kSIST FprEN IEC 61326-2-6:2020

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

2018-12-06: CD draft assessment for EMC requested

Elektrische Mess-, Steuer-, Regel- und Laborgeräte - EMV-Anforderungen - Teil 2-6: Besondere Anforderungen - Medizinische In-vitro-Diagnosegeräte (IVD)

Matériel électrique de mesure, de commande et de laboratoire - Exigences relatives à la CEM - Partie 2-6: Exigences particulières - Matériel médical de diagnostic in vitro (IVD)

IEC 61326-2-6:2020 est disponible sous forme de IEC 61326-2-6:2020 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 61326-2-6:2020 spécifie les exigences minimales pour l’immunité et les émissions relatives à la compatibilité électromagnétique des MATERIELS MEDICAUX DE DIAGNOSTIC IN VITRO (IVD – in vitro diagnostic), en prenant en compte les particularités et aspects spéc ifiques de ces matériels et de leur environnement électromagnétique.

Električna oprema za merjenje, nadzor in laboratorijsko uporabo - Zahteve za elektromagnetno združljivost (EMC) - 2-6. del: Posebne zahteve -In vitro (IVD) diagnostična medicinska oprema

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN IEC 61326-2-6:2019
01-oktober-2019
Električna oprema za merjenje, kontrolo in laboratorijsko uporabo - Zahteve za
elektromagnetno združljivost (EMC) - 2-6. del: Posebne zahteve - Diagnostična
medicinska oprema in vitro (IVD)

Electrical equipment for measurement, control and laboratory use - EMC requirements -

Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

Matériel électrique de mesure, de commande et de laboratoire - Exigences relatives à la

CEM - Partie 2-6: Exigences particulières - Matériel médical de diagnostic in vitro (IVD)

Ta slovenski standard je istoveten z: prEN IEC 61326-2-6:2019
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
19.080 Električno in elektronsko Electrical and electronic
preskušanje testing
33.100.01 Elektromagnetna združljivost Electromagnetic compatibility
na splošno in general
oSIST prEN IEC 61326-2-6:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN IEC 61326-2-6:2019
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oSIST prEN IEC 61326-2-6:2019
65A/928/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61326-2-6 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2019-08-23 2019-11-15
SUPERSEDES DOCUMENTS:
65A/903/CD, 65A/913A/CC
IEC SC 65A : SYSTEM ASPECTS
SECRETARIAT: SECRETARY:
United Kingdom Mr Petar Luzajic
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
TC 77, SC 77A
Other TC/SCs are requested to indicate their interest, if any, in
this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY

SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING

Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for Vote
(CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.

Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they are

aware and to provide supporting documentation.
TITLE:

Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular

requirements – In vitro diagnostic (IVD) medical equipment
PROPOSED STABILITY DATE: 2023
NOTE FROM TC/SC OFFICERS:

Copyright © 2019 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this

electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.

You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without

permission in writing from IEC.
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oSIST prEN IEC 61326-2-6:2019
65A/928/CDV – 2 – IEC CDV 61326-2-6 © IEC 2019
1 CONTENTS

2 FOREWORD ........................................................................................................................... 3

3 1 Scope ............................................................................................................................... 5

4 2 Normative references ....................................................................................................... 5

5 3 Terms and definitions ....................................................................................................... 5

6 3.1 Terms and definitions .............................................................................................. 5

7 4 General ............................................................................................................................ 7

8 5 EMC test plan ................................................................................................................... 7

9 5.1 General ................................................................................................................... 7

10 5.2 Configuration of EUT during testing ......................................................................... 7

11 5.3 Operation conditions of EUT during testing .............................................................. 7

12 5.4 Specification of functional performance ................................................................... 7

13 5.5 Test description ....................................................................................................... 7

14 6 Immunity requirements ..................................................................................................... 8

15 6.1 Conditions during the tests ...................................................................................... 8

16 6.2 Immunity test requirements ..................................................................................... 8

17 6.201 Risk assessment and consideration of EMC immunity requirements ........................ 8

18 6.3 Random aspects.................................................................................................... 11

19 6.4 Performance criteria .............................................................................................. 11

20 7 Emission requirements ................................................................................................... 12

21 8 Test results and test report ............................................................................................. 12

22 9 Instructions for use ......................................................................................................... 12

23 9.101 General requirements for the IVD medical equipment instruction for use ............... 12

24 9.102 Additional requirements for the instruction for use for equipment to be used

25 in a HOME HEALTHCARE ENVIRONMENT ........................................................... 12

26 9.103 Additional requirements for the instruction for use for equipment to be used

27 in a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT .......................... 12

28 Annex A (normative) Immunity test requirements for PORTABLE TEST AND MEASUREMENT

29 EQUIPMENT powered by battery or from the circuit being measured .................................. 14

30 Bibliography .......................................................................................................................... 15

32 Table 101 – Immunity test requirements for equipment intended to be used in

33 PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT .................................................................... 8

34 Table 102 – Immunity test requirements for equipment intended to be used in a HOME

35 HEALTHCARE ENVIRONMENT ..................................................................................................... 10

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oSIST prEN IEC 61326-2-6:2019
IEC CDV 61326-2-6 © IEC 2019 – 3 – 65A/928/CDV
37 INTERNATIONAL ELECTROTECHNICAL COMMISSION
38 ____________
40 ELECTRICAL EQUIPMENT FOR MEASUREMENT,
41 CONTROL AND LABORATORY USE –
42 EMC REQUIREMENTS –
44 Part 2-6: Particular requirements –
45 Invitro diagnostic (IVD) medical equipment
48 FOREWORD

49 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

50 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

51 international co-operation on all questions concerning standardization in the electrical and electronic fields. To

52 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

53 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

54 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

55 in the subject dealt with may participate in this preparatory work. International, governmental and non-

56 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

57 with the International Organization for Standardization (ISO) in accordance with conditions determined by

58 agreement between the two organizations.

59 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

60 consensus of opinion on the relevant subjects since each technical committee has representation from all

61 interested IEC National Committees.

62 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

63 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

64 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

65 misinterpretation by any end user.

66 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

67 transparently to the maximum extent possible in their national and regional publications. Any divergence

68 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

69 the latter.

70 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

71 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

72 services carried out by independent certification bodies.

73 6) All users should ensure that they have the latest edition of this publication.

74 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

75 members of its technical committees and IEC National Committees for any personal injury, property damage or

76 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

77 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

78 Publications.

79 8) Attention is drawn to the normative references cited in this publication. Use of the referenced publications is

80 indispensable for the correct application of this publication.

81 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

82 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

83 International Standard IEC 61326-2-6 has been prepared by subcommittee 65A WG4: System

84 aspects, of IEC technical committee 65: Industrial-process measurement, control and

85 automation.

86 This third edition cancels and replaces the second published in 2012. This edition constitutes

87 a technical revision.
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89 This edition includes the following significant technical change with respect to the previous

90 edition:
91 – Update of the document with respect to IEC 61326-1:202x.
92 The text of this standard is based on the following documents:
FDIS Report on voting
65A/631/FDIS 65A/640/RVD

94 Full information on the voting for the approval of this standard can be found in the report on

95 voting indicated in the above table.

96 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

97 This part of the IEC 61326 series is to be used in conjunction with IEC 61326-1:202x and

98 follows the same numbering of clauses, subclauses, tables and figures.

99 When a particular subclause of IEC 61326-1 is not mentioned in this part, that subclause

100 applies as far as is reasonable. When this standard states “addition”, “modification” or

101 “replacement”, the relevant text in IEC 61326-1 is to be adapted accordingly.

102 NOTE The following numbering system is used:

103 – subclauses, tables and figures that are numbered starting from 101 are additional to those in

104 IEC 61326-1;

105 – unless notes are in a new subclause or involve notes in IEC 61326-1, they are numbered starting from

106 101 including those in a replaced clause or subclause;
107 – additional annexes are lettered AA, BB, etc.

108 A list of all parts of the IEC 61326 series, under the general title Electrical equipment for

109 measurement, control and laboratory use – EMC requirements can be found on the IEC

110 website.

111 The committee has decided that the contents of this publication will remain unchanged until

112 the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data

113 related to the specific publication. At this date, the publication will be
114 • reconfirmed,
115 • withdrawn,
116 • replaced by a revised edition, or
117 • amended.
118
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oSIST prEN IEC 61326-2-6:2019
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119 ELECTRICAL EQUIPMENT FOR MEASUREMENT,
120 CONTROL AND LABORATORY USE –
121 EMC REQUIREMENTS –
122
123 Part 2-6: Particular requirements –
124 In vitro diagnostic (IVD) medical equipment
125
126
127
128 1 Scope

129 In addition to the scope of IEC 61326-1, this part of IEC 61326 series specifies minimum

130 requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO

131 DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific

132 aspects of this electrical equipment and their electromagnetic environment.
133 2 Normative references
134 Clause 2 of IEC 61326-1:202x applies, except as follows:
135 Addition:

136 IEC 61326-1:202x, Electrical equipment for measurement, control and laboratory use – EMC

137 requirements – Part 1: General requirements

138 ISO 14971:201x Medical devices – Application of risk management to medical devices

139 3 Terms and definitions

140 For the purposes of this document, the terms and definitions given in IEC 61326-1 apply,

141 except as follows.
142 3.1 Terms and definitions
143 Addition:
144 3.101
145 In vitro diagnostic (IVD) medical equipment

146 Instruments and apparatus intended for use in the diagnosis of disease or other conditions,

147 including a determination of the state of health, in order to cure, mitigate, treat, or prevent

148 disease

149 NOTE to entry: Such instruments or apparatus are intended for use in the collection, preparation, and examination

150 of specimens taken from the human body. No direct or wired patient connection with the device.

151 3.102
152 professional healthcare facility environment
153 an environment where professional healthcare is administered

154 NOTE 1 to entry: Locations include hospitals, diagnostic laboratories, blood banks, blood donation centres,

155 physician offices, intensive care units, surgical centres, emergency rooms, surgery rooms, clinics, patient rooms,

156 dental offices, limited care facilities, nursing homes, drugstore with trained operator, and first aid rooms.

157 NOTE 2 to entry: Most environments and locations in the PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT are

158 considered to have a CONTROLLED ELECTROMAGNETIC ENVIRONMENT with regard to fixed electromagnetic sources.

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159 Mobile communication devices are widely used by healthcare professionals in providing efficient patient care. For

160 this reason, it is more difficult to control the environment for proximity electromagnetic disturbances.

161 NOTE 3 to entry: Examples of electromagnetic sources that might be used adjacent to IVD medical equipment are:

162 – High Frequency Surgical Equipment
163 – Radio Frequency Identification (RFID) systems
164 – Wireless local area networks (WLAN)
165 – Handheld mobile radios (e.g. TETRA, two-way radio)
166 – Paging systems
167 – Other wireless devices (including consumer devices)

168 NOTE 4 to entry: It is assumed that IVD equipment is not directly connected to the public mains network.

169 NOTE 5 to entry: IVD medical equipment should have a suitable level of immunity to ensure the safe and effective

170 performance of the device in its intended use environment. As such, IVD medical equipment used in ambulances,

171 aircraft, cars and helicopters can require a higher level of immunity than the typical PROFESSIONAL HEALTHCARE

172 FACILITY ENVIRONMENT.
173 3.103
174 home healthcare environment

175 an environment other than a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT with a much

176 more diverse electromagnetic environment with electromagnetic disturbances that may be

177 more uncontrolled and less well-characterized in terms of amplitude and probability of

178 occurrence.

179 NOTE 1 to entry: Except in transportation, IVD equipment is usually connected to the public mains network.

180 NOTE 2 to entry: These reasons justify higher immunity test levels for basic safety and essential performance.

181 Locations include any public setting, including the home of the patient, shops and libraries where anti-theft

182 equipment are used, transportation (e.g. airport security) metal detectors, etc.

183 NOTE 3 to entry: Examples of electromagnetic sources that might be used near IVD medical equipment in these

184 environments or otherwise expose the IVD equipment to intense electromagnetic disturbances are:

185 – Small mains frequency transformers (50 Hz and 60 Hz), e.g. in a clock radio on a bedside table

186 – Main
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