Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

051

Date of Entry 01/14/2019 

FR Recognition Number

4-250

Standard

ISO  7494-1 Third edition 2018-06
Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements

Scope/Abstract

This document specifies requirements and test methods for stationary dental units, dental patient chairs, and combinations of both regardless of whether they are or not electrically powered.

This document also specifies requirements for the instructions for use, for the technical description, for marking and for packaging.

Operator's stools, portable dental equipment and operating lights are not in the scope of this document.

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)*

Regulation Number	Device Name	Device Class	Product Code
§872.6640	Unit, Operative Dental	Class 1	EIA

Relevant FDA Guidance and/or Supportive Publications*

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 Contacts

Joel Anderson   FDA/OC/CDRH/OPEQ/OHTI/DHTIB/   301-796-6520   joel.anderson@fda.hhs.gov

Lauren Giles   FDA/OC/CDRH/OPEQ/OHTI/DHTIB/   301-796-9552   lauren.giles@fda.hhs.gov

Standards Development Organization

ISO International Organization for Standardization https://www.iso.org/

FDA Specialty Task Group (STG)

Dental/ENT

*These are provided as examples and others may be applicable.