1、 Overview of Standard Fundamentals
1.1 Standard Version and Positioning
ISO 15004-2:2024, "Basic Requirements and Test Methods for Ophthalmic Instruments Part 2: Protection against Light Hazards," was officially released
and implemented on December 5, 2024, replacing the old version of ISO 15004-2:2007. It is a global universal basic standard for optobiological safety
of ophthalmic equipment and a mandatory compliance basis for exporting to the European Union and North American medical device markets.
1.2 Scope of Applicable Products
Covering all ophthalmic equipment that projects optical radiation onto the ocular surface and inside the eye, with a wavelength control range of 250nm
to 2500nm, including slit lamps, fundus cameras, surgical microscopes, optometrists, feeding devices, optical measurement and alignment imaging
equipment; Only applicable to treatment beams with laser therapy as the core function, but can be used to evaluate the radiation risk ISO of stray light
and lateral light from treatment equipment on non target eye tissues.
1.3 2024 Core Update Content
Add definitions for time limited and dose limited light source equipment; Supplement the correction limit for long-term repeated use of head mounted
equipment; Reconstruct the classification and judgment logic of continuous light, pulsed light, scanning light, and multi light source combination
equipment; Add a standardized classification and judgment flowchart; Refine the practical methods for spectral weighting and radiance measurement;
Improve mandatory clauses for Group 2 equipment warnings and instructions.
1.4 Supporting Collaboration Standards
Need to synchronize with ISO 15004-1 (General Safety of Ophthalmic Instruments) and IEC 60601-1 Basic Safety of Medical Electrical Equipment; The
EU market has been transformed into EN ISO 15004-2:2024, which serves as the core support for CE 04/05 medical device technical documents; Both
domestic registration and FDA 510 (k) application recognize this standard testing report.
2、 Instrument light hazard classification system
2.1 General grading criteria
Only two major groups are divided, and the ICNIRP non ionizing radiation eye exposure limit is determined based on the measured spectral irradiation
parameters, distinguishing between risk-free and potentially risky equipment. The grading results determine the compliance requirements for the design
of protection, labeling, and instruction manuals.
2.2 Definition of Non Hazardous Equipment for Group 1
Under normal clinical expected use scenarios, any duration of irradiation will not cause corneal, crystalline lens, or retinal light damage; The inherent
constraints of light source components, filter systems, and optical path structures on radiation output meet the standard basic exposure limits throughout
the entire process; No mandatory danger warning is required, simply label the group.
2.3 Definition of Potential Hazardous Equipment for Group 2
Radiation output exceeds the safety threshold of Group 1, posing risks of blue light chemical damage, infrared thermal damage, and ultraviolet corneal
damage; Must be equipped with hardware protection, duration control, warning signs for the entire machine, and detailed safety instructions for use; It
is necessary to calculate the maximum safe exposure duration tmax and the upper limit of safe pulses.
2.4 Special Scene Grading Correction Rules
Tightening of limits for dilated pupil examination and long-term fundus imaging equipment; Intermittent irradiation of surgical microscope can be
moderately converted and relaxed; Head mounted, daily repeated use equipment with long-term exposure correction factor; The multi level adjustable
light source uses the maximum brightness level as the grading criterion.
3、 Core requirements for safety limits of optical radiation
3.1 Group 1 Equipment Foundation Exposure Limits
Set weighted upper limits for ultraviolet, blue light, and near-infrared sub bands, covering four types of hazards: corneal ultraviolet burns, lens aging,
retinal blue light lesions, and fundus thermal damage; Distinguish between independent limits for continuous light sources, pulse light sources, and
scanning light sources; Conventional equipment is calculated based on a basic exposure time of 2 hours, while surgical lighting equipment limits are
halved.
3.2 Recommended maximum exposure value RME for Group 2 devices
Specify the allowed cumulative irradiation dose, maximum safe irradiation time, and maximum number of pulses that can be emitted in each mode;
Provide a reduction factor for pulse train repetition frequency conversion; The multi light source overlay scene adopts the radiation overlay algorithm
to calculate the comprehensive hazard; It is clear that exceeding the RME value will cause irreversible eye damage.
3.3 Sub organizational Hazard Control Regulations
Ultraviolet band (250-400nm): Managing acute burns and chronic aging of the cornea and lens
Visible and Blue Light Region (300-700nm): Managing Retinal Photochemical Damage (Blue Light Hazards)
Near infrared (760-2500nm): Control corneal and fundus thermal burns
3.4 Supplementary clauses on limit values for special models
The movement rate of the scanning light source beam is involved in safety calculations; Single output dose of dose locking equipment is forcibly capped;
The triggering threshold for automatic cut-off of time limited protection equipment shall not exceed 90% of RME; After the detachable filter fails, the
overall radiation of the machine must fall back to the Group 1 range.
4、 Certification of the complete set of testing and experimentation projects
4.1 Pre universal testing conditions
Prototype fully loaded, maximum brightness level of all light sources, standard working distance; Stable temperature and humidity in the laboratory
environment; Equipped with high-precision spectrometer, radiance meter, and beam profile measurement equipment; Complete record of equipment
model, light source type, optical path structure, and filter specifications.
4.2 Testing of Beam Geometric Characteristics
Measurement of effective beam diameter, calibration of beam divergence angle, and positioning of spot boundary; Verify whether the light beam is
focused on the eye examination area to avoid additional radiation exposure caused by scattered stray light overflow; The scanning device synchronously
records the scanning trajectory and movement speed parameters.
4.3 Full spectrum radiation measurement test
Continuous spectral acquisition at 250-2500nm; Using standard spectral weighting functions to convert the hazard weights of each band; Output the
spectral power distribution map of the device and archive it as a permanent technical document; Distinguish between visible light, ultraviolet, infrared
segmented measurement weighted irradiance, and radiance ISO.
4.4 Special testing for different light source modes
Continuous light source: steady-state irradiance, weighted total radiation testing, measuring the maximum safe duration of tmax
Pulse light source: single pulse energy, pulse width, repetition rate, and cumulative pulse safety upper limit testing
Scanning light source: equivalent static radiation converted from scanning period and beam dwell time
Multi light source combination: synchronously turn on all light sources, overlay and calculate the comprehensive light hazard level
4.5 Group 2 Equipment Security Protection Verification
Passive protection: When the filter is missing, displaced, or damaged, the radiation value must be retested and lowered to the Group 1 range; Active
protection: timed, dose limited automatic shutdown, sound and light alarm function reliability verification; The brightness adjustment gear scale should
indicate the relative radiation intensity ratio.
4.6 Long term repeated use simulation test
For head mounted observation and daily high-frequency optometry equipment, combined with multiple daily exposure correction factors, evaluate the
risk of chronic cumulative photodamage, adjust the RME safety threshold, and write it into the instruction manual.
5、 Manufacturer's documentation and labeling compliance requirements
5.1 Essential Information for Technical Archives
Light hazard risk analysis report (supporting ISO 14971 medical device risk management); Complete spectral test spectrum; Grading judgment of raw
detection data; Group 2 equipment tmax and maximum pulse count calculation records; Design verification records of optical path and filtering system;
Reliability verification report for safety protection devices.
5.2 Mandatory Content of Random Instruction Manual
Clear labeling of group classification; Complete warning statements and maximum safe usage duration for Group 2 devices; Restrictions on the use of
dilated pupils, children, and people with sensitive fundus; Suggestions for selecting matching protective lenses; Replacement cycle of optical filters and
calibration cycle of overall optical radiation performance; Emergency operation instructions for faulty optical path protection failure.
5.3 Specification for Permanent Identification of Equipment Body
The whole machine body is engraved with Group 1/Group 2 classification labels; Group 2 equipment pasting standard yellow triangle light hazard warning
symbol; Brightness adjustment area labeling intensity grading; The nameplate shall retain information on radiation safety related models and light source
parameters, and the identification shall not be worn or detached.
