079-3:1999 |
OJ2000/C293/06 | Medical suction equipment—Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999) | BS EN ISO 10079-3:2000 |
| CEN EN ISO 10535:1998 |
OJ2000/C293/06 | Hoists for the transfer of disabled persons—Requirements and test methods (ISO 10535:1998) | BS EN ISO 10535:1998 |
| CEN EN ISO 10555-1:1996 |
OJ99/C181/03 | Sterile, single use intravascular catheters. Part 1: General requirements | BS EN ISO 10555-1:1997 |
| CEN EN ISO 10555-1:1996 Amendment A1 1999 |
OJ2000/C293/06 | Sterile, single use intravascular catheters. Part 1: General requirements (ISO 10555-1:1996/Amd 1:1999) | BS EN ISO 10555-1:1997 incorporates amendment A1 |
| CEN EN ISO 10651-4:2002 |
OJ2002/C310/04 | Lung ventilators—Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) | BS EN ISO 10651-4:2002 |
| CEN EN ISO 10993-1:1997 |
OJ99/C181/03/02 | Biological evaluations of medical devices. Part 1: Evaluation and testing (ISO 10993-1:1997) | BS EN ISO 10993-1:1998 withdrawn and superseded by BS EN ISO 10993-1:2003 |
| CEN EN ISO 10993-4:2002 |
OJ2002/C321/02 | Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002) | BS EN ISO 10993-4:2002 |
| CEN EN ISO 10993-5:1999 |
OJ99/C288/42 | Biological evaluation of medical devices. Part 5: Tests for in vitro cytotoxicity | BS EN ISO 10993-5:1999 |
| CEN EN ISO 10993-7:1995 |
OJ2000/C293/07 | Biological evaluation of medical devices—Part 7: ethylene oxide sterilisation residuals (ISO 10993-7:1995) |
BS EN ISO 10993-7:1996 |
| CEN EN ISO 10993-8:2001 |
OJ2002/C182/06 | Biological evaluation of medical devices—Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000) | BS EN ISO 10993-8:2001 |
| CEN EN ISO 10993-9:1999 |
OJ99/C227/07 | Biological evaluation of medical devices—Part 9: Framework for identification and
quantification of potential degradation products (ISO 10993-9:1999) |
BS EN ISO 10993-9:1999 |
| CEN EN ISO 10993-10:2002 |
OJ2002/C321/02 | Biological evaluations of medical devices. Part 10. Tests for irradiation and sensitisation (ISO 10993-10:2002) | BS EN ISO 10993-10:2002 |
| CEN EN ISO 10993-12:1996 |
OJ99/C181/03 | Biological evaluation of medical devices—Part 12: sample preparation and reference materials (ISO 10993-12:1996) | BS EN ISO 10993-12:1997 withdrawn and replaced by BS EN ISO 10993-12:2004 |
| CEN EN ISO 10993-13:1998 |
OJ99/C227/07 | Biological evaluation of medical devices—Part 13: identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) | BS EN ISO 10993-13:1999 |
| CEN EN ISO 10993-14:2001 |
OJ2002/C182/06 | Biological evaluation of medical devices—Part 14: Identification and quantification
of degradation products from ceramics (ISO 10993-14:2001) |
BS EN ISO 10993-14:2001 |
| CEN EN ISO 10993-15:2000 |
OJ2001/C319/06 | Biological evaluation of medical devices. Identification and quantification of degradation
products from metals and alloys (ISO 10993-15:2000) |
BS EN ISO 10993-15:2001 |
| CEN EN ISO 10993-16:1997 |
OJ99/C181/03 | Biological evaluations of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables. | BS EN ISO 10993-16:1997 |
| CEN EN ISO 10993-17:2002 |
OJ2003/C270/02 | Biological evaluation of medical devices—Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) | BS EN ISO 10993-17:2002 |
| CEN EN ISO 11196:1997 |
OJ99/C181/03 | Anaesthetic gas monitors (ISO 11196:1995 including technical corrigendum 1:1997) | BS EN ISO 11196:1997 withdrawn and superseded by BS EN ISO 21647:2004 |
| CEN EN ISO 11810:2002 |
OJ2002/C321/02 | Optics and optical instruments—Lasers and laser-related equipment—Test method for the laser-resistance of surgical drapes and/or patient-protective covers (ISO 11810:2002) | BS EN ISO 11810:2002 withdrawn and replaced by BS EN ISO 11810-1:2005 |
| CEN EN ISO 11990:2003 |
OJ2003/C268/12 | Optics and optical instruments—Lasers and laser-related equipment—Determination of laser resistance of tracheal tube shafts (ISO 11990:2003) | BS EN ISO 11990:2003 |
| CEN EN 12006-1:1999 |
OJ2000/C293/06 | Non-active surgical implants—Particular requirements for cardiac and vascular implants—Part 1: Heart valve substitutes | BS EN 12006-1:1999 |
| CEN EN 12006-2:1998 |
OJ99/C181/03 | Non-active surgical implants—Particular requirements for cardiac and vascular implants—Part 2: Vascular prostheses including cardiac valve conduits | BS EN 12006-2:1998 |
| CEN EN 12006-3:1998 |
OJ99/C227/09 | Non-active surgical implants—Particular requirements for cardiac and vascular implants—Part 3: Endovascular devices | BS EN 12006-3:1999 |
| CEN EN 12010:1998 |
OJ99/C181/03/06 | Non-active surgical implants—Joint replacement implants—particular requirements | BS EN 12010:1998 |
| CEN EN12011:1998 |
OJ99/C181/03 | Instrumentation to be used in association with non-active surgical implants—General requirements | BS EN 12011:1998 |
| CEN EN 12182:1999 |
OJ2000/C293/06 | Technical aids for disabled persons—General requirements and test methods | BS EN 12182:1999 |
| CEN EN 12183:1999 |
OJ99/C227/09 | Manually propelled wheelchairs—Requirements and test methods | BS EN 12183:1999 |
| CEN EN 12184:1999 |
OJ99/C227/09 | Electrically powered wheelchairs, scooters and their chargers—Requirements and test methods | BS EN 12184:1999 |
| CEN EN 12218:1998 |
OJ2000/C293/06 | Rail systems for supporting medical equipment | BS EN 12218:1999 |
| CEN EN 12218:1998/ Amendment A1:2002 |
OJ2002/C310/04 | Rail systems for supporting medical equipment | BS EN 12218:1999 incorporates the amendment |
| CEN EN 12322:1999/ A1:2001 |
OJ2002/C182/06 | In vitro diagnostic medical devices—Culture media for microbiology—Performance criteria for culture media | BS EN 12322:1999 incorporates the amendment |
| CEN EN 12342:1998 |
OJ99/C181/03/06 | Breathing tubes intended for use with anaesthetic apparatus and ventilators | BS EN 12342:1998 |
| CEN EN 12442-1:2000 |
OJ2001/C319/05 | Animal tissues and their derivatives utilised in the manufacture of medical devices—Part 1: Analysis and management of risk | BS EN 12442-1:2000 |
| CEN EN 12442-2:2000 |
OJ2001/C319/05 | Animal tissues and their derivatives utlised in the manufacture of medical devices—Part 2: Controls on sourcing, collection and handling | BS EN 12442-2:2000 |
| CEN EN 12442-2:2000 |
OJ2001/C1319/05 | Animal tissues and their derivatives utlised in the manufacture of medical devices—Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents | BS EN 12442-3:2000 |
| CEN EN 12470-1:2000 |
OJ2000/C293/06 | Clinical thermometers—Part 1: Metallic liquid-in-glass thermometers with maximum device | BS EN 12470-1:2000 |
| CEN EN 12470-2:2000 |
OJ2001/C319/05 | Clinical thermometers—Part 2: Phase change type (dot matrix) thermometers | BS EN 12470-2:2001 |
| CEN EN 12470-3:2000 |
OJ2000/C293/06 | Clinical thermometers—Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device | BS EN 12470-3:2000 |
| CEN EN 12470-4:2000 |
OJ2001/C319/05 | Clinical thermometers—Part 4: Performance of electrical thermometers for continuous measurement | BS EN 12470-4:2001 |
| CEN EN 12470-5:2003 |
OJ2003/C268/12 | Clinical thermometers—Part 5: Performance of infra-red ear thermometers with maximum device | BS EN 12470-5:2003 |
| CEN EN 12523:1998 |
OJ99/C227/09 | External limb prostheses and external orthoses—Requirements and test methods | BS EN 12523:1999 |
| CEN EN 12563:1998 |
OJ99/C227/09 | Non-active surgical implants—Joint replacement implants—Specific requirements for hip joint replacement implants | BS EN 12563:1999 |
| CEN EN 12564:1998 |
OJ99/C227/09 | Non-active surgical implants—Joint replacement implants—Specific requirements for knee joint replacement implants | BS EN 12564:1999 |
| CEN EN 12598:1999 |
OJ99/C227/09 | Oxygen monitors for patient breathing mixtures—Particular requirements | BS EN 12598:1999 BS 5724-2.27 withdrawn and superseded by BS EN ISO 21647:2004 |
| CEN EN ISO 12870:1997 |
OJ99/C181/03 | Ophthalmic optics—Spectacle frames—General requirements and test methods | BS EN ISO 12870:1998 withdrawn and superseded by BS EN ISO 12870:2004 |
| CEN EN 13014:2000 |
OJ2001/C319/05 | Connections for gas sampling tubes to anaesthetic and respiratory equipment | BS EN 13014:2000 |
| CEN EN 13220:1998 |
OJ2000/C293/06 | Flow-metering devices for connection to terminal units of medical gas pipeline systems | BS EN 13220:1999 |
| CEN EN 13221:2000 |
OJ2001/C319/05 | High-pressure flexible connections for use with medical gases | BS EN 13221:2000 |
| CEN EN 13328-1:2001 |
OJ2002/C182/06 | Breathing system filters for anaesthetic and respiratory use—Part 1: Test method to assess filtration performance | BS EN 13328-1:2001 |
| CEN EN 13328-2:2002 |
OJ2003/C75/09 | Breathing system filters for anaesthetic and respiratory use—Part 2: Non-filtration aspects | BS EN 13328-2:2002 |
| CEN EN ISO 13485:2000 |
OJ2002/C182/05 | Quality systems—Medical devices—Particular requirements for the application of EN ISO 9001:1994 (revision of EN 46001:1996) | BS EN ISO 13485:2001 |
| Reference of the superseded standard: EN 46001 | |||
| Date of cessation of presumption of conformity of the superseded standard: 2004-03-01 | |||
| CEN EN ISO 13488:2000 |
OJ2002/C182/05 | Quality systems—Medical devices—Particular requirements for the application of ISO 9002:1994 (revision of EN 46002:1996) | BS EN ISO 13488:2001 |
| (See warning below) | Reference of the superseded standard: EN 46002 | ||
| Date of cessation of presumption of conformity of the superseded standard: 2004-03-01 | |||
| CEN EN ISO 13485:2003 |
OJ2004/C83/03 | Medical devices—Quality management systems—Requirements regulatory purposes (ISO 13485:2003) | BS EN ISO 13485:2003 |
| 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 EN ISO 13503-8:2000 |
OJ2001/C319/05 | Ophthalmic implants. Intraocular lenses. Fundamental requirements (ISO/FDIS 11979-8:1999, modified) |
BS EN 13503-8:2000 |
| CEN EN 13544-1:2001 |
OJ2002/C182/06 | Respiratory therapy equipment—Part 1: Nebulising systems and their components | BS EN 13544-1:2001 |
| CEN EN 13544-2:2002 |
OJ2002/C321/02 | Respiratory therapy equipment—Part 2: Tubing and connectors | BS EN 13544-2:2002 |
| CEN EN 13544-3:2001 |
OJ2002/C182/06 | Respiratory therapy equipment—Part 3: Air entrainment devices | BS EN 13544-3:2001 |
| CEN EN 13718-1:2002 |
OJ2002/C321/02 | Air, water and difficult terrain ambulances—Part 1: Medical device interface requirements for the continuity of patient care | BS EN 13718-1:2002 |
| CEN EN 13718-2:2002 |
OJ2003/C75/09 | Air, water and difficult terrain ambulances—Part 2: Operational and technical requirements for continuity of patient care | BS EN 13718-2:2002 |
| CEN EN 13726-1:2002 |
OJ2003/C75/09 | Test methods for primary wound dressings—Part 1: Aspects of absorbency | BS EN 13726-1:2002 |
| CEN EN 13726-2:2002 |
OJ2003/C75/09 | Test methods for primary wound dressings—Part 2: Moisture vapour transmission rate of permeable film dressings | BS EN 13726-2:2002 |
| CEN EN 13726-3:2003 |
OJ2003/C268/12 | Non-active medical devices—Test methods for primary wound dressings—Part 3: Waterproofness | BS EN 13726-3:2003 |
| CEN EN 13726-4:2003 |
OJ2003/C268/12 | Non-active medical devices—Test methods for primary wound dressings—Part 4: Conformability | BS EN 13726-4:2003 |
| CEN EN 13867:2002 |
OJ2002/C321/02 | Concentrates for haemodialysis and related therapies | BS EN 13867:2002 |
| CEN EN 14079:2003 |
OJ2003/C268/12 | Non-active medical devices—Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze | BS EN 14079:2003 |
| CEN EN ISO 14155-1:2003 |
OJ2003/C270/02 | Clinical investigation of medical devices for human subjects—Part 1: General requirements (ISO 14155-1:2003) | BS EN ISO 14155-1:2003 |
| CEN EN ISO 14155-2:2003 |
OJ2003/C270/02 | Clinical investigation of medical devices for human subjects—Part 2: Clinical investigation plans (ISO 14155-2:2003) | BS EN ISO 14155-2:2003 |
| CEN EN ISO 14160:1998 |
OJ99/C181/03 | Sterilisation of single-use medical devices incorporating materials of animal origin—Validation and routine control of sterilisation by liquid chemical sterilants | BS EN ISO 14160:1998 |
| CEN EN 14180:2003 |
OJ2003/C268/12 | Sterilizers for medical purposes—Low temperature steam and formaldehyde sterilizers—Requirements and testing | BS EN 14180:2003 |
| CEN EN ISO 14534:2002 |
OJ2002/C310/04 | Ophthalmic optics—Contact lenses and contact lens care products—Fundamental requirements (ISO 14534:2002) | BS EN ISO 14534:2002 |
| CEN EN ISO 14602:1998 |
OJ99/C181/03 | Non-active surgical implants — Implants of osteosynthesis — Particular requirements |
BS EN ISO 14602:1998 |
| CEN EN ISO 14630:1997 |
OJ99/C181/03 | Non-active surgical implants —General requirements |
BS EN ISO 14630:1998 withdrawn and superseded by BS EN ISO 14630:2005 |
| CEN EN ISO 14889:2003 |
OJ2003/C268/12 | Ophthalmic optics— Spectacle lenses— Fundamental requirements for uncut finished lenses (ISO 14889:2003) |
BS EN ISO 14889:2003 |
| CEN EN ISO 14937:2000 |
OJ2002/C182 | Sterilisation of health care products—General requirements for characterisation of a sterilising agent and the development, validation and routine control of a sterilisation process for medical devices (ISO 14937:2000) | BS EN ISO 14937:2001 |
| CEN EN ISO 14971:2000 |
OJ2002/C182/05 | Medical devices—Application of risk management to medical devices (ISO 14971:2000) | BS EN 1SO 14971:2001 |
| Reference of the superseded standard: EN 1441 Date of cessation of presumption of conformity of the superseded standard: 2004-04-01 |
|||
| CEN EN ISO 14971:2000/ Amendment AC:2002 |
OJ2004/C83/03 | Medical devices—Application of risk management to medical devices (ISO 14971:2000) |
BS EN ISO 14971:2001 incorporates the amendment |
| CEN EN ISO 15004:1997 |
OJ99/C181/03/06 | Ophthalmic instruments— Fundamental requirements and test methods (ISO 594-1:1986) |
BS EN ISO 15004:1998 |
| CEN EN ISO 15225:2000 |
OJ2002/C182/06 | Nomenclature—Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) | BS EN ISO 15225:2000 |
| CEN EN ISO 17510-2:2003 |
OJ2003/C268/12 | Sleep apnoea breathing therapy—Part 2: Masks and application accessories (ISO 17510-2:2003) | BS EN ISO 17510-2:2003 |
| CEN EN 20594-1:1993 |
OJ99/C181/03 | Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. Part 1 General requirements | BS EN 20594-1:1994 |
| CEN EN 20594-1:1993/ Amendment A1:1997 |
OJ99/C227/09 | Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical
equipment. Part 1 General requirements |
BS EN 20594-1:1993 incorporates the amendment |
| CEN EN 27740:1992 |
OJ99/C181/03 | Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) | BS EN 27740:1992 |
| CEN EN 27740:1992/ Amendment A1:1997 |
OJ99/C227/09 | Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) | BS EN 27740:1992 incorporates the amendment |
| CEN EN 30993-3:1993 |
OJ99/C181/03 | Biological evaluation of medical devices. Part 3 Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:1992) | BS EN 30993-3:1994 withdrawn and superseded by BS EN ISO 10993-3:2003 |
| CEN EN 30993-4:1993 |
OJ99/C181/03 | Biological evaluation of medical devices. Part 4 Selection of test for interactions with blood (ISO 10993-4:1992) | BS EN 30993-4:1994 withdrawn and superseded by BS EN ISO 10993-4:2002 |
| CEN EN 30993-5:1993 |
OJ99/C181/03 | Biological evaluation of medical devices. Part 5 Tests for cytotoxicity—in vitro methods (ISO 10993-5:1992) | BS EN 30993-5:1994 withdrawn and superseded by BS EN ISO 10993-5:1999 |
| CEN EN30993-6:1994 |
OJ99/C181/03 | Biological evaluation of medical devices. Part 6 Tests for local effects after implantation (ISO 10993-6:1994) | BS EN 30993-6:1995 |
| CEN EN 30993-11:1995 |
OJ99/C181/03 | Biological evaluation of medical devices—Part 11: tests for systemic toxicity (ISO 10993-11:1993) | BS EN ISO 10993-11:1996 |
| CEN/CENELEC EN 46003:1999 |
OJ2005/C103/02 | Quality systems—Medical devices—Particular requirements for the application of EN ISO 9003 | BS EN 46003:1999 |
| CENELEC EN 60118-13:1997 |
OJ2005/C103/02 | Hearing aids. Electromagnetic compatibility (EMC). (IEC 60118-13:1997) |
BS EN 60118-13:1998 |
| CENELEC EN 60522:1999 |
OJ2005/C103/02 | Determination of the permanent filtration of X-ray tube assemblies (IEC 60522:1999) | BS EN 50522:1999 |
| CENELEC EN 60580:2000 |
OJ2005/C103/02 | Medical electrical equipment—Dose area product meters (IEC 60580:2000) | BS EN 60580:2000 |
| CENELEC EN 60601-1:1990 |
OJ2003/C247/04 | Medical electrical equipment. Part 1: General requirements for safety (IEC 60601-1:1988) | BS EN 60601-1:1990 |
| CENELEC EN 60601-1:1990 Amendment A1 1993 |
OJ2005/C103/02 | Medical electrical equipment. Part 1: General requirements for safety—IEC 601-1:1988/A1:1991 | BS EN 60601-1:1990 (Amendment incorporated) |
| CENELEC EN 60601-1:1990 Amendment A2 1995 |
OJ2005/C103/02 | Medical electrical equipment. Part 1: General requirements for safety—IEC 601-1:1988/A2:1995 and corrigendum June 1995 | BS EN 60601-1:1990 (Amendment incorporated) |
| CENELEC EN 60601-1:1990 Amendment A13 1996 |
OJ2005/C103/02 | Medical electrical equipment. Part 1: General requirements for safety—IEC 601-1:1988/A13:1995 | BS EN 60601-1:1990 (Amendment incorporated) |
| CENELEC EN 60601-1-1:2001 |
OJ2005/C103/02 | Medical electrical equipment.—Part 1-1: General requirements for safety. Collateral standard. Safety requirements for medical electrical systems | BS EN 60601-1-1:2001 |
| CENELEC EN 60601-1-2:2001 |
OJ2005/C103/02 | Medical electrical equipment.—Part 1-2: General requirements for safety—Collateral standard: Electromagnetic compatibility—Requirements and tests (IEC 60601-1-2:2001) | BS EN 60601-1-2:2002 |
| CENELEC EN 60601-1-3:1994 |
OJ2005/C103/02 | Medical electrical equipment. Part 1 General requirements for safety. Section 3. Collateral standard, general requirements for radiation protection in diagnostic X-ray Equipment (IEC 60601-1-3:1994) | BS EN 60601-1-3:1995 |
| CENELEC EN 60601-1-4:1996 |
OJ2005/C103/02 | Medical electrical equipment—Part 1 General requirements for safety. Section 4. Collateral standard, programmable electrical medical systems (IEC 60601-1-4:1996) | BS EN 60601-1-4:1997 |
| CENELEC EN 60601-1-4:1996 Amendment A1:1999 |
OJ2005/C103/02 | Medical electrical equipment. General requirements for safety. Collateral standard. Programmable electrical medical systems (IEC 60601-1-4:1996/A1:1999) | BS EN 60601-1-4:1997 (Amendment incorporated) |
| CENELEC EN 60601-2-1:1998 |
OJ2005/C103/02 | Medical electrical equipment.—Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV (IEC 60601-2-1:1998) | BS EN 60601-2-1:1998 |
| EN60601-2-1:1998/ Amendment A1:2002 |
(IEC 60601-2-1:1998/A1:2002) | (Amendment incorporated) | |
| CENELEC EN 60601-2-2:2000 |
OJ2005/C103/02 | Medical electrical equipment. Part 2-2 Particular requirements for the safety of high frequency surgical Equipment (IEC 60601-2-2:1998) | BS EN 60601-2-2:2001 |
| CENELEC EN 60601-2-3:1993 |
OJ95/C307/15 | Medical electrical equipment. Part 2-3 Particular requirements for the safety of short wave therapy equipment (IEC 60601-2-3:1991) | BS EN 60601-2-3:1992 |
| CENELEC EN 60601-2-3:1993 |
OJ2005/C103/02 | Medical electrical equipment. Particular requirements for the safety of short-wave therapy equipment (IEC 60601-2-3:1991) | BS EN 60601-2-3:1993 |
| Amendment A1 1998 | (IEC 60601-2-3:1991/A1:1998) | (Amendment incorporated) | |
| CENELEC EN 60601-2-4:2003 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-4: Particular requirements for the safety of cardiac defibrillators (IEC 60601-2-4:2002) | BS EN 60601-2-4:2003 |
| CENELEC EN 60601-2-5:2000 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment (IEC 60601-2-5:2000) | BS EN 60601-2-5:2001 |
| CENELEC EN 60601-2-7:1998 |
OJ2005/C103/02 | Medical electrical equipment. Part 2-7: Particular requirements for the safety of high voltage generators of diagnostic X-ray generators (IEC 60601-2-7:1998) | BS EN 60601-2-7:1998 |
| CENELEC EN 60601-2-8:1997 |
OJ2005/C103/02 | Medical electrical equipment. Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10kV to 1MV (IEC 60601-2-8:1987) | BS EN 60601-2-8:1998 |
| Amendment A1:1997 | (IEC 60601-2-8:1987/A1:1997) | (Amendment incorporated) |
| CENELEC EN 60601-2-9:1996 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-9: Particular requirements for the safety of patient
contact dosemeters used in radiotherapy with electrically connected radiation detectors (IEC 60601-2-9:1996) |
BS EN 60601-2-0:1997 |
| CENELEC EN 60601-2-10:2000 Amendment A1:2001 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-10: Particular requirements for the safety of
nerve and muscle stimulators (IEC 60601-2-10:1987) (IEC 60601-2-10:1987/A1:2001) |
BS EN 60601-2-10:2001 (Amendment incorporated) |
| CENELEC EN 60601-2-11:1997 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-11: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997) | BS EN 60601-2-11:1998 |
| CENELEC EN 60601-2-16:1998 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:1998) | BS EN 60601-2-16:1998 |
| CENELEC EN 60601-2-17:1996 |
OJ97/C149/04 | Medical electrical equipment—Part 2-17: Particular requirements for the safety of remote controlled automatically driven gamma ray after-loading equipment (IEC 60601-2-17:1989) | BS EN 60601-2-17:1996 |
| CENELEC EN 60601-2-17:1996/ Amendment A1 1996 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-17: Particular requirements for the safety of remote controlled automatically driven gamma ray after-loading equipment/A1:1996 (IEC 60601-2-17:1989/A1:1996) | BS EN 60601-2-17:1996 (Amendment incorporated) |
| CENELEC EN 60601-2-17:2004 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-17: Particular requirements for the safety of automatically controlled brachytherapy afterloading equipment (IEC 60601-2-17:2004) | BS EN 60601-2-17:2004 |
| Presumption of conformity to EN 60601-2-17:1996 and A1:1996 expires 01.03.2007 | |||
| CENELEC EN 60601-2-18:1996/ Amendment A1:2000 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-18: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996/A1:2000) | BS EN 60601-2-18:1997 (Amendment incorporated) |
| CENELEC EN 60601-2-19:1996/ Amendment A1:1996 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-19: Particular requirements for the safety of baby incubators (IEC 60601-2-19:1990/A1:1996) | BS EN 60601-2-19:1997 (Amendment incorporated) |
| CENELEC EN 60601-2-20:1996 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-20: Particular requirements for the safety of transport incubators (IEC 60601-2-20:1990 + A1:1996) | BS EN 60601-2-20:1997 |
| CENELEC EN 60601-2-21:1994 |
OJ99/C288/43 | Medical electrical equipment—Part 2-21: Particular requirements for the safety of infant radiant warmers (IEC 60601-2-21:1994) | BS EN 60601-2-21:1997 |
| CENELEC EN 60601-2-21:1994/ Amendment A1:1996 |
OJ2005/C103/02 | Medical electrical equipment. Particular requirements for the safety of infant radiant warmers (IEC 60601-2-21:1994/A1:1996) | BS EN 60601-2-21:1997 (Amendment incorporated) |
| CENELEC EN 60601-2-22:1996 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-22: Particular requirements for the safety of
diagnostic and therapeutic laser equipment (IEC 60601-2-22:1995) |
BS EN 60601-2-22:1996 |
| CENELEC EN 60601-2-23:2000 |
OJ2005/C103/02 | Medical electrical equipment. Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment (IEC 60601-2-23:1999) | BS EN 60601-2-23:2000 |
| CENELEC EN 60601-2-24:1998 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-24: Particular requirements for the safety of infusion pumps and controllers (IEC 60601-2-24:1998) | BS EN 60601-2-24:1998 |
| CENELEC EN 60601-2-25:1995 |
OJ97/C149/04 | Medical electrical equipment—Part 2-25: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993) | BS EN 60601-2-25:1996 |
| CENELEC EN 60601-2-25:1995 Amendment A1 1999 |
OJ2005/C103/02 | Medical electrical equipment. Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993/A1:1999) | BS EN 60601-2-25:1996 (Amendment incorporated) |
| CENELEC EN 60601-2-26:1994 |
OJ2005/C103/02 | Medical electrical equipment. Part 2-26: Particular requirements for the safety of electroencephalographs (IEC 60601-2-26:1994) | BS EN 60601-2-26:1995 withdrawn and superseded by BS EN 60601-2-26:2003 |
| CENELEC EN 60601-2-26:2003 |
OJ2005/C103/02 | Medical electrical equipment. Part 2-26: Particular requirements for the safety of electroencephalographs (IEC 60601-2-236:2002) | BS EN 60601-2-26:2003 |
| CENELEC EN 60601-2-237:1994 |
OJ2005/C103/02 | Medical electrical equipment. Part 2-27: Particular requirements for the safety of electrocardiographic monitoring equipment (IEC 60601-2-27:1994) | BS EN 60601-2-27:1995 |
| CENELEC EN 60601-2-28:1993 |
OJ2005/C103/02 | Medical electrical equipment. Part 2-28: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:1993) | BS EN 60601-2-28:1993 |
| CENELEC EN 60601-2-29:1999 |
OJ2005/C103/02 | Medical electrical equipment. Particular requirements for the safety of radiotherapy simulators (IEC 60601-2-29:1999) | BS EN 60601-2-29:1999 |
| CENELEC EN 60601-2-30:2000 |
OJ2005/C103/02 | Medical electrical equipment. Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment (IEC 60601-2-30:1999) | BS EN 60601-2-30:2000 |
| CENELEC EN 60601-2-31:1995 Amendment A1 1998 |
OJ2005/C103/02 | Medical electrical equipment. Particular requirements for the safety of external cardiac pacemakers with internal power source (IEC 60601-2-31:1994/A1:1998) | BS EN 60601-2-31:1995 (Amendment incorporated) |
| CENELEC EN 60601-2-32:1994 |
OJ2005/C103/02 | Medical electrical equipment. Part 2-32: Particular requirements for the safety of associated equipment of X-ray equipment (IEC 60601-2-32:1994) | BS EN 60601-2-32:1995 |
| CENELEC EN 60601-2-33:1995 Amendment A11 1997 |
OJ2005/C103/02 | Medical electrical equipment. Particular requirements for the safety of magnetic resonance equipment for medical diagnosis | BS EN 60601-2-33:1996 (Amendment incorporated) |
| CENELEC EN 60601-2-33:2002 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2002) | BS EN 60601-2-33:2002 |
| CENELEC EN 60601-2-34:2000 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment (IEC 60601-2-34:2000) | BS EN 60601-2-34:2001 |
| CENELEC EN 60601-2-35:1996 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-35: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use (IEC 60601-2-35:1996) | BS EN 60601-2-35:1997 |
| CENELEC EN 60601-2-36:1997 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997) | BS EN 60601-2-36:1997 |
| CENELEC EN 60601-2-37:2001 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2001) | BS EN 60601-2-37:2001 |
| CENELEC EN 60601-2-38:1996 Amendment A1 2000 |
OJ2005/C103/02 | Medical electrical equipment. Particular requirements for the safety of electrically operated hospital beds (IEC 60601-2-38:1996/A1:1999) | BS EN 60601-2-38:1997 (Amendment incorporated) |
| CENELEC EN 60601-2-39:1999 |
OJ2005/C103/02 | Medical electrical equipment. Particular requirements for the safety of peritoneal dialysis equipment (IEC 60601-2-39:1999) | BS EN 60601-2-39:1999 |
| CENELEC EN 60601-2-40:1998 |
OJ2005/C103/02 | Medical electrical equipment—Part 2—40: Particular requirements for the safety of
electromyographs and evoked response equipment (EC 60601-2-40:1998) |
BS EN 60601-2-40:1998 |
| CENELEC EN 60601-2-41:2000 |
OJ2005/C103/02 | Medical electrical equipment. Particular requirements for the safety of surgical luminaires
and luminaires for diagnosis (IEC 60601-2-41:2000) |
BS EN 60601-2-41:2000 |
| CENELEC EN 60601-2-43:2000 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-43: Particular requirements for the safety of
X-ray equipment for interventional procedures (IEC 60601-2-43:2000) |
BS EN 60601-2-43:2001 |
| CENELEC EN 60601-2-44:2001 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-43: Particular requirements for the safety of
X-ray equipment for interventional procedures (IEC 60601-2-43:2000) |
BS EN 60601-2-44:2001 |
| CENELEC EN 60601-2-44:2001/Amendment A1:2003 |
OJ2005/C103/02 | (IEC 60601-2-44:2001/A1:2002) | BS EN 60601-2-44:2001 amendment incorporated |
| Presumption of conformity to EN 60601-2-44:2001 (non-amended version) expires on 01.12.2005 | |||
| CENELEC EN 60601-2-45:2001 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-45: Particular requirements for the safety of
mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2001) |
BS EN 60601-2-45:2001 |
| CENELEC EN 60601-2-46:1998 |
OJ2005/C103/02 | Medical electrical equipment. Particular requirements for the safety of operating tables (IEC 60601-2-46:1998) | BS EN 60601-2-46:1998 |
| CENELEC EN 60601-2-47:2001 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-47:Particular requiremments for the safety, including
essential performance, of ambulatory electrocardiographic systems (IEC 60601-2-47:2001) |
BS EN 60601-2-47:2001 |
| CENELEC EN 60601-2-49:2001 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment (IEC 60601-2-49:2001) | BS EN 60601-2-49:2001 |
| CENELEC EN 60601-2-50:2002 |
OJ2005/C103/02 | Medical electrical equipment—Part 2-50: Particular requirements for the safety of infant phototherapy equipment (IEC 60601-2-50:2000) | BS EN 60601-2-50:2002 |
| CENELEC EN 60601-2-51:2003 |
OJ2004/C165/02 | Medical electrical equipment—Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs (IEC 60601-2-51:2003) | BS EN 60601-2-51:2003 |
| CENELEC EN 60627:2001 |
OJ2005/C103/02 | Diagnostic X-ray imaging equipment—Characteristics of general purpose and mammographic
anti-scatter grids (IEC 60627:2001) |
BS EN 60627:2001 |
| CENELEC EN 60645-1:2001 |
OJ2005/C103/02 | Electroacoustics—Audiological equipment—Part 1: Pure-tone audiometers (IEC 60645-1:2001) | BS EN 60645-1:2001 |
| CENELEC EN 60645-2:1997 |
OJ2005/C103/02 | Audiometers. Part 2: Equipment for speec audiometry (IEC 60645-2:1993) | BS EN 60645-2:1997 |
| CENELEC EN 60645-3:1995 |
OJ2005/C103/02 | Audiometers. Part 3: Auditory test signals of short duration for audiometric and naurootological purposes (IEC 60645-3:1994) | BS EN 60645-3:1995 |
| CENELEC EN 60645-4:1995 |
OJ2005/C103/02 | Audiometers. Part 4: Equipment for extended high-frequency audiometry (IEC 60645-4:1994) | BS EN 60645-4:1995 |
| CENELEC EN 61217:1996/Amendment A1:2001 |
OJ2005/C103/02 | Radiotherapy equipment. Co-ordinates, movements and scales (IEC 61217:1996/A1:2000) | BS EN 61217:1997 (Amendment incorporated) |
| CENELEC EN 61223-3-1:1999 |
OJ2005/C103/02 | Evaluation and routine testing in medical imaging departments. Acceptance tests. Imaging
performance of X-ray equipment for radiographic and radioscopic systems. (IEC 61223-3-1:1999) |
BS EN 61223-3-1:1999 |
| CENELEC EN 61223-3-4:2000 |
OJ2005/C103/02 | Evaluation and routine testing in medical imaging departments. Acceptance tests. Imaging
performance of dental X-ray equipment (IEC 61223-3-4:2000) |
BS EN 61223-3-4:2000 |
| CENELEC EN 61676:2002 |
OJ2005/C103/02 | Medical electrical equipment—Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (IEC 61676:2002) | BS EN 61676:2002 |
| CENELEC EN 62083:2001 |
OJ2005/C103/02 | Medical electrical equipment—Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2000) | BS EN 62083:2001 |
| CENELEC EN 62220-1:2004 |
OJ2005/C103/02 | Medical electrical equipment—Characteristics of digital X-ray imaging devices—Part 1: Determination of the detective quantum efficiency (IEC 62220-1:2003) | BS EN 62220-1:2004 |