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.
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Sisällysluettelo
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 Spectral weighting functions (normative)
Annex B Product-related International Standards for ophthalmic instruments to which ISO 15004-2 applies and which contain a specific light hazard section (informative)
Annex C Measurement instruments (informative)
Annex D Measurement methods for radiance/irradiance (normative)
Annex E Guidance on the direct measurement of irradiance (informative)
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 Spectral weighting functions (normative)
Annex B Product-related International Standards for ophthalmic instruments to which ISO 15004-2 applies and which contain a specific light hazard section (informative)
Annex C Measurement instruments (informative)
Annex D Measurement methods for radiance/irradiance (normative)
Annex E Guidance on the direct measurement of irradiance (informative)