BS 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

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.

This part of ISO15004 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, i.e. all ophthalmic instruments listed in AnnexB. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye. Where differences exist between this part of ISO15004 and the light hazard requirements section of the respective vertical International Standard, then the vertical International Standard shall take precedence.

NOTE The emission limits are based on the International Commission on Non-Ionizing Radiation Protection (ICNIRP) guidelines for human exposure to optical radiation. See Bibliography [1].

This part of ISO15004 does not apply to radiation that is in excess of limits specified in ISO15004 and that is intended for treatment of the eye.

This part of ISO15004 classifies ophthalmic instruments into either Group 1 or Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous.