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BSI 23/30468236 DC 2023

BSI 23/30468236 DC 2023

$13.70

BS EN IEC 61326-2-6. Electrical equipment for measurement, control and laboratory use. EMC requirements – Part 2-6. Particular requirements. In vitro diagnostic (IVD) medical equipment

Published By Publication Date Number of Pages
BSI 2023 37
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PDF Catalog

PDF Pages PDF Title
1 30468236-NC.pdf
3 65A_1102e_CDV.pdf
7 FOREWORD
9 1. Scope
2. Normative references
3. Terms and definitions
10 3.1 Terms and definitions
11 3.2 Abbreviations
12 4. General
4.101 Essential Performance
4.102 Basic Safety
13 5. EMC test plan
5.1 General
5.2 Configuration of EUT during testing
14 5.2.101 Subsystems
5.3 Operation conditions of EUT during testing
5.3.101 Operation conditions
5.4 Specification of functional performance
5.5 Test description
15 6. Immunity requirements
6.1 Conditions during the tests
6.101 Conditions during the tests
6.2 Immunity test requirements
6.201 Risk assessment and consideration of EMC immunity requirements
21 6.3 Random aspects
6.4 Performance criteria
6.401 Pass/fail criteria
22 7. Emission requirements
8. Test results and test report
23 9. Instructions for use
9.101 General requirements for the ivd mee instructions for use
24 9.102 Additional requirements for the instructions for use for equipment to be used in a home healthcare environment
9.103 Additional requirements for the instructions for use for equipment to be used in a professional healthcare facility environment
25 Annex A (normative) Immunity test requirements for portable test and measurement equipment powered by battery or from the circuit being measured
26 Annex B (informative) General guidance and rationale
B.1 Background for maintenance leading to edition 4 of this standard
28 Annex C (informative) How to apply this standard and its environments
29 Annex D (informative) (leveraged from IEC 60601-1-2:2020 Annex G) Guidance: Test plan
D.1 Test plan contents
31 Annex E (informative) (leveraged from IEC 60601-1-2:2020 Table 1)
Table E.1 – Power input voltages and frequencies during the tests (1 of 2)
32 Annex F (informative) Guidance on the application of risk management with regard to Electromagnetic Disturbances and the Identification of Immunity pass/fail criteria risks of EUT to identify critical immunity testing
F.1 Immunity pass/fail criteria principles
F.1.1 General
F.1.2 Immunity pass/fail criteria for non-ivd mee used in an ivd mee
F.1.3 Immunity pass/fail criteria determination
F.2 Basic safety
33 F.3 ESSENTIAL PERFORMANCE
34 F.4 Immunity pass/fail criteria examples
F.4.1 General examples
35 F.4.2 essential performance Immunity pass criteria examples for IVD Immunoassay Analyzer
37 Bibliography

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BSI 23/30468236 DC 2023
$13.70