1. Clinical Engineering The Royal Liverpool and Broadgreen University Hospitals NHS Trust NHS LIVERPOOL SHORT COURSES IN ELECTRICAL SAFETY ISO 9001: 2000 ISO 13485: 2003 Learning Method Three weeks prior to the course, participants will receive a questionnaire to be completed before they attend. This requires study of the relevant standard. The courses concentrate on practical examples. Who should attend The courses are aimed at Biomedical Engineers and Technicians who are required to configure, test or approve medical equipment and systems They are also aimed at manufacturers and suppliers of medical electrical equipment and systems and electrical safety testers. Course Staff Dr. Malcolm Brown Mr. Dave Smith Dr. Azzam Taktak Miss Lynsey McNally Registration Registration takes place between 9:00 – 9:30am. Courses are scheduled to conclude at 4:30pm. Fees Courses are individually priced. Details can be found on the application form provided Learning Structure The courses are designed so that each is free standing. However, it is highly recommended that students attend the main Safety of Medical Electrical Equipment (SME) course first as this forms the basic background for the other two courses. Courses Venue Department of Clinical Engineering 1 st Floor, Duncan Building Royal Liverpool University Hospital Daulby Street Liverpool L7 8XP Tel: 0151 706 4202 Fax: 0151 706 5803 For full terms and conditions and to download the application form, please visit our website: www.clineng-liverpool-nhs.com For details of course availability, please contact the ESM Course Organiser at the above address or email: L.McNally@liverpool.ac.uk CD 1363/05

2. Safety of Medical Electrical Systems BS EN 60601-1:2006 (SMS) Introduction Medical equipment is often found interconnected with other medical equipment, or with non-medical apparatus such as computers. Medical equipment may also be connected remotely to other equipment in non-medical rooms such as a Hospital Information System (HIS). These systems may be supplied by a manufacturer as a package, or may be configured locally. Examples of such systems include theatre trolleys, infusion stacks, endoscopy towers, image recording facilities, ITU networks, etc. Until recently, the safety of medical electrical systems were dealt with in the separate collateral standard BS EN 60601-1- 1:2001. This subject is now incorporated in the main BS EN 60601-1 standard, third edition. Objectives To provide Biomedical Engineers and Technicians with a thorough knowledge of the safety aspects of the 60601 standard related specifically to systems. On completion of the course, participants should be competent to configure medical/non-medical equipment systems and to know the extra protection methods recommended in the standard. Course Summary Relevant items from the 60601-1 standard Main points from the systems chapter Refreshments break Management of leakage currents Exercises on test requirements Lunch System configurations and solutions Practical test configuration session Refreshments break Review of questionnaires Who is the manufacturer of a system? Remaining hazards Safety of Medical Electrical Equipment BS EN 60601-1:2006 (SME) Introduction Until recently, there has been no specific UK guidance for the routine testing of medical electrical equipment. Most service organisations perform tests which have become custom and practice over many years, mainly modelled on the tests set out in the BS EN 60601 series of standards for ‘type testing’. The introduction of IEC standard IEC 62353 should change the situation considerably. The standard specifies test methods and procedures for routine testing and testing after repair. This new standard will obviously have an impact on practices in UK hospitals, on commercial service organisations, and on test equipment manufacturers. Objectives The purpose of the course is to improve the competence of Biomedical Engineers and Technicians in performing safety inspections and tests on medical equipment in the field on a routine basis and after modification. On completion of the course, the participant should be competent to perform and interpret electrical safety tests and inspections on common medical equipment without supervision and should have the knowledge to make judgments about the safety of unusual electrical configurations. Introduction There is a legal requirement under the Medical Devices Directive (MDD) to design and construct equipment in such a way that risk to the patient and the operator is minimised. In order to comply with the MDD, manufacturers have to demonstrate that they have met its essential requirements for safety and this is demonstrated by compliance with the relevant Harmonised Standards. For Medical Electrical Equipment, the Harmonised Standard for safety is BS EN 60601-1. The third edition of this standard was released in 2006 and it incorporates some of the old collateral standards. There has been considerable effort in the third edition of the 60601 standard to align the requirements for electrical performance of medical devices with those for information technology. There are also considerable additions in the third edition on risk management issues. Objectives To provide Biomedical Engineers and Technicians with a thorough knowledge of the safety aspects of the 2006 BS EN60601-1 general Standard as the basis for proceeding with configurations of systems and field safety testing Field Testing of Medical Equipment IEC 62353:2007 (FTME) Course Summary Introduction to the 60601-1 standard Effects of electricity on the body Electrical hazards from equipment Refreshments break Small/large currents arising from working and faulty equipment Allowable leakages and impedances for different classes of medical equipment and types of applied part Lunch Test configurations for compliance Safety testing and Inspection Questionnaire review Refreshments break CE marking Introduction to field safety testing and inspection Course Summary Introduction to field electrical testing Risk assessment Computerised equipment management systems Refreshments break Practical test configurations from 60601 Lunch IEC 62353 standard for recurrent testing of medical equipment Electrical safety testers MHRA Bulletin DB2006(05): Managing Medical Devices Exercises in planning test protocols Refreshments break Review of pre-course questionnaire Practical testing and inspection of medical equipment