International Organization for Standardization (ISO)
Latest
ISO 9680:2021
Scope
This document specifies requirements and test methods for operating lights used in the dental office and intended for illuminating the oral cavity of patients. It also contains specifications on the instructions for use, marking and packaging.
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources, for example, from dental handpieces and dental headlamps and also operating lights which are specifically designed for use in oral surgery.
ISO 9680:2021 Referenced Document
CIE 224 CIE 2017 Colour Fidelity Index for accurate scientific use
CIE S 017 ILV: International Lighting Vocabulary - Supplement 1: Light Emitting Diodes (LEDs) and LED Assemblies - Terms and Definitions
IEC 60598-1 Interpretation Sheet 1 — Luminaires — Part 1: General requirements and tests*, 2023-08-31 Update
IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices*, 2024-04-21 Update
IEC 62471:2006 Photobiological safety of lamps and lamp systems
ISO 11664-1 Colorimetry — Part 1: CIE standard colorimetric observers
ISO 14971 Medical devices - Application of risk management to medical devices
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
ISO 17664-1 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 17664-2 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices