Home » Compliance Management Blog- ESG, EHS, EHSQ » New Ophthalmic Equipment Standards for the 3rd Quarter 2014

New Ophthalmic Equipment Standards for the 3rd Quarter 2014

Kyle Bach

Document Center Inc. is pleased to announce that the following New Standards on Ophthalmic Equipment are now available:


  • BS 3062, Withdrawn without replacement, Specification for ophthalmic lens materials
  • BS EN ISO 10343, 2014 Edition, Ophthalmic instruments. Ophthalmometers
  • BS EN ISO 11979-2, 2014 Edition, Ophthalmic implants. Intraocular lenses. Optical properties and test methods
  • BS EN ISO 11979-7, 2014 Edition, Ophthalmic implants. Intraocular lenses. Clinical investigations
  • BS EN ISO 11979-9, 2006 Edition with Amendment 1, Ophthalmic implants. Intraocular lenses. Multifocal intraocular lenses
  • BS EN ISO 11979-10, 2006 Edition with Amendment 1, Ophthalmic implants. Intraocular lenses. Phakic intraocular lenses
  • BS EN ISO 13212, 2014 Edition, Ophthalmic optics. Contact lens care products. Guidelines for determination of shelf-life
  • IEC 80601-2-58, Edition 2.0, Medical electrical equipment — Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
  • ISO 8598-1, 1st Edition, Optics and optical instruments – Focimeters – Part 1: General purpose instruments
  • ISO 10343, 3rd Edition, Ophthalmic instruments – Ophthalmometers
  • ISO 11979-2, 2nd Edition, Ophthalmic implants – Intraocular lenses – Part 2: Optical properties and test methods
  • ISO 11979-6, 3rd Edition, Ophthalmic implants – Intraocular lenses – Part 6: Shelf-life and transport stability testing
  • ISO 11979-7, 3rd Edition, Ophthalmic implants – Intraocular lenses – Part 7: Clinical investigations
  • ISO 11979-9 Amendment 1, Amendment 1 for the 1st Edition, AMENDMENT 1, Part 9: Multifocal intraocular lenses, Ophthalmic implants – Intraocular lenses
  • ISO 11979-10 Amendment 1, Amendment 1 for the 1st Edition, AMENDMENT 1, Part 10: Phakic intraocular lenses, Ophthalmic implants – Intraocular lenses
  • ISO 13212, 3rd Edition, Ophthalmic optics – Contact lens care products – Guidelines for determination of shelf-life


For other standards on this topic, please see our Document Center List of Standards on Ophthalmic Equipment.

You’ll also want to review my previous postings:


And to learn about even more new standards:


New Ophthalmic Equipment Standards for the 1st Quarter 2015