| ISO 7494-2 Second edition 2015-04-01 Dentistry - Dental units - Part 2: Air, water, suction and waste water systems |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 4-221 |
| 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.
This part of ISO 7494 specifies requirements and test methods concerning
a) the configuration of dental unit connections to the compressed air supply, water supply, suction supply, and wastewater drain plumbing,
b) the materials, design, and construction of the compressed air and water system within the dental unit,
c) the quality for incoming water and air, and
d) the performance of dental unit suction system.
This part of ISO 7494 also specifies requirements for instructions for use and technical description.
This part of ISO 7494 is limited to dental units that are not used for life support treatment of ambulatory patients or for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are not included in this International Standard.
| 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. |