| ISO 7494-1 Second edition 2011-08-15 Dentistry - Dental units - Part 1: General requirements and test methods |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 4-213 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Dental/ENT |
| FDA Tech | Sheena Green FDA/OMPT/CDRH/OC/DBM/BCB II/ 301-796-6279 sheena.green@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
ISO 7494-1:2011 specifies requirements and test methods for dental units, regardless of whether or not they are electrically powered.
ISO 7494-1:2011 also specifies requirements for manufacturer's instructions, marking and packaging.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.6640 | Unit, Operative Dental | Class 1 | EIA |
| There is no relevant guidance developed at this time. |