| BIP 2071:2005 | Medical devices: ISO 13485 and ISO 9001 |
| BS 5724-1:1979 | Medical electrical equipment. Specification for general safety requirements |
| BS 7139:1989* IEC 60878:1988 | Guide to graphical symbols for use on medical electrical equipment |
| BS EN 1041:1998 | Information supplied by the manufacturer with medical devices |
| BS EN 13718-1:2002 | Air, water and difficult terrain ambulances. Medical devices interface requirements for the continuity of patient care |
| BS EN 13718-2:2002 | Air, water and difficult terrain ambulances. Operational and technical requirements for the continuity of patient care |
| BS EN 1441:1998 | Medical devices. Risk analysis |
| BS EN 30993-1:1994* ISO 10993-1:1992 | Biological evaluation of medical devices. Guidance on selection of tests |
| BS EN 30993-3:1994* ISO 10993-3:1992 | Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| BS EN 30993-4:1994* ISO 10993-4:1992 | Biological evaluation of medical devices. Selection of tests for interactions with blood |
| BS EN 46001:1994 | Application of EN 29001 (BS 5750:Part 1) to the manufacture of medical devices |
| BS EN 46001:1997 | Specification for application of EN ISO 9001 to the manufacture of medical devices |
| BS EN 46002:1994 | Application of EN 29002 (BS 5750:Part 2) to the manufacture of medical devices |
| BS EN 46002:1997 | Specification for application of EN ISO 9002 to the manufacture of medical devices |
| BS EN 46003:1999 | Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003 |
| BS EN 50103:1996 | Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry |
| BS EN 60601-1-1:1993* BS 5724-1.1:1992* IEC 60601-1-1:1992 | Medical electrical equipment. General requirements for safety. Collateral standard. Safety requirements for medical electrical systems |
| BS EN 60601-1-1:2001 | Medical electrical equipment. General requirements for safety. Collateral standard. Safety requirements for medical electrical systems. Section 1.1 Collateral standard: Safety requirements for medical electrical systems |
| BS EN 60601-1-2:1993* BS 5724-1.2:1993* IEC 60601-1-2:1993 | Medical electrical equipment. General requirements for safety. Collateral standard. Electromagnetic compatibility. Requirements and tests |
| BS EN 60601-1-2:2002* IEC 60601-1-2:2002 | Medical electrical equipment. General requirements for safety. Collateral standard. Electromagnetic compatibility. Requirements and tests |
| BS EN 60601-1-2:2007 | Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests |
| BS EN 60601-1-4:1997* BS 5724-1.4:1997* IEC 60601-1-4:1996 | Medical electrical equipment. General requirements for safety. Collateral standard. General requirements for programmable electrical medical systems |
| BS EN 60601-1-6:2004 | Medical electrical equipment. General requirements for safety. Collateral standard. Usability |
| BS EN 60601-1-6:2007 | Medical electrical equipment. General requirements for basic safety and essential Performance. Collateral standard. Usability |
| BS EN 60601-1-8:2004 | Medical electrical equipment. General requirements for safety. Collateral standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| BS EN 60601-1-8:2007 | Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| BS EN 60601-1:1990* BS 5724-1:1989 | Medical electrical equipment. General requirements for safety |
| BS EN 60601-1:2006 | Medical electrical equipment. General requirements for basic safety and essential performance |
| BS EN 61558-2-15:2001 | Safety of power transformers, power supply units and similar. Particular requirements for isolating transformers for the supply of medical locations |
| BS EN 62304:2006 | Medical device software. Software life-cycle processes |
| BS EN 62353:2008 | Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment |
| BS EN 62366:2008 | Medical devices. Application of usability engineering to medical devices |
| BS EN 793:1998 | Particular requirements for safety of medical supply units |
| BS EN 980:1997 | Graphical symbols for use in the labelling of medical devices |
| BS EN 980:2003 | Graphical symbols for use in the labelling of medical devices |
| BS EN 980:2008 | Symbols for use in the labelling of medical devices |
| BS EN ISO 11197:2004 | Medical supply units |
| BS EN ISO 13485:2001 | Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001 |
| BS EN ISO 13485:2003 | Medical devices. Quality management systems. Requirements for regulatory purposes |
| BS EN ISO 13488:2001 | Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002 |
| BS EN ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects. General requirements |
| BS EN ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects. Clinical investigation plans |
| BS EN ISO 14971:2001 | Medical devices. Application of risk management to medical devices |
| BS EN ISO 14971:2007 | Medical devices. Application of risk management to medical devices |
| BS EN ISO 15225:2000 | Nomenclature. Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange |
| BS EN ISO 15378:2007 | Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) |
| BS EN ISO 389-1:2000 | Acoustics. Reference zero for the calibration of audiometric equipment. Reference equivalent threshold sound pressure levels for pure tones and supra-aural earphones |
| BS EN ISO 389-2:1997 | Acoustics. Reference zero for the calibration of audiometric equipment. Reference equivalent threshold sound pressure levels for pure tones and insert earphones |
| BS EN ISO 389-3:1999 | Acoustics. Reference zero for the calibration of audiometric equipment. Reference equivalent threshold force levels for pure tones and bone vibrators |
| BS EN ISO 389-4:1999 | Acoustics. Reference zero for the calibration of audiometric equipment. Reference levels for narrow-band masking noise |
| BS EN ISO 389-5:2001 | Acoustics. Reference zero for the calibration of audiometric equipment. Reference equivalent threshold sound pressure levels for pure tones in the frequency range 8 kHz to 16 kHz |
| BS EN ISO 389-7:1998 | Acoustics. Reference zero for the calibration of audiometric equipment. Reference threshold of hearing under free-field and diffuse-field listening conditions |
| BS EN ISO 389-7:2005 | Acoustics. Reference zero for the calibration of audiometric equipment. Reference threshold of hearing under free-field and diffuse-field listening conditions |
| BS EN ISO 389-8:2004 | Acoustics. Reference zero for the calibration of audiometric equipment. Reference equivalent threshold sound pressure levels for pure tones and circumaural earphones |
| BS EN ISO 389:1997 | Acoustics. Standard reference zero for the calibration of pure tone air conduction audiometers |
| BS IEC 60825-8:1999 | Safety of laser products. Guidelines for the safe use of medical laser equipment |
| BS ISO 17166:1999 | Erythema reference action spectrum and standard erythema dose |
| DD ISO/TS 19218:2005 | Medical devices. Coding structure for adverse event type and cause |
| KIT 160 | Medical devices kit |
| PD 6573:1994* IEC TR 60513:1994 | Fundamental aspects of safety standards for medical electrical equipment |
| PD 6630:1998* CR 13217:1998 | Nomenclature system for medical devices for the purpose of regulatory data exchange. Rationale |
| PD CEN ISO/TR 14969:2005 | Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003 |
| PD CEN/TR 15133:2005 | Nomenclature. Collective terms and codes for groups of medical devices |
| PD CR 14230:2001 | Global medical device nomenclature for the purpose of regulatory data exchange |
| PD IEC TR 60878:2003 | Graphical symbols for electrical equipment in medical practice |
| PD IEC TR 62296:2003 | Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements |
| PD ISO/TR 16142:2006 | Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
