| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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057
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Date of Entry 12/20/2021
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FR Recognition Number
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19-43
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| Standard | (Included in ASCA) |
IEC 61326-2-6 Edition 3.0 2020-10
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
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Scope/Abstract| In addition to the scope of IEC 61326-1, this part of IEC 61326 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Clause 3 Terms, Definitions and Abbreviations
Clause 5.3.101 Operational conditions
Clause 6 Immunity Requirements
Clause 9 Instructions for Use |
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard is recognized in part (or is not recognized at all) because:
1. Clause 3 (Terms, Definitions and Abbreviations) is in conflict with another recognized standard, see Clause 3 Terms and Definitions in standard #1 listed below.
2. Clause 5.3.101 (Operational conditions) is in conflict with existing published final guidance, see Section IV. E "Medical Device Configuration and Functions Tested" of guidance #2 listed below.
3. Clause 6 (Immunity Requirements) is in conflict with another recognized standard, see Clause 8 and Annex A in standard #1; recall #3; references #5 , #6 listed below. Alternative acceptance criteria and test levels for immunity tests in the referenced standard #1 can be considered for this clause.
4. Clause 9 (Instructions for Use) is in conflict with existing published final guidance, see Section IV. K "Labeling" of the guidance #2 and regulation #4 listed below. |
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Transition Period
| FDA recognition of IEC 61326-2-6 Edition 3.0 2020-10 [Rec# 19-43] will be superseded by recognition of IEC 61326-2-6 Edition 4.0 2025-06 [Rec# 19-57]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 19-43] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 19-43] will not be accepted. |
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Relevant FDA Guidance and/or Supportive Publications*
1. IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Recognition Number: 19-36).
2. Guidance for Industry and Food and Drug Administration Staff: Electromagnetic Compatibility (EMC) of Medical Devices, issued June 2022.
3. U.S. Food and Drug Administration, "Class 2 Device Recall Afinion 2, Afinion AS100 Analyzer," 2020.
4. Mosleh, Susanna et al., A Metrology-Driven Approach to Distilling Live Wireless Signals Into Immunity Test Signals, Volume 13, IEEE Access, Feb 2025.
[Online]. Available: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=180494. [Accessed: 29-Apr-2021].
4. 21 CFR 809.10 Labeling for in vitro diagnostic products.
5. M. Kohani and M. Pecht, "Malfunctions of medical devices due to electrostatic occurrences big data analysis of 10 years of the FDA's reports," IEEE Access, vol. 6, pp. 5805-5811, 2018.
6. Kohani, Mehdi & Kinslow, Lane & Bhandare, Aniket & Guan, Li & Zhou, Jianchi & Spencer, Christopher & Pecht, Michael. (2019). Electrostatic Charging of a Human Body Caused by Activities and Material Combinations in Hospitals. IEEE Transactions on Electromagnetic Compatibility. PP. 1-9.10.1109/TEMC.2019.2914114.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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FDA Specialty Task Groups (STG)
| General II (ES/EMC) (primary) |
| InVitro Diagnostics |
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| *These are provided as examples and others may be applicable. |
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