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BS EN IEC 60601-2-31:2020:2023 Edition

BS EN IEC 60601-2-31:2020:2023 Edition

$198.66

Medical electrical equipment – Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Published By Publication Date Number of Pages
BSI 2023 60
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IEC 60601-2-31:2020 is available as IEC 60601-2-31:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 60601-2-31:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206. HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. This document does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1. This document does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS. This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and antitachycardia ME EQUIPMENT. IEC 60601-2-31:2020 cancels and replaces the second edition published in 2008 and Amendment 1:2011. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) The requirement for testing for energy reduction has been removed; b) The test for exposure to external defibrillation has been completely revised; c) The exclusion for testing ESD immunity only with respect to air discharges has been removed; d) Alignment with the latest edition of ISO 14708-2 for pacemakers, as well as the associated EMC standard ISO 14117; e) Additional rationale for all changes.

PDF Catalog

PDF Pages PDF Title
2 undefined
5 Annex ZA(normative)Normative references to international publicationswith their corresponding European publications
6 Blank Page
7 English
CONTENTS
9 FOREWORD
12 INTRODUCTION
13 201.1 Scope, object and related standards
15 201.2 Normative references
201.3 * Terms and definitions
17 201.4 General requirements
Tables
Table 201.101 – Distributed essential performance requirements
18 201.5 General requirements for testing me equipment
201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents
19 Table 201.102 – Dual chamber connector terminal marking
22 201.8 Protection against electrical hazards from me equipment
23 Figures
Figure 201.101 – Test waveform V test implemented by example RCL circuit using C = 120 μF, L = 25 μH, RL + R = 1 Ω
24 Figure 201.102 – Example circuit of defibrillation test voltage generator for generating a decaying exponential waveform
25 Figure 201.103 – Test setup for a single chamber external cardiac pacemaker
Figure 201.104 – Test setup for a dual chamber external cardiac pacemaker
26 Figure 201.105 – Test setup for a triple chamber external cardiac pacemaker, e.g. bi-ventricular external cardiac pacemaker
Figure 201.106 – Timing sequence
28 201.9 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
Figure 201.107 – Measuring circuit for the patient auxiliary current for me equipment with an internal electrical power source
29 201.12 Accuracy of controls and instruments and protection against hazardous outputs
30 Table 201.103 – me equipment parameters
31 Figure 201.108 – Measuring circuit for the maximum tracking rate
32 Figure 201.109 – Initial oscilloscope display when measuring maximum tracking rate
34 201.13 Hazardous situations and fault conditions for me equipment
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 * Electromagnetic disturbances – Requirements and tests
35 Table 202.101 – Static discharge requirements
36 Annexes
Annex I Identification of immunity pass/fail criteria
37 Annex AA (informative)Particular guidance and rationale
38 Table AA.1 – External pacemaker hazard inventory
44 Figure AA.1 – Simple model of a single chamber external pacemaker during defibrillation
46 Figure AA.2 – First proposal for a defib-protection testof single chamber external pacemaker
47 Figure AA.3 – Circuit for a defibrillation test generator for defibrillation test according to conditions during open heart surgery
48 Figure AA.4 – Defibrillation pulse generated bythe defibrillation test generator from Figure AA.3
49 Table AA.2 – Pulse energies calculated for C = 120 µF ± 5 %
50 Table AA.3 – Pulse energies calculated for C = 122 µF ± 5 %
51 Table AA.4 – Pulse energies calculated for C = 126,32 µF ± 5 %
52 Figure AA.5 – Rise times of a defibrillation pulse according to the circuit proposed in Figure AA.3
57 Bibliography
58 Index of defined terms used in this particular standard

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BS EN IEC 60601-2-31:2020
$198.66