What is ISO 15004-1 about?
ISO 15004-1 discusses ophthalmic instruments. ISO 15004-1 outlines requirements for non-invasive, active, and non-active ophthalmic instruments and devices for enhancing low vision. ISO 15004-1 is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.
Note: ISO 15004-1 does not apply to operation microscopes, endoscopes, and devices intended for laser investigation or laser treatment of the eye.
Who is ISO 15004-1 for?
ISO 15004-1 on ophthalmic instruments is useful for:
- Manufacturers of ophthalmic instruments
- Ophthalmologists
- Test centers for ophthalmic instruments
- Regulatory authorities
Why should you use ISO 15004-1?
Ophthalmic instruments are devices designed to have an application to the eye. The ophthalmic instrument is intended by its manufacturer to be used in the diagnosis, treatment, or monitoring of a patient. Or for the compensation or alleviation of a disease, injury, or disability.
ISO 15004-1 guidelines help you with requirements, design, performance, protection against contaminants, thermal hazards, mechanical hazards, and electrical safety for ophthalmic instruments. ISO 15004-1 also provides test methods and requirements for information supplied by manufacturers of ophthalmic instruments. This ensures that general requirements are met by manufacturers of ophthalmic instruments.
What’s changed since the last update?
BS EN ISO 15004-1:2020 supersedes ISO 15004-1:2006, which has been withdrawn. BS EN ISO 15004-1:2020 has some technical changes with respect to ISO 15004-1:2006. These include:
- Normative references have been updated
- The definition of 3.4 manufacturers has been aligned with the corresponding definition in ISO 13485
- Requirements about environmental conditions have been replaced by a reference to IEC 606011:2005 + A1:2012
- Annex A has been updated
- Some editorial changes have been made