ANSI S3.45-2009 (Reaffirmed 2014)

Standard Organization:

ANSI S3.45-2009 (Reaffirmed 2014)
American National Standard Procedures for Testing Basic Vestibular Function

• Recognition Date: 2015-01-27
• Recognition List: 038
• Recognition Number: 4-185
• Extent: Complete standard
• Standards Orgs: ANSI American National Standards Institute https://www.ansi.org/
• STG: Dental/ENT
• FDA Tech: Shu-Chen Peng FDA/OMPT/CDRH/ODE/DOED/ENTB/ 301-796-6481 shu-chen.peng@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This Standard specifies procedures for conducting six separate tests, which, together with the data analysis and reporting requirements specified in this Standard, constitute the Basic Vestibular Function Test Battery. The six tests cover:

(a) spontaneous nystagmus (see 5.2);

(b) gaze-evoked nystagmus (see 5.3);

(c) saccade test (see 6);

(d) pursuit testing (see 7);

(e) positioning and positional nystagmus (see 8); and

(f) caloric testing (see 9).

Each of these tests evaluates a response of the vestibular system by the vestibulo-ocular reflex through the measurement of electrical signals generated by eye movements recorded by electrooculography.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§890.1575	Platform, Force-Measuring	Class 1	KHX
§882.1460	Nystagmograph	Class 2	GWN

FDA Guidance:

There is no relevant guidance developed at this time.