09/30169318 DC : 0

FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
       201.1.1 *Scope
       201.1.2 Object
       201.1.3 Collateral standards
       201.1.4 Particular standards
201.2 Normative references
201.3 Terminology and definitions
201.4 General requirements
       201.4.3.101 ESSENTIAL PERFORMANCE
201.5 General requirements for testing of ME
       EQUIPMENT
       201.5.4 Other conditions
       201.5.8 * Sequence of tests
201.6 Classification of ME EQUIPMENT and ME
       SYSTEMS
       201.6.2 * Protection against electric shock
       201.6.6 Mode of operation
201.7 ME EQUIPMENT identification, marking
       and documents
       201.7.2 Marking on the outside of ME EQUIPMENT
                 or ME EQUIPMENT parts
                 201.7.2.17 * Protective packaging
201.8 Protection against electrical HAZARDS from
       ME EQUIPMENT
       201.8.3 Classification of APPLIED PARTS
       201.8.5.5 DEFIBRILLATION-PROOF APPLIED PARTS
201.9 Protection against MECHANICAL HAZARDS of
       ME EQUIPMENT and ME SYSTEMS
       201.9.7 Pressure vessels and parts subject to
                pneumatic and hydraulic pressure
                201.9.7.5 * Pressure vessels
201.10 Protection against unwanted and excessive
       radiation HAZARDS
201.11 Protection against excessive temperatures
       and other HAZARDS
       201.11.6.5 * Ingress of water or particulate matter
                  into ME EQUIPMENT and ME SYSTEM
       201.11.8 * Interruption of the power supply/SUPPLY
                MAINS to ME EQUIPMENT
201.12 Accuracy of controls and instruments and
       protection against hazardous outputs
       201.12.1 Accuracy of controls and instruments
                201.12.1.101 * ESSENTIAL PERFORMANCE
       201.12.3 Alarm systems
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
       201.15.1.101 * Constructive requirements
       201.15.3 Mechanical strength
       201.15.4 ME EQUIPMENT components and general assembly
                201.15.4.4 Indicators
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and
       ME SYSTEMS
202 Electromagnetic compatibility - Requirements and tests
    202.5.2.2.2 Requirements applicable to ME EQUIPMENT and
                ME SYSTEMS other than those specified for
                use only in a shielded location
    202.6 ELECTROMAGNETIC COMPATIBILITY
          202.6.1 EMISSIONS
          202.6.2 * IMMUNITY
                   202.6.2.3 Radiated RF electromagnetic fields
                             202.6.2.3.1 Requirements
                             202.6.2.3.2 Tests
                             202.6.2.6.2 Tests
203 General requirements for radiation protection in
    diagnostic X-ray equipment
206 Usability
208 General requirements, tests and guidance for
    alarm systems in medical electrical equipment and
    medical electrical systems
    208.3 Terms and Definitions
    208.6 ALARM SYSTEM
          208.6.6 ALARM LIMIT
                   208.6.6.1.101 Physiological ALARM CONDITIONS,
                                 ALARM LIMITS and delay time of
                                 physiological ALARM SIGNALS
                   208.6.6.1.102 Detection of TRANSDUCER and
                                 TRANSDUCER cable fault
          208.6.8 ALARM SIGNAL inactivation states
                   208.6.8.1.101 * Duration of ALARM PAUSED and
                                 AUDIO PAUSED
          208.6.9 * ALARM RESET
          208.6.10 * NON-LATCHING and LATCHING ALARM SIGNALS
                     208.6.10.101 * NON-LATCHING ALARM SIGNAL for
                                  TECHNICAL ALARM CONDITIONS
          208.6.11 DISTRIBUTED ALARM SYSTEM
                   208.6.11.2.2 * Failure of remote communication
                                of ALARM CONDITIONS
209 Requirements for the reduction of environmental impacts
210 Process requirements for the development of therapeutic
    closed-loop controllers
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Alarm diagrams 208/IEC 60601-1-8:2006

BS EN 60601-2-34