AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
30-05-2020
English
01-01-2012
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
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