Thursday, November 13, 2014

New Ophthalmic Equipment Standards for the 3rd Quarter 2014

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  • BS 3062, Withdrawn without replacement, Specification for ophthalmic lens materials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