{"id":426281,"date":"2024-10-20T07:01:13","date_gmt":"2024-10-20T07:01:13","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iec-60601-2-312020-4\/"},"modified":"2024-10-26T13:16:09","modified_gmt":"2024-10-26T13:16:09","slug":"bs-en-iec-60601-2-312020-4","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iec-60601-2-312020-4\/","title":{"rendered":"BS EN IEC 60601-2-31:2020"},"content":{"rendered":"

IEC 60601-2-31:2020 is available as IEC 60601-2-31:2020 RLV<\/span> which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.<\/p>\n

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.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
5<\/td>\nAnnex ZA(normative)Normative references to international publicationswith their corresponding European publications <\/td>\n<\/tr>\n
6<\/td>\nBlank Page <\/td>\n<\/tr>\n
7<\/td>\nEnglish
CONTENTS <\/td>\n<\/tr>\n
9<\/td>\nFOREWORD <\/td>\n<\/tr>\n
12<\/td>\nINTRODUCTION <\/td>\n<\/tr>\n
13<\/td>\n201.1 Scope, object and related standards <\/td>\n<\/tr>\n
15<\/td>\n201.2 Normative references
201.3 * Terms and definitions <\/td>\n<\/tr>\n
17<\/td>\n201.4 General requirements
Tables
Table 201.101 \u2013 Distributed essential performance requirements <\/td>\n<\/tr>\n
18<\/td>\n201.5 General requirements for testing me equipment
201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents <\/td>\n<\/tr>\n
19<\/td>\nTable 201.102 \u2013 Dual chamber connector terminal marking <\/td>\n<\/tr>\n
22<\/td>\n201.8 Protection against electrical hazards from me equipment <\/td>\n<\/tr>\n
23<\/td>\nFigures
Figure 201.101 \u2013 Test waveform V test implemented by example RCL circuit using C = 120 \u03bcF, L = 25 \u03bcH, RL + R = 1 \u03a9 <\/td>\n<\/tr>\n
24<\/td>\nFigure 201.102 \u2013 Example circuit of defibrillation test voltage generator for generating a decaying exponential waveform <\/td>\n<\/tr>\n
25<\/td>\nFigure 201.103 \u2013 Test setup for a single chamber external cardiac pacemaker
Figure 201.104 \u2013 Test setup for a dual chamber external cardiac pacemaker <\/td>\n<\/tr>\n
26<\/td>\nFigure 201.105 \u2013 Test setup for a triple chamber external cardiac pacemaker, e.g. bi-ventricular external cardiac pacemaker
Figure 201.106 \u2013 Timing sequence <\/td>\n<\/tr>\n
28<\/td>\n201.9 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 \u2013 Measuring circuit for the patient auxiliary current for me equipment with an internal electrical power source <\/td>\n<\/tr>\n
29<\/td>\n201.12 Accuracy of controls and instruments and protection against hazardous outputs <\/td>\n<\/tr>\n
30<\/td>\nTable 201.103 \u2013 me equipment parameters <\/td>\n<\/tr>\n
31<\/td>\nFigure 201.108 \u2013 Measuring circuit for the maximum tracking rate <\/td>\n<\/tr>\n
32<\/td>\nFigure 201.109 \u2013 Initial oscilloscope display when measuring maximum tracking rate <\/td>\n<\/tr>\n
34<\/td>\n201.13 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 \u2013 Requirements and tests <\/td>\n<\/tr>\n
35<\/td>\nTable 202.101 \u2013 Static discharge requirements <\/td>\n<\/tr>\n
36<\/td>\nAnnexes
Annex I Identification of immunity pass\/fail criteria <\/td>\n<\/tr>\n
37<\/td>\nAnnex AA (informative)Particular guidance and rationale <\/td>\n<\/tr>\n
38<\/td>\nTable AA.1 \u2013 External pacemaker hazard inventory <\/td>\n<\/tr>\n
44<\/td>\nFigure AA.1 \u2013 Simple model of a single chamber external pacemaker during defibrillation <\/td>\n<\/tr>\n
46<\/td>\nFigure AA.2 \u2013 First proposal for a defib-protection testof single chamber external pacemaker <\/td>\n<\/tr>\n
47<\/td>\nFigure AA.3 \u2013 Circuit for a defibrillation test generator for defibrillation test according to conditions during open heart surgery <\/td>\n<\/tr>\n
48<\/td>\nFigure AA.4 \u2013 Defibrillation pulse generated bythe defibrillation test generator from Figure AA.3 <\/td>\n<\/tr>\n
49<\/td>\nTable AA.2 \u2013 Pulse energies calculated for C = 120 \u00b5F \u00b1 5 % <\/td>\n<\/tr>\n
50<\/td>\nTable AA.3 \u2013 Pulse energies calculated for C = 122 \u00b5F \u00b1 5 % <\/td>\n<\/tr>\n
51<\/td>\nTable AA.4 \u2013 Pulse energies calculated for C = 126,32 \u00b5F \u00b1 5 % <\/td>\n<\/tr>\n
52<\/td>\nFigure AA.5 \u2013 Rise times of a defibrillation pulse according to the circuit proposed in Figure AA.3 <\/td>\n<\/tr>\n
57<\/td>\nBibliography <\/td>\n<\/tr>\n
58<\/td>\nIndex of defined terms used in this particular standard <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Medical electrical equipment – Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2023<\/td>\n60<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":426289,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2641],"product_tag":[],"class_list":{"0":"post-426281","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-01","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/426281","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/426289"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=426281"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=426281"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=426281"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}