The
International Electrotechnical Commission (IEC) created the document
IEC 60601-2-41 – Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis, 2009 to establish norms and guidelines for the characteristics of a surgical and examination light to secure safety for the patient as well as lower the risk to a reasonable level when the light is used according to the user manual. Some of the standards for surgical lightheads are the following: •
Homogeneous light: The light should offer good illumination on a flat, narrow or deep surface in a cavity, despite obstacles such as
surgeons' heads or hands. •
Lux: The central illuminance should be between 160,000 and 40,000
lux. •
Light field diameter: The D50 diameter should be at least 50% of D10. •
Colour rendition: For the purpose of distinguishing true
tissue colour in a cavity, the
colour rendering index (Ra) should be between 85 and 100. •
Backup possibility: In case of interruption of the
power supply, the light should be restored within 5 seconds with at least 50% of the previous lux intensity, but not less than 40,000 lux. Within 40 seconds the light should be completely restored to the original brightness. •
Announcement: The IEC document also mentions what needs to be notified to the user. For example, the
voltage and
power consumption should be marked on or near the lampholder as well as on the lighthead. In the instructions for use the following should be announced. • Cleaning and
decontamination of the surgical light • Safety aspects of the
optical filter (purpose and warning to prevent removal) • Central illuminance • Light field diameter • Depth of illumination • Shadow dilution •
Correlated colour temperature and
colour rendering index • Total
irradiance • Cleaning and
disinfecting • Handling of the lighthead in case of failure • How the user should respect the national rules for hygiene and disinfecting == References ==