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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 036 Date of Entry 07/09/2014 
FR Recognition Number 13-65
UL ANSI  1998 Third Edition 2013
Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008]
1.1 These requirements apply to non-networked embedded software residing in programmable components performing safety-related functions whose failure is capable of resulting in a risk of fire, electric shock, or injury to persons.

1.2 This is a reference standard in which the requirements are to be applied when specifically referenced by other standards or product safety requirements.

1.3 These requirements address the risks unique to product hardware controlled by software in programmable components.

1.4 These requirements are intended to supplement applicable product or component standards and requirements, and are not intended to serve as the sole basis for investigating the risk of fire, electric shock, or injury to persons.

1.5 These requirements are intended to address risks that occur in the software or in the process used to develop and maintain the software, such as the following:
a) Requirements conversion faults that cause differences between the specification for the programmable component and the software design;
b) Design faults such as incorrect software algorithms or interfaces;
c) Coding faults, including syntax, incorrect signs, endless loops, and other coding faults;
d) Timing faults that cause program execution to occur prematurely or late;
e) Microelectronic memory faults, such as memory failure, not enough memory, or memory overlap;
f) Induced faults caused by microelectronic hardware failure;
g) Latent, user, input/output, range, and other faults that are only detectable when a given state occurs; and
h) Failure of the programmable component to perform any function at all.

1.6 Product standard requirements may amend or supersede the requirements in this standard, as appropriate.

1.7 These requirements are not intended to address cybersecurity. Risks associated with unauthorized access or attack through a network shall be addressed in the product standard or other referenced standard such as the Standard for Software Cybersecurity for Network-Connectable Products, Part 1: General Requirements, UL 2900-1.
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.
Public Law, CFR Citation(s) and Procode(s)*
Medical devices that contain software, accessories to medical devices that contain software, and "standalone software" that meets the definitions of a device or accessory.
Relevant FDA Guidance and/or Supportive Publications*
- Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices, May 11, 2005

- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices, June 4, 1997

General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11,2002

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