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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 10-123
ISO  15004-1 Second edition 2020-5
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.

This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section 2 (Normative references), reference to "ISO 15004-2:2007"
Section 6.3 (Optical radiation hazard), reference to "ISO 15004-2"
Section 8.1.d, reference to "ISO 15004-2:2007"
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.

This standard is recognized in part because:
Sections referencing ISO 15004-2:2007 for light hazard protection are in conflict with another FDA-recognized standard (See sections on light hazard protection of ANSI Z80.36:2016 listed below). FDA has replaced ISO 15004-2:2007 with ANSI Z80.36:2016 as the recognized standard for light hazard protection in ophthalmic instruments.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§874.4350 Source, Carrier, Fiberoptic Light Class 1 EQH
§886.1120 Camera, Ophthalmic, Ac-Powered Class 2 HKI
§886.1570 Ophthalmoscope, Ac-Powered Class 2 HLI
§886.1570 Ophthalmoscope, Battery-Powered Class 2 HLJ
§886.1570 Ophthalmoscopes, Replacement Batteries, Hand-Held Class 2 MSG
§886.1570 Ophthalmoscope, Laser, Scanning Class 2 MYC
§886.1570 Tomography, Optical Coherence Class 2 OBO
§886.1780 Retinoscope, Ac-Powered Class 2 HKL
§886.1780 Retinoscope, Battery-Powered Class 1 HKM
§886.1850 Biomicroscope, Slit-Lamp, Ac-Powered Class 2 HJO
§886.1850 Device, Analysis, Anterior Segment Class 2 MXK
Relevant FDA Guidance and/or Supportive Publications*
ANSI Z80.36-2016 Ophthalmics - Light Hazard Protection for Ophthalmic Instruments.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Shulei Zhao
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.