EN ISO 15004-1:2009

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Fundamental requirements (for non-active and active
  ophthalmic instruments)
  4.1 General
  4.2 Design
  4.3 Performance
  4.4 Combination of different devices
  4.5 Materials
  4.6 Protection against contaminants
  4.7 Scales and displays
  4.8 Thermal hazards
  4.9 Mechanical hazards
5 Environmental conditions (for non-active and active
  ophthalmic instruments)
  5.1 Environmental conditions of use
  5.2 Storage conditions
  5.3 Transport conditions
6 Particular requirements for active ophthalmic instruments
  6.1 Electrical safety
  6.2 Inapplicable clauses of IEC 60601-1:2005
  6.3 Optical radiation hazard
7 Test methods
  7.1 Ignitability
  7.2 Surface temperatures
  7.3 Environmental conditions
  7.4 Checking electrical safety
8 Information supplied by the manufacturer
  8.1 Accompanying documents
  8.2 Marking
Annex A (informative) - Product-related International
        Standards for ophthalmic instruments
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 93/42/EEC

ISO 15004-1:2006 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. ISO 15004-1:2006 is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.ISO 15004-1:2006 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.