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Specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances of medical electrical (ME) equipment and ME systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards. Applicability of this collateral standard includes ME equipment and ME systems that have been found to have no essential performance.

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PDF Pages	PDF Title
1	ANSI/AAMI/IEC 60601-1-2:2014, MEDICAL ELECTRICAL EQUIPMENT – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances –Requirements and tests
2	Objectives and uses of AAMI standards and recommended practices
3	Title page
4	AAMI Standard Copyright information
5	CONTENTS
9	Glossary of equivalent standards
10	Committee representation
11	Background of ANSI/AAMI adoption of IEC 60601-1-2:2014
12	FOREWORD
15	INTRODUCTION
17	1 Scope, object and related standards 1.1 * Scope 1.2 Object 1.3 Related standards 1.3.1 IEC 60601-1 1.3.2 Particular standards
18	2 Normative references
20	3 Terms and definitions
23	4 General requirements 4.1 Risk management process for me equipment and me systems 4.2 * Non-me equipment used in an me system
24	4.3 General test conditions 4.3.1 * Configurations 4.3.2 Artificial hand
25	4.3.3 * Power input voltages and frequencies
27	5 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
28	5.2 Accompanying documents 5.2.1 Instructions for use 5.2.1.1 * General
29	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 5.2.2.2 Requirements applicable to me equipment and me systems specified for use only in a shielded location special environment
30	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 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 6 Documentation of the tests 6.1 General
31	6.2 Test plan 6.3 Test report 7 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
32	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
33	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
34	7.2.2 * Voltage fluctuations and flicker 7.3 Emissions requirements summary 8 Electromagnetic immunity requirements for me equipment and me systems 8.1 * General
38	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
39	8.5 * Subsystems 8.6 Permanently installed large me equipment and large me systems
40	8.7 * Operating modes 8.8 * Non-me equipment 8.9 * Immunity test levels
48	8.10 * Immunity to proximity fields from RF wireless communications equipment
50	9 * Test report
53	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
68	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
70	Annex C (informative) Guidance in classification according to CISPR 11 C.1 General C.2 Separation into groups
71	C.3 Division into classes
72	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
74	Annex E (informative) Determination of immunity test levels for special environments E.1 General
77	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
78	E.6 Reasonably foreseeable maximum em disturbance levels E.7 Determination of immunity test levels
79	E.8 RF radiators in special environments E.9 Examples of mitigations and special conditions
81	Annex F (informative) Risk management for basic safety and essential performance with regard to electromagnetic disturbances F.1 General
82	F.2 General requirements for risk management
83	F.3 Risk analysis
87	F.4 Risk evaluation F.5 Risk control F.5.1 Risk control option analysis F.5.2 Implementation of risk control measure(s)
88	F.5.3 Residual risk evaluation F.5.4 Risk/benefit analysis F.5.5 Risks arising from risk control measures F.5.6 Completeness of risk control
89	F.6 Evaluation of overall residual risk acceptability F.7 Risk management report F.8 Production and post-production information
90	Annex G (informative) Guidance: Test plan G.1 Test plan contents
92	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
94	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
95	I.3 Immunity pass/fail criteria examples I.3.1 General examples
96	I.3.2 Example of immunity pass/fail criteria for a radiological table system
98	Bibliography
101	Index of defined terms used in this collateral standard

Published By	Publication Date	Number of Pages
AAMI	2014	102


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Standard Title	ANSI/AAMI/IEC 60601-1-2:2014 – Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic disturbances – Requirements and tests
Published Code	AAMI
Publication Date	2014
Pages Count	102

AAMI 60601 1 2 2014

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