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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Recognition 03/16/2012 
FR Recognition Number 10-72
ISO 15004-1 First edition 2006-06-01
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
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.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§886.4690 Photocoagulator And Accessories Class 2 HQB
§886.4670 Laser, System, Phacolysis Class 2 MXO
§886.4392 Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla Class 2 LXS
§886.4390 Laser, Ophthalmic Class 2 HQF
§886.4150 Instrument, Vitreous Aspiration And Cutting, Ac-Powered Class 2 HQE
§886.3600 Intraocular Lens Class 3 HQL
§886.3600 Lens, Multifocal Intraocular Class 3 MFK
§886.1850 Biomicroscope, Slit-Lamp, Ac-Powered Class 2 HJO
§886.1850 Device, Analysis, Anterior Segment Class 2 MXK
§886.1850 Microscope, Specular Class 2 NQE
§886.1780 Retinoscope, Ac-Powered Class 2 HKL
§886.1780 Retinoscope, Battery-Powered Class 1 HKM
§886.1570 Ophthalmoscope, Ac-Powered Class 2 HLI
§886.1570 Ophthalmoscope, Battery-Powered Class 2 HLJ
§886.1570 Ophthalmoscope, Laser, Scanning Class 2 MYC
§886.1120 Camera, Ophthalmic, Ac-Powered Class 2 HKI
§876.1500 Endoilluminator Class 2 MPA
§876.1500 Endoilluminator, Reprocessed Class 2 NKZ
§874.4350 Source, Carrier, Fiberoptic Light Class 1 EQH
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Dexiu Shi
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)