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