PD 6573 : 1994 PUBLISHEDDOCUMENT IEC TR 513 : 1994 Fundamental aspects of safety standards for medical electrical equipment BSi NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAW British Standards BSI PD 6573 : 1994 Committees responsible for this Published Document The preparation of this Published Document was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/64, upon which the following bodies were represented: Association of Anaesthetists of Great Britain and Ireland Association of British Health-care Industries Association of X-ray Equipment Manufacturers (BEAMA Ltd.) British Anaesthetic and Respiratory Equipment Manufacturers' Association British Dental Trade Association British Photographic Association British Surgical Trades Association College of Radiographers Department of Health GAMBICA (BEAMA Ltd.) Health and Safety Executive Institute of Hospital Engineering Institute of Physical Sciences in Medicine (Ispm) Institution of Electrical Engineers Medical Sterile Products Association Ministry of Defence Royal College of Radiologists Scottish Health Services Sira Limited This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, Amendmentsissuedsincepublication South was published under the Date authority of the Standards Amd. No. Text affected Board and comes into effect on d Copy: London 15July 1994 BSI1994 The following BSI reference relates to the work on this Published Document: Committee reference HCC/64 Licensed ISBN 0 580 23399 5 ) BSI PD 6573 : 1994 Contents Page Committees responsible Inside front cover National foreword ili Foreword 1 Section 1. General Scope 4 1 2 Concepts 4 Section 2. Safety and standards Hazards 8 3 Factors affecting safety 4 10 Measures to achieve safety 5 10 Goal of standards 6 10 7 Types of standards 11 12 8 Acceptablerisklevels Developing safety and essential performance requirements 9 14 10 Equipment accessories 25 11 Standardization 26 12 Coordination of standards 26 13 Standards and the law 27 14 Role of standards 27 15 Accidents 27 16 Maintenance of standards 28 Section 3. Guide to the development of future product standards 17 Identification of problems 28 18 Priority 28 19 Format and structure 29 20 Specifying safety and essential performance requirements 30 21 Testing requirements 34 22 Design verification 37 23 Clinical trials and similar assessment 38 24 Performance requirements 38 Annexes A Classification of applied parts 40 B The role of standards in the assessment and approval of medical 46 electrical equipment c Improving overall safety 48 D Safety factors 52 E History of IEC 513, 1st edition and IEC 601 series 54 i