ONORM 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 on medical devices

Specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. It 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.