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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 19-41
Standard(Included in ASCA)
ANSI UL  61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019
Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements
1.1.1 Equipment included in scope
This group safety publication is primarily intended to be used as a product safety standard for
the products mentioned in the scope, but shall also be used by technical committees in the preparation of their publications for products similar to those mentioned in the scope of this standard, in accordance with the principles laid down in IEC Guide 104 and lSO/lEC Guide 51.

This part of IEC 61010 specifies general safety requirements for the following types of electrical equipment and their accessories, wherever they are intended to be used.
a) Electrical test and measurement equipment
This is equipment which by electromagnetic means tests, measures, indicates or records
one or more electrical or physical quantities, also non-measuring equipment such as
signal generators, measurement standards, power supplies for laboratory use,
transducers, transmitters, etc.
NOTE 1 This includes bench-top power supplies intended to aid a testing or measuring operation on another piece of equipment. Power supplies intended to power equipment are within the scope of IEC 61558 (see 1.1.2 h)).
This standard also applies to test equipment integrated into manufacturing processes and intended for testing manufactured devices.
NOTE 2 Manufacturing test equipment is likely to be installed adjacent to and interconnected with industrial machinery in this application.
b) Electrical industrial process-control equipment
This is equipment which controls one or more output quantities to specific values, with each value determined by manual setting, by local or remote programming, or by one or more input variables.
c) Electrical laboratory equipment
This is equipment which measures, indicates, monitors, inspects or analyses materials, or is used to prepare materials, and includes in vitro diagnostic (IVD) equipment.
This equipment may also be used in areas other than laboratories; examples include selftest IVD equipment to be used in the home and inspection equipment to be used to check people or material during transportation.

1.1.2 Equipment excluded from scope
This standard does not apply to equipment within the scope of:
a) IEC 60065 (Audio, video and similar electronic apparatus);
b) IEC 60204 (Safety of machinery - Electrical equipment of machines);
c) IEC 60335 (Household and similar electrical appliances);
d) IEC 60364 (Electrical installations of buildings);
e) IEC 60439 (Low-voltage switchgear and controlgear assemblies);
f) IEC 60601 (Medical electrical equipment);
g) IEC 60950 (Information technology equipment including electrical business equipment, except as specified in 1.1.3);
h) IEC 61558 (Power transformers, power supply units and similar);
i) IEC 61010-031 (Hand-held probe assemblies);
j) IEC 61243-3 (Live working - Voltage detectors - Part 3: Two-pole low-voltage type).

1.1.3 Computing equipment
This standard applies only to computers, processors, etc. which form part of equipment within
the scope of this standard or are designed for use exclusively with the equipment.

1.1.4 DV DR Addition of the following referencing the National Electrical Code and the Canadian Electrical Code:

This standard applies to equipment:
a) To be employed in accordance with ANSI/NFPA 70, National Electrical Code (NEC);
b) Designed to comply with the general requirements of CAN/CSA C22.2 No.0 and to be installed in accordance with the Canadian Electrical Code (CEC), Part I, CSA C22.2; or
c) Both (a) and (b).
Extent of Recognition
Complete standard
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.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Radio Frequency Wireless Technology in Medical Devices, Issued August 13, 2013

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
 Hamed Ghods
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
UL Underwriters Laboratories, Inc. http://www.ul.com/
FDA Specialty Task Group (STG)
General II (ES/EMC)
*These are provided as examples and others may be applicable.