Iec 60601

60601-1/FDIS ” IEC 2005

–2–

CONTENTS
FOREWORD.......................................................................................................................11 INTRODUCTION.................................................................................................................13

1

Scope, object and related standards.............................................................................15 1.1 Scope..................................................................................................................15 1.2 Object .................................................................................................................15 1.3 Collateral standards.............................................................................................151.4 Particular standards.............................................................................................16 Normative references....................................................................................................16 Terminology and definitions ..........................................................................................21 General requirements...................................................................................................39 4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS ....................................39 4.2 R ISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS ................................40 4.3 E SSENTIAL PERFORMANCE ......................................................................................404.4 E XPECTED SERVICE LIFE .........................................................................................41 4.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS ...............................................41 4.6 M E EQUIPMENT or ME SYSTEM parts that contact the PATIENT ...................................41 4.7 S INGLE FAULT CONDITION for ME EQUIPMENT............................................................41 4.8 Components of ME EQUIPMENT ..............................................................................42 4.9 Use of COMPONENTS WITH HIGH - INTEGRITY CHARACTERISTICS in ME EQUIPMENT ..........42 4.10 Power supply .......................................................................................................43 4.11 Power input.........................................................................................................44 General requirements for testing ME EQUIPMENT .............................................................45 5.1 T YPE TESTS ..........................................................................................................45 5.2 Number of samples..............................................................................................45 5.3 Ambient temperature, humidity, atmospheric pressure ..........................................45 5.4 Other conditions ..................................................................................................45 5.5 Supply voltages, type of current, nature of supply, frequency ................................45 5.6 Repairs and modifications....................................................................................46 5.7 Humidity preconditioning treatment ......................................................................46 5.8 Sequence of tests ................................................................................................47 5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS.........................................47 Classification of ME EQUIPMENT and ME SYSTEMS ............................................................49 6.1 6.2 6.3 6.4 6.5 6.6 General ...............................................................................................................49 Protection against electric shock ..........................................................................49 Protection against harmful...