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Photo-biological hazards in medical devices

posted Mar 26, 2015, 2:06 PM by Frank O'Brien   [ updated Mar 27, 2015, 7:39 AM ]
light wavelengths
Photo-biological hazards need to be considered whether the medical device employs a light source for the medical purpose or a supporting function.  Examples of light sources in medical devices include:
  • surgical lasers 
  • laser therapy
  • diagnostic lamps 
  • surgical lamps 
  • OCT imaging catheters  
  • IR navigation systems
  • photo therapy devices for jaundice
  • light sources for endoscopes
  • fiber optical transmission of data
  • laser pointers for marking positions
  • optical disc data storage
  • back lighting display
  • indicator lights

IEC 60601-1, the safety standard for medical devices, requires light sources to comply with Clause 10 for radiation hazards. This clause mostly leaves photo-biological hazards to the manufacturer's ISO 14971 risk management process.  In some cases, there's particular standards, such as IEC 60601-2-22 for surgical lasers, and IEC 60601-2-57 for medical light sources to provide requirements for photo-biological hazards. 

Light type

UV (ultraviolet)

Visible

IR (infrared)

Incoherent light, not laser

Clause 10.7, risk management

Clause 10.5, risk management

Clause 10.6, risk management

Coherent light, laser

Clause 10.7, risk management

Clause 10.4, IEC 60825, lasers

Clause 10.6, risk management


When conducting ISO 14971 risk assessment of photo-biological hazards, how do we know the light output level for inherently acceptable risk?  Are there light output classifications for different severity, and risk controls based on classification?  O'Brien Compliance Management has released a new guidance document to point manufacturers towards the light standards that can support risk assessment judgments.  Request this document and many more here.