prEN IEC 61326-2-6:2023
(Main)Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
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)
Električna oprema za merjenje, nadzor in laboratorijsko uporabo - Zahteve za elektromagnetno združljivost (EMC) - 2-6. del: Posebne zahteve - In vitro diagnostična (IVD) medicinska oprema
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Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2023
Električna oprema za merjenje, nadzor in laboratorijsko uporabo - Zahteve za
elektromagnetno združljivost (EMC) - 2-6. del: Posebne zahteve - In vitro
diagnostična (IVD) medicinska oprema
Electrical equipment for measurement, control and laboratory use - EMC requirements -
Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
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)
Ta slovenski standard je istoveten z: prEN IEC 61326-2-6:2023
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
65A/1102/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61326-2-6 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2023-09-29 2023-12-22
SUPERSEDES DOCUMENTS:
65A/1070/CD, 65A/1097/CC
IEC SC 65A : SYSTEM ASPECTS
SECRETARIAT: SECRETARY:
United Kingdom Ms Stephanie Lavy
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.
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Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some
Countries” clauses to be included should this proposal proceed. Recipients are reminded that the CDV stage is
the final stage for submitting ISC clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).
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: 2025
NOTE FROM TC/SC OFFICERS:
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.
– 2 – IEC CDV 61326-2-6 © IEC:2023
1 CONTENTS
3 FOREWORD . 4
4 1. Scope . 6
5 2. Normative references . 6
6 3. Terms and definitions . 6
7 Terms and definitions . 7
8 Abbreviations . 8
9 4. General . 9
10 Essential Performance . 9
11 Basic Safety . 9
12 5. EMC test plan . 10
13 5.1 General . 10
14 5.2 Configuration of EUT during testing . 10
15 5.2.101 Subsystems . 11
16 5.3 Operation conditions of EUT during testing . 11
17 5.3.101 Operation conditions . 11
18 5.4 Specification of functional performance . 11
19 5.5 Test description . 11
20 6. Immunity requirements . 12
21 Conditions during the tests. 12
22 6.101 Conditions during the tests. 12
23 Immunity test requirements . 12
24 6.201 Risk assessment and consideration of EMC immunity requirements . 12
25 Random aspects . 18
26 Performance criteria . 18
27 6.401 Pass/fail criteria . 18
28 7. Emission requirements . 19
29 8. Test results and test report . 19
30 9. Instructions for use . 20
31 9.101 General requirements for the IVD MEE instructions for use. 20
32 9.102 Additional requirements for the instructions for use for equipment to be used
33 in a HOME HEALTHCARE ENVIRONMENT . 21
34 9.103 Additional requirements for the instructions for use for equipment to be used
35 in a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT . 21
36 Annex A (normative) Immunity test requirements for PORTABLE TEST AND MEASUREMENT
37 EQUIPMENT powered by battery or from the circuit being measured . 22
38 Annex B (informative) General guidance and rationale . 23
39 B.1 Background for maintenance leading to edition 4 of this standard . 23
40 Annex C (informative) How to apply this standard and its environments . 25
41 Annex D (informative) (leveraged from IEC 60601-1-2:2020 Annex G) Guidance: Test
42 plan . 26
43 D.1 Test plan contents . 26
44 Annex E (informative) (leveraged from IEC 60601-1-2:2020 Table 1) . 28
45 Table E.1 – Power input voltages and frequencies during the tests (1 of 2) . 28
IEC CDV 61326-2-6 © IEC:2023 – 3 –
46 Annex F (informative) Guidance on the application of risk management with regard to
47 Electromagnetic Disturbances and the Identification of Immunity pass/fail criteria
48 risks of EUT to identify critical immunity testing . 29
49 F.1 Immunity pass/fail criteria principles . 29
50 F.1.1 General . 29
51 F.1.2 Immunity pass/fail criteria for non-IVD MEE used in an IVD MEE . 29
52 F.1.3 Immunity pass/fail criteria determination . 29
53 F.2 BASIC SAFETY . 29
54 F.3 ESSENTIAL PERFORMANCE . 30
55 F.4 Immunity pass/fail criteria examples. 31
56 F.4.1 General examples . 31
57 F.4.2 ESSENTIAL PERFORMANCE Immunity pass criteria examples for IVD
58 Immunoassay Analyzer . 32
59 Bibliography . 34
62 Table 101 – Immunity test requirements for equipment intended to be used in the
63 PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT . 13
64 Table 102 – Immunity test requirements for equipment intended to be used in the
65 . 15
HOME HEALTHCARE ENVIRONMENT
66 Table 103 – Test specifications for ENCLOSURE PORT immunity to RF wireless
67 communications equipment . 17
68 Table 104 – Test specifications for ENCLOSURE PORT immunity to proximity magnetic
69 fields . 18
– 4 – IEC CDV 61326-2-6 © IEC:2023
72 INTERNATIONAL ELECTROTECHNICAL COMMISSION
73 ____________
75 ELECTRICAL EQUIPMENT FOR MEASUREMENT,
76 CONTROL AND LABORATORY USE –
77 EMC REQUIREMENTS –
79 Part 2-6: Particular requirements –
80 In vitro diagnostic (IVD) medical electrical equipment
82 FOREWORD
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