Institute of Decontamination Sciences Blackburn House, Redhouse Road, Seafield, Bathgate, West Lothian EH47 7AQ www.idsc-uk.co.uk 1. BS EN 13795-1:2002+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. General requirements for manufacturers, processors and products 2. BS EN 14885:2006 Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics 3. BS EN 285:2006+A2:2009 Sterilization. Steam sterilizers. Large sterilizers 4. BS EN 13060 +A2:2010 Small steam sterilizers 5. BS EN 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices 6. BS EN 14180:2003+A2:2009 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing 7. BS EN 556-1:2001 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices 8. BS EN 556-2:2003 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices 9. BS EN 868-2:2009
Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods 10. BS EN 980:2008 Symbols for use in the labelling of medical devices 11. BS EN ISO 11138-1:2006 Sterilization of health care products. Biological indicators. General requirements 12. BS EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes 13. BS EN ISO 11737-1:2006 Sterilization of medical devices. Microbiological methods. Determination of a population of microorganisms on products 14. BS EN ISO 11737-2:2009 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process 15. BS EN ISO 13727:2006 Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area. Test method and requirements (Phase 2/Step 1 16. BS EN ISO 13485:2003 Medical devices. Quality management systems. Requirements for regulatory purposes 17. BS EN ISO 13485:2012 Medical devices. Quality management systems. Requirements for regulatory purposes (this is the reviewed and reissued version of the 2003 version no amendments have been made) 18. PD CEN ISO/TR 14969:2005 Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003 19. BS EN 1041:2008 Information supplied by the manufacturer of medical devices 20. BS EN ISO 14001:2004 Environmental management systems. Requirements with guidance for use
21. BS EN ISO 14644-1:1999 Cleanrooms and associated controlled environments. Classification of air cleanliness 22. BS EN ISO 14644-2:2000 Cleanrooms and associated controlled environments. Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 23. BS EN ISO 14644-3:2005 Cleanrooms and associated controlled environments. Test methods 24. BS EN ISO 14644-4:2001 Cleanrooms and associated controlled environments. Design, construction and start-up 25. BS EN ISO 14644-5:2004 Cleanrooms and associated controlled environments. Operations 26. BS EN ISO 14644-6:2007 Cleanrooms and associated controlled environments. Vocabulary 27. BS EN ISO 14698-1:2003 Cleanrooms and associated controlled environments. Biocontamination control. General principles and methods 28. BS EN ISO 14698-2:2003 Cleanrooms and associated controlled environments. Biocontamination control. Evaluation and interpretation of biocontamination data 29. BS EN ISO 14971:2009 Medical devices. Application of risk management to medical devices 30. BS 6079-3:2000 Project management. Guide to the management of business related project risk 31. BS EN ISO 15882:2008 Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results 32. BS EN ISO 15883-1:2009 Washer-disinfectors. General requirements, terms and definitions and tests.
33. BS EN ISO 15883-2:2009 Washer-disinfectors. Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc 34. BS EN ISO 15883-4:2009 Washer-disinfectors. Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes 35. BS EN ISO 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements. 36. BS EN ISO 15883-2:2009 Washer-disinfectors. Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. 37. BS EN ISO 17664:2004 Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices 38. BS EN ISO 1041:2008 Information supplied by the manufacturer of medical devices 39. BS EN ISO 17665-1:2006 Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices 40. BS EN ISO 18472:2006 Sterilization of health care products. Biological and chemical indicators. Test equipment and methods 41. BS EN ISO 9001:2008 Quality management systems. Requirements 42. BS ISO 11140-5:2007 Sterilization of health care products. Chemical indicators. Class 2 indicators for Bowie and Dick-type air removal tests 43. BS ISO 8573-1:2001 Compressed air. Contaminants and purity classes
44. DD CEN ISO/TS 17665-2:2009 Sterilization of health care products. Moist heat. Guidance on the application of ISO 17665-1 V.O Brien Director of Technical Support Version 2_August 2012