09/30169326 DC : 0

201.1 Scope, object and related standards
201.2 Normative references
201.3 Terminology and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME
       EQUIPMENT
201.9 Protection against mechanical hazards of ME EQUIPMENT
       and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
       HAZARDS
201.11 Protection against excessive temperatures and other
       HAZARDS
201.12 Accuracy of controls and instruments and protection
       against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
       and ME SYSTEMS
202 Medical electrical equipment - Part 1-2: General
    requirements for safety - Collateral standard:
    Electromagnetic compatibility - Requirements and tests
    202.6 ELECTROMAGNETIC COMPATIBILITY
          202.6.1 EMISSIONS
          202.6.2 IMMUNITY
                   202.6.2.101 * Electrosurgery interference
203 Medical electrical equipment - Part 1-3: General
    requirements for safety Collateral standard:
    General requirements for radiation protection in
    diagnostic X-ray equipment
206 Medical electrical equipment - Part 1-6: General
    requirements for safety - Collateral standard: Usability
208 Medical electrical equipment - Part 1-8: General
    requirements for safety - Collateral Standard: General
    requirements, tests and guidance for alarm systems
    in medical electrical equipment and medical electrical
    systems
    208.3 Terms and Definitions
    208.6 ALARM SYSTEMS
          208.6.1.2 * ALARM CONDITION priority
          208.6.3.3.1 * Characteristics of auditory ALARM
                      SIGNAL priority
          208.6.3.3.2 Volume of auditory ALARM SIGNALS
                      and INFORMATION SIGNALS
                      208.6.3.3.2.101 * Volume of auditory
                                      ALARM SIGNALS reducible
                                      to zero
          208.6.4.2 * Delays to or from a DISTRIBUTED
                    ALARM SYSTEM
          208.6.6 ALARM LIMIT
                   208.6.6.1.101 PHYSIOLOGICAL ALARM CONDITIONS,
                                 ALARM LIMITS and delay time
                                 of physiological ALARM SIGNALS
          208.6.8 ALARM SIGNAL inactivation states
                   208.6.8.101 * TECHNICAL ALARM CONDITIONS
                   208.6.8.5 * Indication and access
          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
                   208.6.11.101 * Remote inactivation/activation
                                of ALARM SIGNALS
209 Medical electrical equipment - Part 1-9: Medical
    electrical equipment - Part 1-9: General requirements
    for basic safety and essential performance - Collateral
    Standard: Requirements for the reduction of environmental
    impacts
210 Medical electrical equipment - Part 1-10: Medical
    electrical equipment - Part 1-10: General requirements
    for basic safety and essential performance - Collateral
    Standard: Process requirements for the development
    of therapeutic closed-loop controllers
Annex AA (informative) - General guidance and rationale
Annex BB (informative) - Alarm diagrams of clause
         208/IEC 60601-1-8:2006
Annex EE (informative) - Examples of the connection of
         the measuring device (MD) for measurement of the
         PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT