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AAMI 60601 1 2 2021

AAMI 60601 1 2 2021

$172.66

ANSI/AAMI/IEC 60601-1-2:2014 & A1:2021, Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests

Published By Publication Date Number of Pages
AAMI 2021 130
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This standard specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances of medical electrical (ME) equipment and ME systems. Applicability of this collateral standard includes ME equipment and ME systems that have been found to have no essential performance. The amendment addresses changes to terminology and references since the main document was finalized in 2014.

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PDF Pages PDF Title
1 ANSI/AAMI/IEC 60601-1-2:2014 & A1:2021; Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral Standard: Electromagnetic disturbances—Requirements and tests (Consolidated Text; Redline Version)
2 Blank Page
3 Title page
4 AAMI Standard
Copyright information
5 CONTENTS
10 Committee representation
12 Background of ANSI/AAMI adoption of IEC 60601-1-2:2014 and Amendment 1:2020
13 Foreword
16 Introduction
18 INTRODUCTION to Amendment 1
19 Scope, object and related standards
1.1 * Scope
1.2 Object
1.3 Related standards
1.3.1 IEC 60601-1
20 1.3.2 Particular standards
Normative references
22 Terms and definitions
26 General requirements
4.1 Risk management process for me equipment and me systems
4.2 * Non-me equipment used in an me system
4.3 General test conditions
4.3.1 * Configurations
27 4.3.2 Artificial hand
28 4.3.3 * Power input voltages and frequencies
31 Me equipment and me systems identification, marking and documents
5.1 Additional requirements for marking on the outside of me equipment and me systems that are specified for use only in a shielded location special environment
5.2 Accompanying documents
5.2.1 Instructions for use
5.2.1.1 * General
32 5.2.1.2 Requirements applicable to me equipment and me systems classified class A according to CISPR 11
5.2.2 Technical description
5.2.2.1 Requirements applicable to all me equipment and me systems
33 5.2.2.2 Requirements applicable to me equipment and me systems specified for use only in a shielded location special environment
5.2.2.3 Requirements applicable to me equipment that intentionally receives RF electromagnetic energy for the purpose of its operation
5.2.2.4 Requirements applicable to me equipment that includes RF transmitters
34 5.2.2.5 Requirements applicable to permanently installed large me equipment and large me systems
5.2.2.6 Requirements applicable to me equipment and me systems that claim compatibility with hf surgical equipment
Documentation of the tests
6.1 General
6.2 Test plan
6.3 Test report
35 Electromagnetic emissions requirements for me equipment and me systems
7.1 Protection of radio services and other equipment
7.1.1 * General
7.1.2 Operating modes
7.1.3 Multimedia equipment
7.1.4 * Subsystems
7.1.5 Me equipment and me systems specified for use only in a shielded location special environment
36 7.1.6 Me equipment and me systems that include radio equipment
7.1.7 * Me equipment whose main functions are performed by motors and switching or regulating devices
7.1.8 Me equipment and me systems containing X-ray generators
7.1.9 Patient physiological simulation
37 7.1.10 Artificial hand
7.1.11 Patient-coupled cables
7.1.12 * Permanently installed large me equipment and large me systems
7.2 Protection of the public mains network
7.2.1 * Harmonic distortion
7.2.2 * Voltage fluctuations and flicker
38 7.3 Emissions requirements summary
Electromagnetic immunity requirements for me equipment and me systems
8.1 * General
42 8.2 Patient physiological simulation
8.3 Termination of patient-coupled parts
8.4 Hand-held me equipment and parts intended to be hand-held
43 8.5 * Subsystems
8.6 * Permanently installed large me equipment and large me systems
44 8.7 * Operating modes
8.8 * Non-me equipment
8.9 * Immunity test levels
52 8.10 * Immunity to proximity fields from RF wireless communications equipment
55 8.11 * Immunity to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz
56 * Test report
59 Annex A (informative) General guidance and rationale
A.1 Safety and performance
A.2 Testing of normally non-observable functions
A.3 Rationale for particular clauses and subclauses
84 Annex B (informative) Guide to marking and labelling requirements for me equipment and me systems
B.1 Marking on the outside of me equipment, me systems or their parts
B.2 Accompanying documents, instructions for use
B.3 Accompanying documents, technical description
86 Annex C (informative) Guidance in classification according to CISPR 11
C.1 General
C.2 Separation into groups
87 C.3 Division into classes
88 Annex D (informative) Guidance in the application of IEC 60601-1-2 to particular standards
D.1 General
D.2 Recommended modifications
D.2.1 Testing requirements
D.2.2 Accompanying documents
D.3 Cautions
90 Annex E (informative) Determination of immunity test levels for special environments
E.1 General
93 E.2 Summary of method for E.1 a)
E.3 Summary of method for E.1 b), c) and d)
E.4 Determination of em disturbance level reduction
E.5 Assessment of em disturbance sources
94 E.6 Reasonably foreseeable maximum em disturbance levels
E.7 Determination of immunity test levels
95 E.8 RF radiators in special environments
E.9 Examples of mitigations and special conditions
97 Annex F (informative) Risk management for basic safety and essential performance with regard to electromagnetic disturbances
A.1 General
98 A.1 General requirements for risk management
99 A.1 Risk analysis
103 A.1 Risk evaluation
A.1 Risk control
A.1.1 Risk control option analysis
A.1.1 Implementation of risk control measure(s)
104 A.1.1 Residual risk evaluation
A.1.1 Risk/benefit analysis
A.1.1 Risks arising from risk control measures
A.1.1 Completeness of risk control
105 A.1 Evaluation of overall residual risk acceptability
A.1 Risk management report
A.1 Production and post-production information
106 Guidance on the application of risk management with regard to electromagnetic disturbances in this collateral standard
115 Annex G (informative) Guidance: Test plan
G.1 Test plan contents
117 Annex H (informative) Patient-coupled cables emissions
H.1 * Protection of other equipment from patient cable conducted emissions
H.2 Test method
H.3 Rationale
120 Annex I (informative) Identification of immunity pass/fail criteria
I.1 General
I.2 Immunity pass/fail criteria principles
I.2.1 General
I.2.2 Immunity pass/fail criteria for non-me equipment used in an me system
I.2.3 Immunity pass/fail criteria determination
121 I.3 Immunity pass/fail criteria examples
I.3.1 General examples
122 I.3.2 Example of immunity pass/fail criteria for a radiological table system
124 Bibliography

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AAMI 60601 1 2 2021
$172.66