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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 19-42
IEC  61326-1 Edition 3.0 2020-10
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
This part of IEC 61326 specifies requirements for immunity and emissions regarding electromagnetic compatibility (EMC) for electrical equipment, operating from a supply or battery of less than 1 000 V AC or 1 500 V DC or from the circuit being measured. Equipment intended for professional, industrial-process, industrial-manufacturing and educational use is covered by this part. It includes equipment and computing devices for
- measurement and test;
- control;
- accessories intended for use with the above (such as sample handling equipment), intended to be used in industrial and non-industrial locations.

Computing devices and assemblies and similar equipment within the scope of information technology equipment (ITE) and complying with applicable ITE EMC standards may can be used in systems within the scope of this part of IEC 61326 without additional testing, if they are suitable for the intended electromagnetic environment.

It is generally considered that this product family standard takes precedence over the corresponding generic EMC standards.

The following equipment is covered by this document.
a) Electrical measurement and test equipment
This is equipment which, by electrical means, measures, indicates or records one or more electrical or non-electrical quantities, also non-measuring equipment such as signal generators, measurement standards, power supplies and transducers.

b) Electrical control equipment
This is equipment which controls one or more output quantities to specific values, with each value determined by manual settings, by local or remote programming, or by one or more input variables. This includes industrial process measurement and control (IPMC)
equipment, which consists of devices such as:
- process controllers and regulators;
- programmable controllers;
- power supply units for equipment and systems (centralized or dedicated);
- analogue/digital indicators and recorders;
- process instrumentation;
- transducers, positioners, intelligent actuators, etc.

c) Electrical LABORATORY equipment, including In Vitro Diagnostic (IVD) medical equipment
This is equipment used to prepare or analyse materials, or measure, indicate or monitor physical quantities. This equipment might also be used in areas other than laboratories.

d) Equipment a), b) or c) as above when being equipped with components having radio functionality, for example for wireless communication.

Equipment within the scope of this document might be operated in different electromagnetic environments; depending on the electromagnetic environment different emission and immunity test requirements are applicable.

This document considers three types of electromagnetic environments:
Corresponding immunity test requirements are described in Clause 6.

In terms of emission requirements, equipment shall be classified in Class A or Class B equipment, as per the requirements and procedure of CISPR 11. The corresponding emission requirements are described in Clause 7.

The specified emission and immunity requirements aim at achieving electromagnetic compatibility between equipment covered in this document and other equipment that might operate at locations with electromagnetic environments considered in this document.
Guidance for an assessment concerning the risk for achieving EMC is given in Annex B.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 3 Terms, Definitions and Abbreviations
Subclause 5.2.1 General
Subclause 5.2.3 Assembly of EUT
Subclause 5.4 Specification of FUNCTIONAL PERFORMANCE
Clause 6 Immunity Requirements
Clause 8 Test results and test report
Clause 9 Instructions for use
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 5.2.1 General, 5.2.3 Assembly of EUT and 5.4 Specification of FUNCTIONAL PERFORMANCE are in conflict with existing published final guidance, see Section II "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices", E and F of the 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 and references #4 , #5 listed below. Alternative acceptance criteria and test levels for immunity tests in the referenced standard #1 can be considered for this clause.

4. Clause 8 (Test results and test report) is in conflict with existing published final guidance, see Section II "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, D, E, F, and G of the guidance #2 listed below.

5. Clause 9 (Instructions for use) is in conflict with existing published final guidance, regulation and published literature, see Section II "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, I of the guidance #2, and regulation #3 listed below.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§864.9245 Separator, Automated, Blood Cell, Diagnostic Class 2 GKT
§864.9245 Platelet And Plasma Separator For Bone Graft Handling Class 2 ORG
§864.9285 Centrifuge, Cell-Washing, Automated For Immuno-Hematology Class 2 KSN
§868.5830 Apparatus, Autotransfusion Class 2 CAC
§870.4250 Controller, Temperature, Cardiopulmonary Bypass Class 2 DWC
§880.2800 Indicator, Physical/Chemical Sterilization Process Class 2 JOJ
§880.6500 Purifier, Air, Ultraviolet, Medical Class 2 FRA
§880.6600 Antimicrobial Keyboard Class 2 OSZ
§880.6710 Purifier, Water, Ultraviolet, Medical Class 2 KMG
§880.6860 Sterilizer, Chemical Class 2 MLR
§880.6870 Sterilizer, Dry Heat Class 2 KMH
§880.6880 Sterilizer, Steam Class 2 FLE
§880.6991 Device, Pasteurization, Hot Water Class 2 LDS
§880.6992 Disinfector, Medical Devices Class 2 MEC
§884.6150 Micromanipulators And Microinjectors, Assisted Reproduction Class 2 MQJ
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: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically2-Powered Medical Devices, Issued July 2016.

3. 21 CFR 801.5 Labeling: Medical devices; adequate directions for use.

4. 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.

5. 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.
FDA Technical Contact
 Seth Seidman
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
General II (ES/EMC)
*These are provided as examples and others may be applicable.