AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of IEC 60601-1:2005
AAMI deviations from IEC 60601-1:2005
Foreword
Introduction
1 Scope, object, and related standards
   1.1 Scope
   1.2 Object
   1.3 Collateral standards
   1.4 Particular standards
2 Normative references
3 Terminology and definitions
4 General requirements
   4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
   4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS
   4.3 ESSENTIAL PERFORMANCE
   4.4 EXPECTED SERVICE LIFE
   4.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS
   4.6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
   4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
   4.8 Components of ME EQUIPMENT
   4.9 Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in
         ME EQUIPMENT
   4.10 Power supply
   4.11 Power input
5 General requirements for testing ME EQUIPMENT
   5.1 TYPE TESTS
   5.2 Number of samples
   5.3 Ambient temperature, humidity, atmospheric pressure
   5.4 Other conditions
   5.5 Supply voltages, type of current, nature of supply,
         frequency
   5.6 Repairs and modifications
   5.7 Humidity preconditioning treatment
   5.8 Sequence of tests
   5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS
6 Classification of ME EQUIPMENT and ME SYSTEMS
   6.1 General
   6.2 Protection against electric shock
   6.3 Protection against harmful ingress of water or
         particulate matter
   6.4 Method(s) of sterilization
   6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT
   6.6 Mode of operation
7 ME EQUIPMENT identification, marking, and documents
   7.1 General
   7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
   7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts
   7.4 Marking of controls and instruments
   7.5 Safety signs
   7.6 Symbols
   7.7 Colors of the insulation of conductors
   7.8 Indicator lights and controls
   7.9 ACCOMPANYING DOCUMENTS
8 Protection against electrical HAZARDS from ME EQUIPMENT
   8.1 Fundamental rule of protection against electric shock
   8.2 Requirements related to power sources
   8.3 Classification of APPLIED PARTS
   8.4 Limitation of voltage, current, or energy
   8.5 Separation of parts
   8.6 Protective earthing, functional earthing, and potential
         equalization of ME EQUIPMENT
   8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
   8.8 Insulation
   8.9 CREEPAGE DISTANCES and AIR CLEARANCES
   8.10 Components and wiring
   8.11 MAINS PARTS, components, and layout
9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
   ME SYSTEMS
   9.1 MECHANICAL HAZARDS of ME EQUIPMENT
   9.2 HAZARDS associated with moving parts
   9.3 HAZARD associated with surfaces, corners, and edges
   9.4 Instability HAZARDS
   9.5 Expelled parts HAZARD
   9.6 Acoustic energy (including infra- and ultrasound)
         and vibration
   9.7 Pressure vessels and parts subject to pneumatic
         and hydraulic pressure
   9.8 HAZARDS associated with support systems
10 Protection against unwanted and excessive radiation HAZARDS
   10.1 X-Radiation
   10.2 Alpha, beta, gamma, neutron, and other particle radiation
   10.3 Microwave radiation
   10.4 Lasers and light emitting diodes
   10.5 Other visible electromagnetic radiation
   10.6 Infrared radiation
   10.7 Ultraviolet radiation
11 Protection against excessive temperatures and other HAZARDS
   11.1 Excessive temperatures in ME EQUIPMENT
   11.2 Fire prevention
   11.3 Constructional requirements for fire ENCLOSURES of
         ME EQUIPMENT
   11.4 ME EQUIPMENT and ME SYSTEMS intended for use with
         flammable anesthetics
   11.5 ME EQUIPMENT and ME SYSTEMS intended for use in
         conjunction with flammable agents
   11.6 Overflow, spillage, leakage, ingress of water or
         particulate matter, cleaning, disinfection,
         sterilization, and compatibility with substances
         used with the ME EQUIPMENT
   11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS
   11.8 Interruption of the power supply/SUPPLY MAINS to ME
         EQUIPMENT
12 Accuracy of controls and instruments and protection against
   hazardous outputs
   12.1 Accuracy of controls and instruments
   12.2 USABILITY
   12.3 Alarm systems
   12.4 Protection against hazardous output
13 HAZARDOUS SITUATIONS and fault conditions
   13.1 Specific HAZARDOUS SITUATIONS
   13.2 SINGLE FAULT CONDITIONS
14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
   14.1 General
   14.2 Documentation
   14.3 RISK MANAGEMENT plan
   14.4 PEMS DEVELOPMENT LIFE-CYCLE
   14.5 Problem resolution
   14.6 RISK MANAGEMENT PROCESS
   14.7 Requirement specification
   14.8 Architecture
   14.9 Design and implementation
   14.10 VERIFICATION
   14.11 PEMS VALIDATION
   14.12 Modification
   14.13 Connection of PEMS by NETWORK/DATA COUPLING to other
         equipment
15 Construction of ME EQUIPMENT
   15.1 Arrangements of controls and indicators of ME EQUIPMENT
   15.2 Serviceability
   15.3 Mechanical strength
   15.4 ME EQUIPMENT components and general assembly
   15.5 MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and
         transformers providing separation in accordance with 8.5
16 ME SYSTEMS
   16.1 General requirements for the ME SYSTEMS
   16.2 ACCOMPANYING DOCUMENTS of an ME SYSTEM
   16.3 Power supply
   16.4 ENCLOSURES
   16.5 SEPARATION DEVICES
   16.6 LEAKAGE CURRENTS
   16.7 Protection against MECHANICAL HAZARDS
   16.8 Interruption of the power supply to parts of an ME SYSTEM
   16.9 ME SYSTEM connections and wiring
17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Annexes
A - General guidance and rationale
B - Sequence of testing
C - Guide to marking and labelling requirements for ME EQUIPMENT
    and ME SYSTEMS
D - Symbols on marking
E - Examples of the connection of the measuring device (MD) for
    measurement of the PATIENT LEAKAGE CURRENT and PATIENT
    AUXILIARY CURRENT
F - Suitable measuring supply circuits
G - Protection against HAZARDS of ignition of flammable
    anesthetic mixtures
H - PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE, and documentation
I - ME SYSTEMS aspects
J - Survey of insulation paths
K - Simplified PATIENT LEAKAGE CURRENT diagrams
L - Insulated winding wires for use without interleaved insulation
Bibliography
Index
Index of abbreviations and acronyms

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.