ISO 15004-1:2006
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments

Standard No.
ISO 15004-1:2006
Release Date
2006
Published By
International Organization for Standardization (ISO)
Status
Replace By
ISO 15004-1:2020
Latest
ISO 15004-1:2020
Scope
This part of ISO 15004 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. This part of ISO 15004 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. This part of ISO 15004 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

ISO 15004-1:2006 Referenced Document

  • IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • ISO 15004-2 Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection*2007-02-01 Update
  • ISO 9022-2:2002 Optics and optical instruments - Environmental test methods - Part 2: Cold, heat and humidity
  • ISO 9022-3:1998 Optics and optical instruments - Environmental test methods - Part 3: Mechanical stress

ISO 15004-1:2006 history

  • 2020 ISO 15004-1:2020 Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments
  • 2006 ISO 15004-1:2006 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments



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