EN ISO 15004-2:2007

Foreword
1 Scope
2 Normative references
3 Terms, definitions and symbols
  3.1 Terms and definitions
  3.2 Symbols
4 Classification
5 Requirements
  5.1 General
  5.2 Requirements for classification as a Group 1 instrument
  5.3 Requirements for Group 2 instruments
  5.4 Emission limits for determination of Group 1 classification
  5.5 Emission limits and guideline values for Group 2 instruments
6 Test methods
  6.1 General
  6.2 Measurements made to classify instruments into Group 1 or
      Group 2
  6.3 Group 2 instruments: Measurements
  6.4 Determination of area
  6.5 Group 2 instruments: Determination of time and number of
      pulses to reach maximum exposure guidelines
7 Information supplied by the manufacturer
Annex A (normative) Spectral weighting functions
Annex B (informative) Product-related International Standards
        for ophthalmic instruments to which ISO 15004-2 applies
        and which contain a specific light hazard section
Annex C (informative) Measurement instruments
Annex D (normative) Measurement methods for radiance/irradiance
Annex E (informative) Guidance on the direct measurement of
        irradiance
Annex F (informative) Classification flowchart
Bibliography

ISO 15004-2:2007 specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye and for which there is a specific light hazards requirement section within their respective International Standards. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye.ISO 15004-2:2007 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended for treatment of the eye.ISO 15004-2:2007 classifies ophthalmic instruments into either Group 1 or a Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous.