| 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 |
|
