{"id":279465,"date":"2024-10-19T18:51:45","date_gmt":"2024-10-19T18:51:45","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-pd-iec-tr-60601-4-22016\/"},"modified":"2024-10-25T15:25:35","modified_gmt":"2024-10-25T15:25:35","slug":"bsi-pd-iec-tr-60601-4-22016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-pd-iec-tr-60601-4-22016\/","title":{"rendered":"BSI PD IEC\/TR 60601-4-2:2016"},"content":{"rendered":"

IEC TR 60601-4-2:2016(E) applies to the performance of medical electrical equipment or a medical electrical system in the presence of electromagnetic disturbances.<\/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
4<\/td>\nCONTENTS <\/td>\n<\/tr>\n
7<\/td>\nFOREWORD <\/td>\n<\/tr>\n
10<\/td>\nINTRODUCTION
0.1 * General
0.2 Purpose of this document
0.3 How to use this document <\/td>\n<\/tr>\n
11<\/td>\n0.4 Immunity test levels <\/td>\n<\/tr>\n
12<\/td>\n1 Scope and object
1.1 Scope
1.2 Object
2 Normative references <\/td>\n<\/tr>\n
13<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
17<\/td>\n4 General recommendations
4.1 Concurrent and sequential testing
4.2 General test conditions
4.2.1 Configurations
4.2.2 Artificial hand <\/td>\n<\/tr>\n
18<\/td>\n4.2.3 Power input voltages and frequencies
Figures
Figure\u00a01\u00a0\u2013 RC element of the artificial hand <\/td>\n<\/tr>\n
19<\/td>\n5 Me equipment and me systems identification, marking and documents
5.1 Marking on the outside of me equipment or me equipment parts for which the connector testing exemption specified in 8.13.2 d) is used
5.2 Accompanying documents
5.2.1 General
5.2.2 Instructions for use
5.2.3 Requirements applicable to me equipment and me systems for which the connector testing exemption specified in 8.13.2 d) is used
5.2.4 * Technical description <\/td>\n<\/tr>\n
20<\/td>\n6 Documentation of the tests
6.1 Test plan
Tables
Table\u00a01\u00a0\u2013 Recommended minimum test plan (1 of 2) <\/td>\n<\/tr>\n
21<\/td>\n6.2 Test report
7 * Emissions
8 Immunity recommendations
8.1 General <\/td>\n<\/tr>\n
22<\/td>\n8.2 Patient physiological simulation
Figure\u00a02\u00a0\u2013 *\u00a0Ports of me equipment and me systems <\/td>\n<\/tr>\n
23<\/td>\n8.3 Termination of patient-coupled parts
8.4 Hand-held me equipment and parts intended to be hand-held
8.5 Subsystems
8.6 Permanently installed large me equipment and large me systems <\/td>\n<\/tr>\n
24<\/td>\n8.7 Operating modes
8.8 Non-me equipment
8.9 * Environments of intended use <\/td>\n<\/tr>\n
25<\/td>\n8.10 * Performance criteria
8.11 * Immunity test levels <\/td>\n<\/tr>\n
27<\/td>\nFigure\u00a03\u00a0\u2013 Examples of environments (locations) of intended use <\/td>\n<\/tr>\n
28<\/td>\nTable\u00a02\u00a0\u2013 *\u00a0Enclosure port
Table\u00a03\u00a0\u2013 *\u00a0Input AC power port (1 of 2) <\/td>\n<\/tr>\n
30<\/td>\nTable\u00a04\u00a0\u2013 Input DC power port <\/td>\n<\/tr>\n
31<\/td>\nTable\u00a05\u00a0\u2013 *\u00a0Patient coupling port <\/td>\n<\/tr>\n
32<\/td>\n8.12 * Immunity to proximity fields from RF wireless communications equipment
Table\u00a06\u00a0\u2013 Signal input\/output parts port <\/td>\n<\/tr>\n
33<\/td>\n8.13 * ESD testing of connectors
8.13.1 Application of ESD to connectors
Table\u00a07\u00a0\u2013 Test specifications for enclosure port immunity to RF wireless communications equipment <\/td>\n<\/tr>\n
34<\/td>\n8.13.2 Exclusions
Table 8 \u2013 Parts of connectors to be tested for ESD, based on the connector shell and cover material
Table\u00a09\u00a0\u2013 *\u00a0Testing of connectors and pins while connected and disconnected <\/td>\n<\/tr>\n
35<\/td>\n9 Test report
Table\u00a010\u00a0\u2013 Test report minimum contents (1 of 2) <\/td>\n<\/tr>\n
37<\/td>\nAnnexes
Annex A (informative) General guidance and rationale <\/td>\n<\/tr>\n
40<\/td>\nTable\u00a0A.1\u00a0\u2013 Assumptions used in determining immunity test levelsspecified in Table\u00a07 (1 of 2) <\/td>\n<\/tr>\n
42<\/td>\nAnnex B (informative) Guide to labelling recommendations
B.1 Accompanying documents, instructions for use
B.2 Accompanying documents, technical description
Table\u00a0B.1 \u2013 accompanying documents, instructions for use
Table\u00a0B.2 \u2013 Accompanying documents, technical description <\/td>\n<\/tr>\n
43<\/td>\nAnnex C (informative) Determination of immunity test levels for special environments
C.1 General <\/td>\n<\/tr>\n
44<\/td>\nC.2 em disturbance level determination
C.3 Assessment of em disturbance sources
C.4 Test methods
C.5 Test plan <\/td>\n<\/tr>\n
45<\/td>\nC.6 Examples of mitigations and special conditions
Table\u00a0C.1\u00a0\u2013 Examples of adjusted immunity test levels due to mitigations or special conditions <\/td>\n<\/tr>\n
46<\/td>\nAnnex D (informative) Identification of specific immunity performance criteria
D.1 General
D.2 Immunity performance criteria principles
D.2.1 General
D.2.2 Immunity performance criteria for non-me equipment used in an me system
D.2.3 Immunity performance criteria determination
D.3 Immunity performance criteria examples
D.3.1 General examples <\/td>\n<\/tr>\n
48<\/td>\nD.3.2 Example of immunity performance criteria for a radiological table system
D.3.3 Example of immunity performance criteria for ultrasonic diagnostic equipment
Table D.1 \u2013 Example of immunity performance criteria for a radiological table and gantry system <\/td>\n<\/tr>\n
49<\/td>\nTable D.2 \u2013 Example of immunity performance criteria for ultrasonic diagnostic equipment <\/td>\n<\/tr>\n
50<\/td>\nAnnex E (informative) Performance criteria specified by IEC 61000-6-x generic EMC standards <\/td>\n<\/tr>\n
51<\/td>\nAnnex F (informative) Mapping between this document and the elements of IEC 60601-1-2:2014
Table\u00a0F.1\u00a0\u2013 Mapping between the elements of IEC\u00a0TR 60601-4-2 andIEC\u00a060601-1-2:2014 (1 of 5) <\/td>\n<\/tr>\n
56<\/td>\nBibliography <\/td>\n<\/tr>\n
58<\/td>\nIndex of defined terms used in this technical report <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Medical electrical equipment – Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2016<\/td>\n62<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279467,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2641],"product_tag":[],"class_list":{"0":"post-279465","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\/279465","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\/279467"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279465"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279465"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279465"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}