Recognized standard
80601-2-60 Edition 2.0 2019-06
FDA recognition 4-262 · IEC · Dental/ENT
Key facts
| Recognition number | 4-262 |
|---|---|
| Designation | 80601-2-60 Edition 2.0 2019-06 |
| Title | Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Dental/ENT |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE OF DENTAL UNITS, DENTAL PATIENT CHAIRS, DENTAL HANDPIECES AND DENTAL OPERATING LIGHTS, hereafter referred to as DENTAL EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or… |
At a glance
- 10–99 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: